Sample records for bolus methylprednisolone therapy

  1. [Chronic inflammatory demyelinating polyradiculoneuropathy in childhood: outcomes after methylprednisolone pulse therapy].

    PubMed

    Rafai, M A; Moutaouakil, F; El Otmani, H; Fadel, H; Boulaajaj, F Z; El Moutawakil, B; Gam, I; Slassi, I

    2006-06-01

    Chronic inflammatory demyelinating polyneuropathy (CIDP) in children is relatively rare and treatment is based primarily on intravenous immunoglobulins or oral corticosteroids. Boluses of methylprednisolone (MP) are a seldom used alternative. We report the case of an 8-year-old child, first presented at the age of 3 years, with recurring episodes of functional impotence of both lower limbs and walking impairment, partially reversible without treatment. Clinical, progressive, and electrophysiological data and the analysis of the cerebrospinal fluid were compatible with CIDP. MP boluses were administered: after a total eight monthly boluses, very satisfactory progression on the clinical and electrophysiological fronts was noted after 24 months. Childhood CIDP presents clinical, electrophysiological, progressive, and prognostic particularities, they recur readily and the outcome is good. Boluses of methylprednisolone are an alternative to the treatment of these neuropathies in childhood.

  2. Bolus administration of steroid therapy is more favorable than the conventional use in preventing decrease of bone density and the increase of body fat percentage in patients with inflammatory bowel disease.

    PubMed

    Farkas, Klaudia; Bálint, Anita; Valkusz, Zsuzsanna; Szepes, Zoltán; Nagy, Ferenc; Szűcs, Mónika; Bor, Renáta; Wittmann, Tibor; Molnár, Tamás

    2014-09-01

    The effects of short course of corticosteroids on the metabolic processes and bone formation has not been well studied. Our aim was to compare the efficacy, the side effects and the bone and lipid metabolisms in IBD patients using bolus or conventional tapering of methylprednisolone for 12 weeks. Nineteen IBD patients received intravenous methylprednisolone of 1mg/kg for 5 days tapered by 4 mg per week. Patients were prospectively randomized in two groups. In "conventional" group (I) steroids were given daily. In "pulse" group (II) weekly doses of steroids were given on special days of the week. The body mass index (BMI) was measured before and after the corticosteroid therapy. Blood samples were collected to assess glucose level, electrolytes, cholesterol and triglyceride levels, inflammatory parameters, cortisol, osteocalcin and crosslaps values. Total body composition analysis was performed at the beginning and at the end of the steroid therapy. In Group I, BMI increased, total body bone density decreased significantly at the end of the steroid therapy. Body fat percent showed a tendency to be higher at the end of steroid therapy in Group I. Cholesterol level increased significantly in Group I patients. The decrease in serum cortisol level was more remarkable in Group I vs. Group II after steroid therapy. Less side-effect occurred in Group II vs. Group I. Our results suggest that bolus tapering of corticosteroids may have more favorable short term outcome than conventional tapering that may revolutionize steroid therapy in IBD. Copyright © 2014 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.

  3. Delivery confirmation of bolus electron conformal therapy combined with intensity modulated x-ray therapy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kavanaugh, James A.; Hogstrom, Kenneth R.; Fontenot, Jonas P.

    2013-02-15

    Purpose: The purpose of this study was to demonstrate that a bolus electron conformal therapy (ECT) dose plan and a mixed beam plan, composed of an intensity modulated x-ray therapy (IMXT) dose plan optimized on top of the bolus ECT plan, can be accurately delivered. Methods: Calculated dose distributions were compared with measured dose distributions for parotid and chest wall (CW) bolus ECT and mixed beam plans, each simulated in a cylindrical polystyrene phantom that allowed film dose measurements. Bolus ECT plans were created for both parotid and CW PTVs (planning target volumes) using 20 and 16 MeV beams, respectively,more » whose 90% dose surface conformed to the PTV. Mixed beam plans consisted of an IMXT dose plan optimized on top of the bolus ECT dose plan. The bolus ECT, IMXT, and mixed beam dose distributions were measured using radiographic films in five transverse and one sagittal planes for a total of 36 measurement conditions. Corrections for film dose response, effects of edge-on photon irradiation, and effects of irregular phantom optical properties on the Cerenkov component of the film signal resulted in high precision measurements. Data set consistency was verified by agreement of depth dose at the intersections of the sagittal plane with the five measured transverse planes. For these same depth doses, results for the mixed beam plan agreed with the sum of the individual depth doses for the bolus ECT and IMXT plans. The six mean measured planar dose distributions were compared with those calculated by the treatment planning system for all modalities. Dose agreement was assessed using the 4% dose difference and 0.2 cm distance to agreement. Results: For the combined high-dose region and low-dose region, pass rates for the parotid and CW plans were 98.7% and 96.2%, respectively, for the bolus ECT plans and 97.9% and 97.4%, respectively, for the mixed beam plans. For the high-dose gradient region, pass rates for the parotid and CW plans were 93

  4. Methimazole-induced liver injury overshadowed by methylprednisolone pulse therapy: Case report.

    PubMed

    Abramavicius, Silvijus; Velickiene, Dzilda; Kadusevicius, Edmundas

    2017-09-01

    Treatment choices are limited, when deciding how to manage thyrotoxicosis and moderate to severe Graves ophthalmopathy (GO) with suspected optic nerve damage in patients with elevated liver transaminase levels. The situation become even more complicated, if methimazole induced hepatotoxicity is suspected and intravenous methylprednisolone is co-administrated. A 74-year-old woman presented with spontaneous retro-bulbar pain, eyelid swelling and inconstant diplopia. Thyrotoxicosis and severe GO with suspected optic nerve damage and drug induced liver injury (DILI). Intravenous methylprednisolone pulse therapy was administered to treat GO and methimazole was continued for thyrotoxicosis. Dose of methimazole was reduced after exclusion of concurrent infection and active liver disease. The GO symptoms (eyelid swelling, sight loss, proptosis, retro-bulbar pain, diplopia) markedly decreased after the treatment course. Liver transaminases spontaneously returned to normal ranges and remained normal during the next 12 months until the Graves' disease until the treatment was completed. 1. The interaction of methimazole and methylprednisolone may result in DILI. 2. In a patient without concomitant liver diseases MP can be continued if the methimazole dose is reduced if no other treatment options are available.

  5. SU-C-213-03: Custom 3D Printed Boluses for Radiation Therapy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Zhao, B; Yang, M; Yan, Y

    2015-06-15

    Purpose: To develop a clinical workflow and to commission the process of creating custom 3d printed boluses for radiation therapy. Methods: We designed a workflow to create custom boluses using a commercial 3D printer. Contours of several patients were deformably mapped to phantoms where the test bolus contours were designed. Treatment plans were created on the phantoms following our institutional planning guideline. The DICOM file of the bolus contours were then converted to stereoLithography (stl) file for the 3d printer. The boluses were printed on a commercial 3D printer using polylactic acid (PLA) material. Custom printing parameters were optimized inmore » order to meet the requirement of bolus composition. The workflow was tested on multiple anatomical sites such as skull, nose and chest wall. The size of boluses varies from 6×9cm2 to 12×25cm2. To commission the process, basic CT and dose properties of the printing materials were measured in photon and electron beams and compared against water and soft superflab bolus. Phantoms were then scanned to confirm the placement of custom boluses. Finally dose distributions with rescanned CTs were compared with those computer-generated boluses. Results: The relative electron density(1.08±0.006) of the printed boluses resemble those of liquid tap water(1.04±0.004). The dosimetric properties resemble those of liquid tap water(1.04±0.004). The dosimetric properties were measured at dmax with an ion chamber in electron and photon open beams. Compared with solid water and soft bolus, the output difference was within 1% for the 3D printer material. The printed boluses fit well to the phantom surfaces on CT scans. The dose distribution and DVH based on the printed boluses match well with those based on TPS generated boluses. Conclusion: 3d printing provides a cost effective and convenient solution for patient-specific boluses in radiation therapy.« less

  6. Evaluation of N-acetylcysteine and methylprednisolone as therapies for oxygen and acrolein-induced lung damage

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Critchley, J.A.J.H.; Beeley, J.M.; Clark, R.J.

    1990-04-01

    Reactive oxidizing species are implicated in the etiology of a range of inhalational pulmonary injuries. Consequently, various free radical scavengers have been tested as potential prophylactic agents. The sulfydryl compound, N-acetylcysteine (NAC) is the only such compound clinically available for use in realistic dosages, and it is well established as an effective antidote for the hepatic and renal toxicity of paracetamol. Another approach in pulmonary injury prophylaxis is methylprednisolone therapy. The authors evaluated NAC and methylprednisolone in two rats models of inhalation injury: 40-hr exposure to >97% oxygen at 1.1 bar and 15-min exposure to acrolein vapor (210 ppm). Themore » increases in lung wet/dry weight ratios, seen with both oxygen and acrolein toxicity were reduced with both treatments. However, with oxygen, NAC therapy was associated with considerably increased mortality and histological changes. Furthermore, IP NAC administration resulted in large volumes of ascitic fluid. With acrolein, IV, NAC had no significant effect on mortality or pulmonary histological damage. Methylprednisolone had no beneficial effects on either the mortality or histological damage observed in either toxicity model. They caution against the ad hoc use of NAC in the management of inhalational pulmonary injury.« less

  7. 21 CFR 520.1408 - Methylprednisolone tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Systemic therapy with methylprednisolone is contraindicated in animals with arrested tuberculosis, peptic ulcer, acute psychoses, or cushingoid syndrome. The presence of active tuberculosis, diabetes...

  8. Personalized intensification of insulin therapy in type 2 diabetes - does a basal-bolus regimen suit all patients?

    PubMed

    Giugliano, D; Sieradzki, J; Stefanski, A; Gentilella, R

    2016-08-01

    Many patients with type 2 diabetes mellitus (T2DM) require insulin therapy. If basal insulin fails to achieve glycemic control, insulin intensification is one possible treatment intensification strategy. We summarized clinical data from randomized clinical trials designed to compare the efficacy and safety of basal-bolus and premixed insulin intensification regimens. We defined a between-group difference of ≥0.3% in end-of-study glycated hemoglobin (HbA1c) as clinically meaningful. A PubMed database search supplemented by author-identified papers yielded 15 trials which met selection criteria: randomized design, patients with T2DM receiving basal-bolus (bolus injection ≤3 times/day) vs. premixed (≤3 injections/day) insulin regimens, primary/major endpoint(s) HbA1c- and/or hypoglycemia-related, and trial duration ≥12 weeks. Glycemic control improved with both basal-bolus and premixed insulin regimens with - in most cases - acceptable levels of weight gain and hypoglycemia. A clinically meaningful difference between regimens in glycemic control was recorded in only four comparisons, all of which favored basal-bolus therapy. The incidence of hypoglycemia was significantly different between regimens in only three comparisons, one of which favored premixed insulin and two basal-bolus therapy. Of the four trials that reported a significant difference between regimens in bodyweight change, two favored basal-bolus therapy and two favored premixed insulin. Thus, on a population level, neither basal-bolus therapy nor premixed insulin showed a consistent advantage in terms of glycemic control, hypoglycemic risk, or bodyweight gain. It is therefore recommended that clinicians should adopt an individualized approach to insulin intensification - taking into account the benefits and risks of each treatment approach and the attitude and preferences of each patient - in the knowledge that both basal-bolus and premixed regimens may be successful.

  9. Clinical application of 3D-printed-step-bolus in post-total-mastectomy electron conformal therapy.

    PubMed

    Park, Kwangwoo; Park, Sungjin; Jeon, Mi-Jin; Choi, Jinhyun; Kim, Jun Won; Cho, Yoon Jin; Jang, Won-Seok; Keum, Yo Sup; Lee, Ik Jae

    2017-04-11

    The 3D-printed boluses were used during the radiation therapy of the chest wall in six patients with breast cancer after modified radical mastectomy (MRM). We measured the in-vivo skin doses while both conventional and 3D-printed boluses were placed on the chest wall and compared the mean doses delivered to the ipsilateral lung and the heart. The homogeneity and conformity of the dose distribution in the chest wall for both types of boluses were also evaluated. The uniformity index on the chest skin was improved when the 3D-printed boluses were used, with the overall average skin dose being closer to the prescribed one in the former case (-0.47% versus -4.43%). On comparing the dose-volume histogram (DVH), it was found that the 3D-printed boluses resulted in a reduction in the mean dose to the ipsilateral lung by up to 20%. The precision of dose delivery was improved by 3% with the 3D-printed boluses; in contrast, the conventional step bolus resulted in a precision level of 5%. In conclusion, the use of the 3D-printed boluses resulted in better dose homogeneity and conformity to the chest wall as well as the sparing of the normal organs, especially the lung. This suggested that their routine use on the chest wall as a therapeutic approach during post-mastectomy radiation therapy offers numerous advantages over conventional step boluses.

  10. Clinical application of 3D-printed-step-bolus in post-total-mastectomy electron conformal therapy

    PubMed Central

    Park, Kwangwoo; Park, Sungjin; Jeon, Mi-Jin; Choi, Jinhyun; Kim, Jun Won; Cho, Yoon Jin; Jang, Won-Seok; Keum, Yo Sup; Lee, Ik Jae

    2017-01-01

    The 3D-printed boluses were used during the radiation therapy of the chest wall in six patients with breast cancer after modified radical mastectomy (MRM). We measured the in-vivo skin doses while both conventional and 3D-printed boluses were placed on the chest wall and compared the mean doses delivered to the ipsilateral lung and the heart. The homogeneity and conformity of the dose distribution in the chest wall for both types of boluses were also evaluated. The uniformity index on the chest skin was improved when the 3D-printed boluses were used, with the overall average skin dose being closer to the prescribed one in the former case (-0.47% versus -4.43%). On comparing the dose-volume histogram (DVH), it was found that the 3D-printed boluses resulted in a reduction in the mean dose to the ipsilateral lung by up to 20%. The precision of dose delivery was improved by 3% with the 3D-printed boluses; in contrast, the conventional step bolus resulted in a precision level of 5%. In conclusion, the use of the 3D-printed boluses resulted in better dose homogeneity and conformity to the chest wall as well as the sparing of the normal organs, especially the lung. This suggested that their routine use on the chest wall as a therapeutic approach during post-mastectomy radiation therapy offers numerous advantages over conventional step boluses. PMID:27784001

  11. The Effects of Mitiglinide and Repaglinide on Postprandial Hyperglycemia in Patients Undergoing Methylprednisolone Pulse Therapy.

    PubMed

    Tanaka, Kenichi; Okada, Yosuke; Mori, Hiroko; Torimoto, Keiichi; Arao, Tadashi; Tanaka, Yoshiya

    2018-01-01

    One adverse effect of methylprednisolone (MP) pulse therapy is an acute dose-dependent increase in the blood glucose level. Five patients with thyroid ophthalmopathy but normal glucose tolerance received MP pulse therapy (3 cycles, 3 days/week) and were assessed by continuous glucose monitoring. Steroid therapy increased the mean sensor glucose level, and all patients developed steroid-induced diabetes. The patients were treated alternately with mitiglinide (30 mg/day) and repaglinide (1.5 mg/day) during the second or third MP pulse therapy. The sensor glucose levels before lunch and dinner were more favorable during treatment with repaglinide than during treatment with mitiglinide. Repaglinide may be more clinically appropriate than mitiglinide.

  12. Optimizing inpatient glycemic control with basal-bolus insulin therapy.

    PubMed

    Pollom, R Daniel

    2010-11-01

    Hyperglycemia is highly prevalent in the acute-care setting and is associated with an increased risk of morbidity and mortality. Evidence suggests that glycemic control in this population is suboptimal, due in part to continued use of nonphysiologic sliding-scale insulin strategies without scheduled basal insulin doses or prandial insulin with concomitant correction doses. Although the ineffectiveness and risks of sliding-scale insulin regimens have been criticized for decades, sliding-scale insulin is still the most commonly prescribed subcutaneous insulin regimen among inpatients. Improving inpatient management requires the use of scheduled basal-bolus insulin therapy that includes basal insulin, nutritional insulin, and supplemental, or correctional, insulin. Insulin analogs are the preferred insulins, as they provide a more physiologic action than human insulin regimens, are associated with a lower risk of hypoglycemia, and are more convenient to administer than human insulins. Standardized insulin protocols and subcutaneous insulin order sets are critical components of effective inpatient glycemic control. Although preliminary data have demonstrated that inpatient diabetes management programs involving basal-bolus insulin therapy are effective and well tolerated, more research is needed.

  13. Coordinated Basal–Bolus Infusion for Tighter Postprandial Glucose Control in Insulin Pump Therapy

    PubMed Central

    Bondia, Jorge; Dassau, Eyal; Zisser, Howard; Calm, Remei; Vehí, Josep; Jovanovič, Lois; Doyle, Francis J.

    2009-01-01

    Background Basal and bolus insulin determination in intensive insulin therapy for type 1 diabetes mellitus (T1DM) are currently considered independently of each other. A new strategy that coordinates basal and bolus insulin infusion to cope with postprandial glycemia in pump therapy is proposed. Superior performance of this new strategy is demonstrated through a formal analysis of attainable performances in an in silico study. Methods The set inversion via interval analysis algorithm has been applied to obtain the feasible set of basal and bolus doses that, for a given meal, mathematically guarantee a postprandial response fulfilling the International Diabetes Federation (IDF) guidelines (i.e., no hypoglycemia and 2 h postprandial glucose below 140 mg/dl). Hypoglycemia has been defined as a glucose value below 70 mg/dl. A 5 h time horizon has been considered for a 70 kg in silico T1DM subject consuming meals in the range of 30 to 80 g of carbohydrates. Results The computed feasible sets demonstrate that current separated basal/bolus strategy dramatically limits the attainable performance. For a nominal basal of 0.8 IU/h leading to a basal glucose of approximately 100 mg/dl, IDF guidelines cannot be fulfilled for meals greater than 50 g of carbohydrates, independent of the bolus insulin computed. However, coordinating the basal and bolus insulin delivery can achieve this. A decrement of basal insulin during the postprandial period is required together with an increase in bolus insulin, in appropriate percentages, which is meal dependent. After 3 h, basal insulin can be restored to its nominal value. Conclusions The new strategy meets IDF guidelines in a typical day, contrary to the standard basal/bolus strategy, yielding a mean 2 h postprandial glucose reduction of 36.4 mg/dl without late hypoglycemia. The application of interval analysis for the computation of feasible sets is demonstrated to be a powerful tool for the analysis of attainable performance in glucose

  14. [Usefulness of Bolus Administration Using the FLEX Mode(Bolus Infusion Mode)for Baclofen Tolerance].

    PubMed

    Tanaka, Kazunori

    2017-02-01

    Intrathecal baclofen(ITB)is used to treat intractable spasticity of various etiologies and can provide better control of spasticity through the adjustment of the dose administered through the pump. However, in patients who develop tolerance to baclofen with the standard simple continuous mode, a sharp increase in dose becomes necessary, and spasticity can become harder to control. We investigated whether switching from the simple continuous mode to the bolus infusion mode was effective in controlling spasticity in patients with baclofen tolerance. We reported four patients undergoing ITB therapy at our facility who were considered to have developed baclofen tolerance. We observed the number of bolus infusions and total dose suitable for maintaining spasticity control after switching from the simple continuous mode to the bolus infusion mode. After switching to the bolus infusion mode, the total dose could be reduced in the short term; however, in the long term, the frequency of bolus infusions had to be increased to maintain spasticity control. Two years after changing to bolus infusion six times a day, the total dose was higher than that in the simple continuous mode for two of the four patients, and was the same level in the other two patients. Our four cases suggest that bolus infusion is effective in patients with baclofen tolerance during ITB therapy. Therefore, the conditions of bolus infusion should be further investigated.

  15. Institution of basal-bolus therapy at diagnosis for children with type 1 diabetes mellitus.

    PubMed

    Adhikari, Soumya; Adams-Huet, Beverley; Wang, Yu-Chi A; Marks, James F; White, Perrin C

    2009-04-01

    We studied whether the institution of basal-bolus therapy immediately after diagnosis improved glycemic control in the first year after diagnosis for children with newly diagnosed type 1 diabetes mellitus. We reviewed the charts of 459 children > or =6 years of age who were diagnosed as having type 1 diabetes between July 1, 2002, and June 30, 2006 (212 treated with basal-bolus therapy and 247 treated with a more-conventional neutral protamine Hagedorn regimen). We abstracted data obtained at diagnosis and at quarterly clinic visits and compared groups by using repeated-measures, mixed-linear model analysis. We also reviewed the records of 198 children with preexisting type 1 diabetes mellitus of >1-year duration who changed from the neutral protamine Hagedorn regimen to a basal-bolus regimen during the review period. Glargine-treated subjects with newly diagnosed diabetes had lower hemoglobin A1c levels at 3, 6, 9, and 12 months after diagnosis than did neutral protamine Hagedorn-treated subjects (average hemoglobin A1c levels of 7.05% with glargine and 7.63% with neutral protamine Hagedorn, estimated across months 3, 6, 9, and 12, according to repeated-measures models adjusted for age at diagnosis and baseline hemoglobin A1c levels; treatment difference: 0.58%). Children with long-standing diabetes had no clinically important changes in their hemoglobin A1c levels in the first year after changing regimens. The institution of basal-bolus therapy with insulin glargine at the time of diagnosis of type 1 diabetes was associated with improved glycemic control, in comparison with more-conventional neutral protamine Hagedorn regimens, during the first year after diagnosis.

  16. Bolus fluid therapy and sodium homeostasis in paediatric gastroenteritis.

    PubMed

    Freedman, Stephen B; Geary, Denis F

    2013-03-01

    The study aims to assess the risk of developing hyponatraemia when large-volume bolus fluid rehydration therapy is administered. We conducted a prospective randomised study in a tertiary-care centre emergency department. Participants included children with gastroenteritis and dehydration requiring intravenous rehydration. They were randomised to receive 60 mL/kg (large) or 20 mL/kg (standard) 0.9% saline bolus followed by maintenance 0.9% saline for 3 h. Biochemical tests were performed at baseline and 4 h. The primary outcome measure was the development of hyponatraemia at 4 h. Secondary outcome measures were (i) change in sodium relative to baseline value; (ii) magnitude of decrease among those who experienced a decrease; (iii) risk of hypernatraemia; (iv) correlations between urine parameters and hyponatraemia; and (v) fluid overload. Eighty-four of 224 (38%) participants were hyponatraemic at baseline. At 4 h, 22% (48/217) had a dysnatraemia, and similar numbers of children were hyponatraemic in both groups: large (23% (26/112)) versus standard (21% (22/105)) (P = 0.69). Among initially hyponatraemic children, 63% (30/48) who received large-volume rehydration and 44% (15/34) of those administered standard rehydration were isonatraemic at 4 h (P = 0.10). Overall, children who received 60 mL/kg experienced a larger mean increase (1.6 ± 2.4 mEq/L vs. 0.9 ± 2.2 mEq/L; P = 0.04) and were less likely to experience a sodium decrease of ≥2 mEq/L (8/112 vs. 17/105; P = 0.04) than those administered 20 mL/kg. Large-volume bolus rehydration therapy with 0.9% saline is safe. It does not promote the development of hyponatraemia over the short term, but hastens the resolution of baseline hyponatraemia. © 2013 The Authors. Journal of Paediatrics and Child Health © 2013 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

  17. Self-assembled nanoformulation of methylprednisolone succinate with carboxylated block copolymer for local glucocorticoid therapy.

    PubMed

    Kamalov, Marat I; Đặng, Trinh; Petrova, Natalia V; Laikov, Alexander V; Luong, Duong; Akhmadishina, Rezeda A; Lukashkin, Andrei N; Abdullin, Timur I

    2018-04-01

    A new self-assembled formulation of methylprednisolone succinate (MPS) based on a carboxylated trifunctional block copolymer of ethylene oxide and propylene oxide (TBC-COOH) was developed. TBC-COOH and MPS associated spontaneously at increased concentrations in aqueous solutions to form almost monodisperse mixed micelles (TBC-COOH/MPS) with a hydrodynamic diameter of 19.6 nm, zeta potential of -27.8 mV and optimal weight ratio ∼1:6.3. Conditions for the effective formation of TBC-COOH/MPS were elucidated by comparing copolymers and glucocorticoids with different structure. The micellar structure of TBC-COOH/MPS persisted upon dilution, temperature fluctuations and interaction with blood serum components. TBC-COOH increased antiradical activity of MPS and promoted its intrinsic cytotoxicity in vitro attributed to enhanced cellular availability of the mixed micelles. Intracellular transportation and hydrolysis of MPS were analyzed using optimized liquid chromatography tandem mass spectrometry with multiple reaction monitoring which showed increased level of both MPS and methylprednisolone in neuronal cells treated with the formulated glucocorticoid. Our results identify TBC-COOH/MPS as an advanced in situ prepared nanoformulation and encourage its further investigation for a potential local glucocorticoid therapy. Copyright © 2018 Elsevier B.V. All rights reserved.

  18. 21 CFR 556.400 - Methylprednisolone.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Methylprednisolone. 556.400 Section 556.400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... negligible residues of methylprednisolone in milk at 10 parts per billion. ...

  19. 21 CFR 520.1409 - Methylprednisolone, aspirin tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Methylprednisolone, aspirin tablets. 520.1409... Methylprednisolone, aspirin tablets. (a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin. (b) Sponsor. See No. 000009 in § 510.600(c) of this chapter. (c) NAS/NRC...

  20. 21 CFR 520.1409 - Methylprednisolone, aspirin tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Methylprednisolone, aspirin tablets. 520.1409... Methylprednisolone, aspirin tablets. (a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin. (b) Sponsor. See No. 000009 in § 510.600(c) of this chapter. (c) NAS/NRC...

  1. 21 CFR 520.1409 - Methylprednisolone, aspirin tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Methylprednisolone, aspirin tablets. 520.1409... Methylprednisolone, aspirin tablets. (a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin. (b) Sponsor. See No. 000009 in § 510.600(c) of this chapter. (c) NAS/NRC...

  2. 21 CFR 520.1409 - Methylprednisolone, aspirin tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Methylprednisolone, aspirin tablets. 520.1409... Methylprednisolone, aspirin tablets. (a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin. (b) Sponsor. See No. 000009 in § 510.600(c) of this chapter. (c) NAS/NRC...

  3. 21 CFR 520.1409 - Methylprednisolone, aspirin tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Methylprednisolone, aspirin tablets. 520.1409... Methylprednisolone, aspirin tablets. (a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin. (b) Sponsor. See No. 000009 in § 510.600(c) of this chapter. (c) NAS/NRC...

  4. One year results of preoperative single bolus ATG-Fresenius induction therapy in sensitized renal transplant recipients.

    PubMed

    Wang, D; Chen, J H; Wu, W Z; Yang, S L; Wu, G J; Wang, H; Tan, J M

    2007-01-01

    Sensitization in kidney transplantation is associated with more acute rejections, inferior graft survival, and an increase in delayed graft function. This study was designed to evaluate the efficacy and safety of preoperative single bolus antithymocyte globulin (ATG) induction therapy in sensitized renal transplant recipients. Fifty-six cadaveric donor kidney transplant recipients were divided into two groups: Group I (nonsensitized group, n = 30) and group II (sensitized group, PRA>10%, n = 26). ATG was given as a single preoperative bolus induction therapy to group II (ATG IV; 9 mg/kg). The group I patients were treated with mycophenolate mofetil preoperatively as induction therapy. The basic immunosuppressive regimen included tacrolimus (FK-506) or cyclosporine, mycophenolate mofetil, and prednisolone. After hospital discharge, patients were followed on a routine outpatient basis for 12 months. Acute rejection episodes (ARE) occurred in 20% (6/30) of group I and 15.38% (4/26) of group II patients (P = NS). Infections occurred in eight patients (26.7%) as 11 episodes (36.7%), averaging 1.4 episodes per infected patient in group 1, and 6 patients (23.1%) for a total of 10 episodes (38.5%), averaging 1.7 episodes per infected patient, in group II (P = NS). Occurrence of side effects and hospital stay were almost comparable in the two groups. No delayed graft function was observed in either group. The 12-month actuarial patient and graft survival were 100% in Group I and II. A preoperative single bolus ATG induction therapy was an effective and safe therapeutic measure, yielding an acceptable acute rejection rate in presensitized renal transplant recipients.

  5. Reversal of progressive necrotizing vasculitis with intravenous pulse cyclophosphamide and methylprednisolone.

    PubMed

    Fort, J G; Abruzzo, J L

    1988-09-01

    We describe a patient with polyarteritis nodosa who, despite therapy with daily doses of oral prednisone and cyclophosphamide, developed acute renal failure. Renal histopathologic examination demonstrated crescentic glomerulonephritis. Treatment with intravenous pulse cyclophosphamide and methylprednisolone resulted in clinical improvement and significant recovery of renal function.

  6. Evaluation of various boluses in dose distribution for electron therapy of the chest wall with an inward defect

    PubMed Central

    Mahdavi, Hoda; Jabbari, Keyvan; Roayaei, Mahnaz

    2016-01-01

    Delivering radiotherapy to the postmastectomy chest wall can be achieved using matched electron fields. Surgical defects of the chest wall change the dose distribution of electrons. In this study, the improvement of dose homogeneity using simple, nonconformal techniques of thermoplastic bolus application on a defect is evaluated. The proposed phantom design improves the capability of film dosimetry for obtaining dose profiles of a patient's anatomical condition. A modeled electron field of a patient with a postmastectomy inward surgical defect was planned. High energy electrons were delivered to the phantom in various settings, including no bolus, a bolus that filled the inward defect (PB0), a uniform thickness bolus of 5 mm (PB1), and two 5 mm boluses (PB2). A reduction of mean doses at the base of the defect was observed by any bolus application. PB0 increased the dose at central parts of the defect, reduced hot areas at the base of steep edges, and reduced dose to the lung and heart. Thermoplastic boluses that compensate a defect (PB0) increased the homogeneity of dose in a fixed depth from the surface; adversely, PB2 increased the dose heterogeneity. This study shows that it is practical to investigate dose homogeneity profiles inside a target volume for various techniques of electron therapy. PMID:27051169

  7. Decrease in oral bioavailability of ciclosporin by intravenous pulse of methylprednisolone succinate in rats.

    PubMed

    Konishi, Hiroki; Sumi, Masaki; Shibata, Nobuhito; Takada, Kanji; Minouchi, Tokuzo; Yamaji, Akira

    2004-10-01

    We examined the effects of high-dose methylprednisolone on the bioavailability of orally administered ciclosporin in rats. To emulate the clinical protocol of methylprednisolone pulse therapy, methylprednisolone sodium succinate (MPS), a prodrug of methylprednisolone, was intravenously administered as repeated doses (66.3 mg kg(-1)) for 3 days. The area under the blood ciclosporin concentration versus time curve after oral administration was significantly reduced by 60% by pulse treatment with MPS. Based on our previous finding that the total body clearance of ciclosporin was reduced by about 20% by the same methylprednisolone pulse protocol, the extent of reduction in the oral bioavailability of ciclosporin was estimated to be approximately 50%, indicating a drug interaction between high-dose methylprednisolone and orally administered ciclosporin, which affected the absorption process. In rats treated with MPS, an in-situ efflux experiment using rhodamine-123 demonstrated that the reverse transport function of P-glycoprotein (P-gp) in the small intestine was significantly enhanced, although there was no significant increase in the intestinal microsomal activity of triazolam alpha- and 4-hydroxylation, metabolic probes for CYP3A. In addition, a significant decrease was observed in the amount of secreted bile acids serving as an enhancer of gastrointestinal absorption of ciclosporin in MPS treatment. To directly estimate the absorptive capacity, an in-situ absorption test was conducted using a closed-loop of small intestine in control and MPS-treated rats. Intestinal absorption of ciclosporin was significantly decreased, not only in the absence of bile flow but also by treatment with MPS, which well reflected the change in the in-vivo pharmacokinetic behaviour of ciclosporin after methylprednisolone pulsing. These results demonstrate that bioavailability of ciclosporin is markedly reduced by MPS pulse treatment, and the mechanism of this interaction was confirmed to

  8. Bolus Guide: A Novel Insulin Bolus Dosing Decision Support Tool Based on Selection of Carbohydrate Ranges

    PubMed Central

    Shapira, Gali; Yodfat, Ofer; HaCohen, Arava; Feigin, Paul; Rubin, Richard

    2010-01-01

    Background Optimal continuous subcutaneous insulin infusion (CSII) therapy emphasizes the relationship between insulin dose and carbohydrate consumption. One widely used tool (bolus calculator) requires the user to enter discrete carbohydrate values; however, many patients might not estimate carbohydrates accurately. This study assessed carbohydrate estimation accuracy in type 1 diabetes CSII users and compared simulated blood glucose (BG) outcomes using the bolus calculator and the “bolus guide,” an alternative system based on ranges of carbohydrate load. Methods Patients (n = 60) estimated the carbohydrate load of a representative sample of meals of known carbohydrate value. The estimated error distribution [coefficient of variation (CV)] was the basis for a computer simulation (n = 1.6 million observations) of insulin recommendations for the bolus guide and bolus calculator, translated into outcome blood glucose (OBG) ranges (≤60, 61–200, >201 mg/dl). Patients (n = 30) completed questionnaires assessing satisfaction with the bolus guide. Results The CV of typical meals ranged from 27.9% to 44.5%. The percentage of simulated OBG for the calculator and the bolus guide in the <60 mg/dl range were 20.8% and 17.2%, respectively, and 13.8% and 15.8%, respectively, in the >200 mg/dl range. The mean and median scores of all bolus guide satisfaction items and ease of learning and use were 4.17 and 4.2, respectively (of 5.0). Conclusion The bolus guide recommendation based on carbohydrate range selection is substantially similar to the calculator based on carbohydrate point estimation and appears to be highly accepted by type 1 diabetes insulin pump users. PMID:20663453

  9. Gender-based effects on methylprednisolone pharmacokinetics and pharmacodynamics

    PubMed Central

    Lew, Kim H.; Ludwig, Elizabeth A.; Milad, Mark A.; Donovan, Kathleen; Middleton, Elliott; Ferry, James J.; Jusko, William J.

    2014-01-01

    The pharmacokinetics and selected pharmacodynamic responses to methylprednisolone were investigated in six men and six premenopausal women after a dose of 0.6 mg/kg ideal body weight. Women (luteal phase) exhibited a greater methylprednisolone clearance (0.45 versus 0.29 L/hr/kg) and shorter elimination half-life (1.7 versus 2.6 hours) than men. The volume of distribution of methylprednisolone was similar when normalized for ideal body weight. Pharmacodynamic models were used to examine the methylprednisolone suppressive effects on cortisol secretion and basophil and helper T lymphocyte trafficking. A significantly smaller 50% inhibitory concentration (IC50) value (0.1 versus 1.7 ng/ml) was seen in the women for suppression of cortisol secretion, indicating increased sensitivity. However, the area under the concentration-time curve of effect was similar for both groups. The IC50 values for effects of methylprednisolone on basophil trafficking related to estradiol concentrations in a log-linear fashion in women, with increased sensitivity found at higher estradiol concentrations. Men displayed a greater 24-hour net suppression in blood basophil numbers, but no difference was observed in net cortisol and helper T lymphocyte suppression between the sexes. These findings suggest that methylprednisolone dosages should be based on ideal body weight. Although women are more sensitive to methylprednisolone as measured by cortisol suppression, they eliminate the drug more quickly, generally producing a similar net response. PMID:8222483

  10. TU-H-CAMPUS-TeP1-05: Fast Processed 3D Printing-Aided Urethane Resin (PUR) Bolus in Radiation Therapy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Zhao, B; Chiu, T; Gu, X

    Purpose: 3D printed custom bolus is regularly used in radiation therapy clinic as a compensator. However, usual method of bolus printing with 100% filling is very time-consuming. The purpose of this study is to evaluate the feasibility and benefit of 3D printed bolus filled with UR. Methods: Two boluses were designed on nose (9e electrons) and ear (6× photons) for a head phantom in treatment planning system (TPS) to achieve dose coverage to the skin. The bolus structures (56–167cc) were converted to STereoLithographic (STL) model using an in-house developed algorithm and sent to a commercial fused deposition modeling (FDM) printer.more » Only shells were printed with polylactic acid (PLA) material. Liquid UR was then placed in a vacuum pump and slowly poured into the hollow bolus from its top opening. Liquid UR hardened in around half an hour. The phantom was rescanned with custom boluses attached and the dosimetry was compared with original design in TPS. Basic CT and dose properties were investigated. GaF films were irradiated to measure dose profile and output of several open photon and electron beams under solid water and UR slabs of same thicknesses. Results: CT number was 11.2±7.3 and 65.4±7.8, respectively for solid water(∼1.04g/cc) and UR(∼1.08g/cc). The output measurement at dmax for 6× was within 2% for the two materials. The relative dose profiles of the two materials above dmax show 94–99% Gamma analysis passing rates for both photons and electrons. Dose distributions with 3D PUR boluses maintained great coverage on the intended skin regions and resembled that with computer generated boluses. Manufacturing 3D PUR boluses was 3–4 times faster than 100% printed boluses. The efficiency significantly improves for larger boluses. Conclusion: The study suggests UR has similar dose responses as solid water. Making custom bolus with UR greatly increases clinical workflow efficiency.« less

  11. Comparison of an Electronic Glycemic Management System Versus Provider-Managed Subcutaneous Basal Bolus Insulin Therapy in the Hospital Setting.

    PubMed

    Aloi, Joseph; Bode, Bruce W; Ullal, Jagdeesh; Chidester, Paul; McFarland, Raymie S; Bedingfield, Amy E; Mabrey, Melanie; Booth, Robby; Mumpower, April; Wallia, Amisha

    2017-01-01

    American Diabetes Association (ADA) guidelines recommend a basal bolus correction insulin regimen as the preferred method of treatment for non-critically ill hospitalized patients. However, achieving ADA glucose targets safely, without hypoglycemia, is challenging. In this study we evaluated the safety and efficacy of basal bolus subcutaneous (SubQ) insulin therapy managed by providers compared to a nurse-directed Electronic Glycemic Management System (eGMS). This retrospective crossover study evaluated 993 non-ICU patients treated with subcutaneous basal bolus insulin therapy managed by a provider compared to an eGMS. Analysis compared therapy outcomes before Glucommander (BGM), during Glucommander (DGM), and after Glucommander (AGM) for all patients. The blood glucose (BG) target was set at 140-180 mg/dL for all groups. The safety of each was evaluated by the following: (1) BG averages, (2) hypoglycemic events <40 and <70 mg/dL, and (3) percentage of BG in target. Percentage of BG in target was BGM 47%, DGM 62%, and AGM 36%. Patients' BGM BG average was 195 mg/dL, DGM BG average was 169 mg/dL, and AGM BG average was 174 mg/dL. Percentage of hypoglycemic events <70 mg/dL was 2.6% BGM, 1.9% DGM, and 2.8% AGM treatment. Patients using eGMS in the DGM group achieved improved glycemic control with lower incidence of hypoglycemia (<40 mg/dL and <70 mg/dl) compared to both BGM and AGM management with standard treatment. These results suggest that an eGMS can safely maintain glucose control with less hypoglycemia than basal bolus treatment managed by a provider.

  12. High-dose methylprednisolone pulse therapy for treatment of refractory intestinal involvement caused by Henoch-Schönlein purpura: a case report.

    PubMed

    Kang, Hyun Sik; Chung, Hee Sup; Kang, Ki-Soo; Han, Kyoung Hee

    2015-03-24

    Henoch-Schönlein purpura is an immunoglobulin A-mediated, small vascular inflammatory disease that can be associated with palpable purpura, arthralgia, abdominal pain, or nephritis. The presence of purpura facilitates the diagnosis of Henoch-Schönlein purpura at the onset of associated symptoms, whereas the absence of purpura makes the diagnosis challenging. It is important to diagnose Henoch-Schönlein purpura with delayed-onset skin purpura to avoid unnecessary surgery for acute abdomen. Most cases of Henoch-Schönlein purpura with severe abdominal pain are treated with low-dose steroids and intravenous immunoglobulin. A 15-year-old Korean girl complained of severe abdominal pain and delayed-onset purpura on admission. Henoch-Schönlein purpura was diagnosed based on endoscopic findings of hemorrhagic duodenitis and duodenal vasculitis and abdominal computed tomography findings of edematous bowels. Two common initial treatments, a low-dose steroid and intravenous immunoglobulin, were administered, but there was no improvement for 1 month. Subsequently, we used high-dose intravenous methylprednisolone pulse therapy (30 mg/kg/day, with a maximum of 1g/day), which dramatically alleviated her abdominal symptoms. High-dose intravenous methylprednisolone pulse therapy can be used as the ultimate treatment for delayed-onset Henoch-Schönlein purpura with severe abdominal pain when symptoms do not improve after low-dose steroid and intravenous immunoglobulin treatments.

  13. Cerebral Effect of Intratracheal Aerosolized Surfactant Versus Bolus Therapy in Preterm Lambs.

    PubMed

    Rey-Santano, Carmen; Mielgo, Victoria E; López-de-Heredia-y-Goya, Jon; Murgia, Xabier; Valls-i-Soler, Adolfo

    2016-04-01

    Aerosolization has been proposed as a useful alternative to rapid intratracheal instillation for the delivery of exogenous surfactant in neonatal respiratory distress syndrome. However, there is a lack of information regarding the likely safety of this new therapeutic approach for the neonatal brain. We aimed to compare the cerebral effects of aerosolized versus bolus surfactant administration in premature lambs with respiratory distress syndrome. Prospective randomized study. BioCruces Institute Animal Research Facility. Fourteen intensively monitored and mechanically ventilated preterm lambs. Preterm lambs were randomly assigned to receive intratracheal aerosolized surfactant or bolus surfactant. Brain hemodynamics (cerebral and regional cerebral blood flow) and cerebral oxygen metabolism (cerebral oxygen delivery, cerebral metabolic rate of oxygen, and oxygen extraction fraction) were measured every 30 minutes for 6 hours. We also performed cerebral biochemical and histological analysis. In preterm lambs with respiratory distress syndrome, cerebral blood flow, regional cerebral blood flow, cerebral oxygen delivery, and cerebral metabolic rate of oxygen increased significantly in the bolus surfactant group during the first 5 minutes, without changes in cerebral oxygen extraction fraction. By 60 minutes, all parameters had decreased in both groups, cerebral blood flow and regional cerebral blood flow (in inner and cerebellum brainstem regions) remaining higher in the bolus surfactant than in the aerosolized surfactant group. Overall, the impact of aerosol surfactant was not significantly different to that of bolus surfactant in terms of cerebral necrosis, edema, inflammation, hemorrhage, infarct, apoptosis, or oxidative stress. In preterm lambs with severe respiratory distress syndrome, aerosol surfactant administration seems to be as safe as bolus administration, showing more stable cerebral hemodynamics and cerebral oxygen metabolism to the same dose of

  14. WE-F-16A-05: Use of 3D-Printers to Create a Tissue Equivalent 3D-Bolus for External Beam Therapy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Burleson, S; Baker, J; Hsia, A

    2014-06-15

    Purpose: The purpose of this project is to demonstrate that a non-expensive 3D-printer can be used to manufacture a 3D-bolus for external beam therapy. The printed bolus then can be modeled in our treatment planning system to ensure accurate dose delivery to the patient. Methods: We developed a simple method to manufacture a patient-specific custom 3Dbolus. The bolus is designed using Eclipse Treatment Planning System, contoured onto the patients CT images. The bolus file is exported from Eclipse to 3D-printer software, and then printed using a 3D printer. Various tests were completed to determine the properties of the printing material.more » Percent depth dose curves in this material were measured with electron and photon beams for comparison to other materials. In order to test the validity of the 3D printed bolus for treatment planning, a custom bolus was printed and tested on the Rando phantom using film for a dose plane comparison. We compared the dose plane measured on the film to the same dose plane exported from our treatment planning system using Film QA software. The gamma-dose distribution tool was used in our film analysis. Results: We compared point measurements throughout the dose plane and were able to achieve greater than 95% passing rate at 3% dose difference and 3 mm distance to agreement, which is our departments acceptable gamma pixel parameters. Conclusion: The printed 3D bolus has proven to be accurately modeled in our treatment planning system, it is more conformal to the patient surface and more durable than other bolus currently used (wax, superflab etc.). It is also more convenient and less costly than comparable bolus from milling machine companies.« less

  15. [Clotrimazole and ciclopirox olamine respectively in combination with methylprednisolone aceponate as extemporaneous formulations].

    PubMed

    Wohlrab, J; Neubert, R H H; Sommer, E; Michael, J

    2017-04-01

    The combination of topical fungicide and glucocorticoids has been proven as a successful therapy of cutaneous mycoses with accompanying inflammatory reactions, particularly when used at an early stage. Various national and international therapeutic guidelines recommend this practice. In this context, two individually manufactured formulations have been developed and tested for stability: the combination of methylprednisolone aceponate-a topical glucocorticoid with the therapeutic index of 2.0-with clotrimazole and with ciclopirox olamine, respectively. This has been conducted in compliance with the requirements for quality controlled extemporaneous formulations and the legal framework of the German Pharmacy Working Regulations (Apothekenbetriebsordnung). There are now two formulations for clinical use that are microbiologically, physically, and chemically stable, which combine methylprednisolone aceponate-a glucocorticoid with a good risk-benefit ratio-with the broad-spectrum fungicides clotrimazole and, for the first time, ciclopirox olamine.

  16. Prolonged methylprednisolone therapy after the pulse treatment for patients with moderate-to-severe paraquat poisoning: A retrospective analysis.

    PubMed

    Gao, Jie; Feng, ShunYi; Wang, Jian; Yang, SiYuan; Li, Yong

    2017-06-01

    This retrospective study aims to evaluate the effect of prolonged methylprednisolone (MP) therapy on the mortality of patients with moderate-to-severe paraquat (PQ) poisoning after the pulse treatment.We performed a retrospective analysis of patients with acute moderate-to-severe PQ poisoning that were admitted to the emergency department from May 2012 to August 2016. Out of 138 patients, 60 were treated with pulse treatment (15 mg kg day MP for 3 days) and 78 were treated with prolonged MP therapy after pulse treatment (15 mg kg day MP for 3 days; afterward, the dosage was reduced in half every 2 days, and the MP therapy was terminated until 0.47 mg kg day). Kaplan-Meier method was used to compare the mortality between the 2 groups. Cox proportional hazard models were used to estimate the hazard ratios (HR) and 95% confidence intervals (CI).The mortality of the prolonged MP therapy after pulse treatment group was lower than that of the pulse group (47.4% vs 63.3%; log-rank tests, P  =  .003). According to the multivariate Cox analysis, the prolonged MP therapy after pulse treatment was significantly associated with a lower mortality risk (HR: 0.31, 95% CI: 0.19-0.52, P < .001) compared with the pulse group. In addition, the prolonged MP therapy after pulse treatment caused more incidences of leucopenia than the pulse treatment alone (25.6% vs 11.7%, P  =  .04).The prolonged MP therapy after pulse treatment can reduce the mortality of moderate-to-severe PQ poisoning patients.

  17. Brain protection by methylprednisolone in rats with spinal cord injury.

    PubMed

    Chang, Chia-Mao; Lee, Ming-Hsueh; Wang, Ting-Chung; Weng, Hsu-Huei; Chung, Chiu-Yen; Yang, Jen-Tsung

    2009-07-01

    Traumatic spinal cord injury is clinically treated by high doses of methylprednisolone. However, the effect of methylprednisolone on the brain in spinal cord injury patients has been little investigated. This experimental study examined Bcl-2 and Bax protein expression and Nissl staining to evaluate an apoptosis-related intracellular signaling event and final neuron death, respectively. Spinal cord injury produced a significant apoptotic change and cell death not only in the spinal cord but also in the supraventricular cortex and hippocampal cornu ammonis 1 region in the rat brains. The treatment of methylprednisolone increased the Bcl-2/Bax ratio and prevented neuron death for 1-7 days after spinal cord injury. These findings suggest that rats with spinal cord injury show ascending brain injury that could be restricted through methylprednisolone management.

  18. Methylprednisolone therapy in deceased donors reduces inflammation in the donor liver and improves outcome after liver transplantation: a prospective randomized controlled trial.

    PubMed

    Kotsch, Katja; Ulrich, Frank; Reutzel-Selke, Anja; Pascher, Andreas; Faber, W; Warnick, P; Hoffman, S; Francuski, M; Kunert, C; Kuecuek, O; Schumacher, G; Wesslau, C; Lun, A; Kohler, S; Weiss, S; Tullius, S G; Neuhaus, P; Pratschke, Johann

    2008-12-01

    To investigate potential beneficial effects of donor treatment with methylprednisolone on organ function and outcome after liver transplantation. It is proven experimentally and clinically that the brain death of the donor leads to increased levels of inflammatory cytokines and is followed by an intensified ischemia/reperfusion injury after organ transplantation. In experiments, donor treatment with steroids successfully diminished these effects and led to better organ function after transplantation. To investigate whether methylprednisolone treatment of the deceased donor is applicable to attenuate brain death-associated damage in clinical liver transplantation we conducted a prospective randomized treatment-versus-control study in 100 deceased donors. Donor treatment (n = 50) consisted of 250 mg methylprednisolone at the time of consent for organ donation and a subsequent infusion of 100 mg/h until recovery of organs. A liver biopsy was taken immediately after laparotomy and blood samples were obtained after brain death diagnosis and before organ recovery. Cytokines were assessed by real-time reverse transcriptase-polymerase chain reaction. Soluble serum cytokines were measured by cytometric bead array system. After methylprednisolone treatment, steroid plasma levels were significantly higher (P < 0.05), and a significant decrease in soluble interleukins, monocyte chemotactic protein-1, interleukin-2, interleukin-6, tumor necrosis factor-alpha, and inducible protein-10 was observed. Methylprednisolone treatment resulted in a significant downregulation of intercellular adhesion molecule-1, tumor necrosis factor-alpha, major histocompatibility complex class II, Fas-ligand, inducible protein-10, and CD68 intragraft mRNA expression. Significantly ameliorated ischemia/reperfusion injury in the posttransplant course was accompanied by a decreased incidence of acute rejection. Our present study verifies the protective effect of methylprednisolone treatment in deceased

  19. Comparison of intra-articular hyaluronic acid and methylprednisolone for pain management in knee osteoarthritis: A meta-analysis of randomized controlled trials.

    PubMed

    Ran, Jian; Yang, Xiaohui; Ren, Zheng; Wang, Jian; Dong, Hui

    2018-05-01

    We performed a meta-analysis of randomized controlled trials (RCTs) to compare the efficacy and safety of intra-articular methylprednisolone and hyaluronic acid (HA) in term of pain reduction and improvements of knee function in patients with knee osteoarthritis (OA). The PubMed, EMBASE, ScienceDirect, and Cochrane Library databases were systematically searched for literature up to January 2018. RCTs involving HA and methylprednisolone in knee OA were included. Two independent reviewers performed independent data abstraction. The I 2 statistic was used to assess heterogeneity. A fixed or random effects model was adopted for meta-analysis. All meta-analyses were performed by using STATA 14.0. Five RCTs with 1004 patients were included in the meta-analysis. The present meta-analysis indicated that there were no significant differences in terms of WOMAC pain, physical function and stiffness at 4 week, 12 weeks and 26 weeks between HA and methylprednisolone groups. No increased risk of adverse events were identified in both groups. Both HA and methylprednisolone injections were effective therapies for patients with knee OA. Methylprednisolone showed comparable efficacy in reducing pain and improving functional recovery to HA. And no significant difference was found in long-term of follow-up in terms of adverse effects. Copyright © 2018 IJS Publishing Group Ltd. All rights reserved.

  20. Use of nitroglycerin by bolus prevents intensive care unit admission in patients with acute hypertensive heart failure.

    PubMed

    Wilson, Suprat Saely; Kwiatkowski, Gregory M; Millis, Scott R; Purakal, John D; Mahajan, Arushi P; Levy, Phillip D

    2017-01-01

    The purpose of this study was to compare health care resource utilization among patients who were given intravenous nitroglycerin for acute heart failure (AHF) in the emergency department (ED) by intermittent bolus, continuous infusion, or a combination of both. We retrospectively identified 395 patients that received nitroglycerin therapy in the ED for the treatment of AHF over a 5-year period. Patients that received intermittent bolus (n=124) were compared with continuous infusion therapy (n=182) and combination therapy of bolus and infusion (n=89). The primary outcomes were the frequency of intensive care unit (ICU) admission and hospital length of stay (LOS). On unadjusted analysis, rates of ICU admission were significantly lower in the bolus vs infusion and combination groups (48.4% vs 68.7% vs 83%, respectively; P<.0001) and median LOS (interquartile range) was shorter (3.7 [2.5-6.2 days]) compared with infusion (4.7 [2.9-7.1 days]) and combination (5.0 [2.9-6.7 days]) groups; P=.02. On adjusted regression models, the strong association between bolus nitroglycerin and reduced ICU admission rate remained, and hospital LOS was 1.9 days shorter compared with infusion therapy alone. Use of intubation (bolus [8.9%] vs infusion [8.8%] vs combination [16.9%]; P=.096) and bilevel positive airway pressure (bolus [26.6%] vs infusion [20.3%] vs combination [29.2%]; P=.21) were similar as was the incidence of hypotension, myocardial injury, and worsening renal function. In ED patients with AHF, intravenous nitroglycerin by intermittent bolus was associated with a lower ICU admission rate and a shorter hospital LOS compared with continuous infusion. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. The effect of aqueous extract of Kalanchoe Folium on methylprednisolone pharmacokinetic profile

    NASA Astrophysics Data System (ADS)

    Indriyanti, Niken; Garmana, Afrillia Nuryanti; Setiawan, Finna; Sukandar, Elin Yulinah; Adnyana, I. Ketut

    2016-03-01

    Aqueous extract of Kalanchoe pinnata leaves had immunosupressant effect on lupus nephritis model. When it combined with methylprednisolone, there is a risk of interaction. In this study rats divided into two groups, a group that received methylprednisolone (MP) (0.72 mg/kgBW) and a group that received MP in combination with extract (0.36 mg/kg BW MP and 140 mg/kg BW extract). These treatment were given everyday for 4 weeks. Methylprednisolone concentration in rats serum was measured using HPLC with extraction method according to Lawson method (1985). The column used was Inertsil C-18 using mobile phase KH2PO4 : metanol (15:85) buffer, flow rate 0.6 mL/minutes, UV detector (λ = 230 nm) and pressure 1319 psi. The result showed that there was an interaction occurred. The combination of MP and aqueous extract of K. pinnata leaves showed interaction which causing methylprednisolone level comparable with methylprednisolone level in MP group. Mean of decreasing MP level in serum was 0.285 ppm. It means that aqueous extract of Kalanchoe Folium could elevate methylprednisolone concentration in plasma. Adjustment of the dose must be considered in this combination.

  2. Cost-effectiveness analysis of IDegLira versus basal-bolus insulin for patients with type 2 diabetes in the Slovak health system

    PubMed Central

    Psota, Marek; Psenkova, Maria Bucek; Racekova, Natalia; Ramirez de Arellano, Antonio; Vandebrouck, Tom; Hunt, Barnaby

    2017-01-01

    Aims To investigate the cost-effectiveness of once-daily insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in patients with type 2 diabetes not meeting glycemic targets on basal insulin from a healthcare payer perspective in Slovakia. Methods Long-term clinical and economic outcomes for patients receiving IDegLira and basal-bolus therapy were estimated using the IMS CORE Diabetes Model based on a published pooled analysis of patient-level data. Results IDegLira was associated with an improvement in quality-adjusted life expectancy of 0.29 quality-adjusted life years (QALYs) compared with basal-bolus therapy. The average lifetime cost per patient in the IDegLira arm was EUR 2,449 higher than in the basal-bolus therapy arm. Increased treatment costs with IDegLira were partially offset by cost savings from avoided diabetes-related complications. IDegLira was highly cost-effective versus basal-bolus therapy with an incremental cost-effectiveness ratio of EUR 8,590 per QALY gained, which is well below the cost-effectiveness threshold set by the law in Slovakia. Conclusion IDegLira is cost-effective in Slovakia, providing a simple option for intensification of basal insulin therapy without increasing the risk of hypoglycemia or weight gain and with fewer daily injections than a basal-bolus regimen. PMID:29276398

  3. Monthly oral methylprednisolone pulse treatment in progressive multiple sclerosis.

    PubMed

    Ratzer, Rikke; Iversen, Pernille; Börnsen, Lars; Dyrby, Tim B; Romme Christensen, Jeppe; Ammitzbøll, Cecilie; Madsen, Camilla Gøbel; Garde, Ellen; Lyksborg, Mark; Andersen, Birgit; Hyldstrup, Lars; Sørensen, Per Soelberg; Siebner, Hartwig R; Sellebjerg, Finn

    2016-06-01

    There is a large unmet need for treatments for patients with progressive multiple sclerosis (MS). Phase 2 studies with cerebrospinal fluid (CSF) biomarker outcomes may be well suited for the initial evaluation of efficacious treatments. To evaluate the effect of monthly oral methylprednisolone pulse treatment on intrathecal inflammation in progressive MS. In this open-label phase 2A study, 15 primary progressive and 15 secondary progressive MS patients received oral methylprednisolone pulse treatment for 60 weeks. Primary outcome was changes in CSF concentrations of osteopontin. Secondary outcomes were other CSF biomarkers of inflammation, axonal damage and demyelination; clinical scores; magnetic resonance imaging measures of disease activity, magnetization transfer ratio (MTR) and diffusion tensor imaging (DTI); motor evoked potentials; and bone density scans. We found no change in the CSF concentration of osteopontin, but we observed significant improvement in clinical scores, MTR, DTI and some secondary CSF outcome measures. Adverse events were well-known side effects to methylprednisolone. Monthly methylprednisolone pulse treatment was safe, but had no effect on the primary outcome. However, improvements in secondary clinical and MRI outcome measures suggest that this treatment regimen may have a beneficial effect in progressive MS. © The Author(s), 2015.

  4. Effects of methylprednisolone on laser-induced retinal injuries

    NASA Astrophysics Data System (ADS)

    Rosner, Mordechai; Tchirkov, Marina; Dubinski, Galina; Solberg, Yoram; Belkin, Michael

    1997-05-01

    Methylprednisolone have been demonstrated to ameliorate retinal photic injury. In the current study we examined its effect on laser induced retinal injury. Retinal lesions were inflicted by argon laser in 36 pigmented DA rats. The treated groups received intra-peritoneally methylprednisolone in saline, injected 3 times a day for 2 days, starting immediately after exposure. The controls received the vehicle on the same schedule. The rats were sacrificed 3, 20 or 60 days after laser exposure and the lesions were evaluated by light microscopy and morphometric measurements. Laser injuries were associated with disruption of the outer retinal layers. Three and 20 days after exposure, the loss of the photoreceptor-cell nuclei was significantly milder in the treated groups as compared with controls. There was no difference 60 days after exposure. In conclusion, methylprednisolone reduced temporarily the photoreceptor cell loss in argon laser induced retinal injury, when treatment was started immediately after laser exposure. There was no long term effect.

  5. Randomized Clinical Trial of Intraosseous Methylprednisolone Injection for Acute Pulpitis Pain.

    PubMed

    Bane, Khaly; Charpentier, Emmanuel; Bronnec, François; Descroix, Vianney; Gaye-N'diaye, Fatou; Kane, Abdoul Wahabe; Toledo, Rafael; Machtou, Pierre; Azérad, Jean

    2016-01-01

    The present study reports the results of a randomized clinical trial comparing local intraosseous methylprednisolone injection and emergency pulpotomy in the management of acute pulpitis on efficacy, safety, and efficiency end points. After providing prior informed written consent, 94 patients consulting for acute irreversible pulpitis pain at university-affiliated teaching hospital dental clinics in Dakar, Senegal were randomly assigned to either the methylprednisolone treatment group (n = 47) or the pulpotomy treatment group (n = 47). Patients were followed up at 1 week and assessed 6 months later to evaluate the therapeutic outcome of their treatment. At day 7 the patients in the methylprednisolone group reported less intense spontaneous and percussion pain in the day 0-day 7 period than the patients in the pulpotomy group. Methylprednisolone treatment took approximately 7 minutes (4.6-9.3) less to accomplish than pulpotomy (or about half the time). No difference in the therapeutic outcome was found between the 2 treatment groups at 6 months (all credible intervals span 0). This study establishes that methylprednisolone injection for acute pulpitis is relieved by a minimally invasive pharmacologic approach more effectively than by the reference pulpotomy and conserves scarce dental resources (ie, endodontic equipment and supplies, dental surgeon's time). Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  6. SU-C-213-05: Evaluation of a Composite Copper-Plastic Material for a 3D Printed Radiation Therapy Bolus

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Vitzthum, L; Ehler, E; Sterling, D

    2015-06-15

    Purpose: To evaluate a novel 3D printed bolus fabricated from a copper-plastic composite as a thin flexible, custom fitting device that can replicate doses achieved with conventional bolus techniques. Methods: Two models of bolus were created on a 3D printer using a composite copper-PLA/PHA. Firstly, boluses were constructed at thicknesses of 0.4, 0.6 and 0.8 mm. Relative dose measurements were performed under the bolus with an Attix Chamber as well as with radiochromic film. Results were compared to superficial Attix Chamber measurements in a water equivalent material to determine the dosimetric water equivalence of the copper-PLA/PHA plastic. Secondly, CT imagesmore » of a RANDO phantom were used to create a custom fitting bolus across the anterolateral scalp. Surface dose with the bolus placed on the RANDO phantom was measured with radiochromic film at tangential angles with 6, 10, 10 flattening filter free (FFF) and 18 MV photon beams. Results: Mean surface doses for 6, 10, 10FFF and 18 MV were measured as a percent of Dmax for the flat bolus devices of each thickness. The 0.4 mm thickness bolus was determined to be near equivalent to 2.5 mm depth in water for all four energies. Surface doses ranged from 59–63% without bolus and 85–90% with the custom 0.4 mm copper-plastic bolus relative to the prescribed dose for an oblique tangential beam arrangement on the RANDO phantom. Conclusion: Sub-millimeter thickness, 3D printed composite copper-PLA/PHA bolus can provide a build-up effect equivalent to conventional bolus. At this thickness, the 3D printed bolus allows a level of flexure that may provide more patient comfort than current 3D printing materials used in bolus fabrication while still retaining the CT based custom patient shape. Funding provided by an intra-department grant of the University of Minnesota Department of Radiation Oncology.« less

  7. Development of biodegradable methylprednisolone microparticles for treatment of articular pathology using a spray-drying technique

    PubMed Central

    Tobar-Grande, Blanca; Godoy, Ricardo; Bustos, Paulina; von Plessing, Carlos; Fattal, Elias; Tsapis, Nicolas; Olave, Claudia; Gómez-Gaete, Carolina

    2013-01-01

    In this work, microparticles were prepared by spray-drying using albumin, chondroitin sulfate, and hyaluronic acid as excipients to create a controlled-release methylprednisolone system for use in inflammatory disorders such as arthritis. Scanning electron microscopy demonstrated that these microparticles were almost spherical, with development of surface wrinkling as the methylprednisolone load in the formulation was increased. The methylprednisolone load also had a direct influence on the mean diameter and zeta potential of the microparticles. Interactions between formulation excipients and the active drug were evaluated by x-ray diffraction, differential scanning calorimetry, and thermal gravimetric analysis, showing limited amounts of methylprednisolone in a crystalline state in the loaded microparticles. The encapsulation efficiency of methylprednisolone was approximately 89% in all formulations. The rate of methylprednisolone release from the microparticles depended on the initial drug load in the formulation. In vitro cytotoxic evaluation using THP-1 cells showed that none of the formulations prepared triggered an inflammatory response on release of interleukin-1β, nor did they affect cellular viability, except for the 9.1% methylprednisolone formulation, which was the maximum test concentration used. The microparticles developed in this study have characteristics amenable to a therapeutic role in inflammatory pathology, such as arthritis. PMID:23737670

  8. Combination of High-Dose Methylprednisolone and Defibrotide for Veno-Occlusive Disease in Pediatric Hematopoietic Stem Cell Transplant Recipients.

    PubMed

    Gloude, Nicholas J; Jodele, Sonata; Teusink-Cross, Ashley; Grimley, Michael; Davies, Stella M; Lane, Adam; Myers, Kasiani C

    2018-01-01

    Veno-occlusive disease (VOD) is a serious complication of hematopoietic stem cell transplant (HSCT), with high mortality in severe cases and until recently very limited therapeutic options consisting largely of supportive care. Defibrotide was recently approved in the United States for the treatment of severe VOD in patients with renal or pulmonary dysfunction after HSCT. Our group previously published on the use of high-dose methylprednisolone (500 mg/m 2 per dose every 12 hours for 6 doses) in patients with VOD, showing good success. A small subset of these individuals were also treated with defibrotide, but additional studies using the combination of high-dose methylprednisolone and defibrotide for the treatment of VOD are lacking. We present a single-institution retrospective chart review of 15 HSCT patients with VOD treated with the combination of high-dose methylprednisolone and defibrotide. VOD developed at a median of 17 days post-HSCT, and combination therapy was initiated within 1 day of VOD diagnosis. Twelve of 15 patients (80%) had multiorgan failure. Our single-center experience using both high-dose methylprednisolone and defibrotide showed a day +100 survival rate of 73% and an overall VOD complete resolution rate of 66.7%, higher than the rates reported in the recent literature using defibrotide alone (40% to 50% day +100 overall survival). These data suggest that the combination of high-dose steroids and defibrotide may be superior to defibrotide alone and warrant further investigation. Copyright © 2017 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  9. MO-H-19A-03: Patient Specific Bolus with 3D Printing Technology for Electron Radiotherapy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Zou, W; Swann, B; Siderits, R

    2014-06-15

    Purpose: Bolus is widely used in electron radiotherapy to achieve desired dose distribution. 3D printing technologies provide clinicians with easy access to fabricate patient specific bolus accommodating patient body surface irregularities and tissue inhomogeneity. This study presents the design and the clinical workflow of 3D printed bolus for patient electron therapy in our clinic. Methods: Patient simulation CT images free of bolus were exported from treatment planning system (TPS) to an in-house developed software package. Bolus with known material properties was designed in the software package and then exported back to the TPS as a structure. Dose calculation was carriedmore » out to examine the coverage of the target. After satisfying dose distribution was achieved, the bolus structure was transferred in Standard Tessellation Language (STL) file format for the 3D printer to generate the machine codes for printing. Upon receiving printed bolus, a quick quality assurance was performed with patient resimulated with bolus in place to verify the bolus dosimetric property before treatment started. Results: A patient specific bolus for electron radiotherapy was designed and fabricated in Form 1 3D printer with methacrylate photopolymer resin. Satisfying dose distribution was achieved in patient with bolus setup. Treatment was successfully finished for one patient with the 3D printed bolus. Conclusion: The electron bolus fabrication with 3D printing technology was successfully implemented in clinic practice.« less

  10. Optimizing the combination insulin bolus split for a high-fat, high-protein meal in children and adolescents using insulin pump therapy.

    PubMed

    Lopez, P E; Smart, C E; McElduff, P; Foskett, D C; Price, D A; Paterson, M A; King, B R

    2017-10-01

    To determine the optimum combination bolus split to maintain postprandial glycaemia with a high-fat and high-protein meal in young people with Type 1 diabetes. A total of 19 young people (mean age 12.9 ± 6.7 years) participated in a randomized, repeated-measures trial comparing postprandial glycaemic control across six study conditions after a high-fat and high-protein meal. A standard bolus and five different combination boluses were delivered over 2 h in the following splits: 70/30 = 70% standard /30% extended bolus; 60/40=60% standard/40% extended bolus; 50/50=50% standard/50% extended bolus; 40/60=40% standard/60% extended bolus; and 30/70=30% standard/70% extended bolus. Insulin dose was determined using the participant's optimized insulin:carbohydrate ratio. Continuous glucose monitoring was used to assess glucose excursions for 6 h after the test meal. Standard bolus and combination boluses 70/30 and 60/40 controlled the glucose excursion up to 120 min. From 240 to 300 min after the meal, the glucose area under the curve was significantly lower for combination bolus 30/70 compared with standard bolus (P=0.004). High-fat and high-protein meals require a ≥60% insulin:carbohydrate ratio as a standard bolus to control the initial postprandial rise. Additional insulin at an insulin:carbohydrate ratio of up to 70% is needed in the extended bolus for a high fat and protein meal to prevent delayed hyperglycaemia. © 2017 Diabetes UK.

  11. Sustained trilineage recovery and disappearance of abnormal chromosome clone in a patient with myelodysplastic syndrome following combination therapy with cytokines (granulocyte colony-stimulating factor and erythropoietin) and high-dose methylprednisolone.

    PubMed

    Imai, Y; Fukuoka, T; Nakatani, A; Ohsaka, A; Takahashi, A

    1996-04-01

    We report a case of hypoplastic myelodyplastic syndrome (MDS) (refractory anemia (RA)) in which sustained trilineage haematological response and persistent disappearance of an abnormal chromosome clone were achieved after treatment with combination therapy of cytokines (granulocyte colony-stimulating factor (G-CSF) and erythropoietin (Epo)) and methylprednisolone (mPSL) pulse dose. The patient's haematological recovery was rapid and maintained even after cessation of the therapy. In addition, the predominant chromosome clone 13q- in bone marrow cells disappeared in the fourth week. The patient's improved bone marrow haemopoiesis and disappearance of the abnormal chromosome has continued to the present, 13 months after treatment. The occurrence of both trilineage response and abnormal chromosome disappearance in MDS patients treated with cytokine(s) or steroids is rare. Combination therapy might therefore be advantageous in MDS.

  12. Effects of methylprednisolone on the duration of rocuronium-induced neuromuscular block

    PubMed Central

    Geng, Weilian; Nie, Yuyan; Huang, Shaoqiang

    2017-01-01

    Abstract Background: We aim to investigate whether intraoperative use of methylprednisolone could affect the duration of rocuronium-induced neuromuscular blockade. Methods: A double blind, randomized, placebo-controlled trial was conducted. A total of 136 patients underwent gynecologic laparoscopic surgery were randomly divided into 3 groups: pregroup, receiving intravenous injection of methylprednisolone (40 mg) 30 minutes before induction of anesthesia; postgroup, receiving intravenous injection of methylprednisolone (40 mg) immediately after induction of anesthesia and intubation; and control group, receiving intravenous injection of normal saline. Patients were intravenously administrated with rocuronium 0.6 mg/kg, and changes in adductor policies evoked twitch responses were measured by ulnar nerve stimulator. Results: We found that all patients achieved maximum blockade effects, and there was no difference in onset time among the 2 groups. For time required to achieve train-of-four ratio (TOFR) 90%, pregroup (64.50 ± 10.52 minutes) and postgroup (65.29 ± 11.64 minutes) were significantly shorter than that of the control group (71.04 ± 10.55 minutes, P = .027), whereas clinical duration and total duration were significantly shorter in the 2 groups received methylprednisolone than the control group. However, there was no significant difference between the 2 treatment groups either in clinical duration and total duration of muscle relaxants, or time required to achieve TOFR 90%. No significant difference was found in recovery index among the 3 groups. Conclusion: Our findings suggest that a single intravenous injection of methylprednisolone, no matter preoperatively or intraoperatively, could shorten the duration of rocuronium-induced neuromuscular blockade. PMID:28953616

  13. Rituximab, etoposide, methylprednisolone, high-dose cytarabine, and cisplatin in the treatment of secondary hemophagocytic lymphohistiocytosis with classical Hodgkin lymphoma: a case report and review of the literature.

    PubMed

    Hu, Steve; Bansal, Pranshu; Lynch, David; Rojas Hernandez, Cristhiam Mauricio; Dayao, Zoneddy

    2016-12-20

    Hemophagocytic lymphohistiocytosis is becoming an increasingly recognized disorder in adults. Classical Hodgkin lymphoma is a relatively uncommon etiology of hemophagocytic lymphohistiocytosis and may complicate treatment options. Rituximab, etoposide, methylprednisolone, high-dose cytarabine, and cisplatin are discussed here as a treatment regimen. A 66-year-old Hispanic man previously in good health presented with a 1-month history of recurrent fevers, chills, and night sweats and a 3-week history of new onset jaundice. A bone marrow biopsy revealed a normocellular bone marrow with increased histiocytes with areas of hemophagocytic activity. He met five out of eight criteria for hemophagocytic lymphohistiocytosis diagnosis including fevers, pancytopenia, hemophagocytosis, ferritin of 23,292 ng/mL (>500 ng/mL), and soluble-CD25 of 15,330 pg/mL (>1033 pg/mL). A right cervical lymph node biopsy revealed CD15, CD30, MUM-1, and Epstein-Barr virus-encoded small ribonucleic acid-positive cells with morphologic findings of classical Hodgkin lymphoma, lymphocyte-rich subtype. He completed 2 weeks of hemophagocytic lymphohistiocytosis-directed therapy with etoposide and dexamethasone, but then was switched to rituximab, etoposide, methylprednisolone, high-dose cytarabine, and cisplatin due to minimal improvement in his pancytopenia and hepatic impairment. He completed one full cycle of rituximab, etoposide, methylprednisolone, high-dose cytarabine, and cisplatin with notable improvement in serial hepatic function panels and had an undetectable Epstein-Barr virus viral load. However, he eventually died due to complications of Enterococcus faecalis bacteremia and colonic microperforation in the setting of persistent pancytopenia. This case discusses the challenges facing treatment of adult malignancy-associated hemophagocytic lymphohistiocytosis. Rituximab, etoposide, methylprednisolone, high-dose cytarabine, and cisplatin may be a viable option for patients with secondary

  14. Compare the efficacy of inhaled budesonide and systemic methylprednisolone on systemic inflammation of AECOPD.

    PubMed

    Sun, Xuejiao; He, Zhiyi; Zhang, Jianquan; Deng, Jingmin; Bai, Jing; Li, Meihua; Zhong, Xiaoning

    2015-04-01

    Corticosteroids have been shown to improve the outcome of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). However, whether inhaled corticosteroids (IC) alone have similar effects with systemic corticosteroid (SCS) is still unclear. To compare the efficacy of inhaled budesonide and systemic methylprednisolone on systemic inflammation of AECOPD. 30 AECOPD patients were randomly divided into two group. Budesonide group (15 cases) were treated with inhaled budesonide (3 mg Bid); methylprednisolone group (15 cases) were treated with systemic methylprednisolone (methylprednisolone acetate injectable suspension 40 mg Qd for three days and then methylprednisolone tablets 8 mg Bid). Observe symptoms, lung function, blood gas analysis and adverse effects of the patients in two groups. Peripheral blood samples were collected before and after treatment for 1 day, 4 days and 7 days. Interleukin-8 (IL-8) and TNF-α levels were determined by an enzyme linked immunosorbent assay (ELISA). Hs-CRP levels were detected by automatic biochemical analyzer. Western blotting was used to determine histone deacetylase 2 (HDAC2) protein expression. Symptoms, pulmonary function and blood gas analysis were significantly improved after treatment in the two groups (P < 0.05) and no significant differences between the two groups (P > 0.05). There were no significant differences of IL-8, TNF-α and hs-CRP levels in the two groups (P > 0.05). Besides, the levels of HDAC2 protein expression before treatment were significantly lower comparing to that after treatment for 4 and 7 days. Incidence of adverse events (heart rate, blood pressure, glycemic, sleep condition, gastrointestinal symptoms) in budesonide group was lower than methylprednisolone group (P < 0.05). Inhaled budesonide and systemic methylprednisolone have the same effects on systemic inflammation of AECOPD. Inhaled corticosteroid alone could instead systemic corticosteroid in AECOPD treatment. Copyright

  15. A qualitative feasibility study to inform a randomised controlled trial of fluid bolus therapy in septic shock

    PubMed Central

    O’Hara, Caitlin B; Canter, Ruth R; Mouncey, Paul R; Carter, Anjali; Jones, Nicola; Nadel, Simon; Peters, Mark J; Lyttle, Mark D; Harrison, David A; Rowan, Kathryn M; Inwald, David; Woolfall, Kerry

    2018-01-01

    Objective The Fluids in Shock (FiSh) Trial proposes to evaluate whether restrictive fluid bolus therapy (10 mL/kg) is more beneficial than current recommended practice (20 mL/kg) in the resuscitation of children with septic shock in the UK. This qualitative feasibility study aimed to explore acceptability of the FiSh Trial, including research without prior consent (RWPC), potential barriers to recruitment and participant information for a pilot trial. Design Qualitative interview study involving parents of children who had presented to a UK emergency department or been admitted to a paediatric intensive care unit with severe infection in the previous 3 years. Participants Twenty-one parents (seven bereaved) were interviewed 16 (median) months since their child’s hospital admission (range: 1–41). Results All parents said they would have provided consent for the use of their child’s data in the FiSh Trial. The majority were unfamiliar with RWPC, yet supported its use. Parents were initially concerned about the change from currently recommended treatment, yet were reassured by explanations of the current evidence base, fluid bolus therapy and monitoring procedures. Parents made recommendations about the timing of the research discussion and content of participant information. Bereaved parents stated that recruiters should not discuss research immediately after a child’s death, but supported a personalised postal ‘opt-out’ approach to consent. Conclusions Findings show that parents whose child has experienced severe infection supported the proposed FiSh Trial, including the use of RWPC. Parents’ views informed the development of the pilot trial protocol and site staff training. Trial registration number ISRCTN15244462—results. PMID:28847877

  16. Appropriateness of Bolus Antihypertensive Therapy for Elevated Blood Pressure in the Emergency Department

    PubMed Central

    Miller, Joseph B.; Arter, Andrew; Wilson, Suprat S.; Janke, Alexander T.; Brody, Aaron; Reed, Brian P.; Levy, Phillip D.

    2017-01-01

    Introduction While moderate to severely elevated blood pressure (BP) is present in nearly half of all emergency department (ED) patients, the incidence of true hypertensive emergencies in ED patients is low. Administration of bolus intravenous (IV) antihypertensive treatment to lower BP in patients without a true hypertensive emergency is a wasteful practice that is discouraged by hypertension experts; however, anecdotal evidence suggests this occurs with relatively high frequency. Accordingly, we sought to assess the frequency of inappropriate IV antihypertensive treatment in ED patients with elevated BP absent a hypertensive emergency. Methods We performed a retrospective cohort study from a single, urban, teaching hospital. Using pharmacy records, we identified patients age 18–89 who received IV antihypertensive treatment in the ED. We defined treatment as inappropriate if documented suspicion for an indicated cardiovascular condition or acute end-organ injury was lacking. Data abstraction included adverse events and 30-day readmission rates, and analysis was primarily descriptive. Results We included a total of 357 patients over an 18-month period. The mean age was 55; 51% were male and 93% black, and 127 (36.4%) were considered inappropriately treated. Overall, labetalol (61%) was the most commonly used medication, followed by enalaprilat (18%), hydralazine (18%), and metoprolol (3%). There were no significant differences between appropriate and inappropriate BP treatment groups in terms of clinical characteristics or adverse events. Hypotension or bradycardia occurred in three (2%) patients in the inappropriate treatment cohort and in two (1%) patients in the appropriately treated cohort. Survival to discharge and 30-day ED revisit rates were equivalent. Conclusion More than one in three patients who were given IV bolus antihypertensive treatment in the ED received such therapy inappropriately by our definition, suggesting that significant resources could

  17. Appropriateness of Bolus Antihypertensive Therapy for Elevated Blood Pressure in the Emergency Department.

    PubMed

    Miller, Joseph B; Arter, Andrew; Wilson, Suprat S; Janke, Alexander T; Brody, Aaron; Reed, Brian P; Levy, Phillip D

    2017-08-01

    While moderate to severely elevated blood pressure (BP) is present in nearly half of all emergency department (ED) patients, the incidence of true hypertensive emergencies in ED patients is low. Administration of bolus intravenous (IV) antihypertensive treatment to lower BP in patients without a true hypertensive emergency is a wasteful practice that is discouraged by hypertension experts; however, anecdotal evidence suggests this occurs with relatively high frequency. Accordingly, we sought to assess the frequency of inappropriate IV antihypertensive treatment in ED patients with elevated BP absent a hypertensive emergency. We performed a retrospective cohort study from a single, urban, teaching hospital. Using pharmacy records, we identified patients age 18-89 who received IV antihypertensive treatment in the ED. We defined treatment as inappropriate if documented suspicion for an indicated cardiovascular condition or acute end-organ injury was lacking. Data abstraction included adverse events and 30-day readmission rates, and analysis was primarily descriptive. We included a total of 357 patients over an 18-month period. The mean age was 55; 51% were male and 93% black, and 127 (36.4%) were considered inappropriately treated. Overall, labetalol (61%) was the most commonly used medication, followed by enalaprilat (18%), hydralazine (18%), and metoprolol (3%). There were no significant differences between appropriate and inappropriate BP treatment groups in terms of clinical characteristics or adverse events. Hypotension or bradycardia occurred in three (2%) patients in the inappropriate treatment cohort and in two (1%) patients in the appropriately treated cohort. Survival to discharge and 30-day ED revisit rates were equivalent. More than one in three patients who were given IV bolus antihypertensive treatment in the ED received such therapy inappropriately by our definition, suggesting that significant resources could perhaps be saved through education of

  18. Intra-arterial Methylprednisolone Infusion in Treatment-Resistant Graft-Versus-Host Disease

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Weintraub, Joshua L., E-mail: Joshua.Weintraub@mssm.edu; Belanger, Adam R.; Sung, Chris C.

    Acute graft-versus-host disease (GVHD) is a potentially fatal complication following allogeneic hematopoietic stem cell transplant. Standard primary therapy for acute GVHD includes systemic steroids, often in combination with other agents. Unfortunately, primary treatment failure is common and carries a high mortality. There is no generally accepted secondary therapy for acute GVHD. Although few data on localized therapy for GVHD have been published, intra-arterial injection of high-dose corticosteroids may be a viable option. We treated 11 patients with steroid-resistant GVHD using a single administration of intra-arterial high-dose methylprednisolone. Three patients (27%) died periprocedurally. Four patients (36%) had a partial response tomore » intra-arterial treatment and were discharged on total parenteral nutrition and oral medication. Four patients (36%) had a complete response and were discharged on oral diet and oral medication. No immediate treatment or procedure-related complications were noted. Twenty-seven percent of patients survived long-term. Our preliminary results suggest that regional intra-arterial treatment of steroid-resistant GVHD is a safe and potentially viable secondary therapy in primary treatment-resistant GVHD.« less

  19. 21 CFR 520.1158 - Iodochlorhydroxyquin boluses.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Iodochlorhydroxyquin boluses. (a) Specifications. Each bolus contains 10 grams of iodochlorhydroxyquin. (b) Sponsor. See No. 053501 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 1 bolus (10 grams...

  20. 21 CFR 520.1158 - Iodochlorhydroxyquin boluses.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Iodochlorhydroxyquin boluses. (a) Specifications. Each bolus contains 10 grams of iodochlorhydroxyquin. (b) Sponsor. See No. 053501 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 1 bolus (10 grams...

  1. 21 CFR 520.1158 - Iodochlorhydroxyquin boluses.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Iodochlorhydroxyquin boluses. (a) Specifications. Each bolus contains 10 grams of iodochlorhydroxyquin. (b) Sponsor. See No. 053501 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 1 bolus (10 grams...

  2. 21 CFR 520.1158 - Iodochlorhydroxyquin boluses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Iodochlorhydroxyquin boluses. (a) Specifications. Each bolus contains 10 grams of iodochlorhydroxyquin. (b) Sponsor. See No. 053501 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 1 bolus (10 grams...

  3. Unknown Safety and Efficacy of Smartphone Bolus Calculator Apps Puts Patients at Risk for Severe Adverse Outcomes.

    PubMed

    Hirsch, Irl B; Parkin, Christopher G

    2016-07-01

    Manual calculation of bolus insulin dosages can be challenging for individuals treated with multiple daily insulin injections (MDI) therapy. Automated bolus calculator capability has recently been made available via enhanced blood glucose meters and smartphone apps. Use of this technology has been shown to improve glycemic control and reduce glycemic variability without changing hypoglycemia; however, the clinical utility of app-based bolus calculators has not been demonstrated. Moreover, recent evidence challenges the safety and efficacy of these smartphone apps. Although the ability to automatically calculate bolus insulin dosages addresses a critical need of MDI-treated individuals, this technology raises concerns about efficacy of treatment and the protection of patient safety. This article discusses key issues and considerations associated with automated bolus calculator use. © 2016 Diabetes Technology Society.

  4. Effect of high dose methylprednisolone pulse therapy followed by oral prednisolone administration on the production of anti-TSH receptor antibodies and clinical outcome in Graves' disease.

    PubMed

    Kubota, Sumihisa; Ohye, Hidemi; Nishihara, Eijun; Kudo, Takumi; Ito, Mitsuru; Fukata, Shuji; Amino, Nobuyuki; Kuma, Kanji; Miyauchi, Akira

    2005-12-01

    Little is known about the immunosuppressive effect of glucocorticoids on TSH receptor antibodies. We observed the long-term prognosis and serum TSH binding inhibitor immunoglobulin (TBII) levels in patients with Graves' ophthalmopathy who had received intravenous methylprednisolone pulse therapy (pulse therapy) followed by oral prednisolone administration in order to ascertain how long the immunosuppressive effect of glucocorticoids continued. This is the first report on the effect of pulse therapy on Graves' disease outcome. We observed 67 patients who were treated by antithyroid drugs (ATD) alone for 2 years after pulse therapy. TBII was evaluated before and 3, 6, 12, 18, and 24 months after pulse therapy. The mean TBII decreased significantly 3 months after pulse therapy (p<0.001), and was maintained until 24 months. There were 24 patients whose TBII was positive (>15%) at 24 months, in whom the mean TBII decreased significantly 3 to 6 months after pulse therapy (p<0.001), but increased again at 12 to 24 months (p<0.05). Thus, the immunosuppressive effect of glucocorticoids may be lost at 12 months after pulse therapy in these patients. The remission rate in the pulse therapy group was 40.98%, and that of the control patient group was 48.57%. There was no significant difference between the two. These results suggest that the immunosuppressive effect of pulse therapy was temporary, and that pulse therapy did not increase remission rate of Graves' disease.

  5. Intensification of insulin therapy in patients with type 2 diabetes mellitus: An algorithm for basal-bolus therapy

    PubMed Central

    2012-01-01

    The incidence of diabetes mellitus is projected to continue to increase worldwide over the next 20 years leading to increased costs in the management of the disease and its associated co-morbidities. Insulin replacement is one of many treatment options that can help to bring about near normoglycemia in the patient with type 2 diabetes mellitus (T2DM). Glycemic control as close to normoglycemia as possible can help to reduce the risk of microvascular and macrovascular complications, yet less than one-half of patients with T2DM achieve glycemic targets as recommended by practice guidelines. The purpose of this review is to provide guidance to primary care physicians for the initiation and intensification of basal-bolus insulin therapy in patients with T2DM. Two treatment algorithms that can be both patient- and physician-driven are proposed: a stepwise approach and a multiple daily injections approach. Evidence shaping the two approaches will be discussed alongside management issues that surround the patient treated with insulin: hypoglycemia, weight gain, patient education, and quality of life. PMID:22822902

  6. Evaluation of the Eclipse eMC algorithm for bolus electron conformal therapy using a standard verification dataset.

    PubMed

    Carver, Robert L; Sprunger, Conrad P; Hogstrom, Kenneth R; Popple, Richard A; Antolak, John A

    2016-05-08

    The purpose of this study was to evaluate the accuracy and calculation speed of electron dose distributions calculated by the Eclipse electron Monte Carlo (eMC) algorithm for use with bolus electron conformal therapy (ECT). The recent com-mercial availability of bolus ECT technology requires further validation of the eMC dose calculation algorithm. eMC-calculated electron dose distributions for bolus ECT have been compared to previously measured TLD-dose points throughout patient-based cylindrical phantoms (retromolar trigone and nose), whose axial cross sections were based on the mid-PTV (planning treatment volume) CT anatomy. The phantoms consisted of SR4 muscle substitute, SR4 bone substitute, and air. The treatment plans were imported into the Eclipse treatment planning system, and electron dose distributions calculated using 1% and < 0.2% statistical uncertainties. The accuracy of the dose calculations using moderate smoothing and no smooth-ing were evaluated. Dose differences (eMC-calculated less measured dose) were evaluated in terms of absolute dose difference, where 100% equals the given dose, as well as distance to agreement (DTA). Dose calculations were also evaluated for calculation speed. Results from the eMC for the retromolar trigone phantom using 1% statistical uncertainty without smoothing showed calculated dose at 89% (41/46) of the measured TLD-dose points was within 3% dose difference or 3 mm DTA of the measured value. The average dose difference was -0.21%, and the net standard deviation was 2.32%. Differences as large as 3.7% occurred immediately distal to the mandible bone. Results for the nose phantom, using 1% statistical uncertainty without smoothing, showed calculated dose at 93% (53/57) of the measured TLD-dose points within 3% dose difference or 3 mm DTA. The average dose difference was 1.08%, and the net standard deviation was 3.17%. Differences as large as 10% occurred lateral to the nasal air cavities. Including smoothing had

  7. Structural study of polymorphism in methylprednisolone aceponate

    NASA Astrophysics Data System (ADS)

    Knyazev, A. V.; Somov, N. V.; Shipilova, A. S.; Gusarova, E. V.; Knyazeva, S. S.; Stepanova, O. V.; Chuprunov, E. V.

    2017-08-01

    The crystal structures of methylprednisolone aceponate were determined by X-ray diffraction analysis at temperatures 90 K and 150 K: space group P212121, a = 14.8592(2), b = 19.6844(5), c = 26.1626(4) Å, Z = 12; R = 0.0598 (T = 90 K); space group P212121, a = 6.57348(14), b = 14.8295(3), c = 26.2214(5) Å, Z = 4; R = 0.0518 (T = 150 K). Features of structural changes in the phase transition were revealed. The abrupt change in the unit cell parameters in the phase transition was shown by low-temperature X-ray powder. The methods of degree of invariance of crystal electron density and molecular Voronoi-Dirichlet polyhedra were used for the analysis of polymorphism in methylprednisolone aceponate. The atomic structure at 90 K have a translational pseudosymmetry of electron density η = 0.329(1). The decrease of number of intermolecular contacts in the high-temperature modification due to rupture of intermolecular non-valence contacts C/O was observed.

  8. The effects of lipoic acid and methylprednisolone on nerve healing in rats with facial paralysis.

    PubMed

    Tekdemir, Emrah; Tatlipinar, Arzu; Özbeyli, Dilek; Tekdemir, Özge; Kınal, Emrah

    2018-06-01

    To investigate the effects of lipoic acid and methylprednisolone on nerve healing in rats with traumatic facial paralysis. The rats were randomly divided into four groups, with six rats in the control group and eight each in the remaining three groups. The buccal branch of the facial nerve in all groups except the control group was traumatized by a vascular clamp for 40 minutes. Group 1 was given lipoic acid (LA), Group 2 was given methylprednisolone (MP), and Group 3 was given lipoic acid and methylprednisolone (LA + MP) for one week. Nerve stimulus thresholds were measured before trauma, after trauma and at the end of the one week treatment period. When the groups were compared with each other, post-treatment threshold levels of LA + MP were significantly lower than LA. Although post-treatment threshold levels of LA and MP were still higher than the control group, there was no significant difference between LA + MP and control values (p > .05). Lipoic acid has a positive effect on nerve healing and can enhance the effect of methylprednisolone treatment. It is a good alternative in cases where methylprednisolone cannot be used.

  9. Comparison of the therapeutic effects of tri-iodothyronine and methylprednisolone during early sepsis in laboratory animals.

    PubMed

    Coskun, F; Saylam, B; Kulah, B; Dolapci, I; Sungur, A; Ozer, M Vasfi

    2012-01-01

    Despite major advances, the treatment of sepsis is still a challenging problem for surgeons. This study was aimed to compare the therapeutic effects of methylprednisolone and tri-iodothyronine replacement therapy during an early sepsis. Forty male Wistar albino rats weighing 300-340 g were divided into the Control, CLP, CLP/MP, CLP/T3 and CLP/MP/T3 groups. The Control group underwent a sham operation. Only cecal ligation and puncture was performed in the CLP group. The CLP/MP groups received an intramuscular injection of (MP) methylprednisolone (30 mg/kg) at one and half hour before CLP. The CLP/T3 group was given an intraperitoneal (IP) injection of tyroid hormone (T3) 0.4 µg/100 g immediately after CLP. The CLP/MP/T3 group was given IM injection of MP 30 mg/kg before CLP and IP injection of T3 0.4 µg/100 g after CLP. Hemavet changes, blood cultures, peritoneal bacteria content, hormonal alterations and histopathologic changes of intestinal, lung and liver tissue were used to asses the possible therapeutic effects of MP and T3 during early sepsis. A septic insult resulted in significant alterations on hemavet values, free T3, free T4 and cortisol levels, peritoneal bacteria content and intestinal lung and liver tissue samples of the CLP group. Hemavet changes and peritoneal inflammation findings were significantly limited in the CLP/T3 and CLP/MP/T3 groups. Histopathologic changes had no significant difference between the groups during an early sepsis. Compared to the MP replacement therapy, therapeutic effects of T3 replacement therapy have been found significantly more promising (Tab. 1, Fig. 10, Ref. 49).

  10. Lagrangian clustering detection of internal wave boluses

    NASA Astrophysics Data System (ADS)

    Allshouse, M.; Salvador Vieira, G.; Swinney, H. L.

    2016-02-01

    The shoaling of internal waves on a continental slope or shelf produces boluses that travel up the slope with the wave. The boluses are regions of trapped fluid that are transported along with the wave, unlike fluid in the bulk that is temporarily pertubed by a passing wave. Boluses have been observed to transport oxygen-depleted water and induce rapid changes in temperature (Walter et al, JGR, 2012), both of which have potential ramifications for marine biology. Several previous studies have investigated boluses in systems with two layers of different density (e.g., Helfrich, JFM, 1992, and Sutherland et al., JGR, 2013). We conduct laboratory and computational studies of bolus generation and material transport in continuously stratified fluids with a pycnocline, as in the oceans. Our laboratory experiments in a 4 m long tank are complemented by 2-dimensional direct numerical simulations of the Navier-Stokes equations. Efforts have been made to identify boluses with Eularian measures in the past, but a Lagrangian perspective is necessary to objectively identify the bolus over its lifespan. Here we use a Lagrangian based coherent structure method relying on trajectory clustering using the fuzzy c-means approach (Froyland and Padberg-Gehle, Chaos, 2015). The objective detection of a bolus enables examination of the volume, distance traveled, and increased available potential energy of a bolus, as a function of the stratification, wave properties, and the angle of the sloping topography. The decay of a bolus through turbulent mixing is investigated by locating where the Richardson number drops below ¼, where velocity shear overcomes the tendency of a stratified fluid to remain stratified. (supported by ONR MURI grant N000141110701)

  11. Insulin pump therapy: what is the evidence for using different types of boluses for coverage of prandial insulin requirements?

    PubMed

    Heinemann, Lutz

    2009-11-01

    Bolus infusion of insulin along with a meal is a standard procedure with continuous subcutaneous insulin infusion. Modern insulin pumps allow applying this bolus in four different ways: infusion of the total dose at once or splitting the dose into two boluses, infusion of a part of the bolus in the usual manner plus infusion of the other part over a prolonged period of time (with a higher infusion rate than the basal rate), or infusion of the total dose in the form of an elevated basal rate. Depending on the composition of the given meal and its glycemic index, this is an attempt to match the circulating insulin levels to the rate of glucose absorption from the gut in order to minimize postprandial glycemic excursions. However, in the framework of evidence-based medicine, the benefits of this approach should be proven in appropriately designed clinical studies. Performance of meal-related studies requires careful attention to many aspects in order to allow meaningful evaluation of a given intervention (i.e., type of bolus). Critical evaluation of the clinical experimental studies and the one clinical study published about the impact of different types of boluses on postprandial metabolic control revealed fundamental shortcomings in study design and performance in these studies. Insufficient establishment of comparable preprandial glycemia and insulinemia on the different study days within and between the patients studied is one key aspect. Therefore, the recommendation made in most of these studies (i.e., use of dual-wave bolus) has to be accepted with care, until we have better evidence.

  12. Sustained Local Release of Methylprednisolone From a Thiol-Acrylate Poly(Ethylene Glycol) Hydrogel for Treating Chronic Compressive Radicular Pain.

    PubMed

    Slotkin, Jonathan R; Ness, Jennifer K; Snyder, Kristin M; Skiles, Amanda A; Woodard, Eric J; OʼShea, Timothy; Layer, Rick T; Aimetti, Alex A; Toms, Steven A; Langer, Robert; Tapinos, Nikos

    2016-04-01

    A preclinical animal model of chronic ligation of the sciatic nerve was used to compare the effectiveness of a slow-release hydrogel carrying methylprednisolone to methylprednisolone injection alone, which simulates the current standard of care for chronic compressive radiculopathy (CR). To extend the short-term benefits of steroid injections by using a nonswelling, biodegradable hydrogel as carrier to locally release methylprednisolone in a regulated and sustained way at the site of nerve compression. CR affects millions worldwide annually, and is a cause of costly disability with significant societal impact. Currently, a leading nonsurgical therapy involves epidural injection of steroids to temporarily alleviate the pain associated with CR. However, an effective way to extend the short-term effect of steroid treatment to address the chronic component of CR does not exist. We induced chronic compression injury of the sciatic nerves of rats by permanent ligation. Forty-eight hours later we injected our methylprednisolone infused hydrogel and assessed the effectiveness of our treatment for 4 weeks. We quantified mechanical hyperalgesia using a Dynamic Plantar Aesthesiometer (Ugo Basile, Stoelting Co., IL, USA), whereas gait analysis was conducted using the Catwalk automated gait analysis platform (Noldus, Leesburg, VA, USA). Macrophage staining was performed with immunohistochemistry and quantification of monocyte chemoattractant protein-1 in sciatic nerve lysates was performed with multiplex immunoassay using a SECTOR Imager 2400A (Meso Scale Discovery, Rockville, MA, USA). We demonstrate that using the hydrogel to deliver methylprednisolone results in significant (P < 0.05) reduction of hyperalgesia and improvement in the gait pattern of animals with chronic lesions as compared with animals treated with steroid alone. In addition, animals treated with hydrogel plus steroid showed significant reduction in the number of infiltrating macrophages at the sciatic

  13. Modification of procine stress ulceration by methylprednisolone, vitaminA and methysergide treatment.

    PubMed

    Kivilaakso, E; Kalima, T V; Lempinen, M

    1976-01-01

    Using a swine shock ulcer model, three pharmacological agents, methylprednisolone, vitamin A and methysergide were evaluated, as they protect gastric mucosa against acute ulceration. Following haemorrhagic shock (3 h duration; mean arterial pressure 40 mm Hg) nine of the ten control animals (90%) developed gastric ulceration. Of the six test animals treated with intravenous methylprednisolone during the shock, only one (17%) developed gastric lesions (p less than 0.02; x2 = 5.76). Of the ten test animals pretreated with massive doses of parenteral vitamin A, only three (30%) developed lesions (p less than 0.05; x2 = 5.21). In contrast to this, treatment with methysergide, a serotonin antagonist, did not significantly effect the ulceration rate, since four of the six test animals (67%) had gastric lesions. The results suggest that methylprednisolone and vitamin A do protect the gastric mucosa from experiment stress ulceration, but their mechanism of action remain obscure and further investigation is needed to judge their value in clinical use.

  14. A Review of the “Bolus Guide,” A New Insulin Bolus Dosing Support Tool Based on Selection of Carbohydrate Ranges

    PubMed Central

    Pańkowska, Ewa

    2010-01-01

    In this issue of Journal of Diabetes Science and Technology, Shapira and colleagues present new concepts of carbohydrate load estimation in intensive insulin therapy. By using a mathematical model, they attempt to establish how accurately carbohydrate food content should be maintained in order to keep postprandial blood glucose levels in the recommended range. Their mathematical formula, the “bolus guide” (BG), is verified by simulating prandial insulin dosing and responding to proper blood glucose levels. Different variants such as insulin sensitivity factor, insulin-to-carbohydrate ratio, and target blood glucose were taken into this formula in establishing the calculated proper insulin dose. The new approach presented here estimates the carbohydrate content by rearranging the carbohydrate load instead of the simple point estimation that the current bolus calculators (BCs) use. Computerized estimations show that the BG directives, as compared to a BC, result in more glucose levels above 200 mg/dl and thus indicate less hypoglycemia readings. PMID:20663454

  15. 21 CFR 520.2170 - Sulfabromomethazine sodium boluses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Sulfabromomethazine sodium boluses. 520.2170 Section 520.2170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Sulfabromomethazine sodium boluses. (a) Specifications. Each bolus contains 15 grams of sulfabromomethazine sodium. (b...

  16. The cost-effectiveness and budget impact of stepwise addition of bolus insulin in the treatment of type 2 diabetes: evaluation of the FullSTEP trial.

    PubMed

    Saunders, Rhodri; Lian, Jean; Karolicki, Boris; Valentine, William

    2014-12-01

    Abstract Background and aims: Intensification of basal insulin-only therapy in type 2 diabetes is often achieved through addition of bolus insulin 3-times daily. The FullSTEP trial demonstrated that stepwise addition (SWA) of bolus insulin aspart was non-inferior to full basal-bolus (FBB) therapy and reduced the rate of hypoglycemia. Here the cost-effectiveness and budget impact of SWA is evaluated. Cost-effectiveness and budget impact models were developed to assess the cost and quality-of-life (QoL) implications of intensification using SWA compared with FBB in the US setting. At assessment, SWA patients added one bolus dose to their current regimen if the HbA1c target was not met. SWA patients reaching three bolus doses used FBB event rates. Outcomes were evaluated at trial end and projected annually up to 5 years. Models captured hypoglycemic events, the proportion meeting HbA1c target, and self-measured blood glucose. Event rates and QoL utilities were taken from trial data and published literature. Costs were evaluated from a healthcare-payer perspective, reported in 2013 USD, and discounted (like clinical outcomes) at 3.5% annually. This analysis applies to patients with HbA1c 7.0-9.0% and body mass index <40 kg/m(2). SWA was associated with improved QoL and reduced costs compared with FBB. Improvement in QoL and cost reduction were driven by lower rates of hypoglycemia. Sensitivity analyses showed that outcomes were most influenced by the cost of bolus insulin and QoL impact of symptomatic hypoglycemia. Budget impact analysis estimated that, by moving from FBB to SWA, a health plan with 77,000 patients with type 2 diabetes, of whom 7.8% annually intensified to basal-bolus therapy, would save USD 1304 per intensifying patient over the trial period. SWA of bolus insulin should be considered a beneficial and cost-saving alternative to FBB therapy for the intensification of treatment in type 2 diabetes.

  17. Relationship between the flow of bolus and occlusal condition during mastication--computer simulation based on the measurement of characteristics of the bolus.

    PubMed

    Amemiya, K; Hisano, M; Ishida, T; Soma, K

    2002-03-01

    The purpose of the present study was to clarify the relationship between the flow of a bolus and occlusal condition during mastication. First, the characteristics of a bolus under mastication was measured in subjects having different occlusal conditions. Secondly, the flow of a bolus between the upper and lower first molars under mastication was simulated using finite element non-linear dynamic analysis. Measurement of the elasticity of the bolus clarified the phenomenon of its communition. The measurement of the viscosity of the bolus clarified the phenomenon of its mixing with saliva. In addition, a relationship between the elasticity and the viscosity of the bolus at the point of just before swallowing was investigated. The flow of the bolus under mastication was revealed to vary according to the occlusal condition. These results suggest a close relationship between the occlusal condition, the flow of the bolus and its characteristics.

  18. High-Dose Intravenous Methylprednisolone for Hantavirus Cardiopulmonary Syndrome in Chile: A Double-Blind, Randomized Controlled Clinical Trial

    PubMed Central

    Vial, Pablo A.; Valdivieso, Francisca; Ferres, Marcela; Riquelme, Raul; Rioseco, M. Luisa; Calvo, Mario; Castillo, Constanza; Díaz, Ricardo; Scholz, Luis; Cuiza, Analia; Belmar, Edith; Hernandez, Carla; Martinez, Jessica; Lee, Sang-Joon; Mertz, Gregory J.; Abarca, Juan; Tomicic, Vinko; Aracena, M. Eugenia; Rehbein, Ana Maria; Velásquez, Soledad; Lavin, Victoria; Garrido, Felipe; Godoy, Paula; Martinez, Constanza; Chamorro, Juan Carlos; Contreras, Jorge; Hernandez, Jury; Pino, Marcelo; Villegas, Paola; Zapata, Viviana; León, Marisol; Vega, Ivonne; Otarola, Irisol; Ortega, Carlos; Daube, Elizabeth; Huecha, Doris; Neira, Alda; Ruiz, Ines; Nuñez, M. Antonieta; Monsalve, Luz; Chabouty, Henriette; Riquelme, Lorena; Palma, Samia; Bustos, Raul; Miranda, Ruben; Mardones, Jovita; Hernandez, Nora; Betancur, Yasna; Sanhueza, Ligia; Inostroza, Jaime; Donoso, Solange; Navarrete, Maritza; Acuña, Lily; Manriquez, Paulina; Castillo, Fabiola; Unzueta, Paola; Aguilera, Teresa; Osorio, Carola; Yobanolo, Veronica; Mardones, Jorge; Aranda, Sandra; Carvajal, Soledad; Sandoval, Moisés; Daza, Soraya; Vargas, Felipe; Diaz, Violeta; Riquelme, Mauricio; Muñoz, Miriam; Carriel, Andrea; Lanino, Paola; Hernandez, Susana; Schumacher, Patricia; Yañez, Lia; Marco, Claudia; Ehrenfeld, Mildred; Delgado, Iris; Rios, Susana; Vial, Cecilia; Bedrick, Edward

    2013-01-01

    Background. Andes virus (ANDV)–related hantavirus cardiopulmonary syndrome (HCPS) has a 35% case fatality rate in Chile and no specific treatment. In an immunomodulatory approach, we evaluated the efficacy of intravenous methylprednisolone for HCPS treatment, through a parallel-group, placebo-controlled clinical trial. Methods. Patients aged >2 years, with confirmed or suspected HCPS in cardiopulmonary stage, admitted to any of 13 study sites in Chile, were randomized by study center in blocks of 4 with a 1:1 allocation and assigned through sequentially numbered envelopes to receive placebo or methylprednisolone 16 mg/kg/day (≤1000 mg) for 3 days. All personnel remained blinded except the local pharmacist. Infection was confirmed by immunoglobulin M antibodies or ANDV RNA in blood. The composite primary endpoint was death, partial pressure of arterial oxygen/fraction of inspired oxygen ratio ≤55, cardiac index ≤2.2, or ventricular tachycardia or fibrillation within 28 days. Safety endpoints included the number of serious adverse events (SAEs) and quantification of viral RNA in blood. Analysis was by intention to treat. Results. Infection was confirmed in 60 of 66 (91%) enrollees. Fifteen of 30 placebo-treated patients and 11 of 30 methylprednisolone-treated patients progressed to the primary endpoint (P = .43). We observed no significant difference in mortality between treatment groups (P = .41). There was a trend toward more severe disease in placebo recipients at entry. More subjects in the placebo group experienced SAEs (P = .02). There were no SAEs clearly related to methylprednisolone administration, and methylprednisolone did not increase viral load. Conclusions. Although methylprednisolone appears to be safe, it did not provide significant clinical benefit to patients. Our results do not support the use of methylprednisolone for HCPS. Clinical Trials Registration. NCT00128180. PMID:23784924

  19. High-dose intravenous methylprednisolone for hantavirus cardiopulmonary syndrome in Chile: a double-blind, randomized controlled clinical trial.

    PubMed

    Vial, Pablo A; Valdivieso, Francisca; Ferres, Marcela; Riquelme, Raul; Rioseco, M Luisa; Calvo, Mario; Castillo, Constanza; Díaz, Ricardo; Scholz, Luis; Cuiza, Analia; Belmar, Edith; Hernandez, Carla; Martinez, Jessica; Lee, Sang-Joon; Mertz, Gregory J

    2013-10-01

    Andes virus (ANDV)-related hantavirus cardiopulmonary syndrome (HCPS) has a 35% case fatality rate in Chile and no specific treatment. In an immunomodulatory approach, we evaluated the efficacy of intravenous methylprednisolone for HCPS treatment, through a parallel-group, placebo-controlled clinical trial. Patients aged >2 years, with confirmed or suspected HCPS in cardiopulmonary stage, admitted to any of 13 study sites in Chile, were randomized by study center in blocks of 4 with a 1:1 allocation and assigned through sequentially numbered envelopes to receive placebo or methylprednisolone 16 mg/kg/day (≤1000 mg) for 3 days. All personnel remained blinded except the local pharmacist. Infection was confirmed by immunoglobulin M antibodies or ANDV RNA in blood. The composite primary endpoint was death, partial pressure of arterial oxygen/fraction of inspired oxygen ratio ≤55, cardiac index ≤2.2, or ventricular tachycardia or fibrillation within 28 days. Safety endpoints included the number of serious adverse events (SAEs) and quantification of viral RNA in blood. Analysis was by intention to treat. Infection was confirmed in 60 of 66 (91%) enrollees. Fifteen of 30 placebo-treated patients and 11 of 30 methylprednisolone-treated patients progressed to the primary endpoint (P = .43). We observed no significant difference in mortality between treatment groups (P = .41). There was a trend toward more severe disease in placebo recipients at entry. More subjects in the placebo group experienced SAEs (P = .02). There were no SAEs clearly related to methylprednisolone administration, and methylprednisolone did not increase viral load. Although methylprednisolone appears to be safe, it did not provide significant clinical benefit to patients. Our results do not support the use of methylprednisolone for HCPS. NCT00128180.

  20. Fabrication and characterization of bolus material using polydimethyl-siloxane

    NASA Astrophysics Data System (ADS)

    Wiratma Jaya, Gede; Sutanto, Heri

    2018-01-01

    Bolus has been used in radiotherapy to reduce tissue harm and to increase the superficial dose for skin cancer treatment. Commonly, a bolus is made of melamine in several hospitals. In this research, polydimethyl-siloxane (PDMS) material was used for bolus fabrication. The aims of the study are to investigate bolus density, percentage surface dose and its structural strength for each various composition. In bolus preparation, bolus material used composition variation between PDMS volume and catalyst volume. Composition variation were 20:1, 22:1, 24:1, 26:1, 28:1, 30:1 and 32:1. PDMS and catalyst were mixed by chemical solution deposition method. Bolus was molded by using glass cast with the size of 10 × 10 × 0.5 cm3. Bolus density was analyzed by mass per volume equation, for bolus radiation was examined by the linear accelerator using two electron energy (5 and 7 MeV) and bolus strain and tensile strength were examined by Brookfield CT 3 machine. The results of bolus density were similar with soft tissue density, while the lowest and highest density each variation are 22:1 and 28:1. In general, the use of bolus has increased the surface dose. Percentage of surface dose at 5 MeV energy is higher than 7 MeV energy. The highest percentage of surface dose at 5 MeV energy with 0.5 and 1.0 cm bolus thickness was achieved at composition of 32:1. For strain and tensile strength result, the lowest and highest strain each variation are 22:1 and 28:1, then the lowest and highest tensile strength each variation are 32:1 and 28:1. These results is important to select composition material for bolus fabrication in radiotherapy treatment.

  1. Effects of copper oxide wire particle bolus therapy on trichostrongyle fecal egg counts in exotic artiodactylids.

    PubMed

    Fontenot, Deidre K; Kinney-Moscona, Allyson; Kaplan, Ray M; Miller, James

    2008-12-01

    Four species of artiodactylids (scimitar-horned oryx [Oryx dama]), roan antelope [Hippotragus equinus], blackbuck [Antilope cervicapra]), and blesbok [Damaliscus pygargus phillipsi]) totaling 13 animals were treated with a one-time 12.5-g dose of copper oxide wire particles (COWPs) in a bolus form. Pretreatment, individual trichostrongyle fecal egg counts (FECs) were performed using the McMaster technique. Individual posttreatment FECs were performed every 7 days for 35 days beginning 7 days after bolus administration, and FEC reduction ratios (FECRRs) expressed as percentage reductions from pretreatment values were calculated every 7 days. Mean FECRRs for the 13 animals were 93% +/- 16%, 98% +/- 7%, 91% +/- 28%, 94% +/- 16%, and 90% +/- 13% at 7, 14, 21, 28, and 35 days posttreatment, respectively. These data demonstrate that COWPs in a bolus form were an effective method for reducing FEC in exotic artiodactylids. Based on this limited data, COWPs show promise as an anthelmintic alternative for exotic artiodactylids in zoologic collections.

  2. High-dose methylprednisolone treatment of laser-induced retinal injury exacerbates acute inflammation and long-term scarring

    NASA Astrophysics Data System (ADS)

    Schuschereba, Steven T.; Cross, Michael E.; Scales, David K.; Pizarro, Jose M.; Edsall, Peter R.; Stuck, Bruce E.; Marshall, John

    1999-06-01

    Purpose. To evaluate therapeutics for attenuating retinal laser injury. Methods. New Zealand Red rabbits (n=76) were pretreated (IV) with either a single dose of hydroxyethyl starch conjugated deferoxamine (HES-DFO, n=29) (6.1 ml/kg, 16.4 mg/ml) or methylprednisolone sodium succinate (MP, n=22) (30 mg/kg, followed by taper of 30, 20, 20, and 10 mg/kg/day for a total of 5d). Controls were untreated (n=25). Fifteen min later, animals were irradiated with a multiline cw argon laser (285 mW, 10 msec pulse durations, 16 lesions/eye). Funduscopy, fluorescein angiography, histology, and morphometry were performed at 10 min, 1h, 3h, 24h, 1 mo, and 6 mo after irradiation. Leukocytes were counted at lesion centers for retinal and choroidal compartments at 1, 3, and 24h. Results. At 3h, percent area incrase for the lesions was highest for MP (44%) and lowest for HES-DFO (16%)(p<0.05). In hemorrhagic lesions, MP treatment resulted in the highest increase of retinal neotrophils by 24h (p<0.05), and by 1 and 6 mo extensive chorio-retinal scarring occurred in nonhemorrhagic and hemorrhagic lesions. Also, no benefit was demonstrated on sparing of photoreceptors with MP treatment. Conclusions. Treatment of laser-induced retinal injury with methylprednisolone (MP) exacerbates acute inflammation and long-term chorio-retinal scarring; however, hydroxyethyl starch conjugated deferoxamine therapy ameliorates these aspects of injury. Data suggest caution in the use of MP therapy for laser injuries.

  3. Effects of Age, Gender, Bolus Volume, Bolus Viscosity, and Gustation on Swallowing Apnea Onset Relative to Lingual Bolus Propulsion Onset in Normal Adults

    ERIC Educational Resources Information Center

    Hiss, Susan G.; Strauss, Monica; Treole, Kathleen; Stuart, Andrew; Boutilier, Susan

    2004-01-01

    The purpose of this study was to ascertain the normal relation of swallowing apnea (SA) onset relative to lingual bolus propulsion along with factors that may alter this relation. Forty adults, composed of 10 men and 10 women in each of 2 age groups (i.e., 20-30 and 63-79 years) participated. SA onset was assessed during 5- and 20-ml bolus volumes…

  4. Glucagon Is a Safe and Inexpensive Initial Strategy in Esophageal Food Bolus Impaction.

    PubMed

    Haas, Jason; Leo, Julia; Vakil, Nimish

    2016-03-01

    Controversy exists about the utility of pharmacologic agents and endoscopic technique used for esophageal food bolus impaction. To evaluate the utility of glucagon and the technique used for endoscopic removal, including the rate of success and the adverse events of the techniques. The database of the largest healthcare provider in southeastern Wisconsin was retrospectively reviewed for patients presenting with esophageal food bolus impaction. Data extracted included glucagon administration and its success rate, outcome of radiographic studies, and the endoscopic method of removal and adverse events associated with it, including 30-day mortality. A total of 750 patients were identified with food bolus impaction from 2007 to 2012. Glucagon was administered in 440 patients and was successful in 174 (39.5%). Endoscopic removal was performed in 470 patients and was successful in 469 (99.8%). The push technique was utilized in 209 patients, reduction in the bolus size by piecemeal removal followed by the push technique was utilized in 97 patients, and the pull technique was utilized in 107 patients. There were no perforations with endoscopic removal. Only 4.5% of the X-rays performed reported a possible foreign body within the esophagus. Glucagon was a significantly less-expensive strategy than endoscopic therapy (p < 0.0001). Glucagon is low cost, is moderately effective, and may be considered as an initial strategy. Endoscopic removal regardless of technique is safe and effective. The yield of radiography is poor in the setting of food bolus impaction.

  5. Comparison of the effects of chronic intra-articular administration of tenoxicam, diclofenac, and methylprednisolone in healthy rats.

    PubMed

    Orak, Mehmet Müfit; Ak, Dursun; Midi, Ahmet; Laçin, Berna; Purisa, Sevim; Bulut, Güven

    2015-01-01

    Lyophilized drug manufacturing and intra-articular (IA) applications have increased to address gastrointestinal side effects resulting from chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for degenerative joint disease. Accordingly, we histologically examined joint and stomach tissues from rats to determine and compare the effects of long-term treatment with an IA corticosteroid (methylprednisolone acetate), lyophilized NSAID (tenoxicam), and non-lyophilized NSAID (diclofenac) following application to the knee joint. One hundred Wistar albino rats were divided into 4 groups of 25 rats: control, methylprednisolone, tenoxicam, and diclofenac. Ten IA injections were administered at 1-week intervals. Rats were sacrificed at 48 h and 1, 2, 4, and 8 weeks after the tenth injection. Histomorphologically, knee joint samples were examined for osteoarthritic changes and stomach tissue samples for gastric changes. Unlike methylprednisolone, diclofenac and tenoxicam caused increased fibrosis and fibroblast production; furthermore, chronic methylprednisolone use had no negative effects on the synovium or cartilage. Chronic tenoxicam and diclofenac use affects joints more negatively than chronic steroid treatment.

  6. Pharyngeal Pressure and Timing During Bolus Transit

    PubMed Central

    Walczak, Chelsea C.; Jones, Corinne A.; McCulloch, Timothy M.

    2018-01-01

    Determining intrabolus pressure (IBP) at the upper esophageal sphincter (UES) and in the esophagus has given compelling evidence that IBP can be a predictor for swallowing dysfunction. Studies have looked most superiorly at the low hypopharynx region but there has been no inquiry into what IBP measures throughout the entire pharynx can tell us. We present a study to describe the pressures within and surrounding the moving bolus throughout the pharynx and into the UES. Simultaneous HRM and videofluoroscopy were performed in 10 healthy subjects swallowing ten 10 mL thin-liquid barium boluses. Three events surrounding bolus movement were tracked via videofluoroscopy, two additional events were found using manometric measures. As the bolus passes through the pharynx, low pressure is created at and below the head of the bolus. A modest pressure increase is seen as the bolus passes through the pharynx and finally, high pressure is observed at the bolus tail, followed by an even larger pressure generation of a clearance event. HRM allows for greater resolution in data collection in the pharynx and in this study, aided in identifying semi unique characteristics around the hypopharynx and the UES which are consistent with the complex anatomy of the regions and the transition of the UES from active closure to relaxed opening. In the future, additional studies designed to look at aged and diseased populations may lead to better understanding of disease etiology, and treatment options. PMID:27565155

  7. Effect of methylprednisolone on bone mineral density in rats with ovariectomy-induced bone loss and suppressed endogenous adrenaline levels by metyrosine

    PubMed Central

    Yilmaz, Mehmet; Isaoglu, Unal; Uslu, Turan; Yildirim, Kadir; Seven, Bedri; Akcay, Fatih; Hacimuftuoglu, Ahmet

    2013-01-01

    Objectives: In this study, effect of methylprednisolone on bone mineral density (BMD) was investigated in rats with overiectomy induced bone lose and suppressed endogenous adrenalin levels, and compared to alendronate. Materials and Methods: Severity of bone loss in the examined material (femur bones) was evaluated by BMD measurement. Results: The group with the highest BMD value was metyrosinemetyrosine + methylprednisolone combination (0.151 g/cm2), while that with the lowest BMD was methylprednisolone (0.123 g/cm2). Alendronate was effective only when used alone in ovariectomized rats (0.144 g/cm2), but not when used in combination with methylprednisolone (0.124 g/cm2). In the ovariectomized rat group which received only metyrosine, BMD value was statistically indifferent from ovariectomized control group. Conclusions: Methylprednisolone protected bone loss in rats with suppressed adrenaline levels because of metyrosinemetyrosine. PMID:24014908

  8. Use of an Automated Bolus Calculator Reduces Fear of Hypoglycemia and Improves Confidence in Dosage Accuracy in Patients with Type 1 Diabetes Mellitus Treated with Multiple Daily Insulin Injections

    PubMed Central

    Barnard, Katharine; Parkin, Christopher; Young, Amanda; Ashraf, Mansoor

    2012-01-01

    Background Many patients do not intensify their insulin regimens. It is believed that lack of adherence may be largely due to fear of hypoglycemia. We hypothesized that utilization of an automated bolus calculator (bolus advisor) might reduce fear of hypoglycemia and encourage patients to achieve improved glycemic control. Method We surveyed 1,412 type 1 diabetes mellitus (T1DM) patients treated with multiple daily insulin injection therapy at 270 hospitals in the United Kingdom and Republic of Ireland to assess their attitudes and behaviors regarding insulin therapy after use of a bolus advisor (Accu-Chek® Aviva Expert blood glucose meter and bolus advisor system, Roche Diagnostics). The device automatically calculates bolus dosages based on current blood glucose values, anticipated meal intake, and other parameters. Results Five hundred eighty-eight T1DM patients responded to the survey. Respondents were predominantly female, age <1 to 70 years, with diabetes duration of <1 to >15 years. Respondents had 4–12 weeks prior experience using the bolus advisor. 76.7% of respondents indicated current bolus advisor use to calculate insulin boluses for meals/snacks always or quite often. 52.0% of respondents indicated that fear of hypoglycemia was reduced (39.0%) or significantly reduced (13.0%). 78.8% indicated that confidence in the insulin dose calculation improved (50.8%) or significantly improved (28.0%). 89.3% indicated that the bolus advisor made bolus calculation easy or very easy compared with manual calculation. Conclusions Most patients felt that using the bolus advisor was easier than manual bolus calculation, improved their confidence in the accuracy of their bolus dosage, and reduced their fear of hypoglycemia. Randomized trials are needed to confirm these perceptions and determine whether bolus advisor use improves clinical outcomes. PMID:22401332

  9. Dr Michaels® product family (also branded as Soratinex®) versus Methylprednisolone aceponate - a comparative study of the effectiveness for the treatment of plaque psoriasis.

    PubMed

    Hercogovấ, J; Fioranelli, M; Gianfaldoni, S; Chokoeva, A A; Tchernev, G; Wollina, U; Tirant, M; Novotny, F; Roccia, M G; Maximov, G K; França, K; Lotti, T

    2016-01-01

    As one of the most common dermatologic chronic-recurrent disease, variable therapeutic options are available today for management of psoriasis. Although topical high potency corticosteroids, alone or in association with salicylic acid or vitamin D analogues, are still considered the best treatment, they do not seem to possess the capability for a long-term control of the disease or prevent recurrences, as their side effects are major contraindications for continuative use. The aim of this study was to investigate whether Dr. Michaels® product family is comparable to methylprednisolone aceponate (MPA) as a viable alternative treatment option for the treatment and management of stable chronic plaque psoriasis. Thirty adults (13 male, 17 female, mean age 40 years) with mild to severe stable chronic plaque psoriasis, were included in the study. Patients were advised to treat the lesions of the two sides of their body (left and right) with two different unknown modalities for 8 weeks; the pack of Dr. Michaels® products on the left side (consisting of a cleansing gel, an ointment and a skin conditioner) and a placebo pack on the right side, consisting of a cleansing gel, methylprednisolone ointment and a placebo conditioner. Assessment was done using the Psoriasis Activity Severity Index (PASI) scores before treatment and after 2, 4, 6 and 8 weeks. The results achieved with the Dr. Michaels® (Soratinex®) product family for the treatment of chronic plaque psoriasis were better than the results achieved with methylprednisolone aceponate (MPA), even though quicker resolution was achieved with the steroid with 45% of patients achieving resolution within 8-10 days in comparison to 5-6 weeks in the Dr. Michaels® (Soratinex®) group. Before therapy, the mean PASI score of the LHS in Dr. Michaels® (Soratinex®) group was 13.8±4.1 SD and 14.2±4.2 SD in the RHS methylprednisolone aceponate (MPA) group. After 8 weeks of treatment 62% of the Dr. Michaels® (Soratinex

  10. Lung volume is a determinant of aerosol bolus dispersion.

    PubMed

    Schulz, Holger; Eder, Gunter; Heyder, Joachim

    2003-01-01

    The technique of inhaling a small volume element labeled with particles ("aerosol bolus") can be used to assess convective gas mixing in the lung. While a bolus undergoes mixing in the lung, particles are dispersed in an increasing volume of the respired air. However, determining factors of bolus dispersion are not yet completely understood. The present study tested the hypothesis that bolus dispersion is related, among others, to the total volume in which the bolus is allowed to mix--i.e., to the individual lung size. Bolus dispersion was measured in 32 anesthetized, mechanically ventilated dogs with total lung capacities (TLCs) of 1.1-2.5 L. Six-milliliter aerosol boluses were introduced at various preselected time-points during inspiration to probe different volumetric lung depths. Dispersion (SD) was determined by moment analysis of particle concentrations in the expired air. We found linear correlations between SD at a given lung depth and the individual end-inspiratory lung volume (V(L)). The relationship was tightest for boluses inhaled deepest into the lungs: SD(40) = 0.068 V(L) - 1.77, r(2) = 0.59. Normalizing SD to V(L) abolished this dependency and resulted in a considerable reduction of inter-individual variability as compared to the uncorrected measurements. These data indicate that lung size influences measurements of bolus dispersion. It therefore appears reasonable to apply a normalization procedure before interpreting the data. Apart from a reduction in measurement variability, this should help to separate the effects on bolus dispersion of altered lung volumes and altered mixing processes in diseased lungs.

  11. Fungal Infections Associated with Contaminated Methylprednisolone in Tennessee

    PubMed Central

    Kainer, Marion A.; Reagan, David R.; Nguyen, Duc B.; Wiese, Andrew D.; Wise, Matthew E.; Ward, Jennifer; Park, Benjamin J.; Kanago, Meredith L.; Baumblatt, Jane; Schaefer, Melissa K.; Berger, Brynn E.; Marder, Ellyn P.; Min, Jea-Young; Dunn, John R.; Smith, Rachel M.; Dreyzehner, John; Jones, Timothy F.

    2015-01-01

    , seven of whom had stroke. CONCLUSIONS We describe an outbreak of fungal meningitis after epidural or paraspinal glucocorticoid injection with methylprednisolone from a single compounding pharmacy. Rapid recognition of illness and prompt initiation of therapy are important to prevent complications. (Funded by the Tennessee Department of Health and the Centers for Disease Control and Prevention.) PMID:23131029

  12. Causes of death after fluid bolus resuscitation: new insights from FEAST

    PubMed Central

    2013-01-01

    The Fluid Expansion as Supportive Therapy (FEAST study) was an extremely well conducted study that gave unexpected results. The investigators had reported that febrile children with impaired perfusion treated in low-income countries without access to intensive care are more likely to die if they receive bolus resuscitation with albumin or saline compared with no bolus resuscitation at all. In a secondary analysis of the trial, published in BMC Medicine, the authors found that increased mortality was evident in patients who presented with clinical features of severe shock in isolation or in conjunction with features of respiratory or neurological failure. The cause of excess deaths was primarily refractory shock and not fluid overload. These features are consistent with a potential cardiotoxic or ischemia-reperfusion injury following resuscitation with boluses of intravenous fluid. Although these effects may have been amplified by the absence of invasive monitoring, mechanical ventilation or vasopressors, the results provide compelling insights into the effects of intravenous fluid resuscitation and potential adverse effects that extend beyond the initial resuscitation period. These data add to the increasing body of literature about the safety and efficacy of intravenous resuscitation fluids, which may be applicable to management of other populations of critically ill patients. PMID:23497460

  13. Causes of death after fluid bolus resuscitation: new insights from FEAST.

    PubMed

    Myburgh, John; Finfer, Simon

    2013-03-14

    The Fluid Expansion as Supportive Therapy (FEAST study) was an extremely well conducted study that gave unexpected results. The investigators had reported that febrile children with impaired perfusion treated in low-income countries without access to intensive care are more likely to die if they receive bolus resuscitation with albumin or saline compared with no bolus resuscitation at all. In a secondary analysis of the trial, published in BMC Medicine, the authors found that increased mortality was evident in patients who presented with clinical features of severe shock in isolation or in conjunction with features of respiratory or neurological failure. The cause of excess deaths was primarily refractory shock and not fluid overload. These features are consistent with a potential cardiotoxic or ischemia-reperfusion injury following resuscitation with boluses of intravenous fluid. Although these effects may have been amplified by the absence of invasive monitoring, mechanical ventilation or vasopressors, the results provide compelling insights into the effects of intravenous fluid resuscitation and potential adverse effects that extend beyond the initial resuscitation period. These data add to the increasing body of literature about the safety and efficacy of intravenous resuscitation fluids, which may be applicable to management of other populations of critically ill patients.

  14. Metastatic Thymoma-Associated Myasthenia Gravis: Favorable Response to Steroid Pulse Therapy Plus Immunosuppressive Agent

    PubMed Central

    Qi, Guoyan; Liu, Peng; Dong, Huimin; Gu, Shanshan; Yang, Hongxia; Xue, Yinping

    2017-01-01

    Background Our study retrospectively reviewed the therapeutic effect of steroid pulse therapy in combination with an immunosuppressive agent in myasthenia gravis (MG) patients with metastatic thymoma. Material/Methods MG patients with metastatic thymoma that underwent methylprednisolone pulse therapy plus cyclophosphamide were retrospectively analyzed. Patients initially received methylprednisolone pulse therapy followed by oral methylprednisolone. Cyclophosphamide was prescribed simultaneously at the beginning of treatment. Clinical outcomes, including therapeutic efficacy and adverse effects of MG and thymoma, were assessed. Results Twelve patients were recruited. According to histological classification, 4 cases were type B2 thymoma, 3 were type B3, 2 were type B1, and 1 was type AB. After combined treatment for 15 days, both the thymoma and MG responded dramatically to high-dose methylprednisolone plus cyclophosphamide. The symptoms of MG were improved in all patients, with marked improvement in 6 patients and basic remission in 4. Interestingly, complete remission of thymoma was achieved in 5 patients and partial remission in 7 patients. Myasthenic crisis was observed in 1 patient and was relieved after intubation and ventilation. Adverse reactions were observed in 7 patients (58.3%), most commonly infections, and all were resolved without discontinuation of therapy. During the follow-up, all patients were stabilized except for 1 with pleural metastasis who received further treatment and another 1 who died from myasthenic crisis. Conclusions The present study in a series of MG patients with metastatic thymoma indicated that steroid pulse therapy in combination with immunosuppressive agents was an effective and well-tolerated for treatment of both metastatic thymoma and MG. Glucocorticoid pulse therapy plus immunosuppressive agents should therefore be considered in MG patients with metastatic thymoma. PMID:28278141

  15. Clinical implementation of 3D printing in the construction of patient specific bolus for electron beam radiotherapy for non-melanoma skin cancer.

    PubMed

    Canters, Richard A; Lips, Irene M; Wendling, Markus; Kusters, Martijn; van Zeeland, Marianne; Gerritsen, Rianne M; Poortmans, Philip; Verhoef, Cornelia G

    2016-10-01

    Creating an individualized tissue equivalent material build-up (i.e. bolus) for electron beam radiation therapy is complex and highly labour-intensive. We implemented a new clinical workflow in which 3D printing technology is used to create the bolus. A patient-specific bolus is designed in the treatment planning system (TPS) and a shell around it is created in the TPS. The shell is printed and subsequently filled with silicone rubber to make the bolus. Before clinical implementation we performed a planning study with 11 patients to evaluate the difference in tumour coverage between the designed 3D-print bolus and the clinically delivered plan with manually created bolus. For the first 15 clinical patients a second CT scan with the 3D-print bolus was performed to verify the geometrical accuracy. The planning study showed that the V85% of the CTV was on average 97% (3D-print) vs 88% (conventional). Geometric comparison of the 3D-print bolus to the originally contoured bolus showed a high similarity (DSC=0.89). The dose distributions on the second CT scan with the 3D print bolus in position showed only small differences in comparison to the original planning CT scan. The implemented workflow is feasible, patient friendly, safe, and results in high quality dose distributions. This new technique increases time efficiency. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  16. Successful treatment of refractory anemia with a combination regimen containing recombinant human erythropoietin, low-dose methylprednisolone and nandrolone.

    PubMed

    Tsiara, S N; Chaidos, A; Gouva, M; Christou, L; Panteli, K; Kapsali, E; Bourantas, K L

    2004-03-01

    Myelodysplastic syndromes (MDS) are a heterogenous group of hematological clonal malignancies. Patients belonging to the refractory anemia (RA) subtype are usually treated with recombinant human erythropoietin (EPO). Not all patients respond to EPO administration and they are strictly dependent on supportive therapy with red cell blood (RBC) transfusions. The aim of this study was to investigate the efficacy of an alternative combination regimen containing EPO, low-dose methylprednisolone and nandrolone decanoate, in patients with RA unresponsive to EPO administration alone. Ten patients, 4 women and 6 men, median age: 70 years (range: 55-78 years) with refractory anemia unresponsive to EPO administration and RBC transfusion-dependent were included in the study. Median hematological data at baseline were Hb: 8.7 g/dl, (range 6.2-9.8), WBC: 3.35x10(9)/l (range 2.1-4), PLT: 82.5x10(9)/l (range 59-110). EPO 150 U/Kg three times/week subcutaneously, low-dose methylprednisolone 8 mg/day orally and nandrolone decanoate (Decadurabolin) 50 mg two-times/week intramuscularly were administered. As complete response (CR) to treatment was considered the normalization of the peripheral blood and bone marrow smears and biopsy. As partial response (PR) was considered increase in Hb level > or = 2 g/dl, or up to 10 g/dl and discontinuation of RBC transfusions. The response to therapy was evaluated on the 4th week after the initiation of the combination treatment. Bone marrow smear evaluation was carried out at baseline and every six months afterwards. After a 4-week treatment all patients achieved PR and discontinued RBC transfusions. Median and range hematological values on the 4th week after treatment initiation were Hb: 11.2 g/dl, (range: 9.8-12.8), WBC: 4.4x10(9)/l (3.5-6.6), PLT: 130x10(9)/l (95-160). The increase observed in hematological values was significant (p = 0.0001, 0.0004 and < 0.0001, respectively, for Hb, WBC and PLT counts). Treatment was well tolerated

  17. 21 CFR 520.1660c - Oxytetracycline hydrochloride tablets/boluses.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Oxytetracycline hydrochloride tablets/boluses. 520....1660c Oxytetracycline hydrochloride tablets/boluses. (a) Specifications. Each tablet or bolus contains 250, 500, or 1,000 milligrams of oxytetracycline hydrochloride. (b) Sponsors. For sponsors in § 510...

  18. An in vitro evaluation of the anti-inflammatory effects of platelet-rich plasma, ketorolac, and methylprednisolone.

    PubMed

    Mazzocca, Augustus D; McCarthy, Mary Beth R; Intravia, Jessica; Beitzel, Knut; Apostolakos, John; Cote, Mark P; Bradley, James; Arciero, Robert A

    2013-04-01

    The purpose of this study was to quantify the extent of the anti-inflammatory effect of platelet-rich plasma (PRP) in a controlled in vitro environment. Through the stimulation of human umbilical vein endothelial cells with inflammatory cytokines (tumor necrosis factor α and interferon γ), cell adhesion molecule expression (E-selectin, vascular cell adhesion molecule, and human leukocyte antigen DR) and PRP's anti-inflammatory effect can be measured. PRP was produced from 3 individuals using a single-spin (PRPLP) process. Treatment groups include negative (unstimulated) controls, positive (stimulated) controls, ketorolac tromethamine, methylprednisolone, PRP, ketorolac-PRP, and methylprednisolone-PRP. A fluorescence assay of the cellular inflammation markers was measured by the BioTek Synergy HT plate reader (BioTek Instruments, Winooski, VT) at 0, 1, 2, and 5 days. At days 2 and 5, methylprednisolone treatment showed a 2.1- to 5.8-fold reduction (P < .05) in inflammation markers over PRP. In addition, PRP and ketorolac showed a 1.4- to 2.5-fold reduction (P < .05) in cellular inflammation markers over the control. There was no statistically significant difference between ketorolac and PRP. Although PRP and ketorolac reduced cellular inflammation markers (E-selectin, vascular cell adhesion molecule, and human leukocyte antigen DR) compared with control, neither caused as great a reduction as methylprednisolone. Although PRP and ketorolac did not produce as significant a reduction in cellular inflammation markers as methylprednisolone, they reduced cellular inflammation compared with the control. These agents may have clinical application as injectable anti-inflammatory medications. Copyright © 2013 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  19. Crystal structure of methylprednisolone acetate form II, C 24H 32O 6

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Wheatley, Austin M.; Kaduk, James A.; Gindhart, Amy M.

    The crystal structure of methylprednisolone acetate form II, C 24H 32O 6, has been solved and refined using synchrotron X-ray powder diffraction data, and optimized using density functional techniques. Methylprednisolone acetate crystallizes in space groupP2 12 12 1(#19) witha= 8.17608(2),b= 9.67944(3),c= 26.35176(6) Å,V= 2085.474(6) Å 3, andZ= 4. Both hydroxyl groups act as hydrogen bond donors, resulting in a two-dimensional hydrogen bond network in theabplane. C–H…O hydrogen bonds also contribute to the crystal energy. The powder pattern is included in the Powder Diffraction File™ as entry 00-065-1412.

  20. SU-C-213-06: Dosimetric Verification of 3D Printed Electron Bolus

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Rasmussen, K; Corbett, M; Pelletier, C

    2015-06-15

    Purpose: To determine the dosimetric effect of 3D printed bolus in an anthropomorphic phantom. Methods: Conformable bolus material was generated for an anthropomorphic phantom from a DICOM volume. The bolus generated was a uniform expansion of 5mm applied to the nose region of the phantom, as this is a difficult area to uniformly apply bolus clinically. A Printrbot metal 3D Printer using PLA plastic generated the bolus. A 9MeV anterior beam with a 5cm cone was used to deliver dose to the nose of the phantom. TLD measurements were compared to predicted values at the phantom surface. Film planes weremore » analyzed for the printed bolus, a standard 5mm bolus sheet placed on the phantom, and the phantom with no bolus applied to determine depth and dose distributions. Results: TLDs measured within 2.5% of predicted value for the 3D bolus. Film demonstrated a more uniform dose distribution in the nostril region for the 3d printed bolus than the standard bolus. This difference is caused by the air gap created around the nostrils by the standard bolus, creating a secondary build-up region. Both demonstrated a 50% central axis dose shift of 5mm relative to the no bolus film. HU for the bolus calculated the PLA electron density to be ∼1.1g/cc. Physical density was measured to be 1.3g/cc overall. Conclusion: 3D printed PLA bolus demonstrates improved dosimetric performance to standard bolus for electron beams with complex phantom geometry.« less

  1. Methylprednisolone for prevention of ovarian hyperstimulation syndrome in patients with polycystic ovarian syndrome undergoing in-vitro fertilisation: a randomised controlled trial.

    PubMed

    Mohammadi Yeganeh, Ladan; Moini, Ashraf; Shiva, Marzieh; Mirghavam, Naimeh; Bagheri Lankarani, Narges

    2018-02-01

    This study aimed to evaluate the effect of methylprednisolone on prevention of ovarian hyperstimulation syndrome (OHSS) in polycystic ovarian syndrome (PCOS) patients undergoing in-vitro fertilisation (IVF). This randomised controlled trial was carried out between November 2009 and December 2013. A total of 219 eligible patients were randomly allocated for treatment (n = 108) or control groups (n = 111). The treatment group received oral methylprednisolone starting from the first day of stimulation. These patients also received an intravenous dose of methylprednisolone on the days of egg collection and embryo transfer. The control group received no glucocorticoid treatment to prevent OHSS. Nineteen percent of patients (18/93) who received methylprednisolone developed OHSS compared with 16.5% (15/91) in the control group and no significant difference was found (p = .61). There were no significant differences between treatment and control groups in the rates of implantation (10% versus 11%, p = .77) and clinical pregnancy (23.2% versus 17.7%, p = .46). Methylprednisolone did not reduce the incidence and severity of OHSS in PCOS patients undergoing IVF and no improvement in clinical outcomes was observed. Impact statement No significant differences were found in OHSS incidence and clinical outcomes between women who received methylprednisolone and control group. There seems to be no benefit for the routine use of glucocorticoids in IVF/ICSI treatments.

  2. Porous Se@SiO2 nanocomposites protect the femoral head from methylprednisolone-induced osteonecrosis.

    PubMed

    Deng, Guoying; Dai, Chenyun; Chen, Jinyuan; Ji, Anqi; Zhao, Jingpeng; Zhai, Yue; Kang, Yingjie; Liu, Xijian; Wang, Yin; Wang, Qiugen

    2018-01-01

    Methylprednisolone (MPS) is an important drug used in therapy of many diseases. However, osteonecrosis of the femoral head is a serious damage in the MPS treatment. Thus, it is imperative to develop new drugs to prevent the serious side effect of MPS. The potential interferences Se@SiO 2 nanocomposites may have to the therapeutic effect of methylprednisolone (MPS) were evaluated by classical therapeutic effect index of acute respiratory distress syndrome (ARDS), such as wet-to-dry weight ratio, inflammatory factors IL-1β and TNF-α. And oxidative stress species (ROS) index like superoxide dismutase (SOD) and glutathione (GSH) were tested. Then, the protection effects of Se@SiO 2 have in osteonecrosis of the femoral head (ONFH) were evaluated by micro CT, histologic analysis and Western-blot analysis. In the present study, we found that in the rat model of ARDS, Se@SiO 2 nanocomposites induced SOD and GSH indirectly to reduce ROS damage. The wet-to-dry weight ratio of lung was significantly decreased after MPS treatment compared with the control group, whereas the Se@SiO 2 did not affect the reduced wet-to-dry weight ratio of MPS. Se@SiO 2 also did not impair the effect of MPS on the reduction of inflammatory factors IL-1β and TNF-α, and on the alleviation of structural destruction. Furthermore, micro CT and histologic analysis confirmed that Se@SiO 2 significantly alleviate MPS-induced destruction of femoral head. Moreover, compared with MPS group, Se@SiO 2 could increase collagen II and aggrecan, and reduce the IL-1β level in the cartilage of femoral head. In addition, the biosafety of Se@SiO 2 in vitro and in vivo were supported by cell proliferation assay and histologic analysis of main organs from rat models. Se@SiO 2 nanocomposites have a protective effect in MPS-induced ONFH without influence on the therapeutic activity of MPS, suggesting the potential as effective drugs to avoid ONFH in MPS therapy.

  3. Porous Se@SiO2 nanocomposites protect the femoral head from methylprednisolone-induced osteonecrosis

    PubMed Central

    Chen, Jinyuan; Ji, Anqi; Zhao, Jingpeng; Zhai, Yue; Kang, Yingjie; Liu, Xijian; Wang, Yin; Wang, Qiugen

    2018-01-01

    Background Methylprednisolone (MPS) is an important drug used in therapy of many diseases. However, osteonecrosis of the femoral head is a serious damage in the MPS treatment. Thus, it is imperative to develop new drugs to prevent the serious side effect of MPS. Methods The potential interferences Se@SiO2 nanocomposites may have to the therapeutic effect of methylprednisolone (MPS) were evaluated by classical therapeutic effect index of acute respiratory distress syndrome (ARDS), such as wet-to-dry weight ratio, inflammatory factors IL-1β and TNF-α. And oxidative stress species (ROS) index like superoxide dismutase (SOD) and glutathione (GSH) were tested. Then, the protection effects of Se@SiO2 have in osteonecrosis of the femoral head (ONFH) were evaluated by micro CT, histologic analysis and Western-blot analysis. Results In the present study, we found that in the rat model of ARDS, Se@SiO2 nanocomposites induced SOD and GSH indirectly to reduce ROS damage. The wet-to-dry weight ratio of lung was significantly decreased after MPS treatment compared with the control group, whereas the Se@SiO2 did not affect the reduced wet-to-dry weight ratio of MPS. Se@SiO2 also did not impair the effect of MPS on the reduction of inflammatory factors IL-1β and TNF-α, and on the alleviation of structural destruction. Furthermore, micro CT and histologic analysis confirmed that Se@SiO2 significantly alleviate MPS-induced destruction of femoral head. Moreover, compared with MPS group, Se@SiO2 could increase collagen II and aggrecan, and reduce the IL-1β level in the cartilage of femoral head. In addition, the biosafety of Se@SiO2 in vitro and in vivo were supported by cell proliferation assay and histologic analysis of main organs from rat models. Conclusion Se@SiO2 nanocomposites have a protective effect in MPS-induced ONFH without influence on the therapeutic activity of MPS, suggesting the potential as effective drugs to avoid ONFH in MPS therapy. PMID:29606872

  4. Mortality after fluid bolus in African children with severe infection.

    PubMed

    Maitland, Kathryn; Kiguli, Sarah; Opoka, Robert O; Engoru, Charles; Olupot-Olupot, Peter; Akech, Samuel O; Nyeko, Richard; Mtove, George; Reyburn, Hugh; Lang, Trudie; Brent, Bernadette; Evans, Jennifer A; Tibenderana, James K; Crawley, Jane; Russell, Elizabeth C; Levin, Michael; Babiker, Abdel G; Gibb, Diana M

    2011-06-30

    The role of fluid resuscitation in the treatment of children with shock and life-threatening infections who live in resource-limited settings is not established. We randomly assigned children with severe febrile illness and impaired perfusion to receive boluses of 20 to 40 ml of 5% albumin solution (albumin-bolus group) or 0.9% saline solution (saline-bolus group) per kilogram of body weight or no bolus (control group) at the time of admission to a hospital in Uganda, Kenya, or Tanzania (stratum A); children with severe hypotension were randomly assigned to one of the bolus groups only (stratum B). All children received appropriate antimicrobial treatment, intravenous maintenance fluids, and supportive care, according to guidelines. Children with malnutrition or gastroenteritis were excluded. The primary end point was 48-hour mortality; secondary end points included pulmonary edema, increased intracranial pressure, and mortality or neurologic sequelae at 4 weeks. The data and safety monitoring committee recommended halting recruitment after 3141 of the projected 3600 children in stratum A were enrolled. Malaria status (57% overall) and clinical severity were similar across groups. The 48-hour mortality was 10.6% (111 of 1050 children), 10.5% (110 of 1047 children), and 7.3% (76 of 1044 children) in the albumin-bolus, saline-bolus, and control groups, respectively (relative risk for saline bolus vs. control, 1.44; 95% confidence interval [CI], 1.09 to 1.90; P=0.01; relative risk for albumin bolus vs. saline bolus, 1.01; 95% CI, 0.78 to 1.29; P=0.96; and relative risk for any bolus vs. control, 1.45; 95% CI, 1.13 to 1.86; P=0.003). The 4-week mortality was 12.2%, 12.0%, and 8.7% in the three groups, respectively (P=0.004 for the comparison of bolus with control). Neurologic sequelae occurred in 2.2%, 1.9%, and 2.0% of the children in the respective groups (P=0.92), and pulmonary edema or increased intracranial pressure occurred in 2.6%, 2.2%, and 1.7% (P=0

  5. Atorvastatin calcium in combination with methylprednisolone for the treatment of multiple sclerosis relapse.

    PubMed

    Li, Xiao-ling; Zhang, Zhen-chang; Zhang, Bo; Jiang, Hua; Yu, Chun-mei; Zhang, Wen-jing; Yan, Xiang; Wang, Man-xia

    2014-12-01

    This study aimed to investigate the efficacy of combined atorvastatin calcium and methylprednisolone for the treatment of multiple sclerosis relapse. Patients with multiple sclerosis (MS) at the relapse phase were randomized to receive either combined treatment of atorvastatin calcium and methylprednisolone (n = 19) or methylprednisolone alone (n = 19). Expanded Disability Status Scale (EDSS) was administered at baseline, 1 week, 2 weeks, 4 weeks, 3 months, and 6 months after treatment initiation. The number and volume of brain lesions were evaluated using magnetic resonance imaging at baseline and 6 months. The levels of IL-13, IL-35, IFN-γ, and IL-10 in the cerebrospinal fluid were examined using the enzyme-linked immunosorbent assay method. There was no significant difference in EDSS scores at 1, 2, and 4 weeks. At 3 and 6 months, the combined treatment group showed significantly lower EDSS scores than the monotherapy group (P < 0.05). The number and volume of brain lesions in the combined treatment group were significantly lower than the monotherapy group at 6 months (P < 0.001). The mean time to relapse was significantly extended in the combined treatment group than the monotherapy group (P < 0.001). At 2 and 4 weeks, the combined treatment group had significantly higher levels of IL-13, IL-35, and IL-10 in the cerebrospinal fluid than the monotherapy group (P < 0.05), but significantly lower level of IFN-γ (P < 0.001). The levels of IL-13 and IL-10 in the combined treatment group were positively correlated with EDSS scores (r = 0.632, P = 0.001; r = 0.731, P = 0.002). Combined treatment with atorvastatin calcium and methylprednisolone can improve the outcomes of MS relapse compared with glucocorticosteroid alone. Copyright © 2014 Elsevier B.V. All rights reserved.

  6. 21 CFR 520.1720a - Phenylbutazone tablets and boluses.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Phenylbutazone tablets and boluses. 520.1720a... Phenylbutazone tablets and boluses. (a) Specifications. Each tablet contains 100, 200, or 400 milligrams (mg), or...-mg or 1-g tablets, or 2- or 4-g boluses, in dogs and horses. (2) Nos. 000010 and 059130 for use of...

  7. Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy.

    PubMed

    Schaupp, Lukas; Donsa, Klaus; Neubauer, Katharina M; Mader, Julia K; Aberer, Felix; Höll, Bernhard; Spat, Stephan; Augustin, Thomas; Beck, Peter; Pieber, Thomas R; Plank, Johannes

    2015-09-01

    Inpatient glucose management is based on four daily capillary blood glucose (BG) measurements. The aim was to test the capability of continuous glucose monitoring (CGM) for assessing the clinical impact and safety of basal-bolus insulin therapy in non-critically ill hospitalized patients with type 2 diabetes mellitus (T2DM). Eighty-four patients with T2DM (age, 68±10 years; glycosylated hemoglobin, 72±28 mmol/mol; body mass index, 31±7 kg/m(2)) were treated with basal-bolus insulin. CGM was performed with the iPro(®)2 system (Medtronic MiniMed, Northridge, CA) and calibrated retrospectively. A remarkable consistency between CGM and BG measurements and therapy improvement was shown over the study period of 501 patient-days. The number of CGM and BG measurements (CGM/BG) in the range from 3.9-10 mmol/L increased from 67.7%/67.2% (on Day 1) to 77.5%/78.6% (on the last day) (P<0.04). The number of low glycemic episodes (3.3 to <3.9 mmol/L) during nighttime detected by CGM was 15-fold higher, and the number of episodes >13.9 mmol/L detected by CGM during night was 12.5-fold higher than the values from the BG measurements. Ninety-nine percent of data points were in the clinically accurate or acceptable Clarke Error Grid Zones A+B, and the relative numbers of correctly identified episodes of <3.9 and >13.9 mmol/L detected by CGM (sensitivity) were 47.3% and 81.5%, respectively. Our data exhibit a good agreement between overall CGM and BG measurements, but there were a high number of missed hypo- and hyperglycemic episodes with BG measurements, particularly during nighttime. Overall assessment of glycemic control using CGM is feasible, whereas the use of CGM for individualized therapy decisions needs further improvement.

  8. Efficacy of patient-specific bolus created using three-dimensional printing technique in photon radiotherapy.

    PubMed

    Fujimoto, Koya; Shiinoki, Takehiro; Yuasa, Yuki; Hanazawa, Hideki; Shibuya, Keiko

    2017-06-01

    A commercially available bolus ("commercial-bolus") does not make complete contact with the irregularly shaped patient skin. This study aims to customise a patient-specific three-dimensional (3D) bolus using a 3D printing technique ("3D-bolus") and to evaluate its clinical feasibility for photon radiotherapy. The 3D-bolus was designed using a treatment planning system (TPS) in Digital Imaging and Communications in Medicine-Radiotherapy (DICOM-RT) format, and converted to stereolithographic format for printing. To evaluate its physical characteristics, treatment plans were created for water-equivalent phantoms that were bolus-free, or had a flat-form printed 3D-bolus, a TPS-designed bolus ("virtual-bolus"), or a commercial-bolus. These plans were compared based on the percentage depth dose (PDD) and target-volume dose volume histogram (DVH) measurements. To evaluate the clinical feasibility, treatment plans were created for head phantoms that were bolus-free or had a 3D-bolus, a virtual-bolus, or a commercial-bolus. These plans were compared based on the target volume DVH. In the physical evaluation, the 3D-bolus provided effective dose coverage in the build-up region, which was equivalent to the commercial-bolus. With regard to the clinical feasibility, the air gaps were lesser with the 3D-bolus when compared to the commercial-bolus. Furthermore, the prescription dose could be delivered appropriately to the target volume. The 3D-bolus has potential use for air-gap reduction compared to the commercial-bolus and facilitates target-volume dose coverage and homogeneity improvement. A 3D-bolus produced using a 3D printing technique is comparable to a commercial-bolus applied to an irregular-shaped skin surface. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

  9. Evaluation of surface and shallow depth dose reductions using a Superflab bolus during conventional and advanced external beam radiotherapy.

    PubMed

    Yoon, Jihyung; Xie, Yibo; Zhang, Rui

    2018-03-01

    The purpose of this study was to evaluate a methodology to reduce scatter and leakage radiations to patients' surface and shallow depths during conventional and advanced external beam radiotherapy. Superflab boluses of different thicknesses were placed on top of a stack of solid water phantoms, and the bolus effect on surface and shallow depth doses for both open and intensity-modulated radiotherapy (IMRT) beams was evaluated using thermoluminescent dosimeters and ion chamber measurements. Contralateral breast dose reduction caused by the bolus was evaluated by delivering clinical postmastectomy radiotherapy (PMRT) plans to an anthropomorphic phantom. For the solid water phantom measurements, surface dose reduction caused by the Superflab bolus was achieved only in out-of-field area and on the incident side of the beam, and the dose reduction increased with bolus thickness. The dose reduction caused by the bolus was more significant at closer distances from the beam. Most of the dose reductions occurred in the first 2-cm depth and stopped at 4-cm depth. For clinical PMRT treatment plans, surface dose reductions using a 1-cm Superflab bolus were up to 31% and 62% for volumetric-modulated arc therapy and 4-field IMRT, respectively, but there was no dose reduction for Tomotherapy. A Superflab bolus can be used to reduce surface and shallow depth doses during external beam radiotherapy when it is placed out of the beam and on the incident side of the beam. Although we only validated this dose reduction strategy for PMRT treatments, it is applicable to any external beam radiotherapy and can potentially reduce patients' risk of developing radiation-induced side effects. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

  10. Esophageal Transit, Contraction and Perception of Transit After Swallows of Two Viscous Boluses

    PubMed Central

    Dalmazo, Jucileia; Aprile, Lilian Rose Otoboni; Dantas, Roberto Oliveira

    2015-01-01

    Background There have been results showing the influence of bolus viscosities and consistency on esophageal motility and transit. However, there is no description about the influence of two different viscous boluses on esophageal contractions, bolus transit and perception of transit. Our objective in this investigation was to evaluate the esophageal transit and contraction after swallows of two viscous boluses. Methods By impedance and manometric methods, we measured the esophageal transit and contraction after swallows of two viscous boluses of 5 mL volume, 100% barium sulfate and yogurt, swallowed in duplicate in the supine and upright positions. The bolus transit, esophageal contractions and the perception of bolus transit through the esophagus were evaluated in both positions. Impedance and contraction were measured at 5, 10, 15 and 20 cm from the lower esophageal sphincter. After each swallow, the volunteers were asked about the sensation of bolus transit through the esophagus. Results In supine position, the yogurt had a less frequent complete bolus transit than barium. Also in the supine position, the esophageal transit was longer with yogurt than with barium. Esophageal contractions after swallows were similar between barium and yogurt boluses. There was no difference in perception of transit between the two boluses. Conclusion Although both 100% barium sulfate and yogurt are viscous boluses and have similar viscosities, the transit through the esophagus is slower with yogurt bolus than with barium bolus, which suggests that viscosity may be not the sole factor to determine transit. PMID:27785308

  11. 21 CFR 520.1802b - Piperazine-carbon disulfide complex boluses.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Piperazine-carbon disulfide complex boluses. 520....1802b Piperazine-carbon disulfide complex boluses. (a) Specifications. Each bolus contains 20 grams of piperazine-carbon disulfide complex. (b) Sponsor. See 000009 in § 510.600(c) of this chapter. (c) Conditions...

  12. α-Methylprednisolone conjugated cyclodextrin polymer-based nanoparticles for rheumatoid arthritis therapy

    PubMed Central

    Hwang, Jungyeon; Rodgers, Kathleen; Oliver, James C; Schluep, Thomas

    2008-01-01

    A glycinate derivative of α-methylprednisolone (MP) was prepared and conjugated to a linear cyclodextrin polymer (CDP) with a loading of 12.4% w/w. The polymer conjugate (CDP-MP) self-assembled into nanoparticles with a size of 27 nm. Release kinetics of MP from the polymer conjugate showed a half-life (t1/2) of 50 h in phosphate buffer solution (PBS) and 19 h in human plasma. In vitro, the proliferation of human lymphocytes was suppressed to a similar extent but with a delayed effect when CDP-MP was compared with free MP. In vivo, CDP-MP was administered intravenously to mice with collagen-induced arthritis and compared with free MP. CDP-MP was administered weekly for six weeks (0.07, 0.7, and 7 mg/kg/week) and MP was administered daily for six weeks (0.01, 0.1, and 1 mg/kg/day). Body weight changes were minimal in all animals. After 28 days, a significant decrease in arthritis score was observed in animals treated weekly with an intermediate or high dose of CDP-MP. Additionally, dorsoplantar swelling was reduced to baseline in animals treated with CDP-MP at the intermediate and high dose level. Histological evaluation showed a reduction in synovitis, pannus formation and disruption of architecture at the highest dose level of CDP-MP. MP administered daily at equivalent cumulative doses showed minimal efficacy in this model. This study demonstrates that conjugation of MP to a cyclodextrin-polymer may improve its efficacy, leading to lower doses and less frequent administration for a safer and more convenient management of rheumatoid arthritis. PMID:18990945

  13. Modeling the retention of rumen boluses for the electronic identification of goats.

    PubMed

    Carné, S; Caja, G; Ghirardi, J J; Salama, A A K

    2011-02-01

    We constructed a regression model to estimate the retention of electronic boluses in goats. With this aim, 2,482 boluses were administered to goats from dairy (Murciano-Granadina, n=1,326; French Alpine, n=381) and meat (Blanca de Rasquera, n=532) breeds. A total of 19 bolus types made of materials (ceramic, plastic tubes filled with concrete or silicone, and ballasts) differing in their specific gravity (SG) were used, thereby obtaining a wide variation in bolus features: diameter (9 to 22 mm), length (37 to 84 mm), weight (5 to 111 g), volume (2.6 to 26 mL), and SG (1.0 to 5.5). Each bolus contained a half-duplex glass encapsulated transponder (32 × 3.8mm) and was administered using adapted balling guns. Murciano-Granadina and Blanca de Rasquera goats also wore 2 visual plastic ear tags: V1 (double flag, 5.1g) and V2 (flag-button, 4.2g). No data on ear tags in French Alpine goats was available. Bolus and ear tag retention [(retained/monitored) × 100] was recorded for at least 1 yr. Dynamic reading efficiency [(dynamic reading/static reading) × 100] was also evaluated from 1,496 bolus readings. No administration incidences or apparent negative behavior or performance effects were observed for any bolus type. Static reading efficiency of retained boluses was 100%, except for the prototypes with metal ballasts, which yielded a 93.3% reading efficiency. Retention of metal-ballasted boluses was confirmed using x-ray equipment. Excluding ballasted boluses, a 99.5% dynamic reading efficiency was obtained. Ear tag losses were 6.5% for V1 and 3.7% for V2, ranging from 3.2 to 7.8% depending on ear tag type and goat breed. Bolus retention varied (0 to 100%) according to their physical features. Obtained data allowed the fitting of a logistic model of bolus retention rate according to bolus volume and weight (R(2) = 0.98); the SG was implicitly considered. Estimated weight and SG to produce medium- (15 mL) and standard-sized (22 mL) boluses for 99.95% retention rate in

  14. Intravenous Tranexamic Acid Bolus plus Infusion Is Not More Effective than a Single Bolus in Primary Hip Arthroplasty: A Randomized Controlled Trial.

    PubMed

    Zufferey, Paul J; Lanoiselée, Julien; Chapelle, Céline; Borisov, Dmitry B; Bien, Jean-Yves; Lambert, Pierre; Philippot, Rémi; Molliex, Serge; Delavenne, Xavier

    2017-09-01

    Preoperative administration of the antifibrinolytic agent tranexamic acid reduces bleeding in patients undergoing hip arthroplasty. Increased fibrinolytic activity is maintained throughout the first day postoperation. The objective of the study was to determine whether additional perioperative administration of tranexamic acid would further reduce blood loss. This prospective, double-blind, parallel-arm, randomized, superiority study was conducted in 168 patients undergoing unilateral primary hip arthroplasty. Patients received a preoperative intravenous bolus of 1 g of tranexamic acid followed by a continuous infusion of either tranexamic acid 1 g (bolus-plus-infusion group) or placebo (bolus group) for 8 h. The primary outcome was calculated perioperative blood loss up to day 5. Erythrocyte transfusion was implemented according to a restrictive transfusion trigger strategy. The mean perioperative blood loss was 919 ± 338 ml in the bolus-plus-infusion group (84 patients analyzed) and 888 ± 366 ml in the bolus group (83 patients analyzed); mean difference, 30 ml (95% CI, -77 to 137; P = 0.58). Within 6 weeks postsurgery, three patients in each group (3.6%) underwent erythrocyte transfusion and two patients in the bolus group experienced distal deep-vein thrombosis. A meta-analysis combining data from this study with those of five other trials showed no incremental efficacy of additional perioperative administration of tranexamic acid. A preoperative bolus of tranexamic acid, associated with a restrictive transfusion trigger strategy, resulted in low erythrocyte transfusion rates in patients undergoing hip arthroplasty. Supplementary perioperative administration of tranexamic acid did not achieve any further reduction in blood loss.

  15. SU-F-T-325: On the Use of Bolus in Dosimetry and Dose Reduction for Pacemaker and Defibrillator

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Liu, W; Kenneth, R; Higgins, S

    Purpose: Special attention is required in planning and administering radiation therapy to patients with cardiac implantable electronic devices (CIEDs), such as pacemaker and defibrillator. The range of dose to CIEDs that can induce malfunction is very large among CIEDs. Significant defects have been reported at dose as low as 0.15Gy. Failures causing discomfort have been reported at dose as low as 0.05Gy. Therefore, accurate estimation of dose to CIED and dose reduction are both important even if the dose is expected to be less than the often-used 2Gy limit. We investigate the use of bolus in in vivo dosimetry formore » CIEDs. Methods: In our clinic, high-energy beams (>10MV) are not used for patients with CIED due to neutron production. Solid water phantom measurements of out-of-field dose for a 6MV beam were performed using parallel plate chamber at different depth with and without 2cm bolus covering the chamber. In vivo dosimetry at skin surface above the pacemaker was performed with and without bolus for 3 patients with pacemaker <5cm from the field edge. Results: Chamber measured dose at depth ∼1 to 1.5cm below the skin surface, where the CIED is normally located, was reduced by ∼6% – 20% with bolus. The dose reduction became smaller at deeper depth. In vivo dosimetry at skin surface also yielded ∼20% – 60% lower dose when using bolus for the 3 patients. In general, TPS calculation underestimated the dose. The dose measured with bolus is closer to the dose at the depth of the pacemaker and less affected by contaminant electrons and linac head leakage. Conclusion: In vivo CIED dose measurements should be performed with 1 to 2cm bolus covering the dosimeter on the skin above the CIED for more accurate CIED dose estimation. The use of bolus also reduces the dose delivered to CIED.« less

  16. Role of physical bolus properties as sensory inputs in the trigger of swallowing.

    PubMed

    Peyron, Marie-Agnès; Gierczynski, Isabelle; Hartmann, Christoph; Loret, Chrystel; Dardevet, Dominique; Martin, Nathalie; Woda, Alain

    2011-01-01

    Swallowing is triggered when a food bolus being prepared by mastication has reached a defined state. However, although this view is consensual and well supported, the physical properties of the swallowable bolus have been under-researched. We tested the hypothesis that measuring bolus physical changes during the masticatory sequence to deglutition would reveal the bolus properties potentially involved in swallowing initiation. Twenty normo-dentate young adults were instructed to chew portions of cereal and spit out the boluses at different times in the masticatory sequence. The mechanical properties of the collected boluses were measured by a texture profile analysis test currently used in food science. The median particle size of the boluses was evaluated by sieving. In a simultaneous sensory study, twenty-five other subjects expressed their perception of bolus texture dominating at any mastication time. Several physical changes appeared in the food bolus as it was formed during mastication: (1) in rheological terms, bolus hardness rapidly decreased as the masticatory sequence progressed, (2) by contrast, adhesiveness, springiness and cohesiveness regularly increased until the time of swallowing, (3) median particle size, indicating the bolus particle size distribution, decreased mostly during the first third of the masticatory sequence, (4) except for hardness, the rheological changes still appeared in the boluses collected just before swallowing, and (5) physical changes occurred, with sensory stickiness being described by the subjects as a dominant perception of the bolus at the end of mastication. Although these physical and sensory changes progressed in the course of mastication, those observed just before swallowing seem to be involved in swallowing initiation. They can be considered as strong candidates for sensory inputs from the bolus that are probably crucially involved in the triggering of swallowing, since they appeared in boluses prepared in various

  17. Role of Physical Bolus Properties as Sensory Inputs in the Trigger of Swallowing

    PubMed Central

    Peyron, Marie-Agnès; Gierczynski, Isabelle; Hartmann, Christoph; Loret, Chrystel; Dardevet, Dominique; Martin, Nathalie; Woda, Alain

    2011-01-01

    Background Swallowing is triggered when a food bolus being prepared by mastication has reached a defined state. However, although this view is consensual and well supported, the physical properties of the swallowable bolus have been under-researched. We tested the hypothesis that measuring bolus physical changes during the masticatory sequence to deglutition would reveal the bolus properties potentially involved in swallowing initiation. Methods Twenty normo-dentate young adults were instructed to chew portions of cereal and spit out the boluses at different times in the masticatory sequence. The mechanical properties of the collected boluses were measured by a texture profile analysis test currently used in food science. The median particle size of the boluses was evaluated by sieving. In a simultaneous sensory study, twenty-five other subjects expressed their perception of bolus texture dominating at any mastication time. Findings Several physical changes appeared in the food bolus as it was formed during mastication: (1) in rheological terms, bolus hardness rapidly decreased as the masticatory sequence progressed, (2) by contrast, adhesiveness, springiness and cohesiveness regularly increased until the time of swallowing, (3) median particle size, indicating the bolus particle size distribution, decreased mostly during the first third of the masticatory sequence, (4) except for hardness, the rheological changes still appeared in the boluses collected just before swallowing, and (5) physical changes occurred, with sensory stickiness being described by the subjects as a dominant perception of the bolus at the end of mastication. Conclusions Although these physical and sensory changes progressed in the course of mastication, those observed just before swallowing seem to be involved in swallowing initiation. They can be considered as strong candidates for sensory inputs from the bolus that are probably crucially involved in the triggering of swallowing, since they

  18. Combining Basal–Bolus Insulin Infusion for Tight Postprandial Glucose Control: An in Silico Evaluation in Adults, Children, and Adolescents

    PubMed Central

    Revert, Ana; Rossetti, Paolo; Calm, Remei; Vehí, Josep; Bondia, Jorge

    2010-01-01

    Background Achieving good postprandial glycemic control, without triggering hypoglycemia events, is a challenge of treatment strategies for type 1 diabetes subjects. Continuous subcutaneous insulin infusion, the gold standard of therapy, is based on heuristic adjustments of both basal and prandial insulin. Some tools, such as bolus calculators, are available to aid patients in selecting a meal-related insulin dose. However, they are still based on empiric parameters such as the insulin-to-carbohydrate ratio and on the physicians’ and patients’ ability to fit bolus mode to meal composition. Method In this article, a nonheuristic method for assessment of prandial insulin administration is presented and evaluated. An algorithm based on set inversion via interval analysis is used to coordinate basal and bolus insulin infusions to deal with postprandial glucose excursions. The evaluation is carried out through an in silico study using the 30 virtual patients available in the educational version of the Food and Drug Administration-accepted University of Virginia simulator. Results obtained using the standard bolus strategy and different coordinated basal–bolus solutions provided by the algorithm are compared. Results Coordinated basal–bolus solutions improve postprandial glucose performance in most cases, mainly in terms of reducing hypoglycemia risk, but also increasing the percentage of time in normoglycemia. Moreover, glycemic variability is reduced considerably by using these innovative solutions. Conclusions The algorithm presented here is a robust nonheuristic alternative to deal with postprandial glycemic control. It is shown as a powerful tool that could be integrated in future smart insulin pumps. PMID:21129338

  19. Combination Therapy With Exenatide Plus Pioglitazone Versus Basal/Bolus Insulin in Patients With Poorly Controlled Type 2 Diabetes on Sulfonylurea Plus Metformin: The Qatar Study

    PubMed Central

    Abdul-Ghani, Muhammad; Migahid, Osama; Megahed, Ayman; Adams, John; Triplitt, Curtis; DeFronzo, Ralph A.; Zirie, Mahmoud; Jayyousi, Amin

    2017-01-01

    OBJECTIVE The Qatar Study was designed to examine the efficacy of combination therapy with exenatide plus pioglitazone versus basal/bolus insulin in patients with long-standing poorly controlled type 2 diabetes mellitus (T2DM) on metformin plus a sulfonylurea. RESEARCH DESIGN AND METHODS The study randomized 231 patients with poorly controlled (HbA1c >7.5%, 58 mmol/mol) T2DM on a sulfonylurea plus metformin to receive 1) pioglitazone plus weekly exenatide (combination therapy) or 2) basal plus prandial insulin (insulin therapy) to maintain HbA1c <7.0% (53 mmol/mol). RESULTS After a mean follow-up of 12 months, combination therapy caused a robust decrease in HbA1c from 10.0 ± 0.6% (86 ± 5.2 mmol/mol) at baseline to 6.1 ± 0.1% (43 ± 0.7 mmol/mol) compared with 7.1 ± 0.1% (54 ± 0.8 mmol/mol) in subjects receiving insulin therapy. Combination therapy was effective in lowering the HbA1c independent of sex, ethnicity, BMI, or baseline HbA1c. Subjects in the insulin therapy group experienced significantly greater weight gain and a threefold higher rate of hypoglycemia than patients in the combination therapy group. CONCLUSIONS Combination exenatide/pioglitazone therapy is a very effective and safe therapeutic option in patients with long-standing poorly controlled T2DM on metformin plus a sulfonylurea. PMID:28096223

  20. A Comparative Study on the Efficacy of Submucosal Injection of Dexamethasone Versus Methylprednisolone in Reducing Postoperative Sequelae After Third Molar Surgery.

    PubMed

    Lim, Daniel; Ngeow, Wei Cheong

    2017-11-01

    To compare the efficacy of preoperative submucosal injection of 4 mg of dexamethasone versus 40 mg of methylprednisolone in reducing postoperative sequelae after surgical removal of impacted mandibular third molars. This prospective, randomized, double-blind study included 65 patients who required surgical removal of impacted mandibular third molars with Class II or position B impaction (Pell and Gregory classification). Patients were randomly assigned to 1 of 3 groups: dexamethasone, methylprednisolone, or placebo (control). Surgery was performed with patients under local anesthesia. Baseline measurements were obtained preoperatively, and subsequent assessments were made on postoperative day 1, 2, 5, and 7 to measure postoperative facial swelling by use of 2 linear measurements: interincisal mouth opening width and visual analog scale score for pain. The amount of analgesics consumed was recorded. Wound healing also was assessed on postoperative day 7. Descriptive and multivariate statistics were computed, and significance was set at P < .05. Both methylprednisolone and dexamethasone significantly reduced swelling and trismus (P < .05, Kruskal-Wallis test), whereas the methylprednisolone group had significantly less pain (P < .05, Kruskal-Wallis test) and consumed a lower amount of analgesics (P < .05, χ 2 test) during the early postoperative days. The study findings suggest that a single preoperative dose of dexamethasone versus methylprednisolone was equally effective in reducing postoperative swelling and trismus. Pain control by these corticosteroids, however, was variable. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  1. A general dual-bolus approach for quantitative DCE-MRI.

    PubMed

    Kershaw, Lucy E; Cheng, Hai-Ling Margaret

    2011-02-01

    To present a dual-bolus technique for quantitative dynamic contrast-enhanced MRI (DCE-MRI) and show that it can give an arterial input function (AIF) measurement equivalent to that from a single-bolus protocol. Five rabbits were imaged using a dual-bolus technique applicable for high-resolution DCE-MRI, incorporating a time resolved imaging of contrast kinetics (TRICKS) sequence for rapid temporal sampling. AIFs were measured from both the low-dose prebolus and the high-dose main bolus in the abdominal aorta. In one animal, TRICKS and fast spoiled gradient echo (FSPGR) acquisitions were compared. The scaled prebolus AIF was shown to match the main bolus AIF, with 95% confidence intervals overlapping for fits of gamma-variate functions to the first pass and linear fits to the washout phase, with the exception of one case. The AIFs measured using TRICKS and FSPGR were shown to be equivalent in one animal. The proposed technique can capture even the rapid circulation kinetics in the rabbit aorta, and the scaled prebolus AIF is equivalent to the AIF from a high-dose injection. This allows separate measurements of the AIF and tissue uptake curves, meaning that each curve can then be acquired using a protocol tailored to its specific requirements. Copyright © 2011 Elsevier Inc. All rights reserved.

  2. Automated bolus advisor control and usability study (ABACUS): does use of an insulin bolus advisor improve glycaemic control in patients failing multiple daily insulin injection (MDI) therapy? [NCT01460446

    PubMed Central

    2012-01-01

    Background People with T1DM and insulin-treated T2DM often do not follow and/or adjust their insulin regimens as needed. Key contributors to treatment non-adherence are fear of hypoglycaemia, difficulty and lack of self-efficacy associated with insulin dose determination. Because manual calculation of insulin boluses is both complex and time consuming, people may rely on empirical estimates, which can result in persistent hypoglycaemia and/or hyperglycaemia. Use of automated bolus advisors (BA) has been shown to help insulin pump users to more accurately meet prandial insulin dosage requirements, improve postprandial glycaemic excursions, and achieve optimal glycaemic control with an increased time within optimal range. Use of a BA containing an early algorithm based on sliding scales for insulin dosing has also been shown to improve HbA1c levels in people treated with multiple daily insulin injections (MDI). We designed a study to determine if use of an automated BA can improve clinical and psychosocial outcomes in people treated with MDI. Methods/design The Automated Bolus Advisor Control and Usability Study (ABACUS) is a 6-month, prospective, randomised, multi-centre, multi-national trial to determine if automated BA use improves glycaemic control as measured by a change in HbA1c in people using MDI with elevated HbA1c levels (#62;7.5%). A total of 226 T1DM and T2DM participants will be recruited. Anticipated attrition of 20% will yield a sample size of 90 participants, which will provide #62;80% power to detect a mean difference of 0.5%, with SD of 0.9%, using a one-sided 5% t-test, with 5% significance level. Other measures of glycaemic control, self-care behaviours and psychosocial issues will also be assessed. Discussion It is critical that healthcare providers utilise available technologies that both facilitate effective glucose management and address concerns about safety and lifestyle. Automated BAs may help people using MDI to manage their diabetes more

  3. Evaluation of a mixed beam therapy for post-mastectomy breast cancer patients: bolus electron conformal therapy combined with intensity modulated photon radiotherapy and volumetric modulated photon arc therapy.

    PubMed

    Zhang, Rui; Heins, David; Sanders, Mary; Guo, Beibei; Hogstrom, Kenneth

    2018-05-10

    The purpose of this study was to assess the potential benefits and limitations of a mixed beam therapy, which combined bolus electron conformal therapy (BECT) with intensity modulated photon radiotherapy (IMRT) and volumetric modulated photon arc therapy (VMAT), for left-sided post-mastectomy breast cancer patients. Mixed beam treatment plans were produced for nine post-mastectomy radiotherapy (PMRT) patients previously treated at our clinic with VMAT alone. The mixed beam plans consisted of 40 Gy to the chest wall area using BECT, 40 Gy to the supraclavicular area using parallel opposed IMRT, and 10 Gy to the total planning target volume (PTV) by optimizing VMAT on top of the BECT+IMRT dose distribution. The treatment plans were created in a commercial treatment planning system (TPS), and all plans were evaluated based on PTV coverage, dose homogeneity index (DHI), conformity index (CI), dose to organs at risk (OARs), normal tissue complication probability (NTCP), and secondary cancer complication probability (SCCP). The standard VMAT alone planning technique was used as the reference for comparison. Both techniques produced clinically acceptable PMRT plans but with a few significant differences: VMAT showed significantly better CI (0.70 vs. 0.53, p < 0.001) and DHI (0.12 vs. 0.20, p < 0.001) over mixed beam therapy. For normal tissues, mixed beam therapy showed better OAR sparing and significantly reduced NTCP for cardiac mortality (0.23% vs. 0.80%, p = 0.01) and SCCP for contralateral breast (1.7% vs. 3.1% based on linear model, and 1.2% vs. 1.9% based on linear-exponential model, p < 0.001 in both cases), but showed significantly higher mean (50.8 Gy vs. 49.3 Gy, p < 0.001) and maximum skin doses (59.7 Gy vs. 53.3 Gy, p < 0.001) compared with VMAT. Patients with more tissue (minimum distance between the distal PTV surface and lung approximately > 0.5 cm and volume of tissue between the distal PTV surface and heart or lung approximately > 250 cm 3 ) between

  4. The predictive ability of six pharmacokinetic models of rocuronium developed using a single bolus: evaluation with bolus and continuous infusion regimen.

    PubMed

    Sasakawa, Tomoki; Masui, Kenichi; Kazama, Tomiei; Iwasaki, Hiroshi

    2016-08-01

    Rocuronium concentration prediction using pharmacokinetic (PK) models would be useful for controlling rocuronium effects because neuromuscular monitoring throughout anesthesia can be difficult. This study assessed whether six different compartmental PK models developed from data obtained after bolus administration only could predict the measured plasma concentration (Cp) values of rocuronium delivered by bolus followed by continuous infusion. Rocuronium Cp values from 19 healthy subjects who received a bolus dose followed by continuous infusion in a phase III multicenter trial in Japan were used retrospectively as evaluation datasets. Six different compartmental PK models of rocuronium were used to simulate rocuronium Cp time course values, which were compared with measured Cp values. Prediction error (PE) derivatives of median absolute PE (MDAPE), median PE (MDPE), wobble, divergence absolute PE, and divergence PE were used to assess inaccuracy, bias, intra-individual variability, and time-related trends in APE and PE values. MDAPE and MDPE values were acceptable only for the Magorian and Kleijn models. The divergence PE value for the Kleijn model was lower than -10 %/h, indicating unstable prediction over time. The Szenohradszky model had the lowest divergence PE (-2.7 %/h) and wobble (5.4 %) values with negative bias (MDPE = -25.9 %). These three models were developed using the mixed-effects modeling approach. The Magorian model showed the best PE derivatives among the models assessed. A PK model developed from data obtained after single-bolus dosing can predict Cp values during bolus and continuous infusion. Thus, a mixed-effects modeling approach may be preferable in extrapolating such data.

  5. High-Dose Methylprednisolone for Veno-Occlusive Disease of the Liver in Pediatric Hematopoietic Stem Cell Transplantation Recipients

    PubMed Central

    Myers, Kasiani C.; Lawrence, Julia; Marsh, Rebecca A.; Davies, Stella M.; Jodele, Sonata

    2017-01-01

    Veno-occlusive disease (VOD) of the liver is a well-recognized serious complication of hematopoietic stem cell transplantation (HSCT), with few successful treatment modalities available for severe disease. Some reports have demonstrated success in adults with the use of high-dose steroid therapy, but experience in the pediatric population is lacking. We retrospectively reviewed HSCT patients treated at our institution since 2003 and identified 15 (2.4%) who developed VOD. Of these, nine (60%) were treated with intravenous high-dose methylprednisolone (500 mg/m2 per dose every 12 hours for six doses). Steroid therapy was initiated at or before first ultrasound evidence of reversal of portal venous flow and before meeting criteria for initiation of defibrotide therapy. Four patients were also treated with defibrotide starting 2 to 5 days after initiation of steroids. Eight of nine patients (88%) with VOD were diagnosed with multiorgan failure. Response to high-dose steroid therapy as defined by decrease in bilirubin by 50% in 10 days from therapy initiation was noted in six of nine patients (67%), occurring within 3 to 6 days of steroid therapy. Two patients died from multiorgan failure due to VOD. Seven survivors of VOD recovered at the median 6 days (range, 5 to 38) from VOD diagnosis. Overall, VOD survival as a group was 78%; however, survival among responders was 100%. No serious toxicities related to high-dose steroid therapy were observed. We conclude that high-dose steroid therapy if initiated early may reverse VOD of the liver in pediatric HSCT patients, abrogating the need for defibrotide therapy with its associated toxicities and regulatory difficulties. PMID:23211838

  6. Therapeutic efficacy and toxicity of bolus application of chemotherapy protocol in the treatment of metastatic colorectal cancer.

    PubMed

    Šišić, Ibrahim; Pojskić, Belma; Mekić Abazović, Alma; Kovčin, Vladimir

    2015-08-01

    To compare efficacy and toxicity of bolus application of chemotherapy protocol, oxaliplatin, fluorouracil (bolus), leucovorin (folfox) between two groups of patients in the therapy of metastatic colorectal carcinoma (mCRC). A total of 63 patients were treated for mCRC in the period January 2009 - January 2010 at the Department of Oncology of the Cantonal Hospital Zenica, Bosnia and Herzegovina (first group, 30 patients) and at the Department of Oncology of the Clinical Hospital Centre Bežanijska kosa in Belgrade, Serbia, in the period January 2005 - January 2006 (second group, 33 patients). The patients were treated according the same protocol, i.v. bolus infusion, but in different day intervals (D), 1, 8, 15/28 days or D1-D5/28 days, respectively. In all patients the following factors were analyzed: tumor response, overall survival (OS), progression free survival, hematological and non-hematological toxicity . Colon was the primary localization in almost two thirds of patients. There was no statistically significant difference between the groups according to the age, hematological and non-hematological toxicity, as well as in achieved OS. Progression free survival expressed in months was in average 5 months though with a large range between minimal and maximal survival time. Both groups have shown equivalent efficacy to applied chemotherapy protocols. Overall survival in the two groups matched data from the literature. Further research should confirm success of the combination of chemotherapy protocols and their combination with the biological therapy. Copyright© by the Medical Assotiation of Zenica-Doboj Canton.

  7. Triphasic contrast enhanced CT simulation with bolus tracking for pancreas SBRT target delineation.

    PubMed

    Godfrey, Devon J; Patel, Bhavik N; Adamson, Justus D; Subashi, Ergys; Salama, Joseph K; Palta, Manisha

    Bolus-tracked multiphasic contrast computed tomography (CT) is often used in diagnostic radiology to enhance the visibility of pancreas tumors, but is uncommon in radiation therapy pancreas CT simulation, and its impact on gross tumor volume (GTV) delineation is unknown. This study evaluates the lesion conspicuity and consistency of pancreas stereotactic body radiation therapy (SBRT) GTVs contoured in the different contrast phases of triphasic CT simulation scans. Triphasic, bolus-tracked planning CT simulation scans of 10 consecutive pancreas SBRT patients were acquired, yielding images of the pancreas during the late arterial (LA), portal venous (PV), and either the early arterial or delayed phase. GTVs were contoured on each phase by a gastrointestinal-specialized radiation oncologist and reviewed by a fellowship-trained abdominal radiologist who specializes in pancreatic imaging. The volumes of the registered GTVs, their overlap ratio, and the 3-dimensional margin expansions necessary for each GTV to fully encompass GTVs from the other phases were calculated. The contrast difference between tumor and normal pancreas was measured, and 2 radiation oncologists rank-ordered the phases according to their value for the lesion-contouring task. Tumor-to-pancreas enhancement was on average much larger for the LA and PV than the delayed phase or early arterial phases; the LA and PV phases were also consistently preferred by the radiation oncologists. Enhancement differences among the phases resulted in highly variable GTV volumes with no observed trends. Overlap ratios ranged from 18% to 75% across all 3 phases, improving to 43% to 91% when considering only the preferred LA and PV phases. GTV expansions necessary to encompass all GTVs ranged from 0.3 to 1.8 cm for all 3 phases, improving slightly to 0.1 to 1.4 cm when considering just the LA and PV phases. For pancreas SBRT, we recommend combining the GTVs from a multiphasic CT simulation with bolus-tracking, including

  8. 21 CFR 520.2260b - Sulfamethazine sustained-release boluses.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .... Depending on the duration of therapeutic levels desired, administer boluses as a single dose as follows: 31... restricts this drug to use by or on the order of a licensed veterinarian. (b)(1) Sponsor. See No. 053501 in... of use—(i) Amount. 27 grams (1 bolus) for each 150 pounds of body weight as a single dose. (ii...

  9. 21 CFR 520.2260b - Sulfamethazine sustained-release boluses.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    .... Depending on the duration of therapeutic levels desired, administer boluses as a single dose as follows: 31... restricts this drug to use by or on the order of a licensed veterinarian. (b)(1) Sponsor. See No. 053501 in... of use—(i) Amount. 27 grams (1 bolus) for each 150 pounds of body weight as a single dose. (ii...

  10. SU-E-T-09: A Dosimetric Analysis of Various Clinically Used Bolus Materials

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Stowe, M; Yeager, C; Zhou, F

    Purpose: To evaluate the dosimetric effect of various clinically used bolus materials. Methods: Materials investigated include solid water, superflab, wet gauze, wet sheets, Play-Doh{sup ™}, and gauze embedded with petroleum jelly. Each bolusing material was scanned in a Philips CT to determine the Hounsfield unit (HU) and to verify uniformity throughout the material. Using the corresponding HU, boluses of 0.5 cm and 1.0 cm thicknesses were created in the Eclipse treatment planning system (TPS) on a solid water phantom. Dose was calculated at various depths for beam energies 6 MV, 6 MeV, 9 MeV, and 12 MeV to determine themore » effects of each material on deposition of dose. In addition, linac-based measurements at these energies were made using a farmer chamber in solid water. Wet sheets and wet gauze were measured with various water content to quantify the effects on dose. Results: Preliminary CT scans find a range in HU of bolus materials from −120 to almost 300. There is a trend in the dose at depth based on the HU of the material; however inconsistencies are found when the bolus materials have a negative HU value. The measured data indicates that there is a linear relationship between the mass of water in a material and the dose reading, the slope of which is material dependent. Conclusion: Due to the variation in HU of the bolus materials studied, it is recommended that any new bolus be evaluated before clinical use to determine physical and dosimetric properties. If possible, patients should have bolus included in their CT scans; or if the bolus is created in the TPS, the HU should correspond to the material used. For water-soaked materials, once the bolus material is selected (gauze or sheet), the bolusing effect is only dependent on the amount of water applied to the material.« less

  11. An Adaptive Nonlinear Basal-Bolus Calculator for Patients With Type 1 Diabetes

    PubMed Central

    Boiroux, Dimitri; Aradóttir, Tinna Björk; Nørgaard, Kirsten; Poulsen, Niels Kjølstad; Madsen, Henrik; Jørgensen, John Bagterp

    2016-01-01

    Background: Bolus calculators help patients with type 1 diabetes to mitigate the effect of meals on their blood glucose by administering a large amount of insulin at mealtime. Intraindividual changes in patients physiology and nonlinearity in insulin-glucose dynamics pose a challenge to the accuracy of such calculators. Method: We propose a method based on a continuous-discrete unscented Kalman filter to continuously track the postprandial glucose dynamics and the insulin sensitivity. We augment the Medtronic Virtual Patient (MVP) model to simulate noise-corrupted data from a continuous glucose monitor (CGM). The basal rate is determined by calculating the steady state of the model and is adjusted once a day before breakfast. The bolus size is determined by optimizing the postprandial glucose values based on an estimate of the insulin sensitivity and states, as well as the announced meal size. Following meal announcements, the meal compartment and the meal time constant are estimated, otherwise insulin sensitivity is estimated. Results: We compare the performance of a conventional linear bolus calculator with the proposed bolus calculator. The proposed basal-bolus calculator significantly improves the time spent in glucose target (P < .01) compared to the conventional bolus calculator. Conclusion: An adaptive nonlinear basal-bolus calculator can efficiently compensate for physiological changes. Further clinical studies will be needed to validate the results. PMID:27613658

  12. Serum levels of bupivacaine after pre-peritoneal bolus vs. epidural bolus injection for analgesia in abdominal surgery: A safety study within a randomized controlled trial.

    PubMed

    Mungroop, Timothy H; van Samkar, Ganapathy; Geerts, Bart F; van Dieren, Susan; Besselink, Marc G; Veelo, Denise P; Lirk, Philipp

    2017-01-01

    Continuous wound infiltration (CWI) has become increasingly popular in recent years as an alternative to epidural analgesia. As catheters are not placed until the end of surgery, more intraoperative opioid analgesics might be needed. We, therefore, added a single pre-peritoneal bolus of bupivacaine at the start of laparotomy, similar to the bolus given with epidural analgesia. This was a comparative study within a randomized controlled trial (NTR4948). Patients undergoing hepato-pancreato-biliary surgery received either a pre-peritoneal bolus of 30ml bupivacaine 0.25%, or an epidural bolus of 10ml bupivacaine 0.25% at the start of laparotomy. In a subgroup of patients, we sampled blood and determined bupivacaine serum levels 20, 40, 60 and 80 minutes after bolus injection. We assumed toxicity of bupivacaine to be >1000 ng/ml. A total of 20 patients participated in this sub-study. All plasma levels measured as well as the upper limit of the predicted 99% confidence intervals per time point were well below the toxicity limit. In a mixed linear-effect model both groups did not differ statistically significant (p = 0.131). The intra-operative use of opioids was higher with CWI as compared to epidural (86 (SD 73) μg sufentanil vs. 50 (SD 32). In this exploratory study, the pre-peritoneal bolus using bupivacaine resulted in serum bupivacaine concentrations well below the commonly accepted toxic threshold. With CWI more additional analgesics are needed intraoperatively as compared to epidural analgesia, although this is compensated by a reduction in use of vasopressors with CWI. Netherlands Trial Register NTR4948.

  13. Bolus and continuous infusion mitoxantrone in newly diagnosed adult acute lymphoblastic leukemia: results of two consecutive phase II clinical studies.

    PubMed

    Koc, Y; Akpek, G; Kansu, E; Kars, A; Tekuzman, G; Baltali, E; Güler, N; Barista, I; Güllü, I; Ozisik, Y; Firat, D

    1998-01-01

    Two consecutive phase II clinical studies were designed to evaluate the efficacy and safety of bolus and continuous infusion (CI) mitoxantrone (MTZ) in 39 patients with newly diagnosed acute lymphocytic leukemia (ALL). MTZ was used as part of the classical ALL induction regimen. Twenty patients were treated with bolus MTZ (10 mg/m2 for 3 days) combined with vincristine and prednisone. The same regimen was given to a second set of 19 patients, except that MTZ was administered as a 24-hr CI. Both groups received bimonthly intensifications with vincristine and prednisone for 3 years, along with oral maintenance therapy. Patients in the CI-MTZ study arm received additional MTZ on the first day of intensification cycles. Seventeen patients (85%) in the bolus arm and 15 patients (79%) in the CI arm achieved complete remission (CR). Median disease-free survivals (DFS) in the bolus and CI groups were 11 and 15 months after median follow-ups of 16 (3.5-96) and 13 (2.3-32) months, respectively. At 2.5 years, DFS rates were 29.4% and 34.4% in the bolus and CI groups (p > 0.05). There were no significant differences between two groups in rates of early death, degree of organ toxicity, or duration of neutropenia and thrombocytopenia. Significant cardiac toxicity was not observed in either group. Bolus or CI administration of MTZ was equally effective and was well tolerated. Neither the mode of administration nor increasing the dose intensity of MTZ by incorporating intensification cycles reduced relapse rates. Development of new antileukemia agents and novel treatment approaches are still needed to improve the high relapse rates in adult ALL once a complete response is achieved.

  14. Optimization of Chitosan and Cellulose Acetate Phthalate Controlled Delivery of Methylprednisolone for Treatment of Inflammatory Bowel Disease.

    PubMed

    Jagdale, Swati; Chandekar, Apoorva

    2017-06-01

    Purpose: Inflammatory bowel disease (IBD) is a chronic, relapsing and often life-long disorder. The best way to tackle IBD is to develop a site targeted drug delivery. Methylprednisolone is a potent anti-inflammatory steroid. The relative potency of methylprednisolone to hydrocortisone is at least four is to one. The aim of the present research was to develop a colon targeted drug delivery for treatment of IBD. Methods: Compression coated drug delivery system was designed and optimised. Core tablet contained drug, croscarmellose sodium (CCS-superdisintegrant), avicel (binder) and dicalcium phosphate (diluent). Design of experiment with 3 2 factorial design was applied for optimization of compression coated delivery. Chitosan and cellulose acetate phthalate were chosen as independent variables. Swelling index, hardness and % drug release were dependant variables. Results: Core tablet (C5 batch) containing 2.15% CCS showed disintegration in less than 10sec. FTIR, UV and DSC study had shown absence of any significant physical and chemical interaction between drug and polymers. F8 was found to be optimised formulation. F8 contained 35% chitosan and 17.5% cellulose acetate phthalate. It showed drug release of 86.3% ± 6.1%, hardness 6.5 ± 1.5 and lag time 7 hrs. Simulated media drug release was 97.51 ± 8.6% with 7.5 hrs lag time. The results confirmed that the lag time was highly affected by the coating of the polymers as well as the concentration of the superdisintegrant used in core tablet. Conclusion: In-vitro and in-vivo results confirmed a potential colon targeted drug therapy for treatment of IBD.

  15. Optimization of Chitosan and Cellulose Acetate Phthalate Controlled Delivery of Methylprednisolone for Treatment of Inflammatory Bowel Disease

    PubMed Central

    Jagdale, Swati; Chandekar, Apoorva

    2017-01-01

    Purpose: Inflammatory bowel disease (IBD) is a chronic, relapsing and often life-long disorder. The best way to tackle IBD is to develop a site targeted drug delivery. Methylprednisolone is a potent anti-inflammatory steroid. The relative potency of methylprednisolone to hydrocortisone is at least four is to one. The aim of the present research was to develop a colon targeted drug delivery for treatment of IBD. Methods: Compression coated drug delivery system was designed and optimised. Core tablet contained drug, croscarmellose sodium (CCS-superdisintegrant), avicel (binder) and dicalcium phosphate (diluent). Design of experiment with 32 factorial design was applied for optimization of compression coated delivery. Chitosan and cellulose acetate phthalate were chosen as independent variables. Swelling index, hardness and % drug release were dependant variables. Results: Core tablet (C5 batch) containing 2.15% CCS showed disintegration in less than 10sec. FTIR, UV and DSC study had shown absence of any significant physical and chemical interaction between drug and polymers. F8 was found to be optimised formulation. F8 contained 35% chitosan and 17.5% cellulose acetate phthalate. It showed drug release of 86.3% ± 6.1%, hardness 6.5 ± 1.5 and lag time 7 hrs. Simulated media drug release was 97.51 ± 8.6% with 7.5 hrs lag time. The results confirmed that the lag time was highly affected by the coating of the polymers as well as the concentration of the superdisintegrant used in core tablet. Conclusion: In-vitro and in-vivo results confirmed a potential colon targeted drug therapy for treatment of IBD. PMID:28761822

  16. Bolus-dependent dosimetric effect of positioning errors for tangential scalp radiotherapy with helical tomotherapy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lobb, Eric, E-mail: eclobb2@gmail.com

    2014-04-01

    The dosimetric effect of errors in patient position is studied on-phantom as a function of simulated bolus thickness to assess the need for bolus utilization in scalp radiotherapy with tomotherapy. A treatment plan is generated on a cylindrical phantom, mimicking a radiotherapy technique for the scalp utilizing primarily tangential beamlets. A planning target volume with embedded scalplike clinical target volumes (CTVs) is planned to a uniform dose of 200 cGy. Translational errors in phantom position are introduced in 1-mm increments and dose is recomputed from the original sinogram. For each error the maximum dose, minimum dose, clinical target dose homogeneitymore » index (HI), and dose-volume histogram (DVH) are presented for simulated bolus thicknesses from 0 to 10 mm. Baseline HI values for all bolus thicknesses were in the 5.5 to 7.0 range, increasing to a maximum of 18.0 to 30.5 for the largest positioning errors when 0 to 2 mm of bolus is used. Utilizing 5 mm of bolus resulted in a maximum HI value of 9.5 for the largest positioning errors. Using 0 to 2 mm of bolus resulted in minimum and maximum dose values of 85% to 94% and 118% to 125% of the prescription dose, respectively. When using 5 mm of bolus these values were 98.5% and 109.5%. DVHs showed minimal changes in CTV dose coverage when using 5 mm of bolus, even for the largest positioning errors. CTV dose homogeneity becomes increasingly sensitive to errors in patient position as bolus thickness decreases when treating the scalp with primarily tangential beamlets. Performing a radial expansion of the scalp CTV into 5 mm of bolus material minimizes dosimetric sensitivity to errors in patient position as large as 5 mm and is therefore recommended.« less

  17. Post-infectious new daily persistent headache may respond to intravenous methylprednisolone.

    PubMed

    Prakash, Sanjay; Shah, Nilima D

    2010-02-01

    New daily persistent headache (NDPH) is a subtype of chronic daily headache (CDH) that starts acutely and continues as a daily headache from the onset.It is considered as one of the most treatment refractory of all headache syndromes. The pathophysiology is largely unknown. Viral infections, extracranial surgery, and stressful life events are considered as triggers for the onset of NDPH. A few patients may have the onset of their symptoms during an infection. Here we report nine patients with NDPH like headache. All of them had a history suggestive of extracranial infections a few weeks prior to the onset of headache. All patients received intravenous methylprednisolone (IV MPS) for 5 days. Intravenous MPS was followed by Oral steroids for 2-3 weeks in six patients.The relief of headache started between the second and fifth days of infusion in all patients. The steady improvement in headache continued and seven patients experienced almost complete improvement within 2 weeks. Two other patients showed complete improvement between 6 and 8 weeks after initiation of IV MPS therapy. We conclude that NDPH-like headache may occur as a post infectious process following a recent infection. We also speculate on the possible mechanisms of headache in our patients.

  18. Comparison of the Effects of Intermittent Boluses to Simple Continuous Infusion on Patients' Global Perceived Effect in Intrathecal Therapy for Pain: A Randomized Double-Blind Crossover Study.

    PubMed

    Eldabe, Sam; Duarte, Rui V; Madzinga, Grace; Batterham, Alan M; Brookes, Morag E; Gulve, Ashish P; Perruchoud, Christophe; Raphael, Jon H; Lorenzana, David; Buchser, Eric

    2017-05-01

    Intrathecal drug delivery (ITDD) is commonly used for intractable pain management. A paucity of good-quality studies in chronic noncancer patients and concerns over increased dosages have focused interest on different modes of administration. The aim of this international multicenter randomized double-blind crossover trial was to compare the efficacy of the same daily dose of drugs administered by intermittent boluses vs simple continuous infusion. Eligible patients implanted with a programmable ITDD device were randomized to receive two weeks of either intermittent boluses or a simple continuous flow in period 1, followed by a crossover to the alternative mode of administration. The primary outcome measure was the Patients' Global Impression of Change (PGIC) scale. The mean proportion of positive responders (at least "minimally improved") was 38.4% in the continuous condition vs 37.3% in the bolus (difference in proportions = 1.1%, 95% confidence interval [CI] = -21.8-24.0%, P  = 0.93). The mean PGIC in the continuous condition was 3.8 vs 3.9 in the bolus (mean difference = -0.1, -0.6-0.4, P  = 0.72). Exploratory analyses revealed a tendency for the mean proportion of positive responders to be higher at low vs high flow rates for both bolus and continuous administrations. Two patients were withdrawn from the study due to adverse events during the bolus phase, both with symptoms of increased pain, and one patient with additional symptoms of numbness and urinary retention. The mean PGIC and proportion of positive responders was not substantially different after intermittent bolus vs continuous administration. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  19. Serum levels of bupivacaine after pre-peritoneal bolus vs. epidural bolus injection for analgesia in abdominal surgery: A safety study within a randomized controlled trial

    PubMed Central

    Geerts, Bart F.; van Dieren, Susan; Besselink, Marc G.; Veelo, Denise P.; Lirk, Philipp

    2017-01-01

    Background Continuous wound infiltration (CWI) has become increasingly popular in recent years as an alternative to epidural analgesia. As catheters are not placed until the end of surgery, more intraoperative opioid analgesics might be needed. We, therefore, added a single pre-peritoneal bolus of bupivacaine at the start of laparotomy, similar to the bolus given with epidural analgesia. Methods This was a comparative study within a randomized controlled trial (NTR4948). Patients undergoing hepato-pancreato-biliary surgery received either a pre-peritoneal bolus of 30ml bupivacaine 0.25%, or an epidural bolus of 10ml bupivacaine 0.25% at the start of laparotomy. In a subgroup of patients, we sampled blood and determined bupivacaine serum levels 20, 40, 60 and 80 minutes after bolus injection. We assumed toxicity of bupivacaine to be >1000 ng/ml. Results A total of 20 patients participated in this sub-study. All plasma levels measured as well as the upper limit of the predicted 99% confidence intervals per time point were well below the toxicity limit. In a mixed linear-effect model both groups did not differ statistically significant (p = 0.131). The intra-operative use of opioids was higher with CWI as compared to epidural (86 (SD 73) μg sufentanil vs. 50 (SD 32). Conclusions In this exploratory study, the pre-peritoneal bolus using bupivacaine resulted in serum bupivacaine concentrations well below the commonly accepted toxic threshold. With CWI more additional analgesics are needed intraoperatively as compared to epidural analgesia, although this is compensated by a reduction in use of vasopressors with CWI. Trial registration Netherlands Trial Register NTR4948 PMID:28614364

  20. Effects of viscosity, taste, and bolus volume on swallowing apnea duration of normal adults.

    PubMed

    Butler, Susan G; Postma, Gregory N; Fischer, Eileen

    2004-12-01

    The effects of viscosity, taste, and nectar-thick liquid bolus volume on swallowing apnea duration (SAD) were examined. Twenty-two adults, comprised of 10 males and 12 females, participated. SAD was assessed via nasal airflow during swallow conditions of viscosity (thin liquid, thick liquid, and puree), taste (water, apple juice, lemon concentrate), and nectar-thick liquid bolus volumes (5, 10, 15, and 20 mL) across three trials. A significant main effect of nectar-thick liquid bolus volume was found (P < 0.05). Viscosity and taste were not significant. SAD increased with increases in bolus volume; however, neither changes in bolus viscosity nor changes in taste affected SAD. These findings indicate that since viscosity was not significant, the normative data previously published (by this PI) with 60 healthy adults stratified by age and gender can be utilized for comparison to disordered swallowing without regard to the bolus viscosity being used. D.

  1. A randomized, controlled multicentric study of inhaled budesonide and intravenous methylprednisolone in the treatment on acute exacerbation of chronic obstructive pulmonary disease.

    PubMed

    Ding, Zhen; Li, Xiu; Lu, Youjin; Rong, Guangsheng; Yang, Ruiqing; Zhang, Ruixia; Wang, Guiqin; Wei, Xiqiang; Ye, Yongqing; Qian, Zhaoxia; Liu, Hongyan; Zhu, Daifeng; Zhou, Ruiqing; Zhu, Kun; Ni, Rongping; Xia, Kui; Luo, Nan; Pei, Cong

    2016-12-01

    Almost all international guidelines recommend corticosteroids for management of exacerbations of chronic obstructive pulmonary disease (COPD), because it leads to improved outcomes of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Nevertheless, due to its side effects, there are still concerns regarding the use of systemic corticosteroid (SC). Inhaled corticosteroids (IC) can be used as an alternative to SC, while reducing the risk of occurrence of side effects. To measure the clinical efficacy and side effects of nebulized budesonide and systemic methylprednisolone in AECOPD. Valid data from 410 AECOPD patients in 10 hospitals was collected. Patients were randomly divided into 2 groups; budesonide group, treated with nebulized budesonide (2 mg 3 times/day); and methylprednisolone group, treated with intravenously injected methylprednisolone (40 mg/day). COPD assessment test (CAT), arterial blood gas analysis, hospitalization days, adverse effects, fasting blood glucose, serum creatinine, alanine aminotransferase levels, and blood drug were measured and analyzed in both groups. Symptoms, pulmonary function and arterial blood gas analysis were significantly improved after treatment in both groups (P < 0.05), with no significant differences between them (P > 0.05), while incidence of adverse events in the budesonide group was lower (P < 0.05). No significant differences in CAT score, days of admission, blood gas analysis results and physiological and biochemical indexes were found between the two groups. Patients treated with methylprednisolone showed a higher degree of PaO 2 level improvement. Results show that inhalation of budesonide (2 mg 3 times/day) and systemic methylprednisolone (40 mg/day) had similar clinical outcome in AECOPD. In conclusion, inhaled budesonide is an alternative to systemic corticosteroids in AECOPD treatment. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. SU-F-T-86: Electron Dosimetric Effects of Bolus and Lens Shielding in Treating Superficial Eye Lesions

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Young, L; Wootton, L; Gopan, O

    Purpose: Electron therapy for the treatment of ocular lymphomas requires the lens to be shielded to prevent secondary cataracts. This work evaluates the dosimetry under a suspended eyeshield with and without bolus for low energy electron fields. Methods: Film (GafChromic EBT3) dosimetry and relative output factors were measured for 6, 8, and 10 MeV electron energies. A customized 5 cm diameter circle electron orbital cutout was constructed for a 6×6 cm applicator with a lens shield, 1 cm diameter Cerrobend cylinder with 2.2 cm length, suspended from an XV film covering the open field. Relative output factors were measured usingmore » a Scanditronix electron diode in a solid water phantom. Depth dose profiles were collected for bolus thicknesses of 0, 3, and 5 mm in solid water at a source to surface distance (SSD) of 100 cm. These measurements were repeated in a Rando phantom. Results: At 5 mm, the approximate distance of the lens from the surface of the cornea, the estimated dose in solid water under the suspended lens shield was reduced to 16%, 14%, and 13% of the unblocked dose at the same depth, for electron energies of 6, 8, and 10 MeV, respectively. Applying bolus increased estimated doses under the block to 22% for 3-mm and 32% for 5-mm thicknesses for a 6 MeV incident electron beam. This effect is reduced for higher energies where the corresponding values were 15.5% and 18% for 3-mm and 5-mm for an 8 MeV electron beam. Conclusion: The application of bolus to treat superficial eye lesions of the conjunctiva increases lens dose at a depth of 5-mm under the shielding block with decreasing electron energy. Careful selection of electron energy is needed to account for electron scatter under the lens shield with the application of bolus in order to prevent cataracts.« less

  3. Once-Daily Radiation Therapy for Inflammatory Breast Cancer

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Brown, Lindsay; Harmsen, William; Blanchard, Miran

    2014-08-01

    Purpose: Inflammatory breast cancer (IBC) is a rare and aggressive breast cancer variant treated with multimodality therapy. A variety of approaches intended to escalate the intensity and efficacy of radiation therapy have been reported, including twice-daily radiation therapy, dose escalation, and aggressive use of bolus. Herein, we examine our outcomes for patients treated with once-daily radiation therapy with aggressive bolus utilization, focusing on treatment technique. Methods and Materials: A retrospective review of patients with nonmetastatic IBC treated from January 1, 2000, through December 31, 2010, was performed. Locoregional control (LRC), disease-free survival (DFS), overall survival (OS) and predictors thereof weremore » assessed. Results: Fifty-two women with IBC were identified, 49 (94%) of whom were treated with neoadjuvant chemotherapy. All underwent mastectomy followed by adjuvant radiation therapy. Radiation was delivered in once-daily fractions of 1.8 to 2.25 Gy (median, 2 Gy). Patients were typically treated with daily 1-cm bolus throughout treatment, and 33 (63%) received a subsequent boost to the mastectomy scar. Five-year Kaplan Meier survival estimates for LRC, DFS, and OS were 81%, 56%, and 64%, respectively. Locoregional recurrence was associated with poorer OS (P<.001; hazard ratio [HR], 4.1). Extracapsular extension was associated with worse LRC (P=.02), DFS (P=.007), and OS (P=.002). Age greater than 50 years was associated with better DFS (P=.03). Pathologic complete response was associated with a trend toward improved LRC (P=.06). Conclusions: Once-daily radiation therapy with aggressive use of bolus for IBC results in outcomes consistent with previous reports using various intensified radiation therapy regimens. LRC remains a challenge despite modern systemic therapy. Extracapsular extension, age ≤50 years, and lack of complete response to chemotherapy appear to be associated with worse outcomes. Novel strategies are

  4. Open-loop glucose control: Automatic IOB-based super-bolus feature for commercial insulin pumps.

    PubMed

    Rosales, Nicolás; De Battista, Hernán; Vehí, Josep; Garelli, Fabricio

    2018-06-01

    Although there has been significant progress towards closed-loop type 1 diabetes mellitus (T1DM) treatments, most diabetic patients still treat this metabolic disorder in an open-loop manner, based on insulin pump therapy (basal and bolus insulin infusion). This paper presents a method for automatic insulin bolus shaping based on insulin-on-board (IOB) as an alternative to conventional bolus dosing. The methodology presented allows the pump to generate the so-called super-bolus (SB) employing a two-compartment IOB dynamic model. The extra amount of insulin to boost the bolus and the basal cutoff time are computed using the duration of insulin action (DIA). In this way, the pump automatically re-establishes basal insulin when IOB reaches its basal level. Thus, detrimental transients caused by manual or a-priori computations are avoided. The potential of this method is illustrated via in-silico trials over a 30 patients cohort in single meal and single day scenarios. In the first ones, improvements were found (standard treatment vs. automatic SB) both in percentage time in euglycemia (75g meal: 81.9 ± 15.59 vs. 89.51 ± 11.95, ρ ≃ 0; 100g meal: 75.12 ± 18.23 vs. 85.46 ± 14.96, ρ ≃ 0) and time in hypoglecymia (75g meal: 5.92 ± 14.48 vs. 0.97 ± 4.15, ρ=0.008; 100g meal: 9.5 ± 17.02 vs. 1.85 ± 7.05, ρ=0.014). In a single day scenario, considering intra-patient variability, the time in hypoglycemia was reduced (9.57 ± 14.48 vs. 4.21 ± 6.18, ρ=0.028) and improved the time in euglycemia (79.46 ± 17.46 vs. 86.29 ± 11.73, ρ=0.007). The automatic IOB-based SB has the potential of a better performance in comparison with the standard treatment, particularly for high glycemic index meals with high carbohydrate content. Both glucose excursion and time spent in hypoglycemia were reduced. Copyright © 2018 Elsevier B.V. All rights reserved.

  5. The use of Coca-Cola in the management of bolus obstruction in benign oesophageal stricture.

    PubMed Central

    Karanjia, N. D.; Rees, M.

    1993-01-01

    Oesophageal stricture is a complication of oesophageal reflux and may itself be complicated by bolus obstruction. We reviewed the records of patients presenting with dysphagia and who were found to have benign oesophageal strictures. We studied the outcome of bolus obstruction in 13 episodes affecting eight patients. In six episodes Coca-Cola was administered on the day before endoscopy, and in all these patients the bolus had cleared. In seven episodes nothing was administered before endoscopy, and in all seven a bolus was evident at endoscopy. In five of these seven the bolus was removed piecemeal and in each of these instances the endoscope had to be passed between two and five times. In the remaining two instances the procedure was abandoned and the patients returned to the ward for the administration of Coca-Cola. At subsequent endoscopy these patients were found to be clear of any bolus. These results suggest that the administration of Coca-Cola (or other aerated drinks) may clear a bolus in the acutely obstructed oesophagus. PMID:8476194

  6. Asthma: non-responsiveness to conventional therapy.

    PubMed

    Rebuck, A S

    1986-01-01

    Despite regular inhalation of beta-agonists, topical steroids and anticholinergic aerosols and the achievement of therapeutic blood levels of theophylline, some asthmatics have rapidly fluctuating levels of peak flow measurements throughout the day. Often little or no improvement is obtained with larger doses of corticosteroids. Before embarking on more intense drug therapy, attention should be paid to conscientious adherence to the prescribed regimen and avoidance of aspirin and tartrazine, as well as to exposure to allergens such as those associated with household pets. A number of newer therapeutic options are related to the use of air jet or ultrasonic nebulizers, that allow liquid forms of inhalation agents to be taken slowly in the home environment. In this regard, combination therapy with a beta-agonist and the anticholinergic ipratropium has been shown to have bronchodilating properties superior to either agent used alone. Secondly, sodium cromoglycate in its liquid form appears to have bronchodilator properties; taken on a regular basis, four times per day, it appears to have a steroid-sparing effect. Two alternatives are available for increasing the intensity of corticosteroid therapy, other than by prolonged, high-dose prednisone. The first is that of high-dose inhaled beclomethasone (up to 2000 micrograms/day) using the 250 micrograms/puff inhaler. The second is that of intravenous therapy with methylprednisolone, recently shown to have lung permeability superior to that of prednisolone. Office patients can be treated with occasional or even regular 'pulse' doses of methylprednisolone, an approach that is now finding acceptance in the management of the inflammatory alveolitides.

  7. Commentary on “Performance of a Glucose Meter with a Built-In Automated Bolus Calculator versus Manual Bolus Calculation in Insulin-Using Subjects”

    PubMed Central

    Rossetti, Paolo; Vehí, Josep; Revert, Ana; Calm, Remei; Bondia, Jorge

    2012-01-01

    Since the early 2000s, there has been an exponentially increasing development of new diabetes-applied technology, such as continuous glucose monitoring, bolus calculators, and “smart” pumps, with the expectation of partially overcoming clinical inertia and low patient compliance. However, its long-term efficacy in glucose control has not been unequivocally proven. In this issue of Journal of Diabetes Science and Technology, Sussman and colleagues evaluated a tool for the calculation of the prandial insulin dose. A total of 205 insulin-treated patients were asked to compute a bolus dose in two simulated conditions either manually or with the bolus calculator built into the FreeStyle InsuLinx meter, revealing the high frequency of wrong calculations when performed manually. Although the clinical impact of this study is limited, it highlights the potential implications of low diabetes-related numeracy in poor glycemic control. Educational programs aiming to increase patients’ empowerment and caregivers’ knowledge are needed in order to get full benefit of the technology. PMID:22538145

  8. 21 CFR 520.1242b - Levamisole hydrochloride tablet or oblet (bolus).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Levamisole hydrochloride tablet or oblet (bolus... § 520.1242b Levamisole hydrochloride tablet or oblet (bolus). (a) Chemical name. (-)-2,3,5,6-Tetrahydro... using in severely debilitated animals. (2) It is used in a tablet for sheep as follows: (i) Amount. 0...

  9. Flavocoxid counteracts muscle necrosis and improves functional properties in mdx mice: a comparison study with methylprednisolone.

    PubMed

    Messina, Sonia; Bitto, Alessandra; Aguennouz, M'hammed; Mazzeo, Anna; Migliorato, Alba; Polito, Francesca; Irrera, Natasha; Altavilla, Domenica; Vita, Gian Luca; Russo, Massimo; Naro, Antonino; De Pasquale, Maria Grazia; Rizzuto, Emanuele; Musarò, Antonio; Squadrito, Francesco; Vita, Giuseppe

    2009-12-01

    Muscle degeneration in dystrophic muscle is exacerbated by the endogenous inflammatory response and increased oxidative stress. A key role is played by nuclear factor(NF)-kappaB. We showed that NF-kappaB inhibition through compounds with also antioxidant properties has beneficial effects in mdx mice, the murine model of Duchenne muscular dystrophy (DMD), but these drugs are not available for clinical studies. We evaluated whether flavocoxid, a mixed flavonoid extract with anti-inflammatory, antioxidant and NF-kappaB inhibiting properties, has beneficial effects in mdx mice in comparison with methylprednisolone, the gold standard treatment for DMD patients. Five-week-old mdx mice were treated for 5 weeks with flavocoxid, methylprednisolone or vehicle. The evaluation of in vivo and ex vivo functional properties and morphological parameters was performed. Serum samples were assayed for oxidative stress markers, creatine-kinase (CK) and leukotriene B-4. Cyclooxygenase-2 (COX-2), 5-lipoxygenase (5-LOX), tumor necrosis factor-alpha, p-38, JNK1 expression was evaluated in muscle by western blot analysis. NF-kappaB binding activity was investigated by electrophoresis mobility shift assay. The administration of flavocoxid: (1) ameliorated functional properties in vivo and ex vivo; (2) reduced CK; (3) reduced the expression of oxidative stress markers and of inflammatory mediators; (4) inhibited NF-kappaB and mitogen-activated protein kinases (MAPKs) signal pathways; (5) reduced muscle necrosis and enhanced regeneration. Our results highlight the detrimental effects of oxidative stress and NF-kappaB, MAPKs and COX/5-LOX pathways in the dystrophic process and show that flavocoxid is more effective in mdx mice than methylprednisolone.

  10. Effect of the route of administration of methylprednisolone on oedema and trismus in impacted lower third molar surgery.

    PubMed

    Koçer, G; Yuce, E; Tuzuner Oncul, A; Dereci, O; Koskan, O

    2014-05-01

    Due to their anatomical position, the surgical removal of impacted third molars results in oedema, pain, and trismus. The purpose of this study was to evaluate the efficacy of supraperiosteal injection of methylprednisolone compared with an oral tablet form and intravenous (i.v.) injection in the prevention of postoperative pain and oedema associated with inflammation. This randomized, prospective, and controlled study included 44 patients. The patients were randomly divided into four groups: group 1 (control; no steroids), group 2 (local injection), group 3 (oral tablets), and group 4 (i.v. injection). On days 2 and 7 following surgery, linear oedema was determined using facial landmarks, and maximal mouth opening was measured. Postoperative mouth opening and swelling were evaluated for each route of methylprednisolone administration and compared. The female (59%) to male (41%) ratio was 1.44; the mean age of the patients was 29.6 years. The level of significance was set at P<0.01 for mouth opening and P<0.05 for oedema. With regard to trismus, all three routes of administration demonstrated better efficacy in comparison to the control. While oral administration and i.v. injection of methylprednisolone achieved similar results, masseter injection provided better results in reducing oedema and trismus when compared to the control following lower third molar surgery. Copyright © 2013 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  11. The Interactive Effect of Diabetes Family Conflict and Depression on Insulin Bolusing Behaviors for Youth.

    PubMed

    Maliszewski, Genevieve; Patton, Susana R; Midyett, L Kurt; Clements, Mark A

    2017-05-01

    Adherence to type 1 diabetes management declines as children enter adolescence. For youth, psychosocial variables including mood and interpersonal relationships play a large role in diabetes maintenance. The current study assessed the unique and interactive roles diabetes family conflict and depression have on insulin bolusing behaviors for youth ages 10-16 years. Ninety-one youth-parent dyads completed a survey assessing family conflict and depression. Mean daily blood glucose levels, mealtime insulin bolus scores ( BOLUS), and glycated hemoglobin (HbA1c) were collected from the medical record as outcome variables. Parent-reported diabetes-related family conflict and youths' endorsed depression both significantly predicted insulin bolusing behavior, R 2 = .13, F(2, 88) = 6.66, P < .05. The interaction of diabetes family conflict and youth depression played a significant role in youths' bolusing behaviors, above and beyond that which was predicted by conflict and depression separately, R 2 = .18, F change (1, 87) = 4.63, P < .05. BOLUS was negatively related to youths' hemoglobin A1c, r = -.556, P < .001 and mean daily blood glucose levels, r = -.428, P < .001. Among depressed youth, mealtime insulin BOLUS scores declined with greater diabetes-related family conflict, while there was no change in BOLUS scores among depressed youth living in families reporting less conflict. Findings underscore the importance of screening for depression and family conflict in youth experiencing or at risk for poor adherence to mealtime insulin and higher HbA1c levels.

  12. The Physical Properties of a Lavage Mixture of Pulmonary Surfactant, Perfluorodecaline, and Methylprednisolone (Perfactant Lavage)

    DTIC Science & Technology

    2014-05-09

    release: distribution unlimited Purpose: To characterize the physical properties of a lavage mixture of pulmonary surfactant, perfluorocarbon and...methylprednisolone. Background: Perfluorocarbons (PFCs) are compounds derived from hydrocarbons by the substitution of hydrogen atoms with fluorine...atoms. Perfluorocarbon liquids are colorless, odorless and biologically inert. They are highly dense, due to their molecular weight. Their low

  13. SU-F-T-517: Determining the Tissue Equivalence of a Brass Mesh Bolus in a Reconstructed Chest Wall Irradiation

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Shekel, E; Epstein, D; Levin, D

    2016-06-15

    Purpose: To determine the tissue equivalence of a brass mesh bolus (RPD) in the setting of a reconstructed chest wall irradiation Methods: We measured breast skin dose delivered by a tangential field plan on an anthropomorphic phantom using Mosfet and nanoDot (Landauer) dosimeters in five different locations on the breast. We also measured skin dose using no bolus, 5mm and 10 mm superflab bolus. In the Eclipse treatment planning system (Varian, Palo Alto, CA) we calculated skin dose for different bolus thicknesses, ranging from 0 to 10 mm, in order to evaluate which calculation best matches the brass mesh measurements,more » as the brass mesh cannot be simulated due to artefacts.Finally, we measured depth dose behavior with the brass mesh bolus to verify that the bolus does not affect the dose to the breast itself beyond the build-up region. Results: Mosfet and nanoDot measurements were consistent with each other.As expected, skin dose measurements with no bolus had the least agreement with Eclipse calculation, while measurements for 5 and 10 mm agreed well with the calculation despite the difficulty in conforming superflab bolus to the breast contour. For the brass mesh the best agreement was for 3 mm bolus Eclipse calculation. For Mosfets, the average measurement was 90.8% of the expected dose, and for nanoDots 88.33% compared to 83.34%, 88.64% and 93.94% (2,3 and 5 mm bolus calculation respectively).The brass mesh bolus increased skin dose by approximately 25% but there was no dose increase beyond the build-up region. Conclusion: Brass mesh bolus is most equivalent to a 3 mm bolus, and does not affect the dose beyond the build-up region. The brass mesh cannot be directly calculated in Eclipse, hence a 3mm bolus calculation is a good reflection of the dose response to the brass mesh bolus.« less

  14. Effects of a sour bolus on the intramuscular electromyographic (EMG) activity of muscles in the submental region.

    PubMed

    Palmer, Phyllis M; McCulloch, Timothy M; Jaffe, Debra; Neel, Amy T

    2005-01-01

    A sour bolus has been used as a modality in the treatment of oropharyngeal dysphagia based on the hypothesis that this stimulus provides an effective preswallow sensory input that lowers the threshold required to trigger a pharyngeal swallow. The result is a more immediate swallow onset time. Additionally, the sour bolus may invigorate the oral muscles resulting in stronger contractions during the swallow. The purpose of this investigation was to compare the intramuscular electromyographic activity of the mylohyoid, geniohyoid, and anterior belly of the digastric muscles during sour and water boluses with regard to duration, strength, and timing of muscle activation. Muscle duration, swallow onset time, and pattern of muscle activation did not differ for the two bolus types. Muscle activation time was more tightly approximated across the onsets of the three muscles when a sour bolus was used. A sour bolus also resulted in a stronger muscle contraction as evidenced by greater electromyographic activity. These data support the use of a sour bolus as part of a treatment paradigm.

  15. Treatment of extensive scalp lesions with segmental intensity-modulated photon therapy.

    PubMed

    Bedford, James L; Childs, Peter J; Hansen, Vibeke Nordmark; Warrington, Alan P; Mendes, Ruheena L; Glees, John P

    2005-08-01

    To compare static electron therapy, electron arc therapy, and photon intensity-modulated radiation therapy (IMRT) for treatment of extensive scalp lesions and to examine the dosimetric accuracy of the techniques. A retrospective treatment-planning study was performed to evaluate the relative merits of static electron fields, arcing electron fields, and five-field photon IMRT. Thermoluminescent dosimeters (TLD) were used to verify the accuracy of the techniques. The required thickness of bolus was investigated, and an anthropomorphic phantom was also used to examine the effects of air gaps between the wax bolus used for the IMRT technique and the patient's scalp. Neither static nor arcing electron techniques were able to provide a reliable coverage of the planning target volume (PTV), owing to obliquity of the fields in relation to the scalp. The IMRT technique considerably improved PTV dose uniformity, though it irradiated a larger volume of brain. Either 0.5 cm or 1.0 cm of wax bolus was found to be suitable. Air gaps of up to 1 cm between the bolus and the patient's scalp were correctly handled by the treatment-planning system and had negligible influence on the dose to the scalp. Photon IMRT provides a feasible alternative to electron techniques for treatment of large scalp lesions, resulting in improved homogeneity of dose to the PTV but with a moderate increase in dose to the brain.

  16. SU-F-T-500: The Effectiveness of a Patient Specific Bolus Made by Using Three-Dimensional Printing Technique in Photon Radiotherapy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Fujimoto, K; Yuasa, Y; Shiinoki, T

    Purpose: A commercially available bolus (commercial-bolus) would not completely contact with the irregular shape of a patient’s skin. The purposes of this study were to customize a patient specific three-dimensional (3D) bolus using a 3D printer (3D-bolus) and to evaluate its clinical feasibility for photon radiotherapy. Methods: The 3D-bolus was designed using a treatment planning system (TPS) in DICOM-RT format. To print the 3D bolus, the file was converted into stereolithography format. To evaluate its physical characteristics, plans were created for water equivalent phantoms without the bolus, with the 3D-bolus printed in a flat form, and with the virtual bolusmore » which supposed a commercial-bolus. These plans were compared with the percent depth dose (PDD) measured from the TPS. Furthermore, to evaluate its clinical feasibility, the treatment plans were created for RANDO phantoms without the bolus and with the 3D-bolus which was customized for contacting with the surface of the phantom. Both plans were compared with the dose volume histogram (DVH) of the target volume. Results: In the physical evaluation, dmax of the plan without the bolus, with the 3D-bolus, and with the virtual bolus were 2.2 cm, 1.6 cm, and 1.7 cm, respectively. In the evaluation of clinical feasibility, for the plan without the bolus, Dmax, Dmin, Dmean, D90%, and V90% of the target volume were 102.6 %, 1.6 %, 88.8 %, 57.2 %, and 69.3 %, respectively. By using the 3D-bolus, the prescription dose could be delivered to at least 90 % of the target volume, Dmax, Dmin, Dmean, D90%, and V90% of the target volume were 104.3 %, 91.6 %, 92.1 %, 91.7 %, and 98.0 %, respectively. The 3D-bolus has the potential to be useful for providing effective dose coverage in the buildup region. Conclusion: A 3D-bolus produced using 3D printing technique is comparable to a commercially available bolus.« less

  17. Knowledge Translation to Optimize Adult Inpatient Glycemic Management with Basal Bolus Insulin Therapy and Improve Patient Outcomes.

    PubMed

    Helmle, Karmon E; Chacko, Sunita; Chan, Trevor; Drake, Alison; Edwards, Alun L; Moore, Glenda E; Philp, Leta C; Popeski, Naomi; Roedler, Rhonda L; Rogers, Edwin J R; Zimmermann, Gabrielle L; McKeen, Julie

    2017-12-27

    To develop and evaluate a Basal Bolus Insulin Therapy (BBIT) Knowledge Translation toolkit to address barriers to adoption of established best practice with BBIT in the care of adult inpatients. This study was conducted in 2 phases and focused on the hospitalist provider group across 4 acute care facilities in Calgary. Phase 1 involved a qualitative evaluation of provider and site specific barriers and facilitators, which were mapped to validated interventions using behaviour change theory. This informed the co-development and optimization of the BBIT Knowledge Translation toolkit, with each tool targeting a specific barrier to improved diabetes care practice, including BBIT ordering. In Phase 2, the BBIT Knowledge Translation toolkit was implemented and evaluated, focusing on BBIT ordering frequency, as well as secondary outcomes of hyperglycemia (patient-days with BG >14.0 mmol/L), hypoglycemia (patient-days with BG <4.0 mmol/L), and acute length of stay. Implementation of the BBIT Knowledge Translation toolkit resulted in a significant 13% absolute increase in BBIT ordering. Hyperglycemic patient-days were significantly reduced, with no increase in hypoglycemia. There was a significant, absolute 14% reduction in length of stay. The implementation of an evidence-informed, multifaceted BBIT Knowledge Translation toolkit effectively reduced a deeply entrenched in-patient diabetes care gap. The resulting sustained practice change improved patient clinical and system resource utilization outcomes. This systemic approach to implementation will guide further scale and spread of glycemic optimization initiatives. Copyright © 2018 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

  18. Basal-bolus insulin therapy reduces maternal triglycerides in gestational diabetes without modifying cholesteryl ester transfer protein activity.

    PubMed

    Olmos, Pablo R; Borzone, Gisella R

    2017-09-01

    Macrosomia in the offspring of overweight/obese mothers with glucose-controlled gestational diabetes mellitus (GDM) is due to excessive rise of maternal triglycerides (TG). We aimed to ascertain whether basal-bolus insulin therapy (BBIT), or other components of the treatment, could reduce TG in GDM. We studied the records of 131 singleton pregnancies with GDM, using stepwise multiple linear regression, Mann-Whitney, χ 2 , and Jonckheere-Terpstra tests. As maternal TG increased steadily during normal pregnancy, these were transformed as z-scores. The atherogenic index of plasma (AIP) was calculated as a measure of cholesteryl ester transfer protein activity. Multiple regression showed that only BBIT (but neither limitation of weight gain nor metformin) reduced maternal TG z-scores (P = 0.011). When the 131 pregnancies were split into two groups - without BBIT (n = 58; HbA1c = 5.3 ± 0.3%) and with BBIT (n = 73; HbA1c = 5.4 ± 0.6; P = 0.2005) - we observed that BBIT (n = 73) reduced maternal TG z-scores in a dose-related fashion (Jonckheere-Terpstra P = 0.03817). The atherogenic index of plasma remained within normal range in both groups. BBIT (but not weight gain control nor metformin) reduced maternal TG in mothers with glucose-controlled GDM. This beneficial effect of BBIT was not related to changes in the cholesteryl ester transfer protein activity. © 2017 Japan Society of Obstetrics and Gynecology.

  19. Pre-pharyngeal Swallow Effects of Recurrent Laryngeal Nerve Lesion on Bolus Shape and Airway Protection in an Infant Pig Model.

    PubMed

    Gould, Francois D H; Yglesias, B; Ohlemacher, J; German, R Z

    2017-06-01

    Recurrent laryngeal nerve (RLN) damage in infants leads to increased dysphagia and aspiration pneumonia. Recent work has shown that intraoral transport and swallow kinematics change following RLN lesion, suggesting potential changes in bolus formation prior to the swallow. In this study, we used geometric morphometrics to understand the effect of bolus shape on penetration and aspiration in infants with and without RLN lesion. We hypothesized (1) that geometric bolus properties are related to airway protection outcomes and (2) that in infants with RLN lesion, the relationship between geometric bolus properties and dysphagia is changed. In five infant pigs, dysphagia in 188 swallows was assessed using the Infant Mammalian Penetration-Aspiration Scale (IMPAS). Using images from high-speed VFSS, bolus shape, bolus area, and tongue outline were quantified digitally. Bolus shape was analyzed using elliptical Fourier analysis, and tongue outline using polynomial curve fitting. Despite large inter-individual differences, significant within individual effects of bolus shape and bolus area on airway protection exist. The relationship between penetration-aspiration score and both bolus area and shape changed post lesion. Tongue shape differed between pre- and post-lesion swallows, and between swallows with different IMPAS scores. Bolus shape and area affect airway protection outcomes. RLN lesion changes that relationship, indicating that proper bolus formation and control by the tongue require intact laryngeal sensation. The impact of RLN lesion on dysphagia is pervasive.

  20. Cost-effectiveness of once daily GLP-1 receptor agonist lixisenatide compared to bolus insulin both in combination with basal insulin for the treatment of patients with type 2 diabetes in Norway.

    PubMed

    Huetson, Pernilla; Palmer, James L; Levorsen, Andrée; Fournier, Marie; Germe, Maeva; McLeod, Euan

    2015-01-01

    Lixisenatide is a potent, selective and short-acting once daily prandial glucagon-like peptide-1 receptor agonist which lowers glycohemoglobin and body weight by clinically significant amounts in patients with type 2 diabetes treated with basal insulin, with limited risk of hypoglycemia. To assess the cost-effectiveness of lixisenatide versus bolus insulin, both in combination with basal insulin, in patients with type 2 diabetes in Norway. The IMS CORE Diabetes Model, a non-product-specific and validated simulation model, was used to make clinical and cost projections. Transition probabilities, risk adjustments and the progression of complication risk factors were derived from the UK Prospective Diabetes Study, supplemented with Norwegian data. Patients were assumed to receive combination treatment with basal insulin, lixisenatide or bolus insulin therapy for 3 years, followed by intensification of a basal-bolus insulin regimen for their remaining lifetime. Simulated healthcare costs, taken from the public payer perspective, were derived from microcosting and diagnosis related groups, discounted at 4% per annum and reported in Norwegian krone (NOK). Productivity costs were also captured based on extractions from the Norwegian Labor and Welfare Administration. Health state utilities were derived from a systematic literature review. Sensitivity and scenario analyses were performed. Lixisenatide in combination with basal insulin was associated with increased quality-adjusted life years (QALYs) and reduced lifetime healthcare costs compared to bolus insulin in combination with basal insulin in patients with Type 2 diabetes, and can be considered dominant. The net monetary benefit of lixisenatide versus bolus insulin was NOK 39,369 per patient. Results were sensitive to discounting, the application of excess body weight associated disutility and uncertainty surrounding the changes in HbA1c. Lixisenatide may be considered an economically efficient therapy in combination

  1. Effect of bolus volume and viscosity on pharyngeal automated impedance manometry variables derived for broad Dysphagia patients.

    PubMed

    Omari, Taher I; Dejaeger, Eddy; Tack, Jan; Van Beckevoort, Dirk; Rommel, Nathalie

    2013-06-01

    Automated impedance manometry (AIM) analysis measures swallow variables defining bolus timing, pressure, contractile vigour, and bolus presence, which are combined to derive a swallow risk index (SRI) correlating with aspiration. In a heterogeneous cohort of dysphagia patients, we assessed the impact of bolus volume and viscosity on AIM variables. We studied 40 patients (average age = 46 years). Swallowing of boluses was recorded with manometry, impedance, and videofluoroscopy. AIMplot software was used to derive functional variables: peak pressure (PeakP), pressure at nadir impedance (PNadImp), time from nadir impedance to peak pressure (TNadImp-PeakP), the interval of impedance drop in the distal pharynx (flow interval, FI), upper oesophageal sphincter (UES) relaxation interval (UES RI), nadir UES pressure (Nad UESP), UES intrabolus pressure (UES IBP), and UES resistance. The SRI was derived using the formula SRI = (FI * PNadImp)/(PeakP * (TNadImp-PeakP + 1)) * 100. A total of 173 liquid, 44 semisolid, and 33 solid boluses were analysed. The SRI was elevated in relation to aspiration. PeakP increased with volume. SRI was not significantly altered by bolus volume. PNadImp, UES IBP, and UES resistance increased with viscosity. SRI was lower with increased viscosity. In patients with dysphagia, the SRI is elevated in relation to aspiration, reduced by bolus viscosity, and not affected by bolus volume. These data provide evidence that pharyngeal AIM analysis may have clinical utility for assessing deglutitive aspiration risk to liquid boluses.

  2. Pre-pharyngeal swallow effects of recurrent laryngeal nerve lesion on bolus shape and airway protection in an infant pig model

    PubMed Central

    Gould, Francois D. H.; Yglesias, B.; Ohlemacher, J.; German, R. Z.

    2016-01-01

    Recurrent laryngeal nerve (RLN) damage in infants leads to increased dysphagia and aspiration pneumonia. Recent work has shown that intra oral transport and swallow kinematics change following RLN lesion, suggesting potential changes in bolus formation prior to the swallow. In this study we used geometric morphometrics to understand the effect of bolus shape on penetration and aspiration in infants with and without RLN lesion. We hypothesized 1) that geometric bolus properties are related to airway protection outcomes and 2) that in infants with RLN lesion, the relationship between geometric bolus properties and dysphagia is changed. In five infant pigs, dysphagia in 188 swallows was assessed using the Infant Mammalian Penetration Aspiration Score (IMPAS). Using images from high-speed VFSS, bolus shape, bolus area, and tongue outline were quantified digitally. Bolus shape was analyzed using elliptical Fourier analysis, and tongue outline using polynomial curve fitting. Despite large inter-individual differences, significant within individual effects of bolus shape and bolus area on airway protection exist. The relationship between penetration-aspiration score and both bolus area and shape changed post lesion. Tongue shape differed between pre and post lesion swallows, and between swallows with different IMPAS scores. Bolus shape and area affect airway protection outcomes. RLN lesion changes that relationship, indicating that proper bolus formation and control by the tongue requires intact laryngeal sensation. The impact of RLN lesion on dysphagia is pervasive. PMID:27873091

  3. Endoscopic evaluation of food bolus formation and its relationship with the number of chewing cycles.

    PubMed

    Fukatsu, H; Nohara, K; Kotani, Y; Tanaka, N; Matsuno, K; Sakai, T

    2015-08-01

    It is known that solid food is transported to the pharynx actively in parallel to it being crushed by chewing and mixed with saliva in the oral cavity. Therefore, food bolus formation should be considered to take place from the oral cavity to the pharynx. In previous studies, the chewed food was evaluated after the food had been removed from the oral cavity. However, it has been pointed out that spitting food out of the oral cavity interferes with natural food bolus formation. Therefore, we observed food boluses immediately before swallowing using an endoscope to establish a method to evaluate the food bolus-forming function, and simultaneously performed endoscopic evaluation of food bolus formation and its relationship with the number of chewing cycles. The subject was inserted the endoscope nasally and instructed to eat two coloured samples of boiled rice simultaneously in two ingestion conditions ('as usual' and 'chewing well'). The condition of the food bolus was graded into three categories for each item of grinding, mixing and aggregation and scored 2, 1 and 0. The score of aggregation was high under both ingestion conditions. The scores of grinding and mixing tended to be higher in subjects with a high number of chewing cycles, and the score of aggregation was high regardless of the number of chewing cycles. It was suggested that food has to be aggregated, even though the number of chewing cycles is low and the food is not ground or mixed for a food bolus to reach the swallowing threshold. © 2015 John Wiley & Sons Ltd.

  4. Adenovirus-specific T-lymphocyte efficacy in the presence of methylprednisolone: An in vitro study.

    PubMed

    Campidelli, Arnaud; Qian, Chongsheng; Laroye, Caroline; Decot, Véronique; Reppel, Loïc; D'aveni, Maud; Bensoussan, Danièle

    2018-04-01

    Virus-specific T-cell (VST) infusion becomes a promising alternative treatment for refractory viral infections after hematopoietic stem cell transplantation (HSCT). However, VSTs are often infused during an immunosuppressive treatment course, especially corticosteroids, which are a first-line curative treatment of graft-versus-host disease (GVHD). We were interested in whether corticosteroids could affect adenovirus (ADV)-VST functions. After interferon (IFN)-γ based immunomagnetic selection, ADV-VSTs were in vitro expanded according to three different culture conditions: without methylprednisolone (MP; n = 7), with a final concentration of MP 1 µg/mL (n = 7) or MP 2 µg/mL (n = 7) during 28 ± 11 days. Efficacy and alloreactivity of expanded ADV-VSTs was controlled in vitro. MP transitorily inhibited ADV-VST early expansion. No impairment of specific IFN-γ secretion capacity and cytotoxicity of ADV-VSTs was observed in the presence of MP. However, specific proliferation and alloreactivity of ADV-VSTs were decreased in the presence of MP. Altogether, these results and the preliminary encouraging clinical experiences of co-administration of MP 1 mg/kg and ADV-VSTs will contribute to safe and efficient use of anti-viral immunotherapy. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  5. Effects of a long-acting, trace mineral, reticulorumen bolus on range cow productivity and trace mineral profiles.

    PubMed

    Sprinkle, J E; Cuneo, S P; Frederick, H M; Enns, R M; Schafer, D W; Carstens, G E; Daugherty, S B; Noon, T H; Rickert, B M; Reggiardo, C

    2006-06-01

    The objectives were to determine if strategic supplementation of range cows with a long-acting (6 mo), trace mineral, reticulorumen bolus containing Cu, Se, and Co would: (1) increase cow BCS and BW, and calf birth, weaning, and postweaning weights, or weight per day of age (WDA); (2) increase liver concentrations of Cu or Zn in cows, or blood Se, Cu, or Zn concentrations in cows and calves; and (3) vary by cow breed for any of these response variables. There were 192 control and 144 bolused Composite cows (C; 25% Hereford, Angus, Gelbevieh, and Senepol or Barzona); 236 control and 158 bolused Hereford (H) cows; and 208 control and 149 bolused Brahman cross (B) cows used in a 3-yr experiment. Cows were weighed and scored for body condition in January, May, and September, and all bolused cows received boluses in January. Each year, from among the 3 breed groups a subset of 15 control and 15 bolused cows (n = 90) had samples obtained in January and May for liver Cu and Zn, blood Se, and serum Cu and Zn. As for cows, blood and serum from the calves of these cows were sampled each year in May and September for Cu, Se, and Zn. There was a significant breed x year x treatment interaction (P = 0.001) for cow weight loss from January to May. Calf WDA, weaning, and postweaning weights did not differ (P > 0.40) between bolused and control cows, but there was a significant (P = 0.022) breed x year x treatment interaction for birth weight. Liver Cu was deficient (< 75 ppm; P < 0.001) in control cows and adequate (< 75 to 90 ppm) for bolused cows. Liver Cu differed by year (P < 0.001). Blood Se was adequate (< 0.1 ppm) for all cows except in January 2001 and 2002. There was no difference (P > 0.50) in blood Se between treatment groups in January, but bolused cows had greater (P < 0.01) blood Se in May. Breed differences for blood Se concentrations existed for bolused cows, with B having greater (P < 0.05) blood Se than either C or H cows. Breed differences also existed for

  6. Discounting the duration of bolus exposure in impedance testing underestimates acid reflux.

    PubMed

    Vikneswaran, Namasivayam; Murray, Joseph A

    2016-06-08

    Combined impedance-pH testing (MII) allows for detection of reflux episodes regardless of pH. However impedance-based diagnosis of reflux may not routinely account for duration of the reflux episode. We hypothesize that impedance testing may be less sensitive than pH-testing in detecting acid reflux off therapy as a result of discounting duration of exposure. Baseline characteristics and reflux parameters of MII studies performed off-anti-secretory medications were analyzed. Studies on acid suppressive medication and those with recording times less than 20 h or low baseline impedance were excluded. A total of 73 consecutive MII studies were analyzed of which 31 MII studies had elevated acid exposure while 16 were abnormal by impedance criteria. MII testing off-therapy was more likely to be abnormal by pH criteria (percent time pH < 4) than impedance criteria (total reflux):[42 vs 22 % (p =0.02)]. Acid exposure (percent time pH < 4) identified more studies as abnormal than MII-detected acid reflux episodes [42 vs 34 % (p < 0.01)]. Mean acid clearance time (pH-detected) was significantly longer than median bolus clearance time (impedance-detected) in the total [98.7 s vs 12.6 s (p < 0.01)], upright [58.6 s vs 13.1 s (p < 0.01)], and recumbent positions [136.7 s vs 14.2 s (p < 0.01)] with the greatest difference seen in the recumbent position. The mean ratio of mean acid clearance time (pH-detected) and the median bolus clearance time (impedance-detected) was significantly higher in the recumbent position compared to the upright position [11. vs 5.3 (p = 0.01)]. Ambulatory impedance testing underestimates acid reflux compared to esophageal acid exposure by discounting the prolonged period of mucosal contact with each acid reflux episode, particularly in the recumbent position.

  7. Open-label randomized clinical trial of atropine bolus injection versus incremental boluses plus infusion for organophosphate poisoning in Bangladesh.

    PubMed

    Abedin, Mohammed Joynal; Sayeed, Abdullah Abu; Basher, Ariful; Maude, Richard J; Hoque, Gofranul; Faiz, M A

    2012-06-01

    Severe organophosphate compound (OPC) poisoning is an important clinical problem in many countries of the world. Unfortunately, little clinical research has been performed and little evidence exists with which to determine the best therapy. A study was therefore undertaken to determine the optimal dosing regimen for atropine in the treatment of OPC poisoning. An open-label randomized clinical trial was conducted in Chittagong Medical College Hospital, Chittagong, Bangladesh, on 156 hospitalized individuals with OPC poisoning from June to September 2006. The aim was to compare the efficacy and safety of conventional bolus doses with individualized incremental doses of atropine for atropinization followed by continuous atropine infusion for management of OPC poisoning. Inclusion criteria were patients with a clear history of OPC poisoning with clear clinical signs of toxicity, i.e. features of cholinergic crisis. The patients were observed for at least 96 h. Immediate outcome and complications were recorded. Out of 156 patients, 81 patients received conventional bolus dose atropine (group A) and 75 patients received rapidly incremental doses of atropine followed by infusion (group B). The mortality in group 'A' was 22.5% (18/80) and in group 'B' 8% (6/75) (p < 0.05). The mean duration of atropinization in group 'A' was 151.74 min compared to 23.90 min for group 'B' (p < 0.001). More patients in group A experienced atropine toxicity than in group 'B' (28.4% versus 12.0%, p < 0.05); intermediate syndrome was more common in group 'A' than in group 'B' (13.6% versus 4%, p < 0.05), and respiratory support was required more often for patients in group 'A' than in group 'B' (24.7% versus 8%, p < 0.05). Rapid incremental dose atropinization followed by atropine infusion reduces mortality and morbidity from OPC poisoning and shortens the length of hospital stay and recovery. Incremental atropine and infusion should become the treatment of choice for OPC

  8. 21 CFR 520.1120b - Haloxon boluses.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Haloxon boluses. 520.1120b Section 520.1120b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... not use any drug, pesticide or other chemical having cholinesterase inhibiting activity either...

  9. 21 CFR 520.1120b - Haloxon boluses.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Haloxon boluses. 520.1120b Section 520.1120b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... not use any drug, pesticide or other chemical having cholinesterase inhibiting activity either...

  10. 21 CFR 520.1120b - Haloxon boluses.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Haloxon boluses. 520.1120b Section 520.1120b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... not use any drug, pesticide or other chemical having cholinesterase inhibiting activity either...

  11. 21 CFR 520.1120b - Haloxon boluses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Haloxon boluses. 520.1120b Section 520.1120b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... not use any drug, pesticide or other chemical having cholinesterase inhibiting activity either...

  12. Use of a marshmallow bolus for evaluating lower esophageal mucosal rings.

    PubMed

    Ott, D J; Kelley, T F; Chen, M Y; Gelfand, D W; Wu, W C

    1991-07-01

    Sixty-three patients (35 women, 28 men; mean age 55 yr) with lower esophageal mucosal ring shown radiographically were examined with a semi-solid bolus consisting of a portion of a standard marshmallow. The most common symptom was dysphagia, present in 46 (73%) patients. Impaction of the marshmallow bolus by the ring occurred in 40 (63%) of the 63 patients, and produced symptoms in 27 (68%) of these 40 patients. Nine (14%) rings were detected radiographically only with a solid bolus; eight of these patients had dysphagia and seven rings were 20 mm or less in caliber. Impaction related to ring caliber, and was found in all 17 (100%) rings that were 13 mm or less in diameter, in 17/24 (71%) 14- to 19-mm rings, and in 6/22 (27%) rings 20 mm or more in caliber. Endoscopy in 23 patients detected 16 (70%) rings, and also depended on ring caliber: less than or equal to 13 mm, 6/6 (100%); 14-19 mm, 5/9 (56%); greater than or equal to 20 mm, 5/8 (63%). Marshmallow impaction occurred in 17 (74%) of 23 patients who had endoscopy; three of the 23 patients had normal endoscopy. In conclusion, radiographic examination supplemented by the use of a marshmallow bolus best detects lower esophageal mucosal ring.

  13. A Randomized Controlled Study of an Insulin Dosing Application That Uses Recognition and Meal Bolus Estimations

    PubMed Central

    Pańkowska, Ewa; Ładyżyński, Piotr; Foltyński, Piotr; Mazurczak, Karolina

    2016-01-01

    Background: Throughout the insulin pump therapy, decisions of prandial boluses programming are taken by patients individually a few times every day, and, moreover, this complex process requires numerical skills and knowledge in nutrition components estimation. The aim of the study was to determine the impact of the expert system, supporting the patient’s decision on meal bolus programming, on the time in range of diurnal glucose excursion in patients treated with continuous subcutaneous insulin infusion (CSII). Methods: The crossover, randomized study included 12 adults, aged 19 to 53, with type 1 diabetes mellitus, duration ranging from 7 to 30 years. Patients were educated in complex food counting, including carbohydrate units (CU) and fat-protein units (FPU). Subsequently, they were randomly allocated to the experimental group (A), which used the expert software named VoiceDiab, and the control group (B), using a manual method of meal-bolus estimation. Results: It was found that 66.7% of patients within the A group statistically reported a relevant increase in the percentage (%) of sensor glucose (SG) in range (TIR 70-180 mg/dl), compared to the B group. TIR (median) reached 53.9% in the experimental group (A) versus 44% within the control group (B), P < .05. The average difference in the number of hypoglycemia episodes was not statistically significant (–0.2%, SD 11.6%, P = .93). The daily insulin requirement in both groups was comparable—the average difference in total daily insulin dose between two groups was 0.26 (SD 7.06 IU, P = .9). Conclusion: The expert system in meal insulin dosing allows improvement in glucose control without increasing the rates of hypoglycemia or the insulin requirement. PMID:28264177

  14. Multicenter study of crystalloid boluses and transfusion in pediatric trauma-When to go to blood?

    PubMed

    Polites, Stephanie F; Nygaard, Rachel M; Reddy, Pooja N; Zielinski, Martin D; Richardson, Chad J; Elsbernd, Terri A; Petrun, Branden M; Weinberg, Sean L; Murphy, Sherrie; Potter, Donald D; Klinkner, Denise B; Moir, Christopher R

    2018-07-01

    The 9th edition of Advanced Trauma Life Support recommends up to three crystalloid boluses in pediatric trauma patients with consideration of transfusion after the second bolus; however, this approach is debated. We aimed to determine if requirement of more than one fluid bolus predicts the need for transfusion. The 2010 to 2016 highest tier activation patients younger than 15 years from two ACS Level I pediatric trauma centers were identified from prospectively maintained trauma databases. Those with a shock index (heart rate/systolic blood pressure) greater than 0.9 were included. Crystalloid boluses (20 ± 10 mL/kg) and transfusions administered prehospital and within 12 hours of hospital arrival were determined. Univariate and multivariable analyses were conducted to determine association between crystalloid volume and transfusion. Among 208 patients, the mean age was 5 ± 4 years (60% male), 91% sustained blunt injuries, and median (interquartile range) Injury Severity Score was 11 (6,25). Twenty-nine percent received one bolus, 17% received two, and 10% received at least three. Transfusion of any blood product occurred in 50 (24%) patients; mean (range) red blood cells was 23 (0-89) mL/kg, plasma 8 (0-69), and platelets 1 (0-18). The likelihood of transfusion increased logarithmically from 11% to 43% for those requiring 2 or more boluses (Fig. 1). This relationship persisted on multivariable analysis that adjusted for institution, age, and shock index with good discrimination (Area under the Receiver Operating Characteristic, 0.84). Shock index was also strongly associated with transfusion. Almost half of pediatric trauma patients with elevated shock index require transfusion following two crystalloid boluses and the odds of requiring a transfusion plateau at this point in resuscitation. This supports consideration of blood with the second bolus in conjunction with shock index though prospective studies are needed to confirm this and its impact on outcomes

  15. Hearing evaluation of intratympanic methylprednisolone perfusion for refractory sudden sensorineural hearing loss.

    PubMed

    She, Wandong; Dai, Yanhong; Du, Xiaoping; Yu, Chenjie; Chen, Feng; Wang, Junguo; Qin, Xiaoming

    2010-02-01

    To investigate the effectiveness and safety of intratympanic methylprednisolone perfusion (IMP) through a microcatheter in patients with sudden sensorineural hearing loss (SSNHL) who failed a conventional treatment. Prospective clinical study. This study was conducted in Nanjing Drum Tower Hospital, Nanjing University Medical School. Patients who had failed a minimum 10-day conventional treatment were included. Twenty-six patients in the study group (SG) received methylprednisolone perfusion through a microcatheter placed into the tympanum once a day for 10 days and the conventional treatment. Twenty-three patients who received a second conventional treatment (no steroid) served as the comparison group (CG). All patients were followed up for three months after the end of treatment. The effective rates for SG and CG were 50 percent (61.9% when only patients with an interval from onset to IMP < or = 60 days were included) and 21.7 percent, respectively (chi(2) = 4.194, P = 0.041). The pure-tone average improvement was 20.2 +/- 15.6 dB in SG, and 9.2 +/- 13.7 dB in CG (z = 2.51, P = 0.011). In SG, hearing improvement at low frequencies was better than that at high frequencies. The interval from onset to IMP affected the efficacy of IMP. IMP through a microcatheter is a promising treatment for refractory SSNHL. The data suggest that the treatment may be more effective when administered at the earlier stages of SSNHL when the conventional treatment has failed. Copyright 2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation. Published by Mosby, Inc. All rights reserved.

  16. Intravenous immunoglobulin therapy leading to dramatic improvement in a patient with systemic juvenile idiopathic arthritis and severe pericarditis resistant to steroid pulse therapy.

    PubMed

    Aizawa-Yashiro, Tomomi; Oki, Eishin; Tsuruga, Kazushi; Nakahata, Tohru; Ito, Etsuro; Tanaka, Hiroshi

    2012-05-01

    A 7-year-old Japanese boy with a 4-month history of systemic juvenile idiopathic arthritis (s-JIA) experienced disease flare with spiking fever, exanthema and arthralgia. He then developed progressive dyspnea due to severe pericarditis, and proinflammatory hypercytokinemia was suspected. Methylprednisolone pulse therapy was ineffective and echocardiography showed massive pericardial effusion had persisted. Alternatively, subsequent intravenous immunoglobulin (IVIG) therapy resulted in dramatic resolution of the pericardial effusion, and his general condition significantly improved within a few days. This case report may lend further support the use of IVIG for selected patients with s-JIA and severe pericarditis.

  17. Management of Paradoxical Response in Pediatric Tubercular Meningitis with Methylprednisolone

    PubMed Central

    Nema, Nitin; Verma, Abha; Singh, Kuldeep; Mehar, Virendra

    2014-01-01

    Paradoxical response to anti-tubercular drugs remains a diagnostic dilemma. In India where tuberculosis is quite prevalent, paradoxical response to anti-tubercular treatment (ATT) is either misdiagnosed or under-diagnosed. We report two cases of optochiasmatic arachnoiditis due to paradoxical response in children suffering from tuberculous meningitis. Visual acuity was recorded as no light perception in all eyes of both patients while they were taking 4-drug ATT (isoniazid, rifampicin, pyrazinamide and ethambutol). However their systemic conditions did not worsen. They were treated with intravenous methylprednisolone for five days followed by systemic corticosteroids on a tapering dose for four weeks along with ATT. This case report highlights the importance of early recognition of this sight-threatening complication and timely, effective treatment to prevent permanent blindness. PMID:24791114

  18. 21 CFR 520.2520e - Trichlorfon boluses.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Trichlorfon boluses. 520.2520e Section 520.2520e Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL...). (3) Limitations. Do not fast horses before or after treatment. Treatment of mares in late pregnancy...

  19. Intra-articular injection of methylprednisolone for reducing pain in knee osteoarthritis: A systematic review and meta-analysis.

    PubMed

    Tian, Kewei; Cheng, Huiguang; Zhang, Jiangtao; Chen, Ke

    2018-04-01

    To evaluate the efficacy and safety of intra-articular methylprednisolone for reducing pain in patients with knee osteoarthritis. We conduct electronic searches of Medline (1966-2017.11), PubMed (1966-2017.11), Embase (1980-2017.11), ScienceDirect (1985-2017.11), and the Cochrane Library (1900-2017.11) for randomized clinical trials comparing the use of methylprednisolone to treat knee osteoarthritis. The primary outcomes are Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scores and WOMAC function scores. Each outcome was combined and calculated using the statistical software STATA 12.0. Fixed/random effect model was adopted based on the heterogeneity tested by I statistic. A total of 739 patients were analyzed across 4 randomized controlled trials (RCTs). The present meta-analysis revealed that there were significant differences between groups regarding the WOMAC pain scores at 4 weeks (WMD = -1.384, 95% CI: -1.975 to -0.793, P = .000), 12 weeks (WMD = -1.587, 95% CI: -2.489 to -0.685, P = .001), and 24 weeks (WMD = -1.563, 95% CI: -2.245 to -0.881, P = .000). Significant differences were identified in terms of physical function at 4 weeks (WMD = -7.925, 95% CI: -13.359 to -2.491, P = .004), 12 weeks (WMD = -7.314, 95% CI: -13.308 to -1.320, P = .117), and 24 weeks (WMD = -6.484, 95% CI: -11.256 to -1.711, P = .008). Intra-articular methylprednisolone injection was associated with an improved pain relief and physical function in patients with knee osteoarthritis. Additionally, no severe adverse effects were observed. Due to the limited quality of the evidence currently available, higher quality RCTs were required.

  20. Effect of Admission Oral Diuretic Dose on Response to Continuous versus Bolus Intravenous Diuretics in Acute Heart Failure: An Analysis from DOSE-AHF

    PubMed Central

    Shah, Ravi V.; McNulty, Steven; O'Connor, Christopher M.; Felker, G. Michael; Braunwald, Eugene; Givertz, Michael M.

    2014-01-01

    Background Results from the Diuretic Optimization Strategies in Acute Heart Failure (DOSE-AHF) study suggest that an initial continuous infusion of loop diuretics is not superior to bolus dosing with regard to clinical endpoints in AHF. We hypothesized that outpatient furosemide dose was associated with congestion and poorer renal function, and explored the hypothesis that a continuous infusion may be more effective in patients on higher outpatient diuretic doses. Methods DOSE-AHF randomized 308 patients within 24 hours of admission to high vs. low initial intravenous diuretic dose given as either a continuous infusion or bolus. We compared baseline characteristics and assessed associations between mode of administration (bolus vs. continuous) and outcomes in patients receiving high-dose (≥120 mg furosemide equivalent, n=177) versus low-dose (<120 mg furosemide equivalent, n=131) outpatient diuretics. Results Patients on higher doses of furosemide were less frequently on renin-angiotensin system inhibitors (P=.01), and had worse renal function and more advanced symptoms. There was a significant interaction between outpatient dose and mode of therapy (P=0.01) with respect to net fluid loss at 72 hours after adjusting for creatinine and intensification strategy. Admission diuretic dose was associated with an increased risk of death or rehospitalization at 60 days (adjusted HR=1.08 per 20-mg increment in dose, 95% CI 1.01–1.16, P=.03). Conclusions In acute HF, patients on higher diuretic doses have greater disease severity, and may benefit from an initial bolus strategy. PMID:23194486

  1. Impedance spectroscopy measurements as a tool for distinguishing different luminal content during bolus transit studies.

    PubMed

    Ruiz-Vargas, A; Mohd Rosli, R; Ivorra, A; Arkwright, J W

    2018-01-08

    Intraluminal electrical impedance is a well-known diagnostic tool used to study bolus movement in the human esophagus. However, it is use in the human colon it is hindered by the fact that the content cannot be controlled and may include liquid, gas, solid, or a mixture of these at any one time. This article investigates the use of complex impedance spectroscopy to study different luminal content (liquid and gas). An excised section of guinea pig proximal colon was placed in an organ bath with Krebs solution at 37°C and a custom built bioimpedance catheter was placed in the lumen. Liquid (Krebs) and gas (air) content was pumped through the lumen and the intraluminal impedance was measured at five different frequencies (1, 5.6, 31.6, 177.18 kHz and 1 MHz) at 10 samples per second. A numerical model was created to model the passage of bolus with different content and compared to the experimental data. Differences in mean impedance magnitude and phase angle were found (from 1 to 177.18 kHz) for different contents. The numerical results qualitatively agreed with those in the experimental study. Conductivities of bolus had an effect on detecting its passage. Complex impedance spectroscopy can distinguish between different luminal content within a range of measuring frequencies. The numerical model showed the importance of bolus conductivities for bolus transit studies in those where the bolus is controlled. © 2018 John Wiley & Sons Ltd.

  2. Characterization of swallow modulation in response to bolus volume in healthy subjects accounting for catheter diameter.

    PubMed

    Ferris, Lara; Schar, Mistyka; McCall, Lisa; Doeltgen, Sebastian; Scholten, Ingrid; Rommel, Nathalie; Cock, Charles; Omari, Taher

    2018-06-01

    Characterization of the pharyngeal swallow response to volume challenges is important for swallowing function assessment. The diameter of the pressure-impedance recording catheter may influence these results. In this study, we captured key physiological swallow measures in response to bolus volume utilizing recordings acquired by two catheters of different diameter. Ten healthy adults underwent repeat investigations with 8- and 10-Fr catheters. Liquid bolus swallows of volumes 2.5, 5, 10, 20, and 30 mL were recorded. Measures indicative of distension, contractility, and flow timing were assessed. Pressure-impedance recordings with pressure-flow analysis were used to capture key distension, contractility, and pressure-flow timing parameters. Larger bolus volumes increased upper esophageal sphincter distension diameter (P < .001) and distension pressures within the hypopharynx and upper esophageal sphincter (P < .05). Bolus flow timing measures were longer, particularly latency of bolus propulsion ahead of the pharyngeal stripping wave (P < .001). Use of a larger-diameter catheter produced higher occlusive pressures, namely upper esophageal sphincter basal pressure (P < .005) and upper esophageal sphincter postdeglutitive pressure peak (P < .001). The bolus volume swallowed changed measurements indicative of distension pressure, luminal diameter, and pressure-flow timing; this is physiologically consistent with swallow modulation to accommodate larger, faster-flowing boluses. Additionally, catheter diameter predominantly affects lumen occlusive pressures. Appropriate physiological interpretation of the pressure-impedance recordings of pharyngeal swallowing requires consideration of the effects of volume and catheter diameter. NA. Laryngoscope, 128:1328-1334, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

  3. Albumin-based nanoparticles as methylprednisolone carriers for targeted delivery towards the neonatal Fc receptor in glomerular podocytes

    PubMed Central

    Wu, Lin; Chen, Mingyu; Mao, Huijuan; Wang, Ningning; Zhang, Bo; Zhao, Xiufen; Qian, Jun; Xing, Changying

    2017-01-01

    Glucocorticoids (GCs) are commonly used in the treatment of nephrotic syndrome. However, high doses and long periods of GC therapy can result in severe side effects. The present study aimed to selectively deliver albumin-methylprednisolone (MP) nanoparticles towards glomerular podocytes, which highly express the specific neonatal Fc receptor (FcRn) of albumin. Bovine serum albumin (BSA) was labeled with a fluorescent dye and linked with modified MP via an amide bond. The outcome nanoparticle named BSA633-MP showed a uniform size with a diameter of approximately 10 nm and contained 12 drug molecules on average. The nanoconjugates were found to be stable at pH 7.4 and acid-sensitive at pH 4.0, with approximately 72% release of the MP drug after 48 h of incubation. The nanoparticle demonstrated a 36-fold uptake in receptor-specific cellular delivery in the FcRn-expressing human podocytes compared to the uptake in the non-FcRn-expressing control cells. Co-localization further confirmed that uptake of the nanoconjugates involved receptor-mediated endocytosis followed by lysosome associated transportation. In vitro cellular experiments indicated that the BSA633-MP ameliorated puromycin aminonucleoside-induced podocyte apoptosis. Moreover, in vivo fluorescence molecular imaging showed that BSA633-MP was mainly accumulated in the liver and kidney after intravenous dosing for 24 h. Collectively, this study may provide an approach for the effective and safe therapy of nephrotic syndrome. PMID:28259932

  4. Disseminated nocardiosis in a patient on infliximab and methylprednisolone for treatment-resistant Sweet's syndrome.

    PubMed

    Drone, Elizabeth R; McCrory, Allison L; Lane, Natalie; Fiala, Katherine

    2014-07-01

    A 62-year-old white man with a 10-year history of treatment-refractory Sweet's syndrome was admitted to the hospital with the onset of purpuric lesions. Methylprednisolone and infliximab were administered. Our patient developed disseminated Nocardia infection and eventually succumbed. Opportunistic infections such as Nocardia have been associated with infliximab and other tumour necrosis factor (TNF)-α inhibitors. The astute clinician should be aware of the risk of rare opportunistic infections, particularly in patients on TNF-α inhibitors and systemic corticosteroids.

  5. Carotid MR angiography with traditional bolus timing: clinical observations and Fourier-based modelling of contrast kinetics.

    PubMed

    Menke, Jan

    2009-11-01

    This study analyses the relation between image quality and contrast kinetics in bolus-timed carotid magnetic resonance angiography (MRA) and interprets the findings by Fourier-based numerical modelling. One hundred patients prone to carotid stenosis were studied using contrast-enhanced carotid MRA with bolus timing. The carotid MRAs were timed to start relatively early without accounting for the injection time of the contrast medium. For interpretation different starting times were modelled, utilising the spectral information of the test bolus series. In the test bolus series the arterial time-to-peak showed a large 95% confidence interval of 12-27 s, indicating the need for individual MRA timing. All bolus-timed MRAs were of good diagnostic quality. The mean (+/-SD) arterial contrast-to-noise ratio was 53.0 (+/-12.8) and thus high, and 95% of the MRAs showed a slight venous contamination of 11.8% or less (median 5.6%). According to the Fourier-based modelling the central k-space may be acquired about 2 s before the arterial contrast peak. This results in carotid MRAs with sufficiently high arterial enhancement and little venous contamination. In conclusion, in bolus-timed carotid MRA a relatively short timing provides good arterial contrast with little venous contamination, which can be explained by Fourier-based numerical modelling of the contrast kinetics.

  6. Surface dose measurements from air gaps under a bolus by using a MOSFET dosimeter in clinical oblique photon beams

    NASA Astrophysics Data System (ADS)

    Chung, Jin-Beom; Kim, Jae-Sung; Kim, In-Ah; Lee, Jeong-Woo

    2012-10-01

    This study is intended to investigate the effects of surface dose from air gaps under the bolus in clinically used oblique photon beams by using a Markus parallel-plate chamber and a metal-oxide semiconductor field-effect transistor (MOSFET) dosimeter. To evaluate the performances of the two detectors, the percentage surface doses of the MOSFET dosimeters in without an air gap under the bolus material were measured and compared with those of the Markus parallel-plate chamber. MOSFET dosimeters at the surface provided results mostly in good agreement with the parallelplate chamber. The MOSFET dosimeters seemed suitable for surface dose measurements having excellent accuracy for clinical used photon beams. The relative surface doses were measured with air gaps (2, 5, 10 mm) and without an air gap under 3 different bolus setups: (1) unbolused (no bolus), (2) 5-mm bolus, and (3) 10-mm bolus. The reductions in the surface dose substantially increased with small field size, thick bolus, and large air gap. The absolute difference in the reductions of the surface dose between the MOSFET dosimeter and the Markus parallel-plate chamber was less than 1.1%. Results at oblique angles of incidence showed larger reductions in surface dose with increasing angle of incidence. The largest reduction in surface dose was recorded for a 6 × 6 cm2 field at a 60° angle of incidence with an 10-mm air gap under a 10-mm bolus. When a 10-mm bolus was used, a reduction in the surface dose with an air gap of up to 10.5% could be achieved by varying the field size and the incident angle. Therefore, air gaps under the bolus should be avoided in radiotherapy treatment, especially for photon beam with highly oblique angles of incidence.

  7. Influence of everyday bolus consistencies in different body positions on high-resolution esophageal pressure topography (HREPT) parameters.

    PubMed

    Hasan, Y; Go, J; Hashmi, S M; Valestin, J; Schey, R

    2015-04-01

    The standard protocol for esophageal manometry involves placing the patient in the supine position with head turned to left (supine head left [SHL]) while evaluating liquid bolus swallows. Routinely, semisolid or solid boluses are not evaluated. Currently, the daily American diet includes up to 40% solid or semisolid texture. Thus far, the data on the effect of different bolus on high-resolution esophageal pressure topography (HREPT) parameters are scarce. This study aims to evaluate the effect of every day bolus consistencies in different body positions on HREPT variables. HREPT was performed on healthy volunteers with a modified protocol including liquid swallows in the SHL position followed by applesauce (semisolid), cracker (solid), and marshmallow (soft solid) in three different positions (SHL, sitting, and standing). A total of 38 healthy adult subjects (22 males and 16 females, median age = 27, and mean body mass index = 25) were evaluated. The resting upper esophageal sphincter pressure was significantly different while subjects swallowed crackers, applesauce, and marshmallows in most positions compared with liquid SHL (P < 0.05). The lower esophageal sphincter, contractile front velocity, and distal contractile integral pressures did not differ in all different consistencies compared with SHL. The integrated relaxation period was significantly higher with solid bolus compared with liquid bolus only in SHL position. The intrabolus pressure was significantly different with solid and soft solid boluses in all postures compared to liquid SHL. The American diet consistency affects upper esophageal sphincter pressure and partially integrated relaxation period and intrabolus pressure in various positions. Semisolid bolus swallows do not cause substantial pressure changes and are safe for evaluation and maintaining adequate caloric intake in patients with dysphagia who cannot tolerate solids. © 2014 International Society for Diseases of the Esophagus.

  8. Swallowing Mechanics Associated With Artificial Airways, Bolus Properties, and Penetration-Aspiration Status in Trauma Patients.

    PubMed

    Dietsch, Angela M; Rowley, Christopher B; Solomon, Nancy Pearl; Pearson, William G

    2017-09-18

    Artificial airway procedures such as intubation and tracheotomy are common in the treatment of traumatic injuries, and bolus modifications may be implemented to help manage swallowing disorders. This study assessed artificial airway status, bolus properties (volume and viscosity), and the occurrence of laryngeal penetration and/or aspiration in relation to mechanical features of swallowing. Coordinates of anatomical landmarks were extracted at minimum and maximum hyolaryngeal excursion from 228 videofluoroscopic swallowing studies representing 69 traumatically injured U.S. military service members with dysphagia. Morphometric canonical variate and regression analyses examined associations between swallowing mechanics and bolus properties based on artificial airway and penetration-aspiration status. Significant differences in swallowing mechanics were detected between extubated versus tracheotomized (D = 1.32, p < .0001), extubated versus decannulated (D = 1.74, p < .0001), and decannulated versus tracheotomized (D = 1.24, p < .0001) groups per post hoc discriminant function analysis. Tracheotomy-in-situ and decannulated subgroups exhibited increased head/neck extension and posterior relocation of the larynx. Swallowing mechanics associated with (a) penetration-aspiration status and (b) bolus properties were moderately related for extubated and decannulated subgroups, but not the tracheotomized subgroup, per morphometric regression analysis. Specific differences in swallowing mechanics associated with artificial airway status and certain bolus properties may guide therapeutic intervention in trauma-based dysphagia.

  9. Comparison of induced hypertension, fluid bolus, and blood transfusion to augment cerebral oxygen delivery after subarachnoid hemorrhage.

    PubMed

    Dhar, Rajat; Scalfani, Michael T; Zazulia, Allyson R; Videen, Tom O; Derdeyn, Colin P; Diringer, Michael N

    2012-03-01

    Critical reductions in oxygen delivery (DO(2)) underlie the development of delayed cerebral ischemia (DCI) after subarachnoid hemorrhage (SAH). If DO(2) is not promptly restored, then irreversible injury (that is, cerebral infarction) may result. Hemodynamic therapies for DCI (that is, induced hypertension [IH] and hypervolemia) aim to improve DO(2) by raising cerebral blood flow (CBF). Red blood cell (RBC) transfusion may be an alternate strategy that augments DO(2) by improving arterial O(2) content. The authors compared the relative ability of these 3 interventions to improve cerebral DO(2), specifically their ability to restore DO(2) to regions where it is impaired. The authors compared 3 prospective physiological studies in which PET imaging was used to measure global and regional CBF and DO(2) before and after the following treatments: 1) fluid bolus of 15 ml/kg normal saline (9 patients); 2) raising mean arterial pressure 25% (12 patients); and 3) transfusing 1 U of RBCs (17 patients) in 38 individuals with aneurysmal SAH at risk for DCI. Response between groups in regions with low DO(2) (< 4.5 ml/100 g/min) was compared using repeated-measures ANOVA. Groups were similar except that the fluid bolus cohort had more patients with symptoms of DCI and lower baseline CBF. Global CBF or DO(2) did not rise significantly after any of the interventions, except after transfusion in patients with hemoglobin levels < 9 g/dl. All 3 treatments improved CBF and DO(2) to regions with impaired baseline DO(2), with a greater improvement after transfusion (23%) than hypertension (14%) or volume loading (10%); p < 0.001. Transfusion also resulted in a nonsignificantly greater (47%) reduction in the number of brain regions with low DO(2) when compared with fluid bolus (7%) and hypertension (12%) (p = 0.33). The IH, fluid bolus, and blood transfusion interventions all improve DO(2) to vulnerable brain regions at risk for ischemia after SAH. Transfusion appeared to provide a

  10. 21 CFR 520.2380c - Thiabendazole bolus.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Limitations. As a single oral dose; may repeat once in 2 to 3 weeks; do not treat animals within 3 days of...) Chemical name. 2-(4-Thiazolyl) benzimidazole. (b) Specifications. Conforms to N.F. XII. (c) Sponsor. See No...) Limitations. As a single oral dose; as a drench or bolus; may repeat once in 2 to 3 weeks; do not treat...

  11. 21 CFR 520.2380c - Thiabendazole bolus.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Limitations. As a single oral dose; may repeat once in 2 to 3 weeks; do not treat animals within 3 days of...) Chemical name. 2-(4-Thiazolyl) benzimidazole. (b) Specifications. Conforms to N.F. XII. (c) Sponsor. See No...) Limitations. As a single oral dose; as a drench or bolus; may repeat once in 2 to 3 weeks; do not treat...

  12. Disseminated nocardiosis in a patient on infliximab and methylprednisolone for treatment-resistant Sweet's syndrome

    PubMed Central

    Drone, Elizabeth R.; McCrory, Allison L.; Lane, Natalie; Fiala, Katherine

    2014-01-01

    A 62-year-old white man with a 10-year history of treatment-refractory Sweet's syndrome was admitted to the hospital with the onset of purpuric lesions. Methylprednisolone and infliximab were administered. Our patient developed disseminated Nocardia infection and eventually succumbed. Opportunistic infections such as Nocardia have been associated with infliximab and other tumour necrosis factor (TNF)-α inhibitors. The astute clinician should be aware of the risk of rare opportunistic infections, particularly in patients on TNF-α inhibitors and systemic corticosteroids. PMID:25165648

  13. Efficacy and safety of closing postcatheterisation pseudoaneurysms with ultrasound-guided thrombin injections using two approaches: bolus versus slow injection. A prospective randomised trial.

    PubMed

    Lewandowski, Paweł; Maciejewski, Paweł; Wąsek, Wojciech; Pasierski, Tomasz; Budaj, Andrzej

    2011-01-01

    Thrombin injection is a widely accepted treatment of an iatrogenic arterial pseudoaneurysm. However, the optimal mode of injection and type of pseudoaneurysm amenable to this therapy have yet been established. To compare efficacy and safety of two approaches to ultrasound-guided thrombin injections into a femoral artery pseudoaneurysm with or without long neck that developed as an iatrogenic complication of cardiac catheterisation. Patients were randomised to thrombin administration in a bolus or slow injection. The length and width of aneurysm neck and blood flow velocity in the neck were measured with color Doppler ultrasonography before the closure procedure. Thrombin dose, time to thrombotic occlusion, blood oxygen saturation in a toe of the extremity with the pseudoaneurysm (a marker of silent microembolisation), and clinical signs of distal embolisation were recorded. Between 2006 and 2009, 73 consecutive patients (33 males; mean age 67.8 ± 11.9 years) with femoral pseudoaneurysms complicating cardiac catheterisation were randomised into two groups that were treated with thrombin bolus (n = 40) or slow injection (n = 33). The efficacy of aneurysm closure with either method was similarly high (100% vs 96.8%, NS, respectively) and did not depend on the length and width of the aneurysm neck. Independent risk factors for distal embolisation were: thrombin dose (OR 4.2; 95% CI 0.92-19.3), the length of aneurysm neck (OR 4.66; 95% CI 1.1-19.9), age above 80 years (OR 10.9; 95% CI 1.0-116.8), and bolus treatment (OR 7.6; 95% CI 1.3-44.9). We observed silent microembolisation phenomenon that was common (occurring in 38% of patients in the bolus group vs 33% of patients in the slow injection group) but in most cases asymptomatic. Femoral pseudoaneurysm closure with a low dose of thrombin is a valid and beneficial treatment. Either method (bolus or slow injection) was similarly efficacious and safe even in the subgroup of patients with neckless aneurysms. We observed

  14. 21 CFR 520.1197 - Ivermectin sustained-release bolus.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... withdrawal time has not been established, do not use in female dairy cattle of breeding age. Do not slaughter cattle within 180 days of treatment. Consult your veterinarian for assistance in the diagnosis, treatment..., and ticks Amblyomma americanum. (3) Limitations. The bolus was specifically designed for use in cattle...

  15. 21 CFR 520.1197 - Ivermectin sustained-release bolus.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... withdrawal time has not been established, do not use in female dairy cattle of breeding age. Do not slaughter cattle within 180 days of treatment. Consult your veterinarian for assistance in the diagnosis, treatment..., and ticks Amblyomma americanum. (3) Limitations. The bolus was specifically designed for use in cattle...

  16. 21 CFR 520.1197 - Ivermectin sustained-release bolus.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... withdrawal time has not been established, do not use in female dairy cattle of breeding age. Do not slaughter cattle within 180 days of treatment. Consult your veterinarian for assistance in the diagnosis, treatment..., and ticks Amblyomma americanum. (3) Limitations. The bolus was specifically designed for use in cattle...

  17. 21 CFR 520.1197 - Ivermectin sustained-release bolus.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... withdrawal time has not been established, do not use in female dairy cattle of breeding age. Do not slaughter cattle within 180 days of treatment. Consult your veterinarian for assistance in the diagnosis, treatment..., and ticks Amblyomma americanum. (3) Limitations. The bolus was specifically designed for use in cattle...

  18. Methylprednisolone liver toxicity: A new case and a French regional pharmacovigilance survey.

    PubMed

    Dumortier, Jérôme; Cottin, Judith; Lavie, Caroline; Guillaud, Olivier; Hervieu, Valérie; Chambon-Augoyard, Christine; Scoazec, Jean-Yves; Vukusic, Sandra; Vial, Thierry

    2017-09-01

    Reported hepatotoxicity induced by corticosteroids is very rare, and the diagnosis is highly challenging in the context of auto-immune disease. We report here a case of high-dose methylprednisolone (MP)-induced acute hepatitis confirmed by liver histology in a patient with multiple sclerosis (MS) and a case series (n=4) notified to the French Pharmacovigilance center of Lyon. In all 5 cases, other common causes of hepatitis were excluded. The causal relationship with MP pulse therapy was supported by the fact that MP was the only culprit drug. In addition, 3 of these 5 patients underwent unintended single or multiple positive MP rechallenge. Our 5 patients scored a RUCAM score from 6 (probable) to 10 (highly probable). MP-induced liver injury is probably very rare, since only less than 30 cases have been reported in the literature. Nevertheless, our cases strongly illustrates that many cases could have been unrecognized; final diagnosis in 3 of 5 of our patients was made after the second or third episode of acute hepatitis. In conclusion, these cases we report here strongly illustrates that high-dose MP-induced liver injury can occur in patients treated for MS or auto-immune disorder. Unintended re-challenge can confirm the diagnosis and can help to distinguish it from autoimmune hepatitis. Performing liver function tests routinely both before and after MP administration would be beneficial, as the timely recognition of this complication and early drug withdrawal may prevent progression of severe necrosis hepatic injury. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  19. Multiple courses of pulse corticosteroid therapy for alopecia areata.

    PubMed

    Yoshimasu, Takashi; Kanazawa, Nobuo; Yamamoto, Yuki; Furukawa, Fukumi

    2016-09-01

    Various systemic corticosteroid therapies are used for alopecia areata (AA). Pulse therapy using methylprednisolone is a treatment approach for AA. The efficacy of multiple courses of pulse therapy for various severities of AA was evaluated. AA patients with less than 50% hair loss, less than or equal to 6 months after AA onset, needed 1.9 courses of pulse therapy for vellus hair to develop. On the other hand, AA patients with more than 50% hair loss, less than 6 months after AA onset, needed more courses of pulse therapy for vellus hair to develop. Regardless of the disease duration, AA patients with less than 50% hair loss showed a good response rate (100%) after both a short period and a long period after therapy. After receiving multiple courses of pulse therapy, the AA patients with more than 50% hair loss also showed improvement with limited adverse reactions. © 2016 Japanese Dermatological Association.

  20. Swallowing Mechanics Associated with Artificial Airways, Bolus Properties, and Penetration-Aspiration Status in Trauma Patients

    ERIC Educational Resources Information Center

    Dietsch, Angela M.; Rowley, Christopher B.; Solomon, Nancy Pearl; Pearson, William G., Jr.

    2017-01-01

    Purpose: Artificial airway procedures such as intubation and Sare common in the treatment of traumatic injuries, and bolus modifications may be implemented to help manage swallowing disorders. This study assessed artificial airway status, bolus properties (volume and viscosity), and the occurrence of laryngeal penetration and/or aspiration in…

  1. Radiation dermatitis caused by a bolus effect from an abdominal compression device

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Connor, Michael; Wei, Randy L.; Yu, Suhong

    American Association of Physicists in Medicine (AAPM) Task Group 176 evaluated the dosimetric effects caused by couch tops and immobilization devices. The report analyzed the extensive physics-based literature on couch tops, stereotactic body radiation therapy (SBRT) frames, and body immobilization bags, while noting the scarcity of clinical reports of skin toxicity because of external devices. Here, we present a clinical case report of grade 1 abdominal skin toxicity owing to an abdominal compression device. We discuss the dosimetric implications of the utilized treatment plan as well as post hoc alternative plans and quantify differences in attenuation and skin dose/build-up betweenmore » the device, a lower-density alternative device, and an open field. The description of the case includes a 66-year-old male with HER2 amplified poorly differentiated distal esophageal adenocarcinoma treated with neoadjuvant chemo-radiation and the use of an abdominal compression device. Radiation was delivered using volumetric modulated arc therapy (VMAT) with 2 arcs using abdominal compression and image guidance. The total dose was 50.4 Gy delivered over 40 elapsed days. With 2 fractions remaining, the patient developed dermatitis in the area of the compression device. The original treatment plan did not include a contour of the device. Alternative post hoc treatment plans were generated, one to contour the device and a second with anterior avoidance. In conclusion, replanning with the device contoured revealed the bolus effect. The skin dose increased from 27 to 36 Gy. planned target volume (PTV) coverage at 45 Gy was reduced to 76.5% from 95.8%. The second VMAT treatment plan with an anterior avoidance sector and more oblique beam angles maintained PTV coverage and spared the anterior wall, however at the expense of substantially increased dose to lung. This case report provides an important reminder of the bolus effect from external devices such as abdominal compression

  2. High Bolus Tirofiban vs Abciximab in Acute STEMI Patients Undergoing Primary PCI – The Tamip Study

    PubMed Central

    Balghith, Mohammed A.

    2012-01-01

    Background: Primary percutaneous coronary intervention (PCI) has been shown to be an effective therapy for patients with acute myocardial infarction (MI). Glycoprotein (GP) IIb/IIIa receptor blockers reduce thrombotic complications in patients undergoing PCI. Most available data relate to Reopro, which has been registered for this indication. GP IIb/IIIa reduce unfavorable outcome in U/A and non ST-elevation myocardial infarction (STEMI) patients. Only few studies focused on high dose Aggrastat for STEMI patients in the emergency department (ED) before PCI. The aim is to increase the patency during the time awaiting coronary angioplasty in patients with acute MI. Objectives: To study the effect of upfront high bolus dose (HDR) of tirofiban on the extent of residual ST segment deviation 1 hour after primary PCI and the incidence of TIMI 3 flow of the infarct-related artery (IRA). Materials and Methods: A randomized, open label, single center study in the ED. A total of 90 patients with acute ST-elevation MI, diagnosed clinically by ECG criteria (ST segment elevation of >2 mm in two adjacent ECG leads), and with an expectation that a patient will undergo primary PCI. Patients were aged 21-85 years and all received heparin 5000 u, aspirin 160 mg, and Plavix 600 mg. Patients were divided in two groups (group I: triofiban high bolus vs group II: Reopro) with 45 patients in each group. In group I, high bolus triofiban 25 mcg/kg over 3 min was started in the ED with maintenance infusion of 0.15 mcg/ kg/min continued for 12 hours and transferred to cath lab for PCI. Patients in group II were transferred to cath lab, where a standard dose of Reopro was given with a bolus of 0.25 mcg/kg and maintenance infusion of 0.125 mcg/kg/min over 12 hours. Results: ST segment resolution and TIMI flow were evaluated in both groups before and after PCI. Thirty-five patients (78%) enrolled in group I and 29 patients (64%) in group II had resolution of ST segment (P-value 0.24). Twenty

  3. 21 CFR 520.1197 - Ivermectin sustained-release bolus.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Ivermectin sustained-release bolus. 520.1197 Section 520.1197 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1197 Ivermectin...

  4. 21 CFR 520.420 - Chlorothiazide tablets and boluses.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Chlorothiazide tablets and boluses. 520.420 Section 520.420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.420...

  5. 21 CFR 520.420 - Chlorothiazide tablets and boluses.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Chlorothiazide tablets and boluses. 520.420 Section 520.420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.420...

  6. SU-E-T-176: Clinical Experience of Brass Mesh Bolus: Patient-Specific Parameters as Predictors of Measured Dosimetric Effect

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Yock, A; Manger, R; Einck, J

    2015-06-15

    Purpose: Increasingly, brass mesh bolus is used to insure dosimetric coverage of the skin for patients treated post-mastectomy for breast cancer. Contribution of photoelectrons from interactions between the bolus and the primary beam increases dose superficially without affecting dose at greater depths. We present our experience using brass mesh bolus – including patients for whom the bolus was dosimetrically inadequate – along with analysis of relevant patient-specific parameters. Methods: Optically-stimulated luminescent dosimeters (OSLDs) were used to determine the effect of the bolus for 15 patients. They were positioned beneath the bolus within the tangent fields at three positions: 1.5–3cm insidemore » the medial and lateral field edges, and midway between the two. All OSLDs were midfield in the cranial-caudal direction. The measurements were compared with patient-specific parameters including separation, chest wall/breast tissue thickness, beam angle incidence, and planned surface dose. Results: The average OSLD measurement at the medial field edge, midfield, and lateral field edge position was 86.8%, 101.8%, and 92.8% of the prescription dose, respectively. A measurement for one patient was low enough (77.0%) to warrant a switch to an alternative type of bolus. Anatomic parameters were analyzed to investigate the low dose in this case, not observed in the planning system. The patient was observed to have a thin chest wall and very oblique beam angles. A second patient was also switched to an alternative type of bolus due to her being high risk and treated with an electron patch that extended onto the breast. Conclusion: Brass mesh bolus increases dose superficially while leaving dose at greater depths unaffected. However, our results suggest that this effect may be insufficient in patients with a thin chest wall or very oblique beam angles. More data and analysis is necessary to proactively identify patients for whom brass mesh bolus is effective.« less

  7. Aerosol bolus dispersion in acinar airways—influence of gravity and airway asymmetry

    PubMed Central

    Ma, Baoshun

    2012-01-01

    The aerosol bolus technique can be used to estimate the degree of convective mixing in the lung; however, contributions of different lung compartments to measured dispersion cannot be differentiated unambiguously. To estimate dispersion in the distal lung, we studied the effect of gravity and airway asymmetry on the dispersion of 1 μm-diameter particle boluses in three-dimensional computational models of the lung periphery, ranging from a single alveolar sac to four-generation (g4) structures of bifurcating airways that deformed homogeneously during breathing. Boluses were introduced at the beginning of a 2-s inhalation, immediately followed by a 3-s exhalation. Dispersion was estimated by the half-width of the exhaled bolus. Dispersion was significantly affected by the spatial orientation of the models in normal gravity and was less in zero gravity than in normal gravity. Dispersion was strongly correlated with model volume in both normal and zero gravity. Predicted pulmonary dispersion based on a symmetric g4 acinar model was 391 ml and 238 ml under normal and zero gravity, respectively. These results accounted for a significant amount of dispersion measured experimentally. In zero gravity, predicted dispersion in a highly asymmetric model accounted for ∼20% of that obtained in a symmetric model with comparable volume and number of alveolated branches, whereas normal gravity dispersions were comparable in both models. These results suggest that gravitational sedimentation and not geometrical asymmetry is the dominant factor in aerosol dispersion in the lung periphery. PMID:22678957

  8. Aerosol bolus dispersion in acinar airways--influence of gravity and airway asymmetry.

    PubMed

    Ma, Baoshun; Darquenne, Chantal

    2012-08-01

    The aerosol bolus technique can be used to estimate the degree of convective mixing in the lung; however, contributions of different lung compartments to measured dispersion cannot be differentiated unambiguously. To estimate dispersion in the distal lung, we studied the effect of gravity and airway asymmetry on the dispersion of 1 μm-diameter particle boluses in three-dimensional computational models of the lung periphery, ranging from a single alveolar sac to four-generation (g4) structures of bifurcating airways that deformed homogeneously during breathing. Boluses were introduced at the beginning of a 2-s inhalation, immediately followed by a 3-s exhalation. Dispersion was estimated by the half-width of the exhaled bolus. Dispersion was significantly affected by the spatial orientation of the models in normal gravity and was less in zero gravity than in normal gravity. Dispersion was strongly correlated with model volume in both normal and zero gravity. Predicted pulmonary dispersion based on a symmetric g4 acinar model was 391 ml and 238 ml under normal and zero gravity, respectively. These results accounted for a significant amount of dispersion measured experimentally. In zero gravity, predicted dispersion in a highly asymmetric model accounted for ∼20% of that obtained in a symmetric model with comparable volume and number of alveolated branches, whereas normal gravity dispersions were comparable in both models. These results suggest that gravitational sedimentation and not geometrical asymmetry is the dominant factor in aerosol dispersion in the lung periphery.

  9. Prospective Evaluation of Severe Skin Toxicity and Pain During Postmastectomy Radiation Therapy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Pignol, Jean-Philippe, E-mail: j.p.pignol@erasmusmc.nl; Vu, Thi Trinh Thuc; Mitera, Gunita

    Purpose: To prospectively capture acute toxicities and pain associated with postmastectomy radiation therapy (PMRT), to analyze patient and treatment risk factors for severe side effects. Methods and Materials: Women referred for PMRT were prospectively enrolled and assessed weekly during and after radiation therapy. The endpoint included severe National Cancer Institute Common Terminology Criteria for Adverse Effects grade 3 moist desquamation, other skin symptoms, and pain. Results: Of 257 patients, 73 (28.4%) experienced extensive moist desquamation, 84 (32.7%) Common Terminology Criteria for Adverse Effects skin toxicity grade 3, and 57 (22.2%) a pain impacting on daily life activities. Among symptoms only grademore » 3 moist desquamation was significantly associated with severe pain (P<.001). On multivariate analysis, smoking, high-energy photons, and skin bolus were significantly associated with severe moist desquamation. Skin toxicity doubled for smokers, with 40% severe pain, 48% grade 3 moist desquamation, and 64% grade 3 skin toxicity. Without skin bolus 4.2% had severe pain, none moist desquamation, and 2.1% grade 3 skin toxicity. When skin bolus was used on alternate days, the frequency increased to 15% for pain, 22% for moist desquamation, and 26% for grade 3 skin toxicity. When bolus was used daily, 32% had pain, 41% moist desquamation, and 47% grade 3 skin toxicity. Symptoms peaked 1 to 2 weeks after the end of PMRT. Conclusions: The present cohort study suggests excessive radiation toxicity after PMRT. Among factors associated with an increase of toxicity are smoking habits and the use of skin bolus.« less

  10. The comparison of the diuretic and natriuretic efficacy of continuous and bolus intravenous furosemide in patients with chronic kidney disease.

    PubMed

    Sanjay, Srinivas; Annigeri, Rajeev A; Seshadri, Rajagopalan; Rao, Budithi Subba; Prakash, Kowdle C; Mani, Muthu Krishna

    2008-06-01

    To compare natriuretic, kaliuretic, diuretic and free water clearance efficacy of continuous versus bolus intravenous furosemide administration in patients with chronic renal insufficiency. In a prospective randomized cross-over trial, 42 patients of chronic renal insufficiency were randomized to receive the same dose of intravenous furosemide as bolus and continuous infusion. The effects of bolus and intravenous administration of furosemide on the volume of urine, sodium and potassium excretion were assessed. Mean age was 53.6 +/- 14 years and 23 (55%) were male. The mean modification of diet in renal disease glomerular filtration rate was 20.5 +/- 17 mL/min per 1.73 m(2). The urinary excretion of sodium in intravenous bolus and infusion was 98.1 +/- 78 and 114.4 +/- 100 mmol, respectively (P = 0.001). Total urinary volume following bolus and infusion of furosemide was 1064 +/- 627 and 1170 +/- 764 mL, respectively (0.001). The excretion of potassium was similar in bolus (15.8 +/- 16.6) and infusion (14.3 +/- 9) administration (P = 0.11). The fractional excretion of sodium was higher following infusion (16.63 +/- 16.1) than bolus administration (12.87 +/- 9) of furosemide (P = 0.016). Continuous intravenous infusion of furosemide has significantly better natriuretic and diuretic effect than bolus administration of the same dose of the drug in patients with advanced chronic renal insufficiency.

  11. Effect of Oral Methylprednisolone on Clinical Outcomes in Patients With IgA Nephropathy: The TESTING Randomized Clinical Trial.

    PubMed

    Lv, Jicheng; Zhang, Hong; Wong, Muh Geot; Jardine, Meg J; Hladunewich, Michelle; Jha, Vivek; Monaghan, Helen; Zhao, Minghui; Barbour, Sean; Reich, Heather; Cattran, Daniel; Glassock, Richard; Levin, Adeera; Wheeler, David; Woodward, Mark; Billot, Laurent; Chan, Tak Mao; Liu, Zhi-Hong; Johnson, David W; Cass, Alan; Feehally, John; Floege, Jürgen; Remuzzi, Giuseppe; Wu, Yangfeng; Agarwal, Rajiv; Wang, Hai-Yan; Perkovic, Vlado

    2017-08-01

    Guidelines recommend corticosteroids in patients with IgA nephropathy and persistent proteinuria, but the effects remain uncertain. To evaluate the efficacy and safety of corticosteroids in patients with IgA nephropathy at risk of progression. The Therapeutic Evaluation of Steroids in IgA Nephropathy Global (TESTING) study was a multicenter, double-blind, randomized clinical trial designed to recruit 750 participants with IgA nephropathy (proteinuria greater than 1 g/d and estimated glomerular filtration rate [eGFR] of 20 to 120 mL/min/1.73 m2 after at least 3 months of blood pressure control with renin-angiotensin system blockade] and to provide follow-up until 335 primary outcomes occurred. Patients were randomized 1:1 to oral methylprednisolone (0.6-0.8 mg/kg/d; maximum, 48 mg/d) (n = 136) or matching placebo (n = 126) for 2 months, with subsequent weaning over 4 to 6 months. The primary composite outcome was end-stage kidney disease, death due to kidney failure, or a 40% decrease in eGFR. Predefined safety outcomes were serious infection, new diabetes, gastrointestinal hemorrhage, fracture/osteonecrosis, and cardiovascular events. The mean required follow-up was estimated to be 5 years. After randomization of 262 participants (mean age, 38.6 [SD, 11.1] years; 96 [37%] women; eGFR, 59.4 mL/min/1.73 m2; urine protein excretion, 2.40 g/d) and 2.1 years' median follow-up, recruitment was discontinued because of excess serious adverse events. Serious events occurred in 20 participants (14.7%) in the methylprednisolone group vs 4 (3.2%) in the placebo group (P = .001; risk difference, 11.5% [95% CI, 4.8%-18.2%]), mostly due to excess serious infections (11 [8.1%] vs 0; risk difference, 8.1% [95% CI, 3.5%-13.9%]; P < .001), including 2 deaths. The primary renal outcome occurred in 8 participants (5.9%) in the methylprednisolone group vs 20 (15.9%) in the placebo group (hazard ratio, 0.37 [95% CI, 0.17-0.85]; risk difference, 10.0% [95% CI, 2

  12. Total intravenous anaesthesia by boluses or by continuous rate infusion of propofol in mute swans (Cygnus olor).

    PubMed

    Müller, Kerstin; Holzapfel, Judith; Brunnberg, Leo

    2011-07-01

    To investigate intravenous (IV) propofol given by intermittent boluses or by continuous rate infusion (CRI) for anaesthesia in swans. Prospective randomized clinical study. Twenty mute swans (Cygnus olor) (eight immature and 12 adults) of unknown sex undergoing painless diagnostic or therapeutic procedures. Induction of anaesthesia was with 8 mg kg(-1) propofol IV. To maintain anaesthesia, ten birds (group BOLI) received propofol as boluses, whilst 10 (group CRI) received propofol as a CRI. Some physiological parameters were measured. Anaesthetic duration was 35 minutes. Groups were compared using Mann-Whitney U-test. Results are median (range). Anaesthetic induction was smooth and tracheal intubation was achieved easily in all birds. Bolus dose in group BOLI was 2.9 (1.3-4.3) mg kg(-1); interval between and number of boluses required were 4 (1-8) minutes and 6 (4-11) boluses respectively. Total dose of propofol was 19 (12.3-37.1) mg kg(-1). Awakening between boluses was very abrupt. In group CRI, propofol infusion rate was 0.85 (0.8-0.9) mg kg(-1) minute(-1), and anaesthesia was stable. Body temperature, heart and respiratory rates, oxygen saturation (by pulse oximeter) and reflexes did not differ between groups. Oxygen saturations (from pulse oximeter readings) were low in some birds. Following anaesthesia, all birds recovered within 40 minutes. In 55% of all, transient signs of central nervous system excitement occurred during recovery. 8 mg kg(-1) propofol appears an adequate induction dose for mute swans. For maintenance, a CRI of 0.85 mg kg(-1) minute(-1) produced stable anaesthesia suitable for painless clinical procedures. In contrast bolus administration, was unsatisfactory as birds awoke very suddenly, and the short intervals between bolus requirements hampered clinical procedures. Administration of additional oxygen throughout anaesthesia might reduce the incidence of low arterial haemoglobin saturation. © 2011 The Authors. Veterinary Anaesthesia and

  13. Measurement of myocardial blood flow by cardiovascular magnetic resonance perfusion: comparison of distributed parameter and Fermi models with single and dual bolus.

    PubMed

    Papanastasiou, Giorgos; Williams, Michelle C; Kershaw, Lucy E; Dweck, Marc R; Alam, Shirjel; Mirsadraee, Saeed; Connell, Martin; Gray, Calum; MacGillivray, Tom; Newby, David E; Semple, Scott Ik

    2015-02-17

    Mathematical modeling of cardiovascular magnetic resonance perfusion data allows absolute quantification of myocardial blood flow. Saturation of left ventricle signal during standard contrast administration can compromise the input function used when applying these models. This saturation effect is evident during application of standard Fermi models in single bolus perfusion data. Dual bolus injection protocols have been suggested to eliminate saturation but are much less practical in the clinical setting. The distributed parameter model can also be used for absolute quantification but has not been applied in patients with coronary artery disease. We assessed whether distributed parameter modeling might be less dependent on arterial input function saturation than Fermi modeling in healthy volunteers. We validated the accuracy of each model in detecting reduced myocardial blood flow in stenotic vessels versus gold-standard invasive methods. Eight healthy subjects were scanned using a dual bolus cardiac perfusion protocol at 3T. We performed both single and dual bolus analysis of these data using the distributed parameter and Fermi models. For the dual bolus analysis, a scaled pre-bolus arterial input function was used. In single bolus analysis, the arterial input function was extracted from the main bolus. We also performed analysis using both models of single bolus data obtained from five patients with coronary artery disease and findings were compared against independent invasive coronary angiography and fractional flow reserve. Statistical significance was defined as two-sided P value < 0.05. Fermi models overestimated myocardial blood flow in healthy volunteers due to arterial input function saturation in single bolus analysis compared to dual bolus analysis (P < 0.05). No difference was observed in these volunteers when applying distributed parameter-myocardial blood flow between single and dual bolus analysis. In patients, distributed parameter

  14. Effects of therapy on masseter activity and chewing kinematics in patients with unilateral posterior crossbite.

    PubMed

    Piancino, Maria Grazia; Falla, Deborah; Merlo, Andrea; Vallelonga, Teresa; de Biase, Corrado; Dalessandri, Domenico; Debernardi, Cesare

    2016-07-01

    To describe the effects of therapy on masseter activity and chewing kinematic in patients with unilateral posterior crossbite (UPC). Fifty children (age: mean ± SD: 9.1 ± 2.3 years) with UPC (34 on the right side, 16 on the left side) and twenty children (age: 9.5 ± 2.6 years) with normal occlusion were selected for the study. The mandibular motion and the muscular activity during chewing soft and hard boli were simultaneously recorded, before and after correction with function generating bite, after a mean treatment time of 7.3 ± 2.4 months plus the retention time of 5-6 months. The percentage of reverse cycles and the percent difference between ipsilateral and contralateral peaks of the masseter electromyography envelopes were computed. Before therapy, the percentage of reverse cycles during chewing on the crossbite side was greater in patients than in controls (P<0.001) and significantly reduced after therapy (P<0.001) towards the reference normal value (soft bolus; pre: 57 ± 30%, post:12 ± 17%; hard bolus; pre: 65 ± 34%, post: 12 ± 13%; reference value: soft bolus 4 ± 2%, hard bolus 5 ± 3%). Before therapy the percent difference between electromyography envelope peaks in patients was lower than in controls (P<0.01) and significantly increased after therapy (P<0.05) becoming similar to the reference normal value. The correction induced a normal-like coordination of masseter muscles activity together with a significant reduction of the reverse chewing patterns. The previous altered muscular activation corresponded to the altered kinematics of reverse chewing cycles that might be considered a useful indicator of the severity of the masticatory function involvement. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Effectiveness and tolerability of treatment intensification to basal-bolus therapy in patients with type 2 diabetes on previous basal insulin-supported oral therapy with insulin glargine or supplementary insulin therapy with insulin glulisine: the PARTNER observational study.

    PubMed

    Pfohl, Martin; Siegmund, Thorsten; Pscherer, Stefan; Pegelow, Katrin; Seufert, Jochen

    2015-01-01

    Due to the progressive nature of type 2 diabetes mellitus (T2DM), antidiabetic treatment needs to be continuously intensified to avoid long-term complications. In T2DM patients on either basal insulin-supported oral therapy (BOT) or supplementary insulin therapy (SIT) presenting with HbA1c values above individual targets for 3-6 months, therapy should be intensified. This study investigated effectiveness and tolerability of an intensification of BOT or SIT to a basal-bolus therapy (BBT) regimen in T2DM patients in daily clinical practice. This noninterventional, 8-month, prospective, multicenter study evaluated parameters of glucose control, occurrence of adverse events (eg, hypoglycemia), and acceptance of devices in daily clinical practice routine after 12 and 24 weeks of intensifying insulin therapy to a BBT regimen starting from either preexisting BOT with insulin glargine (pre-BOT) or preexisting SIT with ≥3 daily injections of insulin glulisine (pre-SIT). A total of 1,530 patients were documented in 258 German medical practices. A total of 1,301 patients were included in the full analysis set (55% male, 45% female; age median 64 years; body mass index median 30.8 kg/m(2); pre-BOT: n=1,072; pre-SIT: n=229), and 1,515 patients were evaluated for safety. After 12 weeks, HbA1c decreased versus baseline (pre-BOT 8.67%; pre-SIT 8.46%) to 7.73% and 7.66%, respectively (Δ mean -0.94% and -0.80%; P<0.0001). At week 24, HbA1c was further reduced to 7.38% and 7.30%, respectively (Δ mean -1.29% and -1.15%; P<0.0001), with a mean reduction of fasting blood glucose values in both treatment groups by more than 46 mg/dL. An HbA1c goal of ≤6.5% was reached by 17.9% (pre-BOT) and 18.6% (pre-SIT), and an HbA1c ≤7.0% by 46.1% (pre-BOT) and 43.0% (pre-SIT) of patients. During 24 weeks, severe as well as serious hypoglycemic events were rare (pre-BOT: n=5; pre-SIT: n=2; pretreated with both insulins: n=1). Intensifying glargine-based BOT or glulisine-based SIT to a BBT

  16. An implantable bolus infusion pump for use in freely moving, nontethered rats

    PubMed Central

    HOLSCHNEIDER, D. P.; MAAREK, J.-M. I.; HARIMOTO, J.; YANG, J.; SCREMIN, O. U.

    2014-01-01

    One of the current constraints on functional neuroimaging in animals is that to avoid movement artifacts during data acquisition, subjects need to be immobilized, sedated, or anesthetized. Such measures limit the behaviors that can be examined, and introduce the additional variables of stress or anesthetic agents that may confound meaningful interpretation. This study provides a description of the design and characteristics of a self-contained, implantable microbolus infusion pump (MIP) that allows triggering of a bolus injection at a distance in conscious, behaving rats that are not restrained or tethered. The MIP is externally triggered by a pulse of infrared light and allows in vivo bolus drug delivery. We describe application of this technology to the intravenous bolus delivery of iodo[14C]antipyrine in a freely moving animal, followed immediately by lethal injection, rapid removal of the brain, and analysis of regional cerebral blood flow tissue radioactivity with the use of autoradiography. The ability to investigate changes in brain activation in nonrestrained animals makes the MIP a powerful tool for evaluation of complex behaviors. PMID:12234827

  17. The Role of Bolus Injection of Saline with Arm Elevation on Rocuronium onset Time: A Randomized Control Study

    PubMed Central

    Kulkarni, Malavika; Chuchendra, L. S.; Bhavya, P. J.

    2018-01-01

    Background: The onset time of neuromuscular blockade is a crucial time associated with the risk of hypoxia and pulmonary aspiration. Various strategies have been undertaken to shorten this onset time. Therefore, we investigated the effects of bolus of 20 ml saline followed by limb elevation after administration of rocuronium in a dose of 0.6 mg/kg to study the onset time. Methodology: Thirty patients were randomly allocated to the bolus saline group or control group. General anesthesia was induced and maintained with fentanyl and propofol. Rocuronium 0.6 mg/kg intravenous (IV) was administered followed by 20 ml saline bolus and limb elevation in the study group compared to administration of 0.6 mg/kg in a running drip only in the control. Onset of neuromuscular block was assessed by acceleromyography at the adductor pollicis muscle with train-of-four stimulation. Results: The lag time was shorter in bolus group (34 s median) than in control group (45 s median), P < 0.017. The onset time was shorter in bolus group (55 s median) than in control group (110 s median), P < 0.001. The T1 recovery to 25% was longer in bolus group (42 min median) than in control group (39 min median) which was statistically not significant. Conclusion: Rocuronium 0.6 mg/kg IV followed by bolus 20 ml saline and concomitant limb elevation resulted in shorter lag time, faster onset of neuromuscular blockade, good intubating conditions without prolonging clinical duration of action when compared to the control. PMID:29628555

  18. Effects of switching from prandial premixed insulin therapy to basal plus two times bolus insulin therapy on glycemic control and quality of life in patients with type 2 diabetes mellitus

    PubMed Central

    Ito, Hiroyuki; Abe, Mariko; Antoku, Shinichi; Omoto, Takashi; Shinozaki, Masahiro; Nishio, Shinya; Mifune, Mizuo; Togane, Michiko

    2014-01-01

    Background The effects of switching from prandial premixed insulin therapy (PPT) injected three times a day to basal plus two times bolus insulin therapy (B2B) on glycemic control and quality of life were investigated in patients with type 2 diabetes mellitus. Methods The clinical course was prospectively observed during the first 16 weeks after switching to B2B (insulin glargine plus insulin glulisine before breakfast and dinner) in 27 subjects previously treated with PPT using 50/50 premixed insulin. The Diabetes Treatment Satisfaction Questionnaire (DTSQ) was administered at the start and end of the study. Results The glycated hemoglobin (HbA1c) level (8.3%±1.8% to 8.2%±1.1%) and the DTSQ score did not change between the start and end of the study. An improvement in HbA1c level was found in nine (33%) subjects. The change in HbA1c showed a significant negative correlation with baseline HbA1c, and was significantly better in patients with a baseline HbA1c >8.0% than in those with an HbA1c ≤8.0% (−0.9±2.0 versus 0.3±0.6, respectively, P=0.02). The change in DTSQ score representing treatment satisfaction was significantly greater in patients whose HbA1c level was improved than in those in whom it was not (2.7±3.6 versus −0.8±3.5, P=0.04). Conclusion B2B was noninferior to PPT with regard to HbA1c levels in patients with type 2 diabetes mellitus. B2B should be considered particularly for subjects whose glycemic control is poor despite PPT. PMID:24790413

  19. Effects of switching from prandial premixed insulin therapy to basal plus two times bolus insulin therapy on glycemic control and quality of life in patients with type 2 diabetes mellitus.

    PubMed

    Ito, Hiroyuki; Abe, Mariko; Antoku, Shinichi; Omoto, Takashi; Shinozaki, Masahiro; Nishio, Shinya; Mifune, Mizuo; Togane, Michiko

    2014-01-01

    The effects of switching from prandial premixed insulin therapy (PPT) injected three times a day to basal plus two times bolus insulin therapy (B2B) on glycemic control and quality of life were investigated in patients with type 2 diabetes mellitus. The clinical course was prospectively observed during the first 16 weeks after switching to B2B (insulin glargine plus insulin glulisine before breakfast and dinner) in 27 subjects previously treated with PPT using 50/50 premixed insulin. The Diabetes Treatment Satisfaction Questionnaire (DTSQ) was administered at the start and end of the study. The glycated hemoglobin (HbA1c) level (8.3% ± 1.8% to 8.2% ± 1.1%) and the DTSQ score did not change between the start and end of the study. An improvement in HbA1c level was found in nine (33%) subjects. The change in HbA1c showed a significant negative correlation with baseline HbA1c, and was significantly better in patients with a baseline HbA1c >8.0% than in those with an HbA1c ≤ 8.0% (-0.9 ± 2.0 versus 0.3 ± 0.6, respectively, P = 0.02). The change in DTSQ score representing treatment satisfaction was significantly greater in patients whose HbA1c level was improved than in those in whom it was not (2.7 ± 3.6 versus -0.8 ± 3.5, P = 0.04). B2B was noninferior to PPT with regard to HbA1c levels in patients with type 2 diabetes mellitus. B2B should be considered particularly for subjects whose glycemic control is poor despite PPT.

  20. SU-F-T-442: Dose Distribution Comparison for Post-Laryngectomy Stoma Area Between Conventional AP and VMAT Plans with Or Without Bolus

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lee, B; Zhang, J; Cho-Lim, J

    Purpose: To compare dose distributions of conventional AP vs. VMAT treatment plans with or without bolus around post-laryngectomy stoma. Methods: Radiation dose coverage for post-laryngectomy stoma was analyzed using a set of real-case CT-simulation images. After meticulous contouring of the catheter cuff, stoma lumen, peri-stoma skin and subclinical tumor bed at the larynx, the resulting dosimetry plans were analyzed with or without a 5 mm bolus placement. Wet gauze was used to minimize the effect of any air gap. Four plans were generated: AP superclavicular (SCV) plan with or without bolus, and VMAT plan with or without bolus. A dosemore » of 60Gy in 30 fractions was prescribed at 3 cm depth for AP SCV plan, and to 95% of the PTV volume for VMAT plan. Results: For the conventional AP SCV plan, the peri-stoma skin dose is sensitive to bolus placement as well as air gap compensation by wetted gauze (V95% of 20.7%, 33.0% and 94.8% for no bolus, bolus without and with air gap compensation, respectively). For stoma lumen, the dose drops off rapidly in depth. The catheter cuff may have certain dose-buildup effect, but air gap around it and under the bolus placed can pose a more serious problem. The dose distributions of the two VMAT plans are moderately different for peri-stoma skin (V95% of 95.0% with bolus and air gap compensation, and 82.3% without bolus), but nearly identical for stoma lumen (V95% of 91.5% and 92.0%, respectively). VMAT allows beamlets with different angles of incidence that helped achieve such dose distribution around the stoma even without bolus placement. Conclusion: Overall, the dose coverage around the stoma in the VMAT plan is better than the conventional AP SCV plan. To achieve optimal dose distribution, it is still recommended to place physical bolus and reduce the air gaps.« less

  1. Extended versus Bolus Infusion of Broad Spectrum β-Lactams for Febrile Neutropenia: an Unblinded Randomized Trial.

    PubMed

    Ram, Ron; Halavy, Yael; Amit, Odelia; Paran, Yael; Katchman, Eugene; Yachini, Bruria; Kor, Svetlana; Avivi, Irit; Ben-Ami, Ronen

    2018-03-28

    Febrile neutropenia may be a sign of severe infection, and is associated with significant morbidity and mortality in high-risk patients with hematologic malignancies. Extended infusion of β-lactam antibiotics is associated with greater clinical response than is bolus infusion in non-neutropenic critically ill patients, but data are lacking for febrile neutropenic patients. We designed a single-center, non-blinded randomized trial comparing extended infusion (4 hours) and bolus infusion (30 minutes) of piperacillin-tazobactam or ceftazidime in high-risk patients with febrile neutropenia. The primary end-point was overall response on day 4, defined as the combination of resolution of fever, sterile blood cultures, resolution of clinical signs and symptoms, and no need for a change in the antibiotic regimen. Outcome was adjudicated by investigators blinded to treatment allocation. Of 123 enrolled patients, 105 had febrile neutropenia and were included in the intention-to-treat analysis: 47 in the extended infusion arm and 58 in the bolus infusion arm. Overall response occurred in 35 (74.4%) patients treated with extended infusion and 32 (55.1%) patients treated with bolus infusion (P=0.044). The superiority of extended infusion compared with bolus infusion was greatest for patients with clinically documented infections (overall response, 68.4% [13/19] versus 35.7% [10/28]; P=0.039), and specifically for those with pneumonia (80% [4/5] versus 0% [0/8]; P=0.007). Extended infusion of β-lactams is associated with superior treatment outcomes as compared with bolus infusion for high-risk patients with febrile neutropenia. The benefit of extended β-lactam infusion may be greatest for patients with pulmonary infections.

  2. Bolus intrathecal injection of ziconotide (Prialt®) to evaluate the option of continuous administration via an implanted intrathecal drug delivery (ITDD) system: a pilot study.

    PubMed

    Mohammed, Salma I; Eldabe, Sam; Simpson, Karen H; Brookes, Morag; Madzinga, Grace; Gulve, Ashish; Baranidharan, Ganesan; Radford, Helen; Crowther, Tracey; Buchser, Eric; Perruchoud, Christophe; Batterham, Alan Mark

    2013-01-01

    This study evaluated efficacy and safety of bolus doses of ziconotide (Prialt®, Eisai Limited, Hertfordshire, UK) to assess the option of continuous administration of this drug via an implanted intrathecal drug delivery system. Twenty adults with severe chronic pain who were under consideration for intrathecal (IT) therapy were enrolled in this open label, nonrandomized, pilot study. Informed consent was obtained. Demographics, medical/pain history, pain scores, and concomitant medications were recorded. A physical examination was performed. Creatine kinase was measured. Initial visual analog scale (VAS), blood pressure, heart rate, and respiratory rate were recorded. All patients received an initial bolus dose of 2.5 mcg ziconotide; the dose in the subsequent visits was modified according to response. Subsequent doses were 2.5 mcg, 1.2 mcg, or 3.75 mcg as per protocol. A good response (≥30% reduction in baseline pain VAS) with no side-effects on two occasions was considered a successful trial. Data were analyzed using a generalized estimating equations model, with pain VAS as the outcome and time (seven time points; preinjection and one to six hours postinjection) as the predictor. Generalized estimating equations analysis of summary measures showed a mean reduction of pain VAS of approximately 25% at the group level; of 11 responders, seven underwent pump implantation procedure, two withdrew because of adverse effects, one refused an implant, and one could not have an implant (lack of funding from the Primary Care Trust). Our data demonstrated that mean VAS was reduced by approximately 25% at the group level after IT ziconotide bolus. Treatment efficacy did not vary with sex, center, age, or pain etiology. Ziconotide bolus was generally well tolerated. Larger studies are needed to determine if bolus dosing with ziconotide is a good predictor of response to continuous IT ziconotide via an intrathecal drug delivery system. © 2012 International

  3. Fluid bolus therapy in critically ill children: a survey of practice among paediatric intensive care doctors in Australia and New Zealand.

    PubMed

    Gelbart, Ben; Schlapbach, Luregn; Ganeshalingham, Anusha; Ganu, Subodh; Erickson, Simon; Oberender, Felix; Hoq, Monsurul; Williams, Gary; George, Shane; Festa, Marino

    2018-06-01

    Fluid bolus therapy (FBT) is a widely used intervention in paediatric critical illness. The aim of this study was to describe the attitudes and practices towards FBT of paediatric intensive care doctors in Australia and New Zealand. An internet-based survey of paediatric intensive care doctors in Australia and New Zealand between 7 and 30 November 2016. Paediatric intensive care units with greater than 400 admissions annually. Paediatric intensive care specialists and junior medical staff. Preferences for FBT and markers of fluid responsiveness. There were 106/175 respondents (61%); 0.9% saline and 4% albumin are used frequently or almost always by 86% and 57% of respondents respectively. The preferred volume and duration were 10 mL/kg in less than 10 minutes. The highest rated markers of fluid responsiveness were heart rate and blood pressure - rated as "good" or "very good" by 75% and 58% of respondents respectively. Central venous saturations and serum lactate were the highest rated biochemical markers. The most frequently expected magnitude of change for heart rate and blood pressure was 6-15% by 89% and 76% of respondents respectively. The preferred fluid composition for sepsis, trauma, traumatic brain injury and acute lung injury was 0.9% saline, and 4% albumin for post-operative cardiac surgery. Paediatric intensive care doctors prefer 0.9% saline and 4% albumin for FBT. Heart rate and blood pressure are the most preferred markers to assess fluid responsiveness. Preferences for FBT in specific conditions exist.

  4. Effects of different strategies of mineral supplementation (marine algae alone or combined with rumen boluses) in organic dairy systems.

    PubMed

    López-Alonso, M; Rey-Crespo, F; Orjales, I; Rodríguez-Bermúdez, R; Miranda, M

    2016-10-01

    This study was designed to evaluate the effect of marine algae supplementation alone or in combination with a regular mineral supplement (rumen boluses) to improve the mineral status in organic dairy cattle and their effect on the milk mineral composition, milk production, composition (% of fat and protein) and quality (SCC). Thirty-two Holstein Friesian lactating cows were randomly selected and assigned to the algae (A), boluses (B), algae+boluses (AB) and control group (C). For the algae groups (A, AB), a supplement composed of Sea Lettuce (80%), Japanese Wireweed (17.5%) and Furbelows (2.5%) was formulated to be given to the cows at the rate of 100 g/animal per day (A1) for the length of 4 weeks. In the second half of the experiment (weeks 5-8), the algae mixture was reformulated and the proportion of Furbelows was increased from 2.5% to 5.0% with a subsequent decrease of Lettuce to 77.5% (A2). In the boluses group (B), each cow received 2 boluses after calving. Blood (serum) and milk samples were collected at 2 and 4 week intervals, respectively, and analysed for trace element concentrations by ICP-MS. Information related to the milk composition and SCC during a 305-day lactation for each animal were obtained from the Dairy Records Management System. The supplementation with algae, boluses or the combination of both treatments showed a statistically significant effect on the iodine (algae), selenium (boluses) and cobalt (algae+boluses) status of the animals. In milk, treatments had a statistical significant increase on iodine, and a tendency to increase selenium concentrations. The assayed algae mixture combined with another source of selenium could be an effective tool to improve the mineral status in serum and milk. Journal of Animal Physiology and Animal Nutrition © 2016 Blackwell Verlag GmbH.

  5. Innate inflammatory gene expression profiling in potential brain-dead donors: detailed investigation of the effect of common corticosteroid therapy.

    PubMed

    Gholamnezhadjafari, Reza; Tajik, Nader; Falak, Reza; Aflatoonian, Reza; Dehghan, Sanaz; Rezaei, Abbas

    2017-07-01

    Our study aimed to assess the influence of common methylprednisolone therapy on innate inflammatory factors in potential brain-dead organ donors (BDDs). The study groups consisted of 50 potential BDDs who received 15 mg/kg/d methylprednisolone and 25 live organ donors (LDs) as control group. Innate immunity gene expression profiling was performed by RT-PCR array. Soluble serum cytokines and chemokines, complement components, heat shock protein 70 (HSP70) and high mobility group box-1 (HMGB1) were measured by ELISA. Surface expression of TLR2 and TLR4 were determined using flow cytometry. Gene expression profiling revealed up-regulation of TLRs 1, 2, 4, 5, 6, 7 and 8, MYD88, NF-κB, NF-κB1A, IRAK1, STAT3, JAK2, TNF-α, IL-1β, CD86 and CD14 in the BDD group. Remarkably, the serum levels of C-reactive protein and HSP70 were considerably higher in the BDD group. In addition, serum amounts of IL-1β, IL-6, TNF-α, HMGB1, HSP70, C3a and C5a, but not IL-8, sCD86 or monocyte chemoattractant protein-1, were significantly increased in the BDD group. Significant differences were observed in flow cytometry analysis of TLR2 and TLR4 between the two groups. In summary, common methylprednisolone therapy in BDDs did not adequately reduce systemic inflammation, which could be due to inadequate doses or inefficient impact on other inflammatory-inducing pathways, for example oxidative stress or production of damage-associated molecules.

  6. Bolus dose response characteristics of single chain urokinase plasminogen activator and tissue plasminogen activator in a dog model of arterial thrombosis.

    PubMed

    Badylak, S F; Voytik, S; Klabunde, R E; Henkin, J; Leski, M

    1988-11-15

    Tissue plasminogen activator (t-PA) and single chain urokinase-plasminogen activator (scu-PA) are relatively "fibrin-specific" thrombolytic drugs with short plasma half lives of 6-8 minutes. Most treatment regimens with these agents utilize a bolus injection followed by continuous drug infusion, usually combined with anticoagulant therapy. The purpose of this study was to establish the dose-response characteristics for scu-PA and t-PA, when given as a single intravenous bolus injection, in a dog model of arterial thrombosis. Eight groups of 6 dogs each were given one of the following doses of scu-PA (mg/kg): 0.20, 0.50, 1.00, 2.00; or t-PA: 0.05, 0.10, 0.20; or an equivalent amount of saline (control group). All doses were given as a single bolus injection 60 minutes after formation of a totally occlusive femoral artery thrombus. Thrombolysis was measured by monitoring the continuous decrement of 125I activity from a radiolabelled thrombus. Ninety minutes after drug injection, all scu-PA treated dogs showed greater thrombolysis (30%, 45%, 56%, and 67%, respectively) than the control group (15%, p less than 0.01). The 0.10 and 0.20 mg/kg t-PA treated dogs showed greater thrombolysis (35% and 49%, respectively) than the control group (15%, p less than 0.01). Both scu-PA and t-PA caused a partial and dose-dependent decrease in alpha 2-antiplasmin activity but scu-PA caused a greater depletion (72% vs. 18%, respectively, p less than 0.05) at 60 minutes after the highest dose of drug administration. Both drugs showed a longer than expected thrombolytic effect based upon the known half lives. Neither drug caused significant changes in the prothrombin time, activated partial thromboplastin time, thrombin time, hematocrit, platelet count, or fibrin degradation product concentration. Single bolus injections of scu-PA and t-PA produce safe and effective thrombolysis in this dog model of arterial thrombosis.

  7. Modeling magnetization transfer effects of Q2TIPS bolus saturation in multi-TI pulsed arterial spin labeling.

    PubMed

    Petr, Jan; Schramm, Georg; Hofheinz, Frank; Langner, Jens; van den Hoff, Jörg

    2014-10-01

    To estimate the relaxation time changes during Q2TIPS bolus saturation caused by magnetization transfer effects and to propose and evaluate an extended model for perfusion quantification which takes this into account. Three multi inversion-time pulsed arterial spin labeling sequences with different bolus saturation duration were acquired for five healthy volunteers. Magnetization transfer exchange rates in tissue and blood were obtained from control image saturation recovery. Cerebral blood flow (CBF) obtained using the extended model and the standard model was compared. A decrease of obtained CBF of 6% (10%) was observed in grey matter when the duration of bolus saturation increased from 600 to 900 ms (1200 ms). This decrease was reduced to 1.6% (2.8%) when the extended quantification model was used. Compared with the extended model, the standard model underestimated CBF in grey matter by 9.7, 15.0, and 18.7% for saturation durations 600, 900, and 1200 ms, respectively. Results for simulated single inversion-time data showed 5-16% CBF underestimation depending on blood arrival time and bolus saturation duration. Magnetization transfer effects caused by bolus saturation pulses should not be ignored when performing quantification as they can cause appreciable underestimation of the CBF. Copyright © 2013 Wiley Periodicals, Inc.

  8. Suitability of electronic mini-boluses for the early identification of goat kids and effects on growth performance and development of the reticulorumen.

    PubMed

    Castro, N; Martín, D; Castro-Alonso, A; Argüello, A; Capote, J; Caja, G

    2010-10-01

    A total of 60 twin-goat kids (30 male and 30 female) of the Canary Island Majorera dairy breed were used in 2 experiments to evaluate 2 types of electronic identification mini-boluses and their effects on rearing performances and reticulorumen development. Electronic identification mini-boluses were cylindrical and made of ceramic materials (B1, 9.0 g and 38.5 × 9.5 mm; B2, 16.3 g and 42.2 × 12.2 mm), contained a 32-mm half-duplex passive transponder, and were administered to kids at different BW. In Exp. 1, treatments were 1) control, without bolus (n = 15) and 2) identified with B1 at 4.8 kg of BW (n = 15). In Exp. 2, treatments were 1) control, without bolus (n = 15) and 2) identified with B2 at 5.6 kg of BW (n = 15). Kids were penned separately, according to mini-bolus treatments, fed a milk replacer daily, and slaughtered at 10 kg of BW. Milk replacer intake was recorded individually twice weekly and boluses read weekly until slaughter. The full and empty stomach complex was measured immediately after slaughter, and mini-bolus location was recorded. Samples of the reticulum and rumen wall were taken to measure the number and length of the papillae and crest. Despite the light BW of kids at time of mini-bolus treatment, no negative effects (P > 0.05) of B1 and B2 mini-boluses were observed on milk intake, growth rate, or G:F in either experiment. No kid mortality or mini-bolus losses were observed during either experiment. All mini-boluses were retained until slaughter, and all were found in the rumen upon dissection, except one B2, which was found in the reticulum. Mini-bolus treatment did not affect (P > 0.05) the weight of full and empty reticulorumen or the number of papillae and crest size of the reticulum epithelium. Moreover, the B1-treated kids showed a greater number of papillae in the rumen wall than the control kids (22.4 +/- 1.0 vs. 18.9 +/- 0.9 papillae/cm, respectively; P < 0.05) in Exp. 1. In conclusion, the use of mini-boluses was suitable for

  9. Basal-Bolus Insulin Therapy with Gla-300 During Hospitalization Reduces Nocturnal Hypoglycemia in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Study.

    PubMed

    Okajima, Fumitaka; Nakamura, Yuko; Yamaguchi, Yuji; Shuto, Yuki; Kato, Katsuhito; Sugihara, Hitoshi; Emoto, Naoya

    2018-04-04

    Although reduction in the incidence of nocturnal hypoglycemia, as estimated by symptom or self-monitored plasma glucose, was shown to be more pronounced with 300 units/mL insulin glargine (Gla-300) than with 100 units/mL insulin glargine (Gla-100) in type 2 diabetes patients, the exact frequency of nocturnal hypoglycemia estimated with continuous glucose monitoring (CGM) has not been reported. Forty patients with type 2 diabetes who were admitted for glycemic control with basal-bolus insulin therapy (BBT) were randomized into the Gla-100 and Gla-300 groups. Insulin doses were adjusted to maintain blood glucose levels within 100-120 mg/dL at each meal. Plasma glucose and C-peptide profiles were estimated serially after admission and before discharge. Daily CGM was also performed before discharge. In the Gla-100 and Gla-300 groups, the mean duration of hospitalization was 15 ± 2 and 15 ± 1 days, respectively, and the mean basal insulin dose before discharge was 13 ± 7 and 15 ± 10 units, respectively. The dose of meal-time insulin was not different between the two groups. Compared with the Gla-300 group, the Gla-100 group had significantly lower nocturnal profiles of plasma glucose and C-peptide, but significantly higher frequency of CGM-estimated nocturnal hypoglycemia (10.7% ± 18.4% versus 1.2% ± 3.6%, P = 0.033). In type 2 diabetic patients, reduction in the incidence of CGM-estimated nocturnal hypoglycemia by BBT under tightly controlled diet therapy was higher with Gla-300 than with Gla-100. UMIN clinical trials registry (UMIN000023360).

  10. 21 CFR 520.2260b - Sulfamethazine sustained-release boluses.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Sulfamethazine sustained-release boluses. 520.2260b Section 520.2260b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... weight. (ii) Indications for use. Beef and nonlactating cattle for sustained treatment of shipping fever...

  11. 21 CFR 520.2260b - Sulfamethazine sustained-release boluses.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Sulfamethazine sustained-release boluses. 520.2260b Section 520.2260b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... weight. (ii) Indications for use. Beef and nonlactating cattle for sustained treatment of shipping fever...

  12. 21 CFR 520.2260b - Sulfamethazine sustained-release boluses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Sulfamethazine sustained-release boluses. 520.2260b Section 520.2260b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... weight. (ii) Indications for use. Beef and nonlactating cattle for sustained treatment of shipping fever...

  13. The Impact of Injector-Based Contrast Agent Administration on Bolus Shape and Magnetic Resonance Angiography Image Quality.

    PubMed

    Jost, Gregor; Endrikat, Jan; Pietsch, Hubertus

    2017-01-01

    To compare injector-based contrast agent (CA) administration with hand injection in magnetic resonance angiography (MRA). Gadobutrol was administered in 6 minipigs with 3 protocols: (a) hand injection (one senior technician), (b) hand injection (6 less-experienced technicians), and (c) power injector administration. The arterial bolus shape was quantified by test bolus measurements. A head and neck MRA was performed for quantitative and qualitative comparison of signal enhancement. A significantly shorter time to peak was observed for protocol C, whereas no significant differences between protocols were found for peak height and bolus width. However, for protocol C, these parameters showed a much lower variation. The MRA revealed a significantly higher signal-to-noise ratio for injector-based administration. A superimposed strong contrast of the jugular vein was found in 50% of the hand injections. Injector-based CA administration results in a more standardized bolus shape, a higher vascular contrast, and a more robust visualization of target vessels.

  14. Insulin Degludec/Insulin Aspart Administered Once Daily at Any Meal, With Insulin Aspart at Other Meals Versus a Standard Basal-Bolus Regimen in Patients With Type 1 Diabetes

    PubMed Central

    Hirsch, Irl B.; Bode, Bruce; Courreges, Jean-Pierre; Dykiel, Patrik; Franek, Edward; Hermansen, Kjeld; King, Allen; Mersebach, Henriette; Davies, Melanie

    2012-01-01

    OBJECTIVE To evaluate efficacy and tolerability of a co-formulation of insulin degludec and insulin aspart (IDegAsp) with insulin aspart (IAsp) at other meals compared with basal-bolus therapy using insulin detemir (IDet) and IAsp. RESEARCH DESIGN AND METHODS Adults (n = 548) with type 1 diabetes (A1C 7.0–10.0%; BMI ≤35.0 kg/m2) were randomized 2:1 in a 26-week, multinational, parallel-group, treat-to-target trial to IDegAsp or IDet. IDegAsp was given with a meal, and IDet was given in the evening, with a second (breakfast) dose added if needed. RESULTS Non-inferiority for IDegAsp versus IDet was confirmed; A1C improved by 0.75% with IDegAsp and 0.70% with IDet to 7.6% in both groups (estimated treatment difference IDegAsp − IDet: –0.05% [95% CI –0.18 to 0.08]). There was no statistically significant difference between IDegAsp and IDet in the rates of severe hypoglycemia (0.33 and 0.42 episodes/patient-year, respectively) or overall confirmed (plasma glucose <3.1 mmol/L) hypoglycemia (39.17 and 44.34 episodes/patient-year, respectively). Nocturnal confirmed hypoglycemia rate was 37% lower with IDegAsp than IDet (3.71 vs. 5.72 episodes/patient-year, P < 0.05). Weight gain was 2.3 and 1.3 kg with IDegAsp and IDet, respectively (P < 0.05). Total insulin dose was 13% lower in the IDegAsp group (P < 0.0001). No treatment differences were detected in Health-Related Quality of Life, laboratory measurements, physical examination, vital signs, electrocardiograms, fundoscopy, or adverse events. CONCLUSIONS IDegAsp in basal-bolus therapy with IAsp at additional mealtimes improves overall glycemic control and was non-inferior to IDet, with a reduced risk of nocturnal hypoglycemia and fewer injections in comparison with IDet + IAsp basal-bolus therapy. PMID:22933438

  15. Effects of Verbal Cue on Bolus Flow during Swallowing

    ERIC Educational Resources Information Center

    Daniels, Stephanie K.; Schroeder, Mae Fern; DeGeorge, Pamela C.; Corey, David M.; Rosenbek, John C.

    2007-01-01

    Purpose: To examine the effects of verbal cuing to initiate swallowing on bolus flow measures in healthy adults. Method: Videofluoroscopic examinations were completed in 12 healthy older adults (median age = 69 years) as they swallowed 5 ml of self-administered liquid barium in 2 conditions: verbally cued and noncued swallows. In the cued…

  16. Review of Prescribing Practices for Intermittent Bolus Administration of Morphine

    PubMed Central

    Sine, Keith; Vaillancourt, Régis; Pascuet, Elena; Martelli, Brenda; Lamontagne, Christine; Ellis, Jacqueline; Wong, Elaine; Gaboury, Isabelle

    2011-01-01

    Background: Several changes to medication safety practices were proposed in a pediatric hospital, including changing the period of patient observation after administration of opioids and limiting the availability of various concentrations of morphine in the patient care unit. Objective: To document and review postoperative pain management for children on a surgical ward, specifically with regard to intermittent IV bolus administration of morphine, to help in assessing the impact of the proposed nursing practice changes. Methods: Data were collected from records for narcotics and controlled drugs for the surgical ward over a 3-month period (April to June 2006). For each patient, data had been recorded for up to 7 consecutive days after surgery. A patient’s data were included in the review if he or she had received at least 2 doses of morphine by IV bolus, except for the review of weight-based dosing pattern (mg/kg), for which all patients who had received at least one dose of IV morphine were included. Results: Charts for 193 patients were audited. Of these, 163 patients (84.5%) had recieved up to 0.1 mg/kg per dose, and 53 (27.5%) had received only one dose of morphine. Among patients who received more than one dose, the median dose was 0.080 mg/kg on day 1, with a decrease by day 5 to 0.065 mg/kg. Most patients received morphine over the first 2 days after surgery. The median time elapsed between doses was 4.3 h on day 1 and 6.2 h on day 2. Of the 1020 doses included in the analysis, most (801 [78.5%]) were 4 mg or less. Conclusion: The intermittent administration of IV bolus doses of morphine at the study hospital followed common standards for the treatment of postoperative pain. Most doses were no more than 4 mg. On the basis of this information, only 2-mg vials of morphine are now stocked on the ward. The hospital’s change in monitoring practices will increase the surveillance of patients receiving IV bolus doses of morphine. PMID:22479025

  17. Onset and effectiveness of rocuronium for rapid onset of paralysis in patients with major burns: priming or large bolus

    PubMed Central

    Han, T.-H.; Martyn, J. A. J.

    2009-01-01

    Background Burn injury leads to resistance to the effects of non-depolarizing muscle relaxants. We tested the hypothesis that a larger bolus dose is as effective as priming for rapid onset of paralysis after burns. Methods Ninety adults, aged 18–59 yr with 40 (2)% [mean (se)] burn and 30 (2) days after injury, received rocuronium as a priming dose followed by bolus (0.06+0.94 mg kg−1), or single bolus of either 1.0 or 1.5 mg kg−1. Sixty-one non-burned, receiving 1.0 mg kg−1 as a primed (0.06+0.94 mg kg−1) or full bolus dose, served as controls. Acceleromyography measured the onset times. Results Priming when compared with 1.0 mg kg−1 bolus in burned patients shortened the time to first appearance of twitch depression (30 vs 45 s, P<0.05) and time to maximum twitch inhibition (135 vs 210 s, P<0.05). The onset times between priming and higher bolus dose (1.5 mg kg−1) were not different (30 vs 30 s for first twitch depression and 135 vs 135 s for maximal depression, respectively). The onset times in controls, however, were significantly (P<0.05) faster than burns both for priming and for full bolus (15 and 15 s, respectively, for first twitch depression and 75 and 75 s for maximal depression). Priming caused respiratory distress in 10% of patients in both groups. Intubating conditions in burns were significantly better with 1.5 mg kg−1 than with priming or full 1.0 mg kg−1 bolus. Conclusions A dose of 1.5 mg kg−1 not only produces an initial onset of paralysis as early as 30 s, which we speculate could be a reasonable onset time for relief of laryngospasm, but also has an onset as fast as priming with superior intubating conditions and no respiratory side-effects. PMID:19029093

  18. Use of cornmeal bolus as an aid in obtaining cranial four-vessel angiograms.

    PubMed

    Weathers, R M; Lee, A

    1975-01-01

    In cranial angiography it has always been difficult to visualize extracranial vessels of the cervico-thoracic region, upon one radiograph, by using the same exposure factors for both regions. For this reason, we experimented and found that by applying a dry cornmeal bolus on specific areas of the neck a technically superior radiograph of these regions can be achieved. This bolus simulated added soft tissue to the cervical region. The density of the cervical region is now similar to that of the upper thoracic. As a result, factors set for one exposure will adequately penetrate both areas.

  19. A feasibility study of a 3-day basal-bolus insulin delivery device in individuals with type 2 diabetes.

    PubMed

    Mader, Julia K; Lilly, Leslie C; Aberer, Felix; Korsatko, Stefan; Strock, Ellie; Mazze, Roger S; Damsbo, Peter; Pieber, Thomas R

    2014-05-01

    This study tested the feasibility of transition from multiple daily injections (MDI) to a 3-day, basal-bolus insulin delivery device (PaQ) for type 2 diabetes (T2D). Twenty MDI-treated individuals with T2D with HbA(1c) ≤9% (75 mmol/mol) were enrolled in a single-center, single-arm pilot study, lasting three 2-week periods: baseline (MDI), transition to PaQ, and PaQ therapy. Feasibility of use, glycemic control, safety, and patient satisfaction were assessed. Nineteen participants transitioned to PaQ treatment and demonstrated competency in assembling, placing, and using the device. Self-monitored blood glucose and blinded continuous glucose-monitoring data showed glycemic control similar to MDI. Study participants reported high satisfaction and device acceptance. PaQ treatment is both feasible and acceptable in individuals with T2D. Transition from MDI is easy and safe. PaQ treatment might lead to better therapy adherence and improvements in glycemic control and clinical outcomes.

  20. Deposition and dispersion of 1-micrometer aerosol boluses in the human lung: effect of micro- and hypergravity

    NASA Technical Reports Server (NTRS)

    Darquenne, C.; West, J. B.; Prisk, G. K.

    1998-01-01

    We performed bolus inhalations of 1-micrometer particles in four subjects on the ground (1 G) and during parabolic flights both in microgravity (microG) and in approximately 1.6 G. Boluses of approximately 70 ml were inhaled at different points in an inspiration from residual volume to 1 liter above functional residual capacity. The volume of air inhaled after the bolus [the penetration volume (Vp)] ranged from 200 to 1,500 ml. Aerosol concentration and flow rate were continuously measured at the mouth. The deposition, dispersion, and position of the bolus in the expired gas were calculated from these data. For Vp >/=400 ml, both deposition and dispersion increased with Vp and were strongly gravity dependent, with the greatest deposition and dispersion occurring for the largest G level. At Vp = 800 ml, deposition and dispersion increased from 33.9% and 319 ml in microG to 56.9% and 573 ml at approximately 1.6 G, respectively (P < 0.05). At each G level, the bolus was expired at a smaller volume than Vp, and this volume became smaller with increasing Vp. Although dispersion was lower in microG than in 1 G and approximately 1.6 G, it still increased steadily with increasing Vp, showing that nongravitational ventilatory inhomogeneity is partly responsible for dispersion in the human lung.

  1. Multicenter study of combination DEP regimen as a salvage therapy for adult refractory hemophagocytic lymphohistiocytosis.

    PubMed

    Wang, Yini; Huang, Wenqiu; Hu, Liangding; Cen, Xinan; Li, Lihong; Wang, Jijun; Shen, Jianliang; Wei, Na; Wang, Zhao

    2015-11-05

    Hemophagocytic lymphohistiocytosis (HLH) is a refractory immune disorder with a significant risk of death. Although standard therapy has dramatically improved survival in HLH patients, approximately 30%, especially adults, show no response to current treatment strategies. This prospective study aimed to investigate the efficacy of liposomal doxorubicin treatment combined with etoposide and methylprednisolone (doxorubicin-etoposide-methylprednisolone; DEP) as a salvage therapy for adult refractory HLH. Adult patients who did not achieve at least partial response 2 weeks after initial standard HLH therapy were enrolled in this study between June 2013 and June 2014. Response to salvage therapy was assessed at 2 and 4 weeks after initiation of DEP therapy and patients were followed until death or until November 2014. Sixty-three refractory HLH patients were enrolled, including 29 cases of lymphoma-associated HLH, 22 cases of Epstein-Barr virus-associated HLH, and 4 cases of familial HLH. There were 8 cases with unknown underlying diseases. Seventeen cases (27.0%) achieved complete response and 31 cases (49.2%) achieved partial response. The overall response was 76.2% (48/63). Patients who showed no response to DEP died within 4 weeks after salvage therapy. Twenty-nine of the 48 patients who achieved partial or complete response survived to subsequent chemotherapy, allogenic hematopoietic stem cell transplantation, or splenectomy. Our study suggests that DEP regimen is an effective salvage regimen for adult refractory HLH, which can prolong patient survival as we continue to understand the responsible mechanisms and bridge the gap between HLH and its underlying diseases. This study was registered in the Chinese Clinical Trials Registry Platform (http://www.chictr.org.cn/) as ChiCTR-IPC-14005514. © 2015 by The American Society of Hematology.

  2. Intravenous salbutamol bolus compared with an aminophylline infusion in children with severe asthma: a randomised controlled trial.

    PubMed

    Roberts, G; Newsom, D; Gomez, K; Raffles, A; Saglani, S; Begent, J; Lachman, P; Sloper, K; Buchdahl, R; Habel, A

    2003-04-01

    The relative efficacies of aminophylline and salbutamol in severe acute childhood asthma are currently unclear. A single bolus of salbutamol was compared with a continuous aminophylline infusion in children with severe asthma in a randomised double blind study. Children aged 1-16 years with acute severe asthma were enrolled if they showed little improvement with three nebulisers (combined salbutamol and ipratropium) administered over an hour and systemic steroids. Subjects were randomised to receive either a short intravenous bolus of salbutamol (15 micro g/kg over 20 minutes) followed by a saline infusion or an aminophylline infusion (5 mg/kg over 20 minutes) followed by 0.9 mg/kg/h. Forty four subjects were enrolled, with 18 randomly allocated to receive salbutamol and 26 to receive aminophylline. The groups were well matched at baseline. An intention to treat analysis showed that there was no statistically significant difference in the asthma severity score (ASS) at 2 hours between the two groups (median (IQR) 6 (6, 8) and 6.5 (5, 8) for salbutamol and aminophylline respectively, p=0.93). A similar improvement in ASS to 2 hours was seen in the two groups (mean difference -0.08, 95% CI -0.97 to 0.80), there was a trend (p=0.07) towards a longer duration of oxygen therapy in the salbutamol group (17.8 hours (95% CI 8.5 to 37.5) v 7.0 hours (95% CI 3.4 to 14.2)), and a significantly (p=0.02) longer length of hospital stay in the salbutamol group (85.4 (95% CI 66.1 to 110.2) hours v 57.3 hours (95% CI 45.6 to 72.0)). There was no significant difference in adverse events between the two groups. This study suggests that, in severe childhood asthma, there is no significant difference in the effectiveness of a bolus of salbutamol and an aminophylline infusion in the first 2 hours of treatment. Overall, the aminophylline infusion was superior as it significantly reduced the length of stay in hospital.

  3. An automatic bolus injector for use in radiotracer studies of blood flow: design and evaluation.

    PubMed

    Snyder, R E; Overton, T R; Boisvert, D P; Petruk, K C

    1976-12-01

    An electromechanical device is described which automatically injects the radiotracer bolus used in the measurement of cerebral blood flow. It consists of two electronically controlled, solenoid operated syringes, one containing the radiotracer solution and the other heparinized saline. Results are presented which show that use of the automatic bolus injector in place of hand injection leads to an improvement in the precision of measured flow values. Additional advantages of the device are discussed.

  4. Effects of local application of methylprednisolone delivered by the C/GP-hydrogel on the recovery of facial nerves.

    PubMed

    Chao, Xiuhua; Fan, Zhaomin; Han, Yuechen; Wang, Yan; Li, Jianfeng; Chai, Renjie; Xu, Lei; Wang, Haibo

    2015-01-01

    Local administration of MP delivered by the C/GP-MP-hydrogel can improve the recovery of facial nerve following crush injury. The findings suggested that locally injected MP delivered by C/GP-hydrogel might be a promising treatment for facial nerve damage. In this study, the aim is to assess the effectiveness of locally administrating methylprednisolone(MP) loaded by chitosan-β-glycerophosphate hydrogel (C/GP-hydrogel) on the regeneration of facial nerve crush injury. After the crush of left facial nerves, Wistar rats were randomly divided into four different groups. Then, four different therapies were used to treat the damaged facial nerves. At the 1(st), 2(nd), 3(rd), and 4(th) week after injury, the functional recovery of facial nerves and the morphological changes of facial nerves were assessed. The expression of growth associated protein-43 (GAP-43) protein in the facial nucleus were also evaluated. Locally injected MP delivered by C/GP-hydrogel effectively accelerated the facial functional recovery. In addition, the regenerated facial nerves in the C/GP-MP group were more mature than those in the other groups. The expression of GAP-43 protein was also improved by the MP, especially in the C/GP-MP group.

  5. Insulin therapy in children and adolescents with type 1 diabetes.

    PubMed

    Malik, Faisal S; Taplin, Craig E

    2014-04-01

    Treatment of type 1 diabetes mellitus (T1DM) requires lifelong administration of exogenous insulin. The primary goal of treatment of T1DM in children and adolescents is to maintain near-normoglycemia through intensive insulin therapy, avoid acute complications, and prevent long-term microvascular and macrovascular complications, while facilitating as close to a normal life as possible. Effective insulin therapy must, therefore, be provided on the basis of the needs, preferences, and resources of the individual and the family for optimal management of T1DM. To achieve target glycemic control, the best therapeutic option for patients with T1DM is basal-bolus therapy either with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Many formulations of insulin are available to help simulate endogenous insulin secretion as closely as possible in an effort to eliminate the symptoms and complications of hyperglycemia, while minimizing the risk of hypoglycemia secondary to therapy. When using MDI, basal insulin requirements are given as an injection of long- or intermediate-acting insulin analogs, while meal-related glucose excursions are controlled with bolus injections of rapid-acting insulin analogs. Alternatively, CSII can be used, which provides a 24-h preselected but adjustable basal rate of rapid-acting insulin, along with patient-activated mealtime bolus doses, eliminating the need for periodic injections. Both MDI treatment and CSII therapy must be supported by comprehensive education that is appropriate for the individual needs of the patient and family before and after initiation. Current therapies still do not match the endogenous insulin profile of pancreatic β-cells, and all still pose risks of suboptimal control, hypoglycemia, and ketosis in children and adolescents. The safety and success of a prescribed insulin regimen is, therefore, dependent on self-monitoring of blood glucose and/or a continuous glucose monitoring system

  6. Cardiac T1 mapping in congenital heart disease: bolus vs. infusion protocols for measurements of myocardial extracellular volume fraction.

    PubMed

    Al-Wakeel-Marquard, Nadya; Rastin, Sanaz; Muench, Frédéric; O H-Ici, Darach; Yilmaz, Sevim; Berger, Felix; Kuehne, Titus; Messroghli, Daniel R

    2017-12-01

    Myocardial extracellular volume fraction (ECV) reflecting diffuse myocardial fibrosis can be measured with T1 mapping cardiovascular magnetic resonance (CMR) before and after the application of a gadolinium-based extracellular contrast agent. The equilibrium between blood and myocardium contrast concentration required for ECV measurements can be obtained with a primed contrast infusion (equilibrium contrast-CMR). We hypothesized that equilibrium can also be achieved with a single contrast bolus to accurately measure diffuse myocardial fibrosis in patients with congenital heart disease (CHD). Healthy controls (n = 17; median age 24.0 years) and patients with CHD (n = 19; 25.0 years) were prospectively enrolled. Using modified Look-Locker inversion recovery T1 mapping before, 15 min after bolus injection, and during constant infusion of gadolinium-DOTA, T1 values were obtained for blood pool and myocardium of the left ventricle (LV), the interventricular septum (IVS), and the right ventricle (RV) in a single midventricular plane in short axis or in transverse orientation. ECV of LV, IVS and RV by bolus-only and bolus-infusion correlated significantly in CHD patients (r = 0.94, 0.95, and 0.74; p < 0.01, respectively) and healthy controls (r = 0.96, 0.89, and 0.64; p < 0.05, respectively). Bland-Altman plots revealed no significant bias between the techniques for any of the analyzed regions. ECV of LV and RV myocardium measured by bolus-only T1 mapping agrees well with bolus-infusion measurements in patients with CHD. The use of a bolus-only approach facilitates the integration of ECV measurements into existing CMR imaging protocols, allowing for assessment of diffuse myocardial fibrosis in CHD in clinical routine.

  7. Vitamin D in newborns. A randomised controlled trial comparing daily and single oral bolus vitamin D in infants.

    PubMed

    Huynh, Julie; Lu, Thao; Liew, Danny; Doery, James Cg; Tudball, Ronald; Jona, Madeleine; Bhamjee, Roisin; Rodda, Christine P

    2017-02-01

    There are no published data to demonstrate the efficacy of bolus dose vitamin D in newborn infants. The study sought to evaluate this alternative approach of supplementation. This single centre, open randomised controlled trial was conducted from August 2013 to May 2014. It compared the efficacy and safety of daily (400 IU) versus a bolus dose (50 000 IU) of cholecalciferol in newborn infants of vitamin D deficient mothers. The primary outcome measure was the rate of 25 hydroxyvitamin D (25OHD) repletion-defined as 25OHD greater than 50 nmol/L. The secondary objective was determining safety using adjusted total serum calcium. Of 70 eligible infants, 36 received a daily dose and 34 received a single high-dose cholecalciferol. Mean 25OHD in the bolus group (154 nmol/L, 95% confidence interval (CI) 131-177) was higher than the daily group (48 nmol/L, 95% CI 42-54) at 1-2 weeks of age. This was reversed at 3-4 months, (65 nmol/L, 95% CI 59-71) compared with the daily group (81 nmol/L, 95% CI 77-85). More infants in the single bolus group achieved vitamin D repletion (100 vs. 31%) at 1-2 weeks. By 3-4 months, both groups achieved similar vitamin D repletion rates (91 vs. 89%). Mean adjusted total serum calcium in the bolus group were normal at 1-2 weeks (2.73 mmol/L) and 3-4 months (2.55 mmol/L). Single bolus dosing of 50 000 IU cholecalciferol achieves higher 25OHD repletion rates at 1-2 weeks of age compared with daily dosing, but repletion rates were similar by 3-4 months. There was no hypercalcaemia documented with single bolus dosing in this study. © 2016 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).

  8. Anxiety can significantly explain bolus perception in the context of hypotensive esophageal motility: Results of a large multicenter study in asymptomatic individuals.

    PubMed

    Cisternas, D; Scheerens, C; Omari, T; Monrroy, H; Hani, A; Leguizamo, A; Bilder, C; Ditaranto, A; Ruiz de León, A; Pérez de la Serna, J; Valdovinos, M A; Coello, R; Abrahao, L; Remes-Troche, J; Meixueiro, A; Zavala, M A; Marin, I; Serra, J

    2017-09-01

    Previous studies have not been able to correlate manometry findings with bolus perception. The aim of this study was to evaluate correlation of different variables, including traditional manometric variables (at diagnostic and extreme thresholds), esophageal shortening, bolus transit, automated impedance manometry (AIM) metrics and mood with bolus passage perception in a large cohort of asymptomatic individuals. High resolution manometry (HRM) was performed in healthy individuals from nine centers. Perception was evaluated using a 5-point Likert scale. Anxiety was evaluated using Hospitalized Anxiety and Depression scale (HAD). Subgroup analysis was also performed classifying studies into normal, hypotensive, vigorous, and obstructive patterns. One hundred fifteen studies were analyzed (69 using HRM and 46 using high resolution impedance manometry (HRIM); 3.5% swallows in 9.6% of volunteers were perceived. There was no correlation of any of the traditional HRM variables, esophageal shortening, AIM metrics nor bolus transit with perception scores. There was no HRM variable showing difference in perception when comparing normal vs extreme values (percentile 1 or 99). Anxiety but not depression was correlated with perception. Among hypotensive pattern, anxiety was a strong predictor of variance in perception (R 2 up to .70). Bolus perception is less common than abnormal motility among healthy individuals. Neither esophageal motor function nor bolus dynamics evaluated with several techniques seems to explain differences in bolus perception. Different mechanisms seem to be relevant in different manometric patterns. Anxiety is a significant predictor of bolus perception in the context of hypotensive motility. © 2017 John Wiley & Sons Ltd.

  9. Evaluation of the esophagus with a marshmallow bolus: clarifying the cause of dysphagia.

    PubMed

    Ott, D J; Kelley, T F; Chen, M Y; Gelfand, D W

    1991-01-01

    We reviewed the radiographic examinations of the esophagus and medical records in 117 patients (55 women and 62 men; mean age, 52 years) in which a marshmallow bolus was also given. A one-third to one-half piece of a standard marshmallow was used with a mean size of 23 mm (+/- 4.5 mm SD) measured in vivo. In 62 patients with no intrinsic structural narrowing of the esophagus, impaction occurred in only seven (11%). Four of these patients had an esophageal motility disorder, and three had a previous Nissen fundoplication. The remaining 55 patients had lower esophageal mucosal rings (47) or peptic strictures (8). Marshmallow impaction was seen in 27 of 47 rings (57%) and was inversely related to ring size, and in six of eight strictures (75%). Also, impaction was related to the ratio of bolus size to ring caliber, and invariably occurred when this ratio was greater than 1.5. Dysphagia was the presenting complaint in 76 (65%) patients, but was found equally in those without intrinsic narrowing and in those with ring or stricture. However, dysphagia was reproduced by the marshmallow bolus only in patients with esophageal narrowing or abnormal motility.

  10. 21 CFR 520.1802b - Piperazine-carbon disulfide complex boluses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ....1802b Section 520.1802b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...) per 500 pounds body weight; removal of large strongyles, pinworms, and bots, 1 bolus per 250 pounds body weight.1 (2) Indications for use. For removing ascarids (large roundworms, Parascaris equorum...

  11. 21 CFR 520.1802b - Piperazine-carbon disulfide complex boluses.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....1802b Section 520.1802b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...) per 500 pounds body weight; removal of large strongyles, pinworms, and bots, 1 bolus per 250 pounds body weight.1 (2) Indications for use. For removing ascarids (large roundworms, Parascaris equorum...

  12. 21 CFR 520.1802b - Piperazine-carbon disulfide complex boluses.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ....1802b Section 520.1802b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...) per 500 pounds body weight; removal of large strongyles, pinworms, and bots, 1 bolus per 250 pounds body weight.1 (2) Indications for use. For removing ascarids (large roundworms, Parascaris equorum...

  13. 21 CFR 520.1802b - Piperazine-carbon disulfide complex boluses.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ....1802b Section 520.1802b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...) per 500 pounds body weight; removal of large strongyles, pinworms, and bots, 1 bolus per 250 pounds body weight.1 (2) Indications for use. For removing ascarids (large roundworms, Parascaris equorum...

  14. Combined treatment of methylprednisolone pulse and memantine hydrochloride prompts recovery from neurological dysfunction and cerebral hypoperfusion in carbon monoxide poisoning: a case report.

    PubMed

    Iwamoto, Konosuke; Ikeda, Ken; Mizumura, Sunao; Tachiki, Kazuhiro; Yanagihashi, Masaru; Iwasaki, Yasuo

    2014-03-01

    A 49-year-old healthy man developed sudden unconsciousness under inadequate ventilation. Blood gas analysis showed carboxyhemoglobin of 7.3%. After normobaric oxygen therapy, he recovered completely 7 days later. At 3 weeks after carbon monoxide (CO) exposures, memory and gait disturbances appeared. Neurological examination revealed Mini-Mental State Examination (MMSE) score of 5 of 30 points, leg hyper-reflexia with Babinski signs, and Parkinsonism. Brain fluid-attenuated inversion recovery imaging disclosed symmetric hypointense lesions in the thalamus and the globus pallidus, and hyperintense lesions in the cerebral white matter. Brain single-photon emission tomography (SPECT) scanning with (99m)Technesium-ethyl cysteinate dimer displayed marked hypoperfusion in the cerebellum, the thalamus, the basal ganglia, and the entire cerebral cortex. He was diagnosed as CO poisoning and treated with hyperbaric oxygen therapy. The neurological deficits were not ameliorated. At 9 weeks after neurological onset, methylprednisolone (1000 mg/day, intravenous, 3 days) and memantine hydrochloride (20 mg/day, per os) were administered. Three days later, MMSE score was increased from 3 to 20 points. Neurological examination was normal 3 weeks later. Brain SPECT exhibited 20% increase of regional cerebral blood flows in the cerebellum, the thalamus, the basal ganglia, and the entire cerebral cortex. These clinicoradiological changes supported that the treatment with steroid pulse and memantine hydrochloride could prompt recovery from neurological dysfunction and cerebral hypoperfusion. Further clinical trials are warranted whether such combined therapy can attenuate neurological deficits and cerebral hypoperfusion in patients with CO poisoning. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  15. A Tracer Bolus Method for Investigating Glutamine Kinetics in Humans

    PubMed Central

    Mori, Maiko; Smedberg, Marie; Klaude, Maria; Tjäder, Inga; Norberg, Åke; Rooyackers, Olav; Wernerman, Jan

    2014-01-01

    Glutamine transport between tissues is important for the outcome of critically ill patients. Investigation of glutamine kinetics is, therefore, necessary to understand glutamine metabolism in these patients in order to improve future intervention studies. Endogenous glutamine production can be measured by continuous infusion of a glutamine tracer, which necessitates a minimum measurement time period. In order to reduce this problem, we used and validated a tracer bolus injection method. Furthermore, this method was used to measure the glutamine production in healthy volunteers in the post-absorptive state, with extra alanine and with glutamine supplementation and parenteral nutrition. Healthy volunteers received a bolus injection of [1-13C] glutamine, and blood was collected from the radial artery to measure tracer enrichment over 90 minutes. Endogenous rate of appearance (endoRa) of glutamine was calculated from the enrichment decay curve and corrected for the extra glutamine supplementation. The glutamine endoRa of healthy volunteers was 6.1±0.9 µmol/kg/min in the post-absorptive state, 6.9±1.0 µmol/kg/min with extra alanyl-glutamine (p = 0.29 versus control), 6.1±0.4 µmol/kg/min with extra alanine only (p = 0.32 versus control), and 7.5±0.9 µmol/kg/min with extra alanyl-glutamine and parenteral nutrition (p = 0.049 versus control). In conclusion, a tracer bolus injection method to measure glutamine endoRa showed good reproducibility and small variation at baseline as well as during parenteral nutrition. Additionally, we showed that parenteral nutrition including alanyl-glutamine increased glutamine endoRa in healthy volunteers, which was not attributable to the alanine part of the dipeptide. PMID:24810895

  16. Endoscopic techniques and management of foreign body ingestion and food bolus impaction in the upper gastrointestinal tract: a retrospective analysis of 139 cases.

    PubMed

    Katsinelos, Panagiotis; Kountouras, Jannis; Paroutoglou, George; Zavos, Christos; Mimidis, Kostas; Chatzimavroudis, Grigoris

    2006-10-01

    Ingested foreign bodies and food bolus impaction are frequently seen in endoscopic practice. Successful foreign body and food bolus removal may depend on the method used, the choice of device, and the experience level of the endoscopist, although few papers report experience and outcome of tertiary centers. To investigate the effectiveness of our protocol designed for removal of ingested foreign bodies and food boluses. We retrospectively reviewed all patients with a diagnosis of foreign body ingestion and food bolus impaction from 1994 to 2005 identified by computer search. Patients were excluded if medical record was incomplete. The analysis included 171 patients. Foreign bodies and impacted food boluses were found in 77 and 62 patients, respectively. In 32 cases (23%), the foreign bodies passed spontaneously through the gastrointestinal tract. The overall success rate for endoscopic management was obtained in 137 patients (98.6%). Surgical removal of a foreign body was required in only 2 cases (1.4%). According to the type and location of the foreign object and food bolus we used Dormia baskets, retrieval forceps, polypectomy snares, and all sizes of Roth net. No complications relating to the endoscopic procedure were observed; 50 patients (35.2%) had an underlying esophageal disease. Endoscopic removal of upper gastrointestinal tract foreign bodies and food bolus impaction is efficacious and safe. Especially the Roth net is the best device for safe retrieval of food boluses and button disc batteries.

  17. Oesophageal intraluminal impedance can identify subtle bolus transit abnormalities in patients with mild oesophagitis.

    PubMed

    Sifrim, Daniel; Tutuian, Radu

    2005-03-01

    In a subgroup of patients with non-erosive gastroesophageal reflux disease (GORD) or mild oesophagitis, acid clearance is prolonged in spite of favourable gravity and normal or minimally impaired oesophageal peristalsis. Dysphagia is rare in this group but might also be present or develop after anti-reflux surgery. The causal relationship between prolonged clearance or dysphagia and oesophageal body dysmotility in these patients is not completely clear. New techniques are now available to assess oesophageal motility and transit and might help to detect more subtle defects underlying functional impairment in patients with GORD. Combined video-fluoroscopy and intraluminal impedance indicate an excellent correlation between both methods in detecting oesophageal bolus transit. Combined intraluminal impedance and manometry has the capability to evaluate oesophageal contractions and bolus transit without the use of radiation. Subtle bolus transit abnormalities were identified in a small proportion of patients with mild oesophagits and normal oesophageal peristalsis. Outcome data are needed to evaluate the prognostic value of combined manometry-impedance in patients with GORD undergoing anti-reflux surgery.

  18. Continuous versus bolus intermittent loop diuretic infusion in acutely decompensated heart failure: a prospective randomized trial

    PubMed Central

    2014-01-01

    Introduction Intravenous loop diuretics are a cornerstone of therapy in acutely decompensated heart failure (ADHF). We sought to determine if there are any differences in clinical outcomes between intravenous bolus and continuous infusion of loop diuretics. Methods Subjects with ADHF within 12 hours of hospital admission were randomly assigned to continuous infusion or twice daily bolus therapy with furosemide. There were three co-primary endpoints assessed from admission to discharge: the mean paired changes in serum creatinine, estimated glomerular filtration rate (eGFR), and reduction in B-type natriuretic peptide (BNP). Secondary endpoints included the rate of acute kidney injury (AKI), change in body weight and six months follow-up evaluation after discharge. Results A total of 43 received a continuous infusion and 39 were assigned to bolus treatment. At discharge, the mean change in serum creatinine was higher (+0.8 ± 0.4 versus -0.8 ± 0.3 mg/dl P <0.01), and eGFR was lower (-9 ± 7 versus +5 ± 6 ml/min/1.73 m2P <0.05) in the continuous arm. There was no significant difference in the degree of weight loss (-4.1 ± 1.9 versus -3.5 ± 2.4 kg P = 0.23). The continuous infusion arm had a greater reduction in BNP over the hospital course, (-576 ± 655 versus -181 ± 527 pg/ml P = 0.02). The rates of AKI were comparable (22% and 15% P = 0.3) between the two groups. There was more frequent use of hypertonic saline solutions for hyponatremia (33% versus 18% P <0.01), intravenous dopamine infusions (35% versus 23% P = 0.02), and the hospital length of stay was longer in the continuous infusion group (14. 3 ± 5 versus 11.5 ± 4 days, P <0.03). At 6 months there were higher rates of re-admission or death in the continuous infusion group, 58% versus 23%, (P = 0.001) and this mode of treatment independently associated with this outcome after adjusting for baseline and intermediate variables (adjusted

  19. Rapid Bolus Administration Does not Increase The Extravasation Rate of Albumin: A Randomized Controlled Trial in The Endotoxemic Pig.

    PubMed

    von Seth, Magnus; Lipcsey, Miklós; Engström, Peter; Larsson, Anders; Hillered, Lars; Maripuu, Enn; Widström, Charles; Sjölin, Jan

    2017-04-01

    Some experimental data suggest that rapid bolus administration of albumin causes less plasma-expanding effects than slow, continuous infusion. To determine whether rapid bolus administration, in comparison with slow infusion, results in greater extravasation of albumin in experimental septic shock we performed a randomized controlled trial with 32 endotoxemic pigs. The animals were monitored and ventilated with standard intensive care equipment and given 10 mL × kg 5% albumin labeled with Technetium-99m, either as a rapid 15-min bolus (Bolus group, n = 16) or as a 2-h infusion (Infusion group, n = 16). Radioactivity was monitored in plasma, extracellular microdialysate, and urine for 6 h. Physiological parameters were monitored hourly. Radioactivity in the liver, spleen, kidney, and lung was analyzed post mortem.The plasma area under the curve activity0-6 h was 4.4 ± 0.9 × 10 in the Bolus group and 4.4 ± 1.1 × 10 counts × min × mL × h in the Infusion group. Blood hemoglobin levels increased in both groups, suggesting severe capillary leakage. Yet, there were no group differences in albumin radioactivity in plasma, muscle tissue, urine, or in the post-mortem analysis of the organs. Following albumin administration, circulatory and respiratory parameters were similar in the two groups.In conclusion, the present results suggest that albumin might be given as a bolus without leading to increased extravasation of albumin, in contrast to previous animal experiments in rodents.

  20. Segmental lichen aureus: a report of two cases treated with methylprednisolone aceponate.

    PubMed

    Moche, John; Glassman, Steven; Modi, Deepak; Grayson, Wayne

    2011-05-01

    Two cases of segmental lichen aureus with a response to topical 0.1% methylprednisolone aceponate ointment are reported. A 9-year-old child and a 23-year-old man showed complete resolution of their lesions following treatment with the latter after 7 months and 4 months, respectively. Lichen aureus is a rare form of the pigmented purpuric dermatoses characterized by golden-brown and lichenoid macules and papules, most often on the lower extremities. Segmental presentations have seldom been described. Histology showed a lichenoid infiltrate with extravasation of red blood cells and haemosiderin deposition. The aetiology is unclear and treatment is disappointing. We report an uncommon segmental presentation of lichen aureus with resolution of the lesions after treatment with a topical corticosteroid. © 2010 The Authors. Australasian Journal of Dermatology © 2010 The Australasian College of Dermatologists.

  1. Update on Multistate Outbreak of Fungal Infections Associated with Contaminated Methylprednisolone Injections, 2012-2014.

    PubMed

    McCotter, Orion Z; Smith, Rachel M; Westercamp, Mathew; Kerkering, Thomas M; Malani, Anurag N; Latham, Robert; Peglow, Sheree L; Mody, Rajal K; Pappas, Peter G; Chiller, Tom M

    2015-10-30

    During September 2012, CDC, in collaboration with state and local health departments and the Food and Drug Administration (FDA), investigated a multistate outbreak of fungal meningitis and other infections caused by injections of contaminated methylprednisolone acetate solution (MPA). After this unprecedented outbreak, scientists in the CDC Mycotic Diseases Branch, along with infectious diseases specialists who cared for patients from the outbreak, clinical experts, and public health officials from affected states, have continued to monitor the recovery of affected patients. A long-term follow-up study involving these patients was initiated and is being conducted by the Mycoses Study Group Education and Research Consortium (MSGERC). This update summarizes subsequent information about the current state of the outbreak.

  2. Comparison of efficacy and ocular surface toxicity of topical preservative-free methylprednisolone and preserved prednisolone in the treatment of acute anterior uveitis.

    PubMed

    Hedayatfar, Alireza; Hashemi, Hassan; Asgari, Soheila; Chee, Soon-Phaik

    2014-04-01

    The aim of this study was to compare the antiinflammatory effect and ocular surface toxicity of topical nonpreserved methylprednisolone sodium succinate 1% and preserved prednisolone acetate suspension 1% for the management of acute anterior uveitis (AAU). In this prospective, randomized, investigator-masked, comparative clinical trial, patients with mild-to-moderate noninfectious AAU were assigned randomly to receive either hourly nonpreserved methylprednisolone 1% (group A) or preserved prednisolone 1% (group B) eye drops followed by a 2-week tapering regimen. Anterior chamber cells and flare were clinically evaluated for the objective comparison of the antiinflammatory effect. The main outcome measure was the percentage of patients with a resolution of inflammation (anterior chamber cells <1+) on day 14. Ocular surface toxicity was assessed by means of the corneal fluorescein staining score, tear breakup time, Schirmer I test, and questionnaire-based grading of ocular discomfort parameters. Seventy-two eyes of 68 patients were studied, of which 38 eyes were enrolled in group A and 34 eyes were enrolled in group B. On day 14, 76.3% of the patients in group A had resolution of inflammation compared with 70.6% of the patients in group B, proving noninferiority (χ = 0.303, P = 0.582). The mean anterior chamber cell grade reduction for patients in group A was similar to that in group B (2.52 vs. 2.86, respectively; P = 0.92). Group A patients showed significantly lower corneal fluorescein staining scores (P < 0.001) and reported milder subjective ocular discomfort (0.55 vs. 1.43, P = 0.01) as compared with group B. Both preparations demonstrated equal antiinflammatory effects for the treatment of AAU. Nonpreserved methylprednisolone eye drops exhibited a significantly lower ocular surface toxicity profile and milder subjective discomfort when compared with that exhibited by preserved prednisolone.

  3. Simple and rapid quantification of serotonin transporter binding using [11C]DASB bolus plus constant infusion.

    PubMed

    Gryglewski, G; Rischka, L; Philippe, C; Hahn, A; James, G M; Klebermass, E; Hienert, M; Silberbauer, L; Vanicek, T; Kautzky, A; Berroterán-Infante, N; Nics, L; Traub-Weidinger, T; Mitterhauser, M; Wadsak, W; Hacker, M; Kasper, S; Lanzenberger, R

    2017-04-01

    In-vivo quantification of serotonin transporters (SERT) in human brain has been a mainstay of molecular imaging in the field of neuropsychiatric disorders and helped to explore the underpinnings of several medical conditions, therapeutic and environmental influences. The emergence of PET/MR hybrid systems and the heterogeneity of SERT binding call for the development of efficient methods making the investigation of larger or vulnerable populations with limited scanner time and simultaneous changes in molecular and functional measures possible. We propose [ 11 C]DASB bolus plus constant infusion for these applications and validate it against standard analyses of dynamic PET data. [ 11 C]DASB bolus/infusion optimization was performed on data acquired after [ 11 C]DASB bolus in 8 healthy subjects. Subsequently, 16 subjects underwent one scan using [ 11 C]DASB bolus plus constant infusion with K bol 160-179min and one scan after [ 11 C]DASB bolus for inter-method reliability analysis. Arterial blood sampling and metabolite analysis were performed for all scans. Distribution volumes (V T ) were obtained using Logan plots for bolus scans and ratios between tissue and plasma parent activity for bolus plus infusion scans for different time spans of the scan (V T-70 for 60-70min after start of tracer infusion, V T-90 for 75-90min, V T-120 for 100-120min) in 9 subjects. Omitting blood data, binding potentials (BP ND ) obtained using multilinear reference tissue modeling (MRTM2) and cerebellar gray matter as reference region were compared in 11 subjects. A K bol of 160min was observed to be optimal for rapid equilibration in thalamus and striatum. V T-70 showed good intraclass correlation coefficients (ICCs) of 0.61-0.70 for thalamus, striatal regions and olfactory cortex with bias ≤5.1% compared to bolus scans. ICCs increased to 0.72-0.78 for V T-90 and 0.77-0.93 for V T-120 in these regions. BP ND-90 had negligible bias ≤2.5%, low variability ≤7.9% and ICCs of 0

  4. Modulation of early functional recovery of Achilles tendon to bone unit after transection by BPC 157 and methylprednisolone.

    PubMed

    Krivic, A; Majerovic, M; Jelic, I; Seiwerth, S; Sikiric, P

    2008-05-01

    In the presented study we compared the effect of stable peptide BPC 157 and methylprednisolone on early functional recovery after Achilles tendon to bone transection in a rat model before collagen healing started. Surgical transection of the right Achilles tendon to bone area was performed in seventy two Wistar Albino male rats. Healing Achilles tendon edges were harvested at days 1-4 following the transection. Using Achilles functional index (AFI), myeloperoxidase activity, histological inflammatory cell influx and vascular index early functional recovery was evaluated. Agents (stable peptide BPC 157 10 microg methylprednisolone 5 mg, normal saline 5 ml) were given alone (/kg b.w., intraperitoneally, once daily, first 30 min after surgery, last 24 h before analysis). Control group received normal saline 5 ml/kg. BPC 157 improved functional recovery (AFI values increased at all time points, p <0.05) by anti-inflammatory (decreased myeloperoxidase (MPO) activity and histological inflammatory cell influx, p <0.05) and increased new blood vessel formation (increased vascular index, p <0.05). Methyprednisolone decreased MPO activity and histological inflammatory cell influx, (p <0.05) but also decreased new blood vessel formation and did not affect early functional recovery. Stable peptide BPC 157 with combined anti-inflammatory action and induction of early new blood vessel formation facilitates early functional recovery in Achilles tendon to bone healing.

  5. Repeatability of Bolus Kinetics Ultrasound Perfusion Imaging for the Quantification of Cerebral Blood Flow.

    PubMed

    Vinke, Elisabeth J; Eyding, Jens; de Korte, Chris L; Slump, Cornelis H; van der Hoeven, Johannes G; Hoedemaekers, Cornelia W E

    2017-12-01

    Ultrasound perfusion imaging (UPI) can be used for the quantification of cerebral perfusion. In a neuro-intensive care setting, repeated measurements are required to evaluate changes in cerebral perfusion and monitor therapy. The aim of this study was to determine the repeatability of UPI in quantification of cerebral perfusion. UPI measurement of cerebral perfusion was performed three times in healthy patients. The coefficients of variation of the three bolus injections were calculated for both time- and volume-derived perfusion parameters in the macro- and microcirculation. The UPI time-dependent parameters had overall the lowest CVs in both the macro- and microcirculation. The volume-related parameters had poorer repeatability, especially in the microcirculation. Both intra-observer variability and inter-observer variability were low. Although UPI is a promising tool for the bedside measurement of cerebral perfusion, improvement of the technique is required before implementation in routine clinical practice. Copyright © 2017 World Federation for Ultrasound in Medicine and Biology. Published by Elsevier Inc. All rights reserved.

  6. Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device.

    PubMed

    Hayek, Salim M; Veizi, Elias; Hanes, Michael

    2016-03-01

    Intrathecal (IT) pumps have become a valuable tool in managing intractable non-cancer pain. The purpose of this study was to evaluate the efficacy of using a rigorous treatment algorithm for trialing and implanting IT pumps with hydromorphone and bupivacaine in managing a more homogeneous population of post-laminectomy syndrome or failed back surgery syndrome (FBSS) patients. This is a retrospective analysis of FBSS patients with chronic intractable back pain implanted with IT pumps delivering hydromorphone and bupivacaine. A cohort of 57 (26 males, 31 females) consecutively implanted FBSS patients was analyzed. The average age at implant was 65.4 years. Average pain scores were 8.4 ± 0.2 (pre-implant), 4.9 ± 0.4 (6 months), 5.2 ± 0.5 (12 months), and 4.3 ± 0.5 (24 months). Average oral opioid doses in morphine equivalents were 56 ± 10 mg/day (pre-implant), 12.0 ± 3.5 mg/day (12 months), 15 ± 6 mg/day (24 months). Average IT hydromorphone doses were 79 ± 6.8 mcg/day (at implant), 184 ± 22 mcg/day (6 months), 329 ± 48 mcg/day (12 months), and 487 ± 80 mcg (24 months). IT hydromorphone dose escalation from baseline was 133% (6 months vs baseline), 78% (12 months vs 6 months), and 48% from 12 months to 24 months. Average IT bupivacaine doses were 5.8 ± 0.3 mg/day (implant), 9.5 ± 0.6 mg/day (6 months), 12.2 ± 0.7 mg/day (12 months), and 12.6 ± 0.9 mg/day (24 months). IT hydromorphone and bupivacaine are effective in treating chronic pain of FBSS, as demonstrated by the reduction of pain intensity and oral opioid consumption. However, an IT dose escalation phenomenon was observed, although at a reduced rate compared with what had been previously reported in the literature. It is possible that the local anesthetic combination delivered via a patient-activaed bolus device is an important factor. Despite demonstrating effectiveness, the clinical utility of myPTM-optimized IT therapy remains limited

  7. The influence of a slow-release multi-trace element ruminal bolus on trace element status, number of ovarian follicles and pregnancy outcomes in synchronized Afshari ewes

    PubMed Central

    Abdollahi, E.; Kohram, H.; Shahir, M. H.; Nemati, M. H.

    2015-01-01

    Published data on the effects of ruminal bolus on the number of ovulatory follicles in ewes does not exist. The present study determined the effects of a ruminal bolus on trace element status, follicular dynamics and reproductive performance in ewes. Eighty Afshari cycling ewes were synchronized during breeding season using CIDR for 14 days and assigned to 4 groups (n=20); group 1 received a single Ferrobloc bolus four weeks prior to CIDR insertion following 400 IU eCG on CIDR removal, group 2 received two boluses four weeks prior to CIDR insertion following 400 IU eCG on CIDR removal, group 3 received only 400 IU eCG on CIDR removal and group 4 (control) received no bolus and no eCG. Transrectal ultrasonography was done to monitor the ovarian follicles on the day of CIDR removal and a day later. Results showed that boluses increased the status of copper, selenium and iodine on mating day and days 90 to 100 of gestation. Ruminal bolus did not significantly increase the number of different classes of ovarian follicles in ewes fed a diet meeting all trace mineral requirements. All ewes eventually became pregnant with 1 or 2 boluses but the multiple births rate (80%) was higher (P<0.05) after 2 boluses compared to the other groups. PMID:27175153

  8. Bolus oral glutamine protects rats against CPT-11-induced diarrhea and differentially activates cytoprotective mechanisms in host intestine but not tumor.

    PubMed

    Xue, Hongyu; Sawyer, Michael B; Field, Catherine J; Dieleman, Levinus A; Murray, David; Baracos, Vickie E

    2008-04-01

    Dietary glutamine has been suggested to preserve structural and functional integrity of the gut and high dose bolus glutamine has been hypothesized to protect against potentially fatal endotoxic shock, hyperthermic stress, and side effects of chemotherapy. In this study, we aimed to relate the ability of high dose oral bolus glutamine to mitigate the severe diarrhea induced by 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxy-camptothecin (CPT-11) chemotherapy to specific cytoprotective mechanisms [heat shock response, glutathione (GSH)] in gut and tumor tissues. Female rats bearing Ward colon tumor received CPT-11 (125 mg x kg(-1) x d(-1)x 3 d) with or without an oral glutamine bolus (0.75 g/kg) administered 30 min prior to each CPT-11 dose. Glutamine reduced incidence and severity of late-onset diarrhea following CPT-11 treatment (P < 0.05) and was associated with potentially beneficial and protective responses in the colon: 1) a 3.1- to 7.2-fold increase of heat shock protein (Hsp)25,-70, and -90alpha (P < 0.05); 2) increased reduced GSH (rGSH):oxidized GSH ratio (P < 0.05); 3) prevention of upregulated activity of a key bacterial enzyme (beta-glucuronidase) in the cecal content that mediates CPT-11 intestinal toxicity (P < 0.05); and 4) increased proportions of CD3+CD8+ lymphocytes and memory CD8+ subset in mesenteric lymph nodes following CPT-11 therapy. By contrast, glutamine treatment did not alter CPT-11's antitumor activity, the amino acid concentrations, Hsp expression, or the ratio of rGSH:oxidized GSH in the tumor. Our data demonstrate a striking dichotomy in the response of tumor and host to oral glutamine administration, concurring with the concept that this nutrient may favorably alter the balance between the host and tumor.

  9. Post-infectious bronchiolitis obliterans in children: CT features that predict responsiveness to pulse methylprednisolone.

    PubMed

    Yoon, H M; Lee, J S; Hwang, J-Y; Cho, Y A; Yoon, H-K; Yu, J; Hong, S-J; Yoon, C H

    2015-05-01

    Intravenous pulse methylprednisolone therapy (IPMT) is an important treatment option for post-infectious obliterative bronchiolitis (OB), although it must be used carefully and only in selected patients because of its drawbacks. This study evaluated whether CT and clinical features of children with post-infectious OB can predict their responsiveness to IPMT. We searched the medical records for patients (less than 18 years of age) who were diagnosed with post-infectious OB between January 2000 and December 2011. 17 children who received IPMT were included in this study. All underwent chest CT before and after IPMT. The radiological features seen on pre-treatment CT were recorded. The air-trapping area percentages on pre- and post-treatment CT images were determined. The nine patients who exhibited decreased air trapping on post-treatment CT scans relative to pre-treatment scans were classed as responders. The patient ages and time from initial pneumonia to IPMT were recorded. All responders and only four non-responders had thickened bronchial walls before treatment (p = 0.029). The two groups did not differ significantly in terms of bronchiolitis, bronchiectasis or the extent of air trapping, although the responders had a significantly shorter median interval between initial pneumonia and IPMT (4 vs 50 months; p = 0.005) and were significantly younger (median, 2.0 vs 7.5 years; p = 0.048). Immediate IPMT may improve the degree of air trapping in children with post-infectious OB if they show a thickened bronchial wall on CT. Children with post-infectious OB may respond favourably to IPMT when pre-treatment CT indicates bronchial-wall thickening.

  10. Comparing the effect of preoperative administration of methylprednisolone and its administration before and during surgery on the clinical outcome in pediatric open heart surgeries.

    PubMed

    Soltani, Ghasem; Abbasi Tashnizi, Mohammad; Moeinipour, Ali Asghar; Ganjifard, Mahmoud; Esfahanizadeh, Jamil; Sepehri Shamloo, Alireza; Purafzali Firuzabadi, Seyed Javad; Zirak, Nahid

    2013-06-01

    Cardiac surgery under Cardiopulmonary bypass causes a systemic inflammatory response with a multifactorial etiology including direct tissue damage, ischemia and stimulation of immune system induced by cardiopulmonary bypass. This study was designed due to the high prevalence and complications of this stimulated immune system in mortality, morbidity, length of ICU stay, and mechanical ventilation. This study was aimed to compare preoperative and intraoperative methylprednisolone (MP) to intraoperative MP alone with respect to postbypass inflammation and clinical outcome. Sixty pediatric patients (age < 5years) undergoing cardiopulmonary bypass surgery between September 2011-2012 at Imam Reza hospital-Mashhad were randomly assigned to receive preoperative and intraoperative MP (group 1: 30 mg/kg, 4 hours before bypass and in bypass prime, n = 30) or intraoperative MP only (group 2: 30 mg/kg, n = 30). Postoperative temperature (peak temperature and average temperature during the first 24 hours), amount of inotropic, duration of mechanical ventilation, ICU stay, WBC, BUN, creatinine, and CRP were recorded and compared in both groups. Data were analyzed with SPSS version 13 by T-test, Mann-Whitney test if necessary, and Chi-squared distribution. Patient characteristics including age, weight, gender, and duration of bypass were almost similar in both groups (P > 0.05). No significant difference in amount of inotropic medications used for hemodynamic supports, duration of mechanical ventilation, peak and average temperature and length of ICU stay was observed. Among the laboratory tests (WBC, BUN, creatinine, CRP) only WBC counts raised more in group 2 when compared to group 1(P < 0.05). There was no difference in clinical outcome after cardiac surgery when we administered an additional dose of methylprednisolone compared to a single dose of methylprednisolone.

  11. Practical approaches to four-dimensional heavy-charged-particle lung therapy.

    PubMed

    Mori, Shinichiro; Wu, Ziji; Folkert, Michael R; Kumagai, Motoki; Dobashi, Suguru; Sugane, Toshio; Baba, Masayuki

    2010-01-01

    We have developed new design algorithms for compensating boli to facilitate the implementation of four-dimensional charged-particle lung therapy in clinical applications. Four-dimensional CT (4DCT) data for eight lung cancer patients were acquired with a 16-slice CT under free breathing. Six compensating boli were developed that may be categorized into three classes: (1) boli-based on contoured gross tumor volumes (GTV) from a 4DCT data set during each respiratory phase, subsequently combined into one (GTV-4DCT bolus); (2) boli-based on contoured internal target volume (ITV) from image-processed 3DCT data only [temporal-maximum-intensity-projection (TMIP)/temporal-average-intensity-projection (TAIP)] with calculated boli (ITV-TMIP and ITV-TAIP boli); and (3) boli-based on contoured ITV utilizing image-processed 3DCT data, applied to 4DCT for design of boli for each phase, which were then combined. The carbon beam dose distribution within each bolus was calculated as a function of time and compared to plans in which respiratory-ungated/gated strategies were used. The GTV-4DCT treatment plan required a prohibitively long time for contouring the GTV manually for each respiratory phase, but it delivered more than 95% of the prescribed dose to the target volume. The TMIP and TAIP treatments, although more time-efficient, resulted in an unacceptable excess dose to normal tissues and underdosing of the target volume. The dose distribution for the ITV-4DCT bolus was similar to that for the GTV-4DCT bolus and required significantly less practitioner time. The ITV-4DCT bolus treatment plan is time-efficient and provides a high-quality dose distribution, making it a practical alternative to the GTV-4DCT bolus treatment plan.

  12. A mathematical model for the movement of food bolus of varying viscosities through the esophagus

    NASA Astrophysics Data System (ADS)

    Tripathi, Dharmendra

    2011-09-01

    This mathematical model is designed to study the influence of viscosity on swallowing of food bolus through the esophagus. Food bolus is considered as viscous fluid with variable viscosity. Geometry of esophagus is assumed as finite length channel and flow is induced by peristaltic wave along the length of channel walls. The expressions for axial velocity, transverse velocity, pressure gradient, volume flow rate and stream function are obtained under the assumptions of long wavelength and low Reynolds number. The impacts of viscosity parameter on pressure distribution, local wall shear stress, mechanical efficiency and trapping are numerically discussed with the help of computational results. On the basis of presented study, it is revealed that swallowing of low viscous fluids through esophagus requires less effort in comparison to fluids of higher viscosity. This result is similar to the experimental result obtained by Raut et al. [1], Dodds [2] and Ren et al. [3]. It is further concluded that the pumping efficiency increases while size of trapped bolus reduces when viscosity of fluid is high.

  13. Management and endoscopic techniques for digestive foreign body and food bolus impaction.

    PubMed

    Chauvin, Armelle; Viala, Jerome; Marteau, Philippe; Hermann, Philippe; Dray, Xavier

    2013-07-01

    Ingested foreign bodies, food bolus impaction, migration or retention of medical devices are frequent, in children as well as in adults. Most of these foreign bodies will naturally pass through the gastro-intestinal tract. Complications are rare but sometimes severe (oesophageal perforations are the most frequent and most feared). We aimed to review the literature on therapeutic management of digestive foreign bodies and food bolus impaction, with special focus on endoscopic indications, material, timing and techniques for removal. The role of the gastroenterologist is to recognise specific situations and to plan endoscopic removal in a timely manner with the most adequate conditions and extraction tools. Risk factors and underlying pathology, for example eosinophilic esophagitis, must be investigated and if necessary treated. Copyright © 2012 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  14. An in vitro evaluation of the pressure generated during programmed intermittent epidural bolus injection at varying infusion delivery speeds.

    PubMed

    Klumpner, Thomas T; Lange, Elizabeth M S; Ahmed, Heena S; Fitzgerald, Paul C; Wong, Cynthia A; Toledo, Paloma

    2016-11-01

    Programmed intermittent bolus injection of epidural anesthetic solution results in decreased anesthetic consumption and better patient satisfaction compared with continuous infusion, presumably by better spread of the anesthetic solution in the epidural space. It is not known whether the delivery speed of the bolus injection influences analgesia outcomes. The objective of this in vitro study was to determine the pressure generated by a programmed intermittent bolus pump at 4 infusion delivery speeds through open-ended, single-orifice and closed-end, multiorifice epidural catheters. In vitro observational study. Not applicable. Not applicable. A CADD-Solis Pain Management System v3.0 with Programmed Intermittent Bolus Model 2110 was connected via a 3-way adapter to an epidural catheter and a digital pressure transducer. Pressures generated by delivery speeds of 100, 175, 300, and 400 mL/h of saline solution were tested with 4 epidural catheters (2 single orifice and 2 multiorifice). These runs were replicated on 5 pumps. Analysis of variance was used to compare the mean peak pressures of each delivery speed within each catheter group (single orifice and multiorifice). Thirty runs at each delivery speed were performed with each type of catheter for a total of 240 experimental runs. Peak pressure increased with increasing delivery speeds in both catheter groups (P<.001). Peak pressures were higher with the multiorifice catheter compared with the single-orifice catheter at all delivery speeds (P<.001, for all). Using a pump designed for programmed intermittent infusion boluses, the delivery speed of saline solution through epidural catheters was directly related to the peak pressures. Future work should evaluate whether differences in the delivery speed of anesthetic solution into the epidural space correlate with differences in the duration and quality of analgesia during programmed intermittent epidural bolus delivery. Copyright © 2016 Elsevier Inc. All rights

  15. Differential Response Pattern of Oropharyngeal Pressure by Bolus and Dry Swallows.

    PubMed

    Hasegawa, Mana; Kurose, Masayuki; Okamoto, Keiichiro; Yamada, Yoshiaki; Tsujimura, Takanori; Inoue, Makoto; Sato, Taisuke; Narumi, Takatsune; Fujii, Noritaka; Yamamura, Kensuke

    2018-02-01

    The aim of this study was to determine if bolus and dry swallow showed similar pressure changes in the oropharynx using our newly developed device. A unique character of it includes that baropressure can be measured with the sensor being placed in the balloon and can assess the swallowing mechanics in terms of pressure changes in the oropharynx with less influences of direct contacts of boluses and oropharyngeal structures during swallow indirectly. Fifteen healthy subjects swallowed saliva (dry), 15 ml of water, 45 ml of water, and 15 ml of two different types of food in terms of viscosity (potage soup-type and mayonnaise-type foods). Suprahyoid muscle activity was recorded simultaneously. Three parameters, area under the curve (AUC), peak amplitude, and duration of pressure, were analyzed from each swallow. Almost all of the bolus swallowing events had biphasic baropressure responses consisting of an early phase and late phase (99%), whereas 90% of the saliva swallowing events had a single phase. AUC, peak, and duration displayed greater effects during the late phase than during the early phase. Baropressure of the early phase, but not of the late phase, significantly increased with increasing volume; however, small but significant viscosity effects on pressure were seen during both phases. Peak pressure of the late phase was preceded by maximum muscle activity, whereas that of the early phase was seen when muscle activity displayed a peak response. These findings indicated that our device with the ability to measure baropressure has the potential to provide additional parameter to assess the swallow physiology, and biphasic baropressure responses in the early and late phases could reflect functional aspects of the swallowing reflexes.

  16. TU-F-CAMPUS-I-01: Investigation of the Effective Dose From Bolus Tracking Acquisitions at Different Anatomical Locations in the Chest for CT

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Nowik, P; Bujila, R; Merzan, D

    2015-06-15

    Purpose: Stationary table acquisitions (Bolus tracking) in X-ray Computed Tomography (CT) can Result in dose length products (DLP) comparable to spiral scans. It is today unclear whether or not the effective dose (E) for Bolus Tracking can be approximated using target region specific conversion factors (E/DLP). The purpose of this study was to investigate how E depends on the anatomical location of the Bolus Tracking in relation to Chest CT scans with the same DLP. Methods: Effective doses were approximated for the ICRP 110 adult Reference Male (AM) and adult Reference Female (FM) computational voxel phantoms using software for CTmore » dose approximations (pre-simulated MC data). The effective dose was first approximated for a Chest CT scan using spiral technique and a CTDIvol (32 cm) of 6 mGy. The effective dose from the spiral scan was then compared to E approximated for contiguous Bolus Tracking acquisitions (1 cm separation), with a total collimation of 1 cm, over different locations of the chest of the voxel phantoms. The number of rotations used for the Bolus Tracking acquisitions was adjusted to yield the same DLP (32 cm) as the spiral scan. Results: Depending on the anatomical location of the Bolus Tracking, E ranged by factors of 1.3 to 6.8 for the AM phantom and 1.4 to 3.3 for the AF phantom, compared to the effective dose of the spiral scans. The greatest E for the Bolus Tracking acquisitions was observed for anatomical locations coinciding with breast tissue. This can be expected as breast tissue has a high tissue weighting factor in the calculation of E. Conclusion: For Chest CT scans, the effective dose from Bolus Tracking is highly dependent on the anatomical location where the scan is administered and will not always accurately be represented using target region specific conversion factors.« less

  17. Poster - 38: On the physical and dosimetric properties of 3D printed electron bolus fabricated using polylactic acid

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sasaki, David; Jensen, Martin; Rickey, Daniel W

    Purpose: 3D printing technology could simplify and improve electron bolus fabrication. The purpose of this study was to characterize the density, dimensional accuracy, uniformity, and attenuation of PLA boluses fabricated with a low-cost 3D printer. Methods: Several solid square slabs were printed with specific requested dimensions and 100% infill using different fill patterns. These pieces were imaged using an x-ray flat panel imager in order to check for uniformity of the prints. Percentage depth doses (PDDs) were measured downstream of the slabs in solid water using a parallel plate chamber and compared to measurements in water in order to characterizemore » attenuation. The dimensions of the PLA slabs were measured using digital calipers. The slabs were also weighed to find their density. Results: The fill pattern used to create boluses can affect the attenuation of the bolus. Fill patterns should be chosen carefully and quality assurance should be done for each printed piece. PLA causes the electron PDD to shift towards shallower depths, compared to water, by 1.7 mm for each centimeter of PLA. Agreement with design dimensions was within 1 mm in the plane of the printer bed, and within 1/3 of a millimeter (roughly the thickness of a single layer), perpendicular to the printer bed. Average density was in the range 1.20 – 1.22. Conclusions: 3D printing shows great promise for use in fabricating electron bolus. This work indicates that printed PLA can be a suitable material provided the increased attenuation is properly accounted for.« less

  18. 21 CFR 520.1242b - Levamisole hydrochloride tablet or oblet (bolus).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Levamisole hydrochloride tablet or oblet (bolus). 520.1242b Section 520.1242b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS...

  19. 3-dimensional beam scanning system for particle radiation therapy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Leemann, C.; Alonso, J.; Grunder, H.

    1977-03-01

    In radiation therapy treatment volumes up to several liters have to be irradiated. Today's charged particle programs use ridge filters, scattering foils, occluding rings collimators and boluses to shape the dose distribution. An alternative approach, scanning of a small diameter beam, is analyzed and tentative systems specifications are derived. Critical components are scheduled for fabrication and testing at LBL.

  20. Factors predicting incremental administration of antihypertensive boluses during deep brain stimulator placement for Parkinson's disease.

    PubMed

    Rajan, Shobana; Deogaonkar, Milind; Kaw, Roop; Nada, Eman Ms; Hernandez, Adrian V; Ebrahim, Zeyd; Avitsian, Rafi

    2014-10-01

    Hypertension is common in deep brain stimulator (DBS) placement predisposing to intracranial hemorrhage. This retrospective review evaluates factors predicting incremental antihypertensive use intraoperatively. Medical records of Parkinson's disease (PD) patients undergoing DBS procedure between 2008-2011 were reviewed after Institutional Review Board approval. Anesthesia medication, preoperative levodopa dose, age, preoperative use of antihypertensive medications, diabetes mellitus, anxiety, motor part of the Unified Parkinson's Disease Rating Scale score and PD duration were collected. Univariate and multivariate analysis was done between each patient characteristic and the number of antihypertensive boluses. From the 136 patients included 60 were hypertensive, of whom 32 were on angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB), told to hold on the morning of surgery. Antihypertensive medications were given to 130 patients intraoperatively. Age (relative risk [RR] 1.01; 95% confidence interval [CI] 1.00-1.02; p=0.005), high Joint National Committee (JNC) class (p<0.0001), diabetes mellitus (RR 1.4; 95%CI 1.2-17; p<0.0001) and duration of PD >10 years (RR 1.2; 95%CI 1.1-1.3; p=0.001) were independent predictors for antihypertensive use. No difference was noted in the mean dose of levodopa (p=0.1) and levodopa equivalent dose (p=0.4) between the low (I/II) and high severity (III/IV) JNC groups. Addition of dexmedetomidine to propofol did not influence antihypertensive boluses required (p=0.38). Intraoperative hypertension during DBS surgery is associated with higher age group, hypertensive, diabetic patients and longer duration of PD. Withholding ACEI or ARB is an independent predictor of hypertension requiring more aggressive therapy. Levodopa withdrawal and choice of anesthetic agent is not associated with higher intraoperative antihypertensive medications. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. Methylprednisolone for acute spinal cord injury: an increasingly philosophical debate.

    PubMed

    Bowers, Christian A; Kundu, Bornali; Hawryluk, Gregory W J

    2016-06-01

    Following publication of NASCIS II, methylprednisolone sodium succinate (MPSS) was hailed as a breakthrough for patients with acute spinal cord injury (SCI). MPSS use for SCI has since become very controversial and it is our opinion that additional evidence is unlikely to break the stalemate amongst clinicians. Patient opinion has the potential to break this stalemate and we review our recent findings which reported that spinal cord injured patients informed of the risks and benefits of MPSS reported a preference for MPSS administration. We discuss the implications of the current MPSS debate on translational research and seek to address some misconceptions which have evolved. As science has failed to resolve the MPSS debate we argue that the debate is an increasingly philosophical one. We question whether SCI might be viewed as a serious condition like cancer where serious side effects of therapeutics are tolerated even when benefits may be small. We also draw attention to the similarity between the side effects of MPSS and isotretinoin which is prescribed for the cosmetic disorder acne vulgaris. Ultimately we question how patient autonomy should be weighed in the context of current SCI guidelines and MPSS's status as a historical standard of care.

  2. Distribution and mixing of a liquid bolus in pleural space.

    PubMed

    Bodega, Francesca; Tresoldi, Claudio; Porta, Cristina; Zocchi, Luciano; Agostoni, Emilio

    2006-02-28

    Distribution and mixing time of boluses with labeled albumin in pleural space of anesthetized, supine rabbits were determined by sampling pleural liquid at different times in various intercostal spaces (ics), and in cranial and caudal mediastinum. During sampling, lung and chest wall were kept apposed by lung inflation. This was not necessary in costo-phrenic sinus. Here, 10 min after injection, lung inflation increased concentration of labeled albumin by 50%. Lung inflation probably displaces some pleural liquid cranio-caudally, increasing labeled albumin concentration caudally to injection point (6th ics), and decreasing it cranially. Boluses of 0.1-1 ml did not preferentially reach mediastinal regions, as maintained by others. Time for an approximate mixing was approximately 1 h for 0.1 ml, and approximately 30 min for 1 ml. This relatively long mixing time does not substantially affect determination of contribution of lymphatic drainage through stomata to overall removal of labeled albumin from 0.3 ml hydrothoraces lasting 3 h [Bodega, F., Agostoni, E., 2004. Contribution of lymphatic drainage through stomata to albumin removal from pleural space. Respir. Physiol. Neurobiol. 142, 251-263].

  3. Lung Volume during Swallowing: Single Bolus Swallows in Healthy Young Adults

    ERIC Educational Resources Information Center

    Hegland, Karen M. Wheeler; Huber, Jessica E.; Pitts, Teresa; Sapienza, Christine M.

    2009-01-01

    Purpose: This study examined the relationship between swallowing and lung volume initiation in healthy adults during single swallows of boluses differing in volume and consistency. Differences in lung volume according to respiratory phase surrounding the swallow were also assessed. Method: Nine men and 11 women between the ages of 19 and 28 years…

  4. A critical appraisal of the reporting of the National Acute Spinal Cord Injury Studies (II and III) of methylprednisolone in acute spinal cord injury.

    PubMed

    Coleman, W P; Benzel, D; Cahill, D W; Ducker, T; Geisler, F; Green, B; Gropper, M R; Goffin, J; Madsen, P W; Maiman, D J; Ondra, S L; Rosner, M; Sasso, R C; Trost, G R; Zeidman, S

    2000-06-01

    From the beginning, the reporting of the results of National Acute Spinal Cord Injury Studies (NASCIS) II and III has been incomplete, leaving clinicians in the spinal cord injury (SCI) community to use or avoid using methylprednisolone in acute SCI on the basis of faith rather than a publicly developed scientific consensus. NASCIS II was initially reported by National Institutes of Health announcements, National Institutes of Health facsimiles to emergency room physicians, and the news media. The subsequent report in the New England Journal of Medicine implied that there was a positive result in the primary efficacy analysis for the entire 487 patient sample. However, this analysis was in fact negative, and the positive result was found only in a secondary analysis of the subgroup of patients who received treatment within 8 hours. In addition, that subgroup apparently had only 62 patients taking methylprednisolone and 67 receiving placebo. The NASCIS II and III reports embody specific choices of statistical methods that have strongly shaped the reporting of results but have not been adequately challenged or or even explained. These studies show statistical artifacts that call their results into question. In NASCIS II, the placebo group treated before 8 hours did poorly, not only when compared with the methylprednisolone group treated before 8 hours but even when compared with the placebo group treated after 8 hours. Thus, the positive result may have been caused by a weakness in the control group rather than any strength of methylprednisolone. In NASCIS III, a randomization imbalance occurred that allocated a disproportionate number of patients with no motor deficit (and therefore no chance for recovery) to the lower dose control group. When this imbalance is controlled for, much of the superiority of the higher dose group seems to disappear. The NASCIS group's decision to admit persons with minor SCIs with minimal or no motor deficit not only enables statistical

  5. Regular intermittent bolus provides similar incidence of maternal fever compared with continuous infusion during epidural labor analgesia.

    PubMed

    Feng, Shan-Wu; Xu, Shi-Qin; Ma, Li; Li, Cai-Juan; Wang, Xian; Yuan, Hong-Mei; Wang, Fu-Zhou; Shen, Xiao-Feng; Ding, Zheng-Nian

    2014-10-01

    To compare the effects of regular intermittent bolus versus continuous infusion for epidural labor analgesia on maternal temperature and serum interleukin-6 (IL-6) level. This randomized trial was performed in Nanjing Maternity and Child Health Care Hospital, Nanjing, Jiangsu Province, China between October 2012 and February 2014. Either regular intermittent bolus (RIB, n=66) or continuous infusion (CI, n=66) was used for epidural labor analgesia. A bolus dose (10 ml of 0.08% ropivacaine + 0.4 ug·ml-1 sufentanil) was manually administrated once an hour in the RIB group, whereas the same solution was continuously infused at a constant rate of 10 ml·h-1 in the CI group. Maternal tympanic temperature and serum IL-6 level were measured hourly from baseline to one hour post partum. The incidences of fever (>/=38 degree celsius ) were calculated. The incidence of maternal fever was similar between the 2 groups. There was a rising trend in mean temperature over time in both groups, but no statistical difference was detected between the groups at respective time points; maternal serum IL-6 showed similar changes. Compared with continuous infusion, regular intermittent bolus presents with the same incidence of maternal fever for epidural labor analgesia. Interleukin-6 elevation could be involved in mean maternal temperature increase. 

  6. The Effect of Rheological Properties of Foods on Bolus Characteristics After Mastication

    PubMed Central

    Hwang, Junah; Bae, Jung Hyun; Kang, Si Hyun; Seo, Kyung Mook; Kim, Byong Ki; Lee, Sook Young

    2012-01-01

    Objective To evaluate the effects of physical properties of foods on the changes of viscosity and mass as well as the particle size distribution after mastication. Method Twenty subjects with no masticatory disorders were recruited. Six grams of four solid foods of different textures (banana, tofu, cooked-rice, cookie) were provided, and the viscosity and mass after 10, 20, and 30 cycles of mastication and just before swallowing were measured. The physical properties of foods, such as hardness, cohesiveness, and adhesiveness, were measured with a texture analyzer. Wet sieving and laser diffraction were used to determine the distribution of food particle size. Results When we measured the physical characteristics of foods, the cookie was the hardest food, and the banana exhibited marked adhesiveness. Tofu and cooked-rice exhibited a highly cohesive nature. As the number of mastication cycles increased, the masses of all foods were significantly increased (p<0.05), and the viscosity was significantly decreased in the case of banana, tofu, and cooked-rice (p<0.05). The mass and viscosity of all foods were significantly different between the foods after mastication (p<0.05). Analyzing the distribution of the particle size, that of the bolus was different between foods. However, the curves representing the particle size distribution for each food were superimposable for most subjects. Conclusion The viscosity and particle size distribution of the bolus were different between solid foods that have different physical properties. Based on this result, the mastication process and food bolus formation were affected by the physical properties of the food. PMID:23342309

  7. Can the use of methylprednisolone, vitamin C, or alpha-trinositol prevent cold-induced fluid extravasation during cardiopulmonary bypass in piglets?

    PubMed

    Farstad, M; Heltne, J K; Rynning, S E; Onarheim, H; Mongstad, A; Eliassen, F; Husby, P

    2004-02-01

    Hypothermic cardiopulmonary bypass is associated with capillary fluid leakage, resulting in edema and occasionally organ dysfunction. Systemic inflammatory activation is considered responsible. In some studies methylprednisolone has reduced the weight gain during cardiopulmonary bypass. Vitamin C and alpha-trinositol have been demonstrated to reduce the microvascular fluid and protein leakage in thermal injuries. We therefore tested these three agents for the reduction of cold-induced fluid extravasation during cardiopulmonary bypass. A total of 28 piglets were randomly assigned to four groups of 7 each: control group, high-dose vitamin C group, methylprednisolone group, and alpha-trinositol-group. After 1 hour of normothermic cardiopulmonary bypass, hypothermic cardiopulmonary bypass was initiated in all animals and continued to 90 minutes. The fluid level in the extracorporeal circuit reservoir was kept constant at the 400-mL level and used as a fluid gauge. Fluid needs, plasma volume, changes in colloid osmotic pressure in plasma and interstitial fluid, hematocrit, and total water contents in different tissues were recorded, and the protein masses and the fluid extravasation rate were calculated. Hemodilution was about 25% after start of normothermic cardiopulmonary bypass. Cooling did not cause any further changes in hemodilution. During steady-state normothermic cardiopulmonary bypass, the fluid need in all groups was about 0.10 mL/(kg.min), with a 9-fold increase during the first 30 minutes of cooling (P <.001). This increased fluid need was due mainly to increased fluid extravasation from the intravascular to the interstitial space at a mean rate of 0.6 mL/(kg.min) (range 0.5-0.7 mL/[kg.min]; P <.01) and was reflected by increased total water content in most tissues in all groups. The albumin and protein masses remained constant in all groups throughout the study. Pretreatment with methylprednisolone, vitamin C, or alpha-trinositol was unable to prevent the

  8. Comparing the Effect of Preoperative Administration of Methylprednisolone and its Administration Before and During Surgery on the Clinical Outcome in Pediatric Open Heart Surgeries

    PubMed Central

    Soltani, Ghasem; Abbasi Tashnizi, Mohammad; Moeinipour, Ali Asghar; Ganjifard, Mahmoud; Esfahanizadeh, Jamil; Sepehri Shamloo, Alireza; Purafzali Firuzabadi, Seyed Javad; Zirak, Nahid

    2013-01-01

    Background Cardiac surgery under Cardiopulmonary bypass causes a systemic inflammatory response with a multifactorial etiology including direct tissue damage, ischemia and stimulation of immune system induced by cardiopulmonary bypass. This study was designed due to the high prevalence and complications of this stimulated immune system in mortality, morbidity, length of ICU stay, and mechanical ventilation. Objectives This study was aimed to compare preoperative and intraoperative methylprednisolone (MP) to intraoperative MP alone with respect to postbypass inflammation and clinical outcome. Patients and Methods Sixty pediatric patients (age < 5years) undergoing cardiopulmonary bypass surgery between September 2011-2012 at Imam Reza hospital-Mashhad were randomly assigned to receive preoperative and intraoperative MP (group 1: 30 mg/kg, 4 hours before bypass and in bypass prime, n = 30) or intraoperative MP only (group 2: 30 mg/kg, n = 30). Postoperative temperature (peak temperature and average temperature during the first 24 hours), amount of inotropic, duration of mechanical ventilation, ICU stay, WBC, BUN, creatinine, and CRP were recorded and compared in both groups. Data were analyzed with SPSS version 13 by T-test, Mann-Whitney test if necessary, and Chi-squared distribution. Results Patient characteristics including age, weight, gender, and duration of bypass were almost similar in both groups (P > 0.05). No significant difference in amount of inotropic medications used for hemodynamic supports, duration of mechanical ventilation, peak and average temperature and length of ICU stay was observed. Among the laboratory tests (WBC, BUN, creatinine, CRP) only WBC counts raised more in group 2 when compared to group 1(P < 0.05). Conclusions There was no difference in clinical outcome after cardiac surgery when we administered an additional dose of methylprednisolone compared to a single dose of methylprednisolone. PMID:24349746

  9. Comparison between preoperative administration of methylprednisolone with its administration before and during congenital heart surgery on serum levels of IL-6 and IL-10.

    PubMed

    Abbasi Tashnizi, Mohammad; Soltani, Ghasem; Moeinipour, Ali Asghar; Ayatollahi, Hossein; Tanha, Amir Saber; Jarahi, Lida; Sepehri Shamloo, Alireza; Zirak, Nahid

    2013-02-01

    Steroid administration during cardiopulmonary bypass is considered to improve cardiopulmonary function by modulating inflammations caused by bypass. This study was performed to compare effectiveness of preoperative and intraoperative methylprednisolone (MP) to preoperative methylprednisolone alone in post bypass inflammatory (IL-6) and anti-inflammatory (IL-10) factors. Fifty pediatric patients undergoing cardiopulmonary bypass surgery from August 2011 to 2012 in the cardiac surgery department of Imam Reza Hospital, the major center for CPB, in Mashhad, Iran were randomly assigned to receive preoperative and intraoperative MP (30 mg/kg, 4 hours before bypass and in bypass prime, number 25) or preoperative MP only (30 mg/kg, number 25). Before and after bypass, four and 24 hours after bypass, serum IL-6 and IL-10 were measured by ELISA. In both groups, no significant difference with variation of expression for IL-6 (inflammatory factor) and IL-10 (anti-inflammatory factor) in different times after bypass was observed. No significant difference in reducing post bypass inflammation between preoperative steroid treatment and combined preoperative and intraoperative steroid administration reported and they had the same effects.

  10. Effects of bolus doses of fat on small intestinal structure and on release of gastrin, cholecystokinin, peptide tyrosine-tyrosine, and enteroglucagon.

    PubMed Central

    Jenkins, A P; Ghatei, M A; Bloom, S R; Thompson, R P

    1992-01-01

    To investigate the enterotrophic effects of bolus doses of long chain triglycerides, two groups of eight female Wistar rats were fed identical diets with 48.2% total calories as the essential fatty acid rich oil Efamol. To one group the oil was given in twice daily bolus doses by gavage, while for the other group the oil was mixed with the remainder of the feed and thus consumed over 24 hours. The animals were killed after 20 to 22 days. Bolus dosing significantly increased parameters of mucosal mass along the length of the small intestine in association with an increase in two hour accumulation of vincristine arrested metaphases in small intestinal crypts. In a second experiment, four replicate studies were carried out, each involving two groups of 12 rats respectively fed as described above. After 21 days one animal from each group was killed every two hours, providing regular plasma samples over 24 hours for measurement of gastrin, cholecystokinin, peptide tyrosine-tyrosine and enteroglucagon. Bolus dosing markedly enhanced release of peptide tyrosine-tyrosine and enteroglucagon, but not of gastrin or cholecystokinin. Thus, the enhanced enterotrophic effects of bolus doses of long chain triglycerides could be mediated by release of a distally located gut peptide, perhaps enteroglucagon. PMID:1541417

  11. Methamphetamine-induced striatal apoptosis in the mouse brain: Comparison of a binge to an acute bolus drug administration

    PubMed Central

    Zhu, Judy P.Q.; Xu, Wenjing; Angulo, Nieves; Angulo, Jesus A.

    2010-01-01

    Methamphetamine (METH) is a psychostimulant that induces neural damage in experimental animals and humans. A binge (usually in the 5–10 mg/kg dose range 4× at 2 h intervals) and the acute bolus drug administration (20–40 mg/kg) of METH have been employed frequently to study neurotoxicity in the brain. In this study we have compared these drug delivery schedules to determine their efficacy to induce striatal apoptosis. Exposure of male mice to a binge of METH at 10 mg/kg 4× at 2 h intervals (cumulative dose of 40 mg/kg) was approximately four times less effective in inducing apoptotic cell death (TUNEL staining) 24 h after METH treatment in the striatum than a single bolus administration of 30 mg/kg of METH. The residual TUNEL staining observed three days after METH treatment is proportionately equivalent between a binge and the acute bolus drug administration. Interestingly, a binge of METH induces a hyperthermic response of longer duration. This study demonstrates that an acute bolus drug administration of METH is more effective inducing striatal apoptosis in mice, and therefore, is more suitable for studies assessing the impact of METH on sites post-synaptic to the striatonigral dopamine terminals. PMID:16165214

  12. Comparison of Power Versus Manual Injection in Bolus Shape and Image Quality on Contrast-Enhanced Magnetic Resonance Angiography: An Experimental Study in a Swine Model.

    PubMed

    Tsuboyama, Takahiro; Jost, Gregor; Pietsch, Hubertus; Tomiyama, Noriyuki

    2017-09-01

    The aim of this study was to compare power versus manual injection in bolus shape and image quality on contrast-enhanced magnetic resonance angiography (CE-MRA). Three types of CE-MRA (head-neck 3-dimensional [3D] MRA with a test-bolus technique, thoracic-abdominal 3D MRA with a bolus-tracking technique, and thoracic-abdominal time-resolved 4-dimensional [4D] MRA) were performed after power and manual injection of gadobutrol (0.1 mmol/kg) at 2 mL/s in 12 pigs (6 sets of power and manual injections for each type of CE-MRA). For the quantitative analysis, the signal-to-noise ratio was measured on ascending aorta, descending aorta, brachiocephalic trunk, common carotid artery, and external carotid artery on the 6 sets of head-neck 3D MRA, and on ascending aorta, descending aorta, brachiocephalic trunk, abdominal aorta, celiac trunk, and renal artery on the 6 sets of thoracic-abdominal 3D MRA. Bolus shapes were evaluated on the 6 sets each of test-bolus scans and 4D MRA. For the qualitative analysis, arterial enhancement, superimposition of nontargeted enhancement, and overall image quality were evaluated on 3D MRA. Visibility of bolus transition was assessed on 4D MRA. Intraindividual comparison between power and manual injection was made by paired t test, Wilcoxon rank sum test, and analysis of variance by ranks. Signal-to-noise ratio on 3D MRA was statistically higher with power injection than with manual injection (P < 0.001). Bolus shapes (test-bolus, 4D MRA) were represented by a characteristic standard bolus curve (sharp first-pass peak followed by a gentle recirculation peak) in all the 12 scans with power injection, but only in 1 of the 12 scans with manual injection. Standard deviations of time-to-peak enhancement were smaller in power injection than in manual injection. Qualitatively, although both injection methods achieved diagnostic quality on 3D MRA, power injection exhibited significantly higher image quality than manual injection (P = 0.001) due to

  13. [Observing the density increase curve after intravenous contrast medium administration using a bolus triggering system: a method for detection cardiovascular disorders?].

    PubMed

    Stückle, C A; Kickuth, R; Kirchner, E M; Liermann, D; Kirchner, J

    2002-06-01

    Recently bolus tracking systems were developed to improve the timing of intravenous contrast media application in helical computed tomography. We investigated the benefit of this new method as a parameter of the cardiac function. Retrospective analysis of 64 patients which incidentally underwent bolus triggered contrast enhanced helical CT and invasive investigation of the heart within one week. All examinations were performed on the CT scanner Somatom Plus 4 Volume Zoom (Siemens Corp., Forchheim, Germany) using the C.A.R.E. Bolus software. This performs repetitive low-dose test scans (e.g. for the abdomen: 140 kV, 20 mA, Tl 0.5 s) and measures the Hounsfield attenuation (increase over the baseline) in a preselected region of interest. The displayed increase of vascular density over the time after peripheral contrast media injection (75 ml lopromid (300 mg/ml), 2 ml/s) was categorised to three types: (a) rapid increase, (b) deceleration before a 100 HE threshold was reached and (c) one or more peaks. The findings of the invasive investigation of the heart were correlated to the findings of the bolus-tracking measurements. The examinations were categorized as follows: 19 type A, 34 type B, 11 type C. We found a high significant correlation between the type of the Hounsfield attenuation and systolic pressure in the left ventricle. There was no correlation between the type of the Hounsfield attenuation and the diastolic pressure in the left ventricle, the pressures related to the right ventricle or the ejection fraction. The bolus-tacking system showed a sensitivity of 53, a specificity of 82, an accuracy of 70%, a positive predictive value of 70% and a negative predictive value of 70% in detection of left heart failure. The bolus tracking system C.A.R.E.-bolus often shows atypical Hounsfield attenuation in cases of cardiac failure but is not suitable as a screening method of the cardiopulmonary function.

  14. Outcomes of intrathecal baclofen therapy in patients with cerebral palsy and acquired brain injury

    PubMed Central

    Yoon, Young Kwon; Lee, Kil Chan; Cho, Han Eol; Chae, Minji; Chang, Jin Woo; Chang, Won Seok; Cho, Sung-Rae

    2017-01-01

    Abstract Intrathecal baclofen (ITB) has been known to reduce spasticity which did not respond to oral medications and botulinum toxin treatment. However, few results have been reported comparing the effects of ITB therapy in patients with cerebral palsy (CP) and acquired brain injury. This study aimed to investigate beneficial and adverse effects of ITB bolus injection and pump therapy in patients with CP and to compare outcomes to patients with acquired brain injury such as traumatic brain injury and hypoxic brain injury. ITB test trials were performed in 37 patients (19 CP and 18 acquired brain injury). Based on ambulatory function, CP patients were divided into 2 groups: 11 patients with nonambulatory CP and 8 patients with ambulatory CP. Change of spasticity was evaluated using the Modified Ashworth Scale. Additional positive or negative effects were also evaluated after ITB bolus injection. In patients who received ITB pump implantation, outcomes of spasticity, subjective satisfaction and adverse events were evaluated until 12 months post-treatment. After ITB bolus injection, 32 patients (86.5%) (CP 84.2% versus acquired brain injury 88.9%) showed a positive response of reducing spasticity. However, 8 patients with CP had negative adverse effects. Particularly, 3 ambulatory CP patients showed standing impairment and 1 ambulatory CP patient showed impaired gait pattern such as foot drop because of excessive reduction of lower extremity muscle tone. Ambulatory CP patients received ITB pump implantation less than patients with acquired brain injury after ITB test trials (P = .003 by a chi-squared test). After the pump implantation, spasticity was significantly reduced within 1 month and the effect maintained for 12 months. Seventeen patients or their caregivers (73.9%) were very satisfied, whereas 5 patients (21.7%) suffered from adverse events showed no subjective satisfaction. In conclusion, ITB therapy was effective in reducing spasticity in patients with

  15. Cerebral arterial bolus arrival time is prolonged in multiple sclerosis and associated with disability

    PubMed Central

    Paling, David; Thade Petersen, Esben; Tozer, Daniel J; Altmann, Daniel R; Wheeler-Kingshott, Claudia AM; Kapoor, Raju; Miller, David H; Golay, Xavier

    2014-01-01

    Alterations in the overall cerebral hemodynamics have been reported in multiple sclerosis (MS); however, their cause and significance is unknown. While potential venous causes have been examined, arterial causes have not. In this study, a multiple delay time arterial spin labeling magnetic resonance imaging sequence at 3T was used to quantify the arterial hemodynamic parameter bolus arrival time (BAT) and cerebral blood flow (CBF) in normal-appearing white matter (NAWM) and deep gray matter in 33 controls and 35 patients with relapsing–remitting MS. Bolus arrival time was prolonged in MS in NAWM (1.0±0.2 versus 0.9±0.2 seconds, P=0.031) and deep gray matter (0.90±0.18 versus 0.80±0.14 seconds, P=0.001) and CBF was increased in NAWM (14±4 versus 10±2 mL/100 g/min, P=0.001). Prolonged BAT in NAWM (P=0.042) and deep gray matter (P=0.01) were associated with higher expanded disability status score. This study demonstrates alteration in cerebral arterial hemodynamics in MS. One possible cause may be widespread inflammation. Bolus arrival time was longer in patients with greater disability independent of atrophy and T2 lesion load, suggesting alterations in cerebral arterial hemodynamics may be a marker of clinically relevant pathology. PMID:24045400

  16. Modified ESHAP as salvage chemotherapy for recurrent or refractory non-Hodgkin's lymphoma: results of a single-center study of 32 patients. Modified etoposide, methylprednisolone, cytarabine and cisplatin.

    PubMed

    Oztürk, Mehmet Akif; Barişta, Ibrahim; Altundağ, M Kadri; Türker, Alev; Yalçin, Suayib; Celik, Ismail; Güllü, Ibrahim; Güler, Nilüfer; Ozişik, Yavuz; Kars, Ayşe; Kansu, Emin; Baltali, Eşmen; Tekuzman, Gülten

    2002-12-01

    We have evaluated the clinical efficacy and toxicity of a modified etoposide, methylprednisolone, cytarabine and cisplatin (ESHAP) chemotherapy regimen that has been used by the Hacettepe University Department of Medical Oncology (Ankara, Turkey) since 1993. Thirty-two patients (18 men and 14 women) with refractory or recurrent non-Hodgkin's lymphoma (NHL) were treated with this protocol. The median age of the patients was 39 years (range 21-66 years). Patients were hospitalized during therapy. On the first day, 2 g/m(2) cytarabine was given, followed on days 2-5 by 60 mg/m(2) etoposide, 500 mg of methylprednisolone and 25 mg/m(2) cisplatin. After two cycles of chemotherapy, clinical efficacy was assessed by clinical examination, chest radiography, ultrasonography and/or computed tomography. The complications were assessed on the basis of the World Health Organization criteria. Nine patients (28%) had a complete response and 8 patients (25%) had a partial response. In responders, the median duration of remission was 6 months. By the end of the first year, 27% of the patients were still disease free and 66% were alive. High serum levels of lactate dehydrogenase had an adverse effect on disease-free survival, but no effect on overall survival (OS). The only unfavorable prognostic factor for OS was the presence of bulky disease. Neutropenia developed in 59% of patients, and febrile neutropenia developed in 74% of these patients, requiring hospitalization for an average of 8 days. Three patients died of neutropenia-associated sepsis despite broad-spectrum antibacterial and antifungal treatment. Thrombocytopenia was detected in 10 patients and anemia in 3 patients; among these, 7 patients with thrombocytopenia and 1 patient with anemia required transfusions. The modified ESHAP regimen induced remission in more than half of the patients with refractory or recurrent NHL. However, the duration of remission was brief. Moreover, significant myelotoxicity was common, and the

  17. S-adenosylmethionine decreases the peak blood alcohol levels 3 h after an acute bolus of ethanol by inducing alcohol metabolizing enzymes in the liver.

    PubMed

    Bardag-Gorce, Fawzia; Oliva, Joan; Wong, Wesley; Fong, Stephanie; Li, Jun; French, Barbara A; French, Samuel W

    2010-12-01

    An alcohol bolus causes the blood alcohol level (BAL) to peak at 1-2 h post ingestion. The ethanol elimination rate is regulated by alcohol metabolizing enzymes, primarily alcohol dehydrogenase (ADH1), acetaldehyde dehydrogenase (ALDH), and cytochrome P450 (CYP2E1). Recently, S-adenosylmethionine (SAMe) was found to reduce acute BALs 3 h after an alcohol bolus. The question, then, was: what is the mechanism involved in this reduction of BAL by feeding SAMe? To answer this question, we investigated the changes in ethanol metabolizing enzymes and the epigenetic changes that regulate the expression of these enzymes during acute binge drinking and chronic drinking. Rats were fed a bolus of ethanol with or without SAMe, and were sacrificed at 3 h or 12 h after the bolus. RT-PCR and Western blot analyses showed that SAMe significantly induced ADH1 levels in the 3 h liver samples. However, SAMe did not affect the changes in ADH1 protein levels 12 h post bolus. Since SAMe is a methyl donor, it was postulated that the ADH1 gene expression up regulation at 3 h was due to a histone modification induced by methylation from methyl transferases. Dimethylated histone 3 lysine 4 (H3K4me2), a modification responsible for gene expression activation, was found to be significantly increased by SAMe at 3 h post bolus. These results correlated with the low BAL found at 3 h post bolus, and support the concept that SAMe increased the gene expression to increase the elimination rate of ethanol in binge drinking by increasing H3K4me2. Copyright © 2010 Elsevier Inc. All rights reserved.

  18. Home therapy with continuous infusion of factor VIII after minor surgery or serious haemorrhage.

    PubMed

    Varon, D; Schulman, S; Bashari, D; Martinowitz, U

    1996-10-01

    Administration of factor VIII (F VIII) concentrates by continuous infusion is now routinely used at several haemophilia centers but almost exclusively for hospitalized patients. We evaluated various aspects of home therapy with continuous infusion of an immunoaffinity purified F VIII concentrate (Monoclate P®, Armour) in patients who would normally have been treated with high doses in bolus injections or with continuous infusion as in-patients. Twenty haemophilia A patients, eight after minor surgery and 12 for serious haemorrhage, received continuous infusion with undiluted F VIII by a minipump for a mean of 0.9 days in the hospital, followed by 3.3 days at home. Infusion bags were exchanged every 2.5 days. No haemorrhagic complications occurred, and five haemorrhages that had been resistant to treatment with bolus injections responded promptly to the continuous infusion. There were no technical problems and patient compliance and acceptance was good. We find this mode of therapy safe, efficacious and convenient for the patients as well as for the staff.

  19. The effect of food bolus location on jaw movement smoothness and masticatory efficiency.

    PubMed

    Molenaar, W N B; Gezelle Meerburg, P J; Luraschi, J; Whittle, T; Schimmel, M; Lobbezoo, F; Peck, C C; Murray, G M; Minami, I

    2012-09-01

    Masticatory efficiency in individuals with extensive tooth loss has been widely discussed. However, little is known about jaw movement smoothness during chewing and the effect of differences in food bolus location on movement smoothness and masticatory efficiency. The aim of this study was to determine whether experimental differences in food bolus location (anterior versus posterior) had an effect on masticatory efficiency and jaw movement smoothness. Jaw movement smoothness was evaluated by measuring jerk-cost (calculated from acceleration) with an accelerometer that was attached to the skin of the mentum of 10 asymptomatic subjects, and acceleration was recorded during chewing on two-colour chewing gum, which was used to assessed masticatory efficiency. Chewing was performed under two conditions: posterior chewing (chewing on molars and premolars only) and anterior chewing (chewing on canine and first premolar teeth only). Jerk-cost and masticatory efficiency (calculated as the ratio of unmixed azure colour to the total area of gum, the unmixed fraction) were compared between anterior and posterior chewing with the Wilcoxon signed rank test (two-tailed). Subjects chewed significantly less efficiently during anterior chewing than during posterior chewing (P = 0·0051). There was no significant difference in jerk-cost between anterior and posterior conditions in the opening phase (P = 0·25), or closing phase (P = 0·42). This is the first characterisation of the effect of food bolus location on jaw movement smoothness at the same time as recording masticatory efficiency. The data suggest that anterior chewing decreases masticatory efficiency, but does not influence jerk-cost. © 2012 Blackwell Publishing Ltd.

  20. Whole-brain radiotherapy and high-dose methylprednisolone for elderly patients with primary central nervous system lymphoma: Results of North Central Cancer Treatment Group (NCCTG) 96-73-51

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Laack, Nadia N.; Ballman, Karla V.; Mayo Clinic Cancer Center, Rochester, MN

    Purpose: The aim of this study was to evaluate the efficacy, toxicity, and survival of whole-brain radiotherapy-treated (WBRT) and high-dose methylprednisolone (HDMP)-treated in elderly patients with primary central nervous system lymphoma (PCNSL). Methods and Materials: Patients with PCNSL who were 70 years and older received 1 g of methylprednisolone daily for 5 days, 30 days after WBRT. Patients then received 1 g of methylprednisolone every 28 days until progression. The primary endpoint was overall survival (OS) at 6 months. Results were compared with those in patients on the previous North Central Cancer Treatment Group (NCCTG) trial who received pre-WBRT cytoxan,more » adriamycin, vincristine, prednisone (CHOP) and high-dose cytarabine (CHOP-WBRT). A planned interim analysis was performed. The current regimen would be considered inactive if survival was not improved from patients treated with CHOP-WBRT. Results: Nineteen patients were accrued between 1998 and 2003. Median age was 76 years. Interim analysis revealed a 6-month survival of 33%, resulting in closure of the trial. Toxicity, OS, and event-free survival (EFS) were similar to those in patients more than 70 years of age who received CHOP-WBRT. The subgroup of patients who received HDMP had longer OS (12.1 vs. 7.0 months, p = 0.76) and EFS (11.7 vs. 4.0 months, p = 0.04) compared with the CHOP-WBRT patients alive 60 days after the start of treatment. Conclusions: Patients on-study long enough to receive HDMP had prolongation of OS and EFS compared to patients receiving CHOP-WBRT. Although the numbers of patients are too small for statistical conclusions, the HDMP regimen deserves further study.« less

  1. Dispersion of a Nanoliter Bolus in Microfluidic Co-Flow.

    PubMed

    Conway, A J; Saadi, W M; Sinatra, F L; Kowalski, G; Larson, D; Fiering, J

    2014-03-01

    Microfluidic systems enable reactions and assays on the scale of nanoliters. However, at this scale nonuniformities in sample delivery become significant. To determine the fundamental minimum sample volume required for a particular device, a detailed understanding of mass transport is required. Co-flowing laminar streams are widely used in many devices, but typically only in the steady-state. Because establishing the co-flow steady-state consumes excess sample volume and time, there is a benefit to operating devices in the transient state, which predominates as the volume of the co-flow reactor decreases. Analysis of the co-flow transient has been neglected thus far. In this work we describe the fabrication of a pneumatically controlled microfluidic injector constructed to inject a discrete 50nL bolus into one side of a two-stream co-flow reactor. Using dye for image analysis, injections were performed at a range of flow rates from 0.5-10μL/min, and for comparison we collected the co-flow steady-state data for this range. The results of the image analysis were also compared against theory and simulations for device validation. For evaluation, we established a metric that indicates how well the mass distribution in the bolus injection approximates steady-state co-flow. Using such analysis, transient-state injections can approximate steady-state conditions within predefined errors, allowing straight forward measurements to be performed with reduced reagent consumption.

  2. Comparison Between Preoperative Administration of Methylprednisolone With its Administration Before and During Congenital Heart Surgery on Serum Levels of IL-6 And IL-10

    PubMed Central

    Abbasi Tashnizi, Mohammad; Soltani, Ghasem; Moeinipour, Ali Asghar; Ayatollahi, Hossein; Tanha, Amir Saber; Jarahi, Lida; Sepehri Shamloo, Alireza; Zirak, Nahid

    2013-01-01

    Background Steroid administration during cardiopulmonary bypass is considered to improve cardiopulmonary function by modulating inflammations caused by bypass. Objectives This study was performed to compare effectiveness of preoperative and intraoperative methylprednisolone (MP) to preoperative methylprednisolone alone in post bypass inflammatory (IL-6) and anti-inflammatory (IL-10) factors. Patients and Methods Fifty pediatric patients undergoing cardiopulmonary bypass surgery from August 2011 to 2012 in the cardiac surgery department of Imam Reza Hospital, the major center for CPB, in Mashhad, Iran were randomly assigned to receive preoperative and intraoperative MP (30 mg/kg, 4 hours before bypass and in bypass prime, number 25) or preoperative MP only (30 mg/kg, number 25). Before and after bypass, four and 24 hours after bypass, serum IL-6 and IL-10 were measured by ELISA. Results In both groups, no significant difference with variation of expression for IL-6 (inflammatory factor) and IL-10 (anti-inflammatory factor) in different times after bypass was observed. Conclusions No significant difference in reducing post bypass inflammation between preoperative steroid treatment and combined preoperative and intraoperative steroid administration reported and they had the same effects. PMID:23682327

  3. Continuous versus bolus intragastric tube feeding for preterm and low birth weight infants with gastro-oesophageal reflux disease.

    PubMed

    Richards, Robyn; Foster, Jann P; Psaila, Kim

    2014-07-17

    Gastro-oesophageal reflux disease is a particularly common condition in preterm and low birth weight infants. These infants are also more likely to have excessive regurgitation, as they do not have a fully developed antireflux mechanism. Preterm and low birth weight infants who are unable to suck oral feeds are required to be fed via an intragastric tube for varying lengths of time. Intragastric tube feeding can be delivered by the intermittent bolus or continuous feeding method. Use of continuous or intermittent bolus intragastric feeding may have a positive or negative effect on the incidence or severity of gastro-oesophageal reflux disease. To determine whether continuous or intermittent bolus intragastric tube feeding reduces the number of episodes and the duration of gastro-oesophageal reflux disease (GORD) in preterm and low birth weight infants.We intended to perform subgroup analyses for gestational age; birth weight; age in days from birth at full enteral feeding via intragastric tube (breast vs bottle); frequency of intermittent bolus feed; and type of medication for treatment of GORD (only if medication prescribed and given similarly to both intervention groups). We used the standard search strategy of the Cochrane Neonatal Group as described in The Cochrane Library (www.thecochranelibrary.com) to search for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 9), MEDLINE (1966 to September 2013), EMBASE (1980 to September 2013) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to September 2013). We also searched previous reviews, including cross-references, abstracts and conference and symposia proceedings of the Perinatal Society of Australia and New Zealand and the Pediatric Academic Societies (American Pediatric Society/Society for Pediatric Research and European Society for Paediatric Research) from 1990 to 2012. Published and unpublished RCTs and quasi

  4. High-resolution gadolinium-enhanced 3D MRA of the infrapopliteal arteries. Lessons for improving bolus-chase peripheral MRA.

    PubMed

    Hood, Maureen N; Ho, Vincent B; Foo, Thomas K F; Marcos, Hani B; Hess, Sandra L; Choyke, Peter L

    2002-09-01

    Peripheral magnetic resonance angiography (MRA) is growing in use. However, methods of performing peripheral MRA vary widely and continue to be optimized, especially for improvement in illustration of infrapopliteal arteries. The main purpose of this project was to identify imaging factors that can improve arterial visualization in the lower leg using bolus chase peripheral MRA. Eighteen healthy adults were imaged on a 1.5T MR scanner. The calf was imaged using conventional three-station bolus chase three-dimensional (3D) MRA, two dimensional (2D) time-of-flight (TOF) MRA and single-station Gadolinium (Gd)-enhanced 3D MRA. Observer comparisons of vessel visualization, signal to noise ratios (SNR), contrast to noise ratios (CNR) and spatial resolution comparisons were performed. Arterial SNR and CNR were similar for all three techniques. However, arterial visualization was dramatically improved on dedicated, arterial-phase Gd-enhanced 3D MRA compared with the multi-station bolus chase MRA and 2D TOF MRA. This improvement was related to optimization of Gd-enhanced 3D MRA parameters (fast injection rate of 2 mL/sec, high spatial resolution imaging, the use of dedicated phased array coils, elliptical centric k-space sampling and accurate arterial phase timing for image acquisition). The visualization of the infrapopliteal arteries can be substantially improved in bolus chase peripheral MRA if voxel size, contrast delivery, and central k-space data acquisition for arterial enhancement are optimized. Improvements in peripheral MRA should be directed at these parameters.

  5. No Beneficial Effect of General and Specific Anti-Inflammatory Therapies on Aortic Dilatation in Marfan Mice

    PubMed Central

    den Hartog, Alexander W.; Radonic, Teodora; de Vries, Carlie J. M.; Zwinderman, Aeilko H.; Groenink, Maarten; Mulder, Barbara J. M.; de Waard, Vivian

    2014-01-01

    Aims Patients with Marfan syndrome have an increased risk of life-threatening aortic complications, mostly preceded by aortic dilatation. In the FBN1 C1039G/+ Marfan mouse model, losartan decreases aortic root dilatation. We recently confirmed this beneficial effect of losartan in adult patients with Marfan syndrome. The straightforward translation of this mouse model to man is reassuring to test novel treatment strategies. A number of studies have shown signs of inflammation in aortic tissue of Marfan patients. This study examined the efficacy of anti-inflammatory therapies in attenuating aortic root dilation in Marfan syndrome and compared effects to the main preventative agent, losartan. Methods and Results To inhibit inflammation in FBN1 C1039G/+ Marfan mice, we treated the mice with losartan (angiotensin II receptor type 1 inhibitor), methylprednisolone (corticosteroid) or abatacept (T-cell-specific inhibitor). Treatment was initiated in adult Marfan mice with already existing aortic root dilatation, and applied for eight weeks. Methylprednisolone- or abatacept-treated mice did not reveal a reduction in aortic root dilatation. In this short time frame, losartan was the only treatment that significantly reduced aorta inflammation, transforming growth factor-beta (TGF-β) signaling and aortic root dilatation rate in these adult Marfan mice. Moreover, the methylprednisolone-treated mice had significantly more aortic alcian blue staining as a marker for aortic damage. Conclusion Anti-inflammatory agents do not reduce the aortic dilatation rate in Marfan mice, but possibly increase aortic damage. Currently, the most promising therapeutic drug in Marfan syndrome is losartan, by blocking the angiotensin II receptor type 1 and thereby inhibiting pSmad2 signaling. PMID:25238161

  6. WE-F-16A-03: 3D Printer Application in Proton Therapy: A Novel Method to Deliver Passive-Scattering Proton Beams with a Fixed Range and Modulation for SRS and SRT

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Ding, X; Witztum, A; Liang, X

    2014-06-15

    Purpose: To present a novel technique to deliver passive-scattering proton beam with fixed range and modulation using a 3D printed patient-specific bolus for proton stereotactic radiosurgery and radiotherapy. Methods: A CIRS head phantom was used to simulate a patient with a small brain lesion. A custom bolus was created in the Eclipse Treatment Planning System (TPS) to compensate for the different water equivalent depths from the patient surface to the target from multiple beam directions. To simulate arc therapy, a plan was created on the initial CT using three passive-scattering proton beams with a fixed range and modulations irradiating frommore » different angles. The DICOM-RT structure file of the bolus was exported from the TPS and converted to STL format for 3D printing. The phantom was rescanned with the printed custom bolus and head cup to verify the dose distribution comparing to the initial plan. EBT3 films were placed in the sagital plane of the target to verify the delivered dose distribution. The relative stopping power of the printing material(ABSplus-P430) was measured using the Zebra multi-plate ion chamber. Results: The relative stopping power of the 3D printing material, ABSplus-P430 was 1.05 which is almost water equivalent. The dose difference between verification CT and Initial CT is almost negligible. Film measurement also confirmed the accuracy for this new proton delivery technique. Conclusion: Our method using 3D printed range modifiers simplify the treatment delivery of multiple passive-scattering beams in treatment of small lesion in brain. This technique makes delivery of multiple beam more efficient and can be extended to allow arc therapy with proton beams. The ability to create and construct complex patient specific bolus structures provides a new dimension in creating optimized quality treatment plans not only for proton therapy but also for electron and photon therapy.« less

  7. Optimized enhancement in helical CT: experiences with a real-time bolus tracking system in 628 patients.

    PubMed

    Kirchner, J; Kickuth, R; Laufer, U; Noack, M; Liermann, D

    2000-05-01

    Ultrafast detector technology enables bolus-triggered application of contrast media. In a prospective study we investigated the benefit of this new method with the intention of optimizing enhancement during examination of the chest and abdomen. In total, we examined 548 patients under standardized conditions. All examinations were performed on a Somatom Plus 4 Power CT system (Siemens Corp., Forchheim, Germany) using the CARE-Bolus software. This produces repetitive low-dose test images (e.g. for the lung: 140 kV, 43 mA, TI 0.5 s) and measures the Hounsfield attenuation in a pre-selected region of interest. After exceeding a defined threshold, a diagnostic spiral CT examination was begun automatically. The data obtained from 321 abdominal CT and 179 lung CT examinations were correlated with different parameters such as age, weight and height of the patients and parameters of vascular access. In a group of 80 patients, the injection of contrast medium was stopped after reaching a pre-defined threshold of an increase of 100 HU over the baseline. Then, we assessed the maximal enhancement of liver, pulmonal artery trunk and aortic arch. There was no correlation between bolus geometry and age, body surface or weight. In helical CT of the abdomen the threshold was reached after a mean trigger time of 27 s (range 13-67 s) and only 65 ml (range 41-105 ml) of contrast medium were administered. In helical CT of the lung the threshold was reached after 21 s (range 12-48 s) and the mean amount of administered contrast medium was 48 ml (range 38-71 ml). Bolus triggering allows optimized enhancement of the organs and reduces the dose of contrast material required compared with standard administration. Copyright 2000 The Royal College of Radiologists.

  8. Effect of programmed intermittent epidural boluses and continuous epidural infusion on labor analgesia and obstetric outcomes: a randomized controlled trial.

    PubMed

    Ferrer, Leopoldo E; Romero, David J; Vásquez, Oscar I; Matute, Ednna C; Van de Velde, Marc

    2017-11-01

    Continuous epidural infusion and programmed intermittent epidural boluses are analgesic techniques routinely used for pain relief in laboring women. We aimed to assess both techniques and compare them with respect to labor analgesia and obstetric outcomes. After Institutional Review Board approval, 132 laboring women aged between 18 and 45 years were randomized to epidural analgesia of 10 mL of a mixture of 0.1% bupivacaine plus 2 µg/mL of fentanyl either by programmed intermittent boluses or continuous infusion (66 per group). Primary outcome was quality of analgesia. Secondary outcomes were duration of labor, total drug dose used, maternal satisfaction, sensory level, motor block level, presence of unilateral motor block, hemodynamics, side effects, mode of delivery, and newborn outcome. Patients in the programmed intermittent epidural boluses group received statistically less drug dose than those with continuous epidural infusion (24.9 vs 34.4 mL bupivacaine; P = 0.01). There was no difference between groups regarding pain control, characteristics of block, hemodynamics, side effects, and Apgar scores. Our study evidenced a lower anesthetic consumption in the programmed intermittent boluses group with similar labor analgesic control, and obstetric and newborn outcomes in both groups.

  9. A fully coupled bolus-esophageal-gastric model for esophageal emptying based on the immersed boundary method

    NASA Astrophysics Data System (ADS)

    Kou, Wenjun; Pandolfino, John E.; Kahrilas, Peter J.; Patankar, Neelesh A.

    2016-11-01

    In this work, we develop a fully coupled bolus-esophageal-gastric model to study esophageal emptying based on the immersed boundary method. The model includes an esophageal segment, an ellipsoid-shaped stomach, and a bolus. It can easily handle the passive and active function of the lower esophageal sphincter (LES). Two groups of case studies are presented. The first group is about the influence from tissue anisotropy. Simulation shows that the weaker (or more compliant) part suffers from a higher wall shear stress and higher pressure load when the bolus is filled in and emptied from the LES segment. This implies a degradation cycle in which a weaker tissue becomes much weaker due to an increased load, a possible pathway to the esophageal lower diverticulum. The second group is about bulge formation resulting from asymmetric anatomy and a compliant LES. In particular, we find a right bulge tends to develop for a compliant LES. The bulge is most pronounced with a highest stiffness of the gastric wall. This implies that the competition between the LES stiffness and gastric wall stiffness might be another factor related to the esophageal lower diverticulum. The support of Grant R01 DK56033 and R01 DK079902 from NIH is gratefully acknowledged.

  10. Optimization of initial propofol bolus dose for EEG Narcotrend Index-guided transition from sevoflurane induction to intravenous anesthesia in children.

    PubMed

    Dennhardt, Nils; Boethig, Dietmar; Beck, Christiane; Heiderich, Sebastian; Boehne, Martin; Leffler, Andreas; Schultz, Barbara; Sümpelmann, Robert

    2017-04-01

    Sevoflurane induction followed by intravenous anesthesia is a widely used technique to combine the benefits of an easier and less traumatic venipuncture after sevoflurane inhalation with a recovery with less agitation, nausea, and vomiting after total intravenous anesthesia (TIVA). Combination of two different anesthetics may lead to unwanted burst suppression in the electroencephalogram (EEG) during the transition phase. The objective of this prospective clinical observational study was to identify the optimal initial propofol bolus dose for a smooth transition from sevoflurane induction to TIVA using the EEG Narcotrend Index (NI). Fifty children aged 1-8 years scheduled for elective pediatric surgery were studied. After sevoflurane induction and establishing of an intravenous access, a propofol bolus dose range 0-5 mg·kg -1 was administered at the attending anesthetist's discretion to maintain a NI between 20 and 64, and sevoflurane was stopped. Anesthesia was continued as TIVA with a propofol infusion dose of 15 mg·kg -1 ·h -1 for the first 15 min, followed by stepwise reduction according to McFarlan's pediatric infusion regime, and remifentanil 0.25 μg·kg -1 ·min -1 . Endtidal concentration of sevoflurane, NI, and hemodynamic data were recorded during the whole study period using a standardized case report form. Propofol plasma concentrations were calculated using the paedfusor dataset and a TIVA simulation program. Median endtidal concentration of sevoflurane at the time of administration of the propofol bolus was 5.1 [IQR 4.7-5.9] Vol%. The median propofol bolus dose was 1.2 [IQR 0.9-2.5] mg·kg -1 and median NI thereafter was 33 [IQR 23-40]. Nine children presented with a NI 13-20 and three children with burst suppression in the EEG (NI 0-12); all of them received an initial propofol bolus dose >2 mg·kg -1 . Regression equation demonstrated that NI 20-64 was achieved with a 95% probability when using a propofol bolus dose of 1 mg·kg -1 after

  11. COMPARED EFFICACY OF INTRA-ARTICULAR INJECTION OF METHYLPREDNISOLONE AND TRIAMCINOLONE.

    PubMed

    Buyuk, Abdul Fettah; Kilinc, Eray; Camurcu, Ismet Yalkin; Camur, Savas; Ucpunar, Hanifi; Kara, Adnan

    2017-01-01

    To compare the effect of two different corticosteroid types in bilateral and symmetrical knee osteoarthritis (OA). One hundred and twenty-six patients received injections of methylprednisolone acetate (MP) in one knee and triamcinolone hexacetonide (TH) in the contralateral knee. Patients were evaluated before injection and 2, 4, 8, 12, and 24 weeks after. Mean patient age was 68.5±9 years. Mean BMI was 26.3±2.6 kg/m 2 . At first admission, mean VAS score was 7.7±1.3 for the right side and 7.5±1.5 for the left side, and mean WOMAC score was 67.6±14.4. After bilateral intra-articular injection, VAS scores for both knees and WOMAC scores decreased significantly when initial scores were compared with 2, 4, 8, 12, and 24 weeks after injection (p<0.05). A statistically significant change was seen over time when VAS and WOMAC scores for 2, 4, 8, 12, and 24 weeks post-injection were compared to each other (p<0.05). No significant difference was seen between knee sides (p>0.05). MP and TH have similar efficacy in relieving pain and improving function. The efficacy of intra-articular corticosteroid injection peaks 2 weeks after injection and the effect continues until the 24 th week. Level of Evidence II, Comparative Prospective Study.

  12. COMPARED EFFICACY OF INTRA-ARTICULAR INJECTION OF METHYLPREDNISOLONE AND TRIAMCINOLONE

    PubMed Central

    BUYUK, ABDUL FETTAH; KILINC, ERAY; CAMURCU, ISMET YALKIN; CAMUR, SAVAS; UCPUNAR, HANIFI; KARA, ADNAN

    2017-01-01

    ABSTRACT Objective: To compare the effect of two different corticosteroid types in bilateral and symmetrical knee osteoarthritis (OA). Methods: One hundred and twenty-six patients received injections of methylprednisolone acetate (MP) in one knee and triamcinolone hexacetonide (TH) in the contralateral knee. Patients were evaluated before injection and 2, 4, 8, 12, and 24 weeks after. Results: Mean patient age was 68.5±9 years. Mean BMI was 26.3±2.6 kg/m2. At first admission, mean VAS score was 7.7±1.3 for the right side and 7.5±1.5 for the left side, and mean WOMAC score was 67.6±14.4. After bilateral intra-articular injection, VAS scores for both knees and WOMAC scores decreased significantly when initial scores were compared with 2, 4, 8, 12, and 24 weeks after injection (p<0.05). A statistically significant change was seen over time when VAS and WOMAC scores for 2, 4, 8, 12, and 24 weeks post-injection were compared to each other (p<0.05). No significant difference was seen between knee sides (p>0.05). Conclusion: MP and TH have similar efficacy in relieving pain and improving function. The efficacy of intra-articular corticosteroid injection peaks 2 weeks after injection and the effect continues until the 24th week. Level of Evidence II, Comparative Prospective Study. PMID:29081706

  13. Cerebral perfusion imaging with bolus harmonic imaging (Honorable Mention Poster Award)

    NASA Astrophysics Data System (ADS)

    Kier, Christian; Toth, Daniel; Meyer-Wiethe, Karsten; Schindler, Angela; Cangur, Hakan; Seidel, Gunter; Aach, Til

    2005-04-01

    Fast visualisation of cerebral microcirculation supports diagnosis of acute stroke. However, the commonly used CT/MRI-based methods are time consuming, costly and not applicable to every patient. The bolus perfusion harmonic imaging (BHI) method is an ultrasound imaging technique which makes use of the fact, that ultrasound contrast agents unlike biological tissues resonate at harmonic frequencies. Exploiting this effect, the contrast between perfused and non-perfused areas can be improved. Thus, BHI overcomes the low signal-to-noise ratio of transcranial ultrasound and the high impedance of the skull. By analysing image sequences, visualising the qualitative characteristics of an US contrast agent bolus injection becomes possible. The analysis consists of calculating four perfusion-related parameters, Local Peak Intensity, Time To Peak, Area Under Curve, and Average Rising, from the time/intensity curve and providing them as colour-coded images. For calculating these parameters the fundamental assumption is that image intensity corresponds to contrast agent concentration which in turn shows the perfusion of the corresponding brain region. In a clinical study on patients suffering from acute ischemic stroke it is shown that some of the parameters correlate significantly to the infarction area. Thus, BHI becomes a less time-consuming and inexpensive bedside method for diagnosis of cerebral perfusion deficits.

  14. How do dairy cows chew?--particle size analysis of selected feeds with different particle length distributions and of respective ingested bolus particles.

    PubMed

    Schadt, I; Ferguson, J D; Azzaro, G; Petriglieri, R; Caccamo, M; Van Soest, P; Licitra, G

    2012-08-01

    Not only feed but also respective bolus particle size could alter diet efficiency and cow performance. The objective of this project was to characterize particle size of selected feeds and respective swallowed boli. Feed samples included 6 different particle length rye grass hay samples, 1 grass silage, 1 corn silage, and 1 total mixed ration (TMR). Rye grass hay samples consisted of long hay and chopped hay particles retained on the 19- (19_PSPS hay), 8- (8_PSPS hay), and 1.18-mm (1.18_PSPS hay) Penn State Particle Separator (PSPS) screens and those collected on the pan (PSPS_pan hay). A sixth hay treatment was rye grass forage cut at 50-mm lengths and dried to hay (50-mm hay). Treatments were offered to 4 nonlactating and 4 lactating cows following rumen evacuation. Swallowed boli were collected and the number of chews per gram of ingested feed dry matter was determined. Feed and bolus particles of lengths ≥5mm were collected on a 1.6-mm screen using a horizontal wet sieving technique. This cut point was chosen, as the literature suggests that most fecal particles are shorter than 5mm. Dry matter proportions on this screen (PROP_1.6) were determined and particle lengths of retained particles were measured by image analysis. Mean particle lengths (ML) were calculated considering particles ≥5mm in length. Boli of long hay, of 19_PSPS hay, of 8_PSPS hay, and of 50-mm hay had similar ML of 10 to 11mm. Bolus PROP_1.6 were also similar between these treatments, ranging from 0.54 to 0.69. Bolus particle lengths and distributions of these treatments were not related to respective hay particles. Bolus of 1.18_PSPS hay had PROP_1.6 of 0.51 and a smaller ML of 8mm. The PSPS_pan hay had PROP_1.6 of only 0.33, but was still chewed intensely. Apparently, little particle size reduction occurred when cows ate the TMR or the silages. Feed and respective bolus PROP_1.6 were as follows: 0.66 and 0.59 in grass silage, 0.52 and 0.55 in corn silage, and 0.44 and 0.38 in the TMR

  15. Enhancing automatic closed-loop glucose control in type 1 diabetes with an adaptive meal bolus calculator - in silico evaluation under intra-day variability.

    PubMed

    Herrero, Pau; Bondia, Jorge; Adewuyi, Oloruntoba; Pesl, Peter; El-Sharkawy, Mohamed; Reddy, Monika; Toumazou, Chris; Oliver, Nick; Georgiou, Pantelis

    2017-07-01

    Current prototypes of closed-loop systems for glucose control in type 1 diabetes mellitus, also referred to as artificial pancreas systems, require a pre-meal insulin bolus to compensate for delays in subcutaneous insulin absorption in order to avoid initial post-prandial hyperglycemia. Computing such a meal bolus is a challenging task due to the high intra-subject variability of insulin requirements. Most closed-loop systems compute this pre-meal insulin dose by a standard bolus calculation, as is commonly found in insulin pumps. However, the performance of these calculators is limited due to a lack of adaptiveness in front of dynamic changes in insulin requirements. Despite some initial attempts to include adaptation within these calculators, challenges remain. In this paper we present a new technique to automatically adapt the meal-priming bolus within an artificial pancreas. The technique consists of using a novel adaptive bolus calculator based on Case-Based Reasoning and Run-To-Run control, within a closed-loop controller. Coordination between the adaptive bolus calculator and the controller was required to achieve the desired performance. For testing purposes, the clinically validated Imperial College Artificial Pancreas controller was employed. The proposed system was evaluated against itself but without bolus adaptation. The UVa-Padova T1DM v3.2 system was used to carry out a three-month in silico study on 11 adult and 11 adolescent virtual subjects taking into account inter-and intra-subject variability of insulin requirements and uncertainty on carbohydrate intake. Overall, the closed-loop controller enhanced by an adaptive bolus calculator improves glycemic control when compared to its non-adaptive counterpart. In particular, the following statistically significant improvements were found (non-adaptive vs. adaptive). Adults: mean glucose 142.2 ± 9.4vs. 131.8 ± 4.2mg/dl; percentage time in target [70, 180]mg/dl, 82.0 ± 7.0vs. 89.5 ± 4

  16. Tissue distribution of sup 3 H-nicotine in rats after bolus or constant injection

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Chowdhury, P.; Pasley, J.N.; Rayford, P.L.

    1989-01-01

    Two groups of rats, (N = 7), were fasted for 24 hrs prior to the study. On the day of the experiment, the animals were anesthetized and infused with either 5 ml nicotine solution (200 {mu}g/L) in saline containing 5 {mu}c {sup 3}H-nicotine, (sp. activity 50-80 mCi/mol) for 90 minutes or injected as a bolus with 0.5 ml of the same nicotine (200 {mu}g/L) solution. The animals were sacrificed 60 minutes after the injection or after the infusion was stopped. Blood and tissue samples were counted by liquid scintillation counting. Percent distribution of {sup 3}H-nicotine per gm of tissue wasmore » calculated from the total radioactivity recovered in individual tissues over the total activity injected into the rat and the values were compared using student's t test. Results: Distribution of {sup 3}H-nicotine was found highest in kidney (45-49%) among all tissues examined and was not different between routes of administration. Significantly higher retention of {sup 3}H-nicotine was found with continuous infusion in esophagus, fundus, antrum, spleen, cecum, pancreas, testes, heart and muscle when {sup 3}H-nicotine retentions were compared with bolus injection. In contrast, the distribution of {sup 3}H-nicotine in adrenal gland, was significantly lower in continuous infusion group. Distribution in blood was 6 fold higher in continuous infusion (7.26%) compared to bolus (1.11%) injection. The distribution {sup 3}H-nicotine in other tissues were not different by either routes of injection.« less

  17. Lower esophageal mucosal ring: correlation of referred symptoms with radiographic findings using a marshmallow bolus.

    PubMed

    Smith, D F; Ott, D J; Gelfand, D W; Chen, M Y

    1998-11-01

    The purpose of this investigation was to determine the prevalence of lower esophageal mucosal rings and to correlate the relationship between these mucosal rings and the presence and anatomic level of symptoms evoked using a marshmallow bolus. Our prospective study included 130 patients who underwent barium examination of the esophagus. All patients completed a questionnaire regarding the anatomic location of their symptoms of dysphagia. In addition to a multiphasic examination of the esophagus, all patients also underwent fluoroscopic observation and videotaping while swallowing a marshmallow bolus; any symptoms that were provoked were recorded. Lower esophageal mucosal rings were shown in 26 (20%) of the 130 patients. The diameter of the rings was 9-12 mm in six patients, 13-20 mm in 18 patients, and larger than 20 mm in two patients. In 16 (62%) of the 26 patients, a marshmallow bolus became impacted at the ring; the impaction caused dysphagia in 12 (75%) of the 16 patients. In these 12 patients, dysphagia was referred to the neck in seven, the sternal angle in two, the mid chest in two, and the lower chest in one patient. None of the 12 patients had a pharyngeal or cervical esophageal abnormality that would account for their symptoms. Because proximal referral of symptoms is common in patients with lower esophageal mucosal rings, a thorough radiographic examination of the entire esophagus and esophagogastric region is required regardless of the level of their swallowing complaints.

  18. Successful Treatment of Corticosteroid with Antiviral Therapy for a Neonatal Liver Failure with Disseminated Herpes Simplex Virus Infection

    PubMed Central

    Maeba, Shinji; Hasegawa, Shunji; Shimomura, Maiko; Ichimura, Takuya; Takahashi, Kazumasa; Motoyama, Masashi; Fukunaga, Shinnosuke; Ito, Yoshinori; Ichiyama, Takashi; Ohga, Shouichi

    2015-01-01

    Background Herpes simplex virus (HSV) infection carries one of the poorest outcomes of neonatal liver failure (NLF). Neonates with disseminated HSV infection can develop hemophagocytic lymphohistiocytosis (HLH), and occasionally need orthotopic liver transplantation. Early interventions may be critical for the cure of NLF. Case Report We describe herewith a 6-day-old neonate with fulminant hepatic failure due to disseminated HSV-1 infection, who successfully responded to high-dose corticosteroid therapy 72 hours after the onset of disease. Preceding acyclovir, gamma globulin, and exchange blood transfusion therapies failed to control the disease. Methylprednisolone pulse therapy led to a drastic improvement of liver function and cytokine storms, and prevented the disease progression to HLH. Sustained levels of plasma and cerebrospinal fluid HSV DNA declined after prolonged acyclovir therapy. Bilateral lesions of the periventricular white matter areas, assessed by magnetic resonance imaging, disappeared at 3 months of age. The infant showed normal growth and development at 4 years of age. Conclusion Early anti-hypercytokinemia therapy using corticosteroid, and prolonged antiviral therapy might only provide the transplantation-free cure of NLF with HSV dissemination. PMID:26495160

  19. INDUCED SPUTUM DERIVES FROM THE CENTRAL AIRWAYS: CONFIRMATION USING A RADIOLABELED AEROSOL BOLUS DELIVERY TECHNIQUE

    EPA Science Inventory

    Indirect evidence suggests that induced sputum derives from the surfaces of the bronchial airways. To confirm this experimentally, we employed a radiolabeled aerosol bolus delivery technique that preferentially deposits aerosol in the central airways in humans. We hypothesized th...

  20. MO-B-BRD-03: Principles, Pitfalls and Techniques of 3D Printing for Bolus and Compensators

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Baker, J.

    This session is designed so that the learning objectives are practical. The intent is that the attendee may take home an understanding of not just the technology, but also the logistical steps necessary to execute these 3D printing techniques in the clinic. Four practical 3D printing topics will be discussed: (i) Creating bolus and compensators for photon machines; (ii) tools for proton therapy; (iii) clinical applications in imaging; (iv) custom phantom design for clinic and research use. The use of 3D printers within the radiation oncology setting is proving to be a useful tool for creating patient specific bolus andmore » compensators with the added benefit of cost savings. Creating the proper protocol is essential to ensuring that the desired effect is achieved and modeled in the treatment planning system. The critical choice of printer material (since it determines the interaction with the radiation) will be discussed. Selection of 3D printer type, design methods, verification of dose calculation, and the printing process will be detailed to give the basis for establishing your own protocol for electron and photon fields. A practical discussion of likely obstacles that may be encountered will be included. The diversity of systems and techniques in proton facilities leads to different facilities having very different requirements for beam modifying hardware and quality assurance devices. Many departments find the need to design and fabricate facility-specific equipment, making 3D printing an attractive technology. 3D printer applications in proton therapy will be discussed, including beam filters and compensators, and the design of proton therapy specific quality assurance tools. Quality control specific to 3D printing in proton therapy will be addressed. Advantages and disadvantages of different printing technology for these applications will also be discussed. 3D printing applications using high-resolution radiology-based imaging data will be presented

  1. An additional bolus of rapid-acting insulin to normalise postprandial cardiovascular risk factors following a high-carbohydrate high-fat meal in patients with type 1 diabetes: A randomised controlled trial.

    PubMed

    Campbell, Matthew D; Walker, Mark; Ajjan, Ramzi A; Birch, Karen M; Gonzalez, Javier T; West, Daniel J

    2017-07-01

    To evaluate an additional rapid-acting insulin bolus on postprandial lipaemia, inflammation and pro-coagulation following high-carbohydrate high-fat feeding in people with type 1 diabetes. A total of 10 males with type 1 diabetes [HbA 1c 52.5 ± 5.9 mmol/mol (7.0% ± 0.5%)] underwent three conditions: (1) a low-fat (LF) meal with normal bolus insulin, (2), a high-fat (HF) meal with normal bolus insulin and (3) a high-fat meal with normal bolus insulin with an additional 30% insulin bolus administered 3-h post-meal (HFA). Meals had identical carbohydrate and protein content and bolus insulin dose determined by carbohydrate-counting. Blood was sampled periodically for 6-h post-meal and analysed for triglyceride, non-esterified-fatty acids, apolipoprotein B48, glucagon, tumour necrosis factor alpha, fibrinogen, human tissue factor activity and plasminogen activator inhibitor-1. Continuous glucose monitoring captured interstitial glucose responses. Triglyceride concentrations following LF remained similar to baseline, whereas triglyceride levels following HF were significantly greater throughout the 6-h observation period. The additional insulin bolus (HFA) normalised triglyceride similarly to low fat 3-6 h following the meal. HF was associated with late postprandial elevations in tumour necrosis factor alpha, whereas LF and HFA was not. Fibrinogen, plasminogen activator inhibitor-1 and tissue factor pathway levels were similar between conditions. Additional bolus insulin 3 h following a high-carbohydrate high-fat meal prevents late rises in postprandial triglycerides and tumour necrosis factor alpha, thus improving cardiovascular risk profile.

  2. Amniotic fluid index predicts the relief of variable decelerations after amnioinfusion bolus.

    PubMed

    Spong, C Y; McKindsey, F; Ross, M G

    1996-10-01

    Our purpose was to determine whether intrapartum amniotic fluid index before amnioinfusion can be used to predict response to therapeutic amnioinfusion. Intrapartum patients (n = 85) with repetitive variable decelerations in fetal heart rate that necessitated amnioinfusion (10 ml/min for 60 minutes) underwent determination of amniotic fluid index before and after bolus amnioinfusion. The fetal heart tracing was scored (scorer blinded to amniotic fluid index values) for number and characteristics of variable decelerations before and 1 hour after initiation of amnioinfusion. The amnioinfusion was considered successful if it resulted in a decrease of > or = 50% in total number of variable decelerations or a decrease of > or = 50% in the rate of atypical or severe variable decelerations after administration of the bolus. Spontaneous vaginal births before completion of administration of the bolus (n = 18) were excluded from analysis. The probability of success of amnioinfusion in relation to amniotic fluid index was analyzed with the chi(2) test for progressive sequence. The mean amniotic fluid index before amnioinfusion was 6.2 +/- 3.3 cm. An amniotic fluid index of < or = 5 cm was present in 40% of patients (27/67), and an amniotic fluid index of < or = 8 cm was present in 72% of patients (48/67). The probability of success of amnioinfusion decreased with increasing amniotic fluid index before amnioinfusion (76% [16/21] when initial amniotic fluid index was 0 to 4 cm, 63% [17/27] when initial amniotic fluid index was 4 to 8 cm, 44% [7/16] when initial amniotic fluid index was 8 to 12 cm, and 33% [1/3] when initial amniotic fluid index was > 12 cm, p = 0.03). The incidence of nuchal cords or true umbilical cord knots increased in relation to amniotic fluid index before amnioinfusion. Amniotic fluid index before amnioinfusion can be used to predict the success of amnioinfusion for relief of variable decelerations in fetal heart rate. Failure of amnioinfusion at a high

  3. Prevalence of eosinophilic oesophagitis in adults presenting with oesophageal food bolus obstruction.

    PubMed

    Heerasing, Neel; Lee, Shok Yin; Alexander, Sina; Dowling, Damian

    2015-11-06

    To look at the relationship between eosinophilic oesophagitis (EO) and food bolus impaction in adults. We retrospectively analysed medical records of 100 consecutive patients who presented to our hospital with oesophageal food bolus obstruction (FBO) between 2012 and 2014. In this cohort, 96 were adults (64% male), and 4 paediatric patients were excluded from the analysis as our centre did not have paediatric gastroenterologists. Eighty-five adult patients underwent emergency gastroscopy. The food bolus was either advanced into the stomach using the push technique or retrieved using a standard retrieval net. Biopsies were obtained in 51 patients from the proximal and distal parts of the oesophagus at initial gastroscopy. All biopsy specimens were assessed and reviewed by dedicated gastrointestinal pathologists at the Department of Pathology, University Hospital Geelong. The diagnosis of EO was defined and established by the presence of the following histological features: (1) peak eosinophil counts > 20/hpf; (2) eosinophil microabscess; (3) superficial layering of eosinophils; (4) extracellular eosinophil granules; (5) basal cell hyperplasia; (6) dilated intercellular spaces; and (7) subepithelial or lamina propria fibrosis. The histology results of the biopsy specimens were accessed from the pathology database of the hospital and recorded for analysis. Our cohort had a median age of 60. Seventeen/51 (33%) patients had evidence of EO on biopsy findings. The majority of patients with EO were male (71%). Classical endoscopic features of oesophageal rings, furrows or white plaques and exudates were found in 59% of patients with EO. Previous episodes of FBO were present in 12/17 patients and 41% had a history of eczema, hay fever or asthma. Reflux oesophagitis and benign strictures were found in 20/34 patients who did not have biopsies. EO is present in approximately one third of patients who are admitted with FBO. Biopsies should be performed routinely at index

  4. Pathological bolus exposure may define gastro-esophageal reflux better than pathological acid exposure in patients with globus.

    PubMed

    Sinn, Dong Hyun; Kim, Beom Jin; Son, Hee Jung; Kim, Jae J; Rhee, Jong Chul; Rhee, Poong-Lyul

    2012-01-01

    Conventionally, pathological acid exposure (PAE), defined by acid reflux only, is used to identify gastro-esophageal reflux disease (GERD). However, weak acid reflux or non-acid reflux also induces reflux symptoms. Defining abnormal reflux based on all reflux episodes may better identify GERD and would be more useful among patients with atypical GERD symptoms, such as globus. Impedance-pHmetry results of 31 globus patients, off acid suppressants, were analysed. A median of 24 episodes of reflux were observed. Of the reflux episodes, 54% were non-acid reflux and 50% reached the proximal extent. PAE was observed in 6 patients (19%). For 5 patients (16%) without PAE, there was evidence of increased bolus exposure compared to normal controls (an intraesophageal bolus exposure for more than 1.4% of the recording time, defined as pathological bolus exposure, PBE). When GERD was defined by PAE or esophagitis, the prevalence of GERD was 29%. When GERD was defined by PBE, PAE or esophagitis, the prevalence was 42%. PBE identified 13% of the patients who otherwise would have been missed. A significant proportion of patients without PAE had evidence of PBE. PBE may be a more useful definition for identifying patients with abnormal increase in reflux in patients with globus. Further studies are warranted.

  5. Clinical performance of three bolus calculators in subjects with type 1 diabetes mellitus: a head-to-head-to-head comparison.

    PubMed

    Zisser, Howard; Wagner, Robin; Pleus, Stefan; Haug, Cornelia; Jendrike, Nina; Parkin, Chris; Schweitzer, Matthias; Freckmann, Guido

    2010-12-01

    Insulin pump systems now provide automated bolus calculators (ABCs) that electronically calculate insulin boluses to address carbohydrate intake and out-of-range blood glucose (bG) levels. We compared the efficacy of three ABCs (Accu-Chek(®) Combo [Roche Insulin Delivery Systems (IDS), Inc., Fishers, IN, a member of the Roche Group], Animas(®) 2020 [Animas Corp., West Chester, PA, a Johnson and Johnson company], and MiniMed Paradigm Bolus Wizard(®) [Medtronic MiniMed, Northridge, CA]) to safely reduce postprandial hyperglycemia in type 1 diabetes mellitus (T1DM). T1DM subjects (n = 24) were recruited at a single center for a prospective, triple crossover study. ABCs with the programmed target range (80-140 mg/dL) were used in random order. Postprandial hyperglycemia was induced by reducing the calculated bolus by 25%. Two hours after test meals, the ABCs were allowed to determine whether a correction bolus was needed. Differences between 6-h bG values after test meals that achieved 2-h postprandial hyperglycemia and the mean of the target range (110 mg/dL) were determined. The mean difference between 6-h bG levels following test meals and the 110 mg/dL bG target with the MiniMed device (47.4 ± 31.8 mg/dL) was significantly higher than the Animas (17.3 ± 30.9 mg/dL) and Roche IDS (18.8 ± 33.8 mg/dL) devices (P = 0.0022 and P = 0.0049, respectively). The number of meals with 2-h postprandial hyperglycemia and bG levels at 2 h was similar. Roche IDS and Animas devices recommended correction boluses significantly (P = 0.0001 and P = 0.0002, respectively) more frequently than the MiniMed device. ABC use was not associated with severe hypoglycemia. There was no significant difference in the rate of mild hypoglycemia (bG <60 mg/dL not requiring assistance) among the three groups (Roche IDS and Animas, n = 2; MiniMed, n = 0). In this study, the Roche IDS and Animas devices were more efficacious in controlling

  6. Effects of aquaporin 4 and inward rectifier potassium channel 4.1 on medullospinal edema after methylprednisolone treatment to suppress acute spinal cord injury in rats.

    PubMed

    Li, Ye; Hu, Haifeng; Liu, Jingchen; Zhu, Qingsan; Gu, Rui

    2018-02-01

    To investigate the effects of aquaporin 4 (AQP4) and inward rectifier potassium channel 4.1 (Kir4.1) on medullospinal edema after treatment with methylprednisolone (MP) to suppress acute spinal cord injury (ASCI) in rats. Sprague Dawley rats were randomly divided into control, sham, ASCI, and MP-treated ASCI groups. After the induction of ASCI, we injected 30 mg/kg MP via the tail vein at various time points. The Tarlov scoring method was applied to evaluate neurological symptoms, and the wet-dry weights method was applied to measure the water content of the spinal cord. The motor function score of the ASCI group was significantly lower than that of the sham group, and the spinal water content was significantly increased. In addition, the levels of AQP4 and Kir4.1 were significantly increased, as was their degree of coexpression. Compared with that in the ASCI group, the motor function score and the water content were significantly increased in the MP group; in addition, the expression and coexpression of AQP4 and Kir4.1 were significantly reduced. Methylprednisolone inhibited medullospinal edema in rats with acute spinal cord injury, possibly by reducing the coexpression of aquaporin 4 and Kir4.1 in medullospinal tissues.

  7. A Factor Increasing Venous Contamination on Bolus Chase Three-dimensional Magnetic Resonance Imaging: Charcot Neuroarthropathy.

    PubMed

    Çildağ, Mehmet B; Ertuğrul, Mustafa B; Köseoğlu, Ömer Fk; Armstrong, David G

    2018-01-01

    The study aimed to evaluate the ratio of venous contamination in diabetic cases without foot lesion, with foot lesion and with Charcot neuroarthropathy (CN). Bolus-chase three-dimensional magnetic resonance (MR) of 396 extremities of patients with diabetes mellitus was analyzed, retrospectively. Extremities were divided into three groups as follows: diabetic patients without foot ulcer or Charcot arthropathy (Group A), patients with diabetic foot ulcers (Group B) and patients with CN accompanying diabetic foot ulcers (Group C). Furthermore, amount of venous contamination classified as no venous contamination, mild venous contamination, and severe venous contamination. The relationship between venous contamination and extremity groups was investigated. Severe venous contamination was seen in Group A, Group B, and Group C, 5.6%, 15.2%, and 34.1%, respectively. Statistically significant difference was seen between groups with regard to venous contamination. Venous contamination following bolus chase MR was higher in patients with CN.

  8. Steroid therapy in children with fulminant hepatitis A.

    PubMed

    Zakaria, H M; Salem, T A; El-Araby, H A; Salama, R M; Elbadry, D Y; Sira, A M; Ali, M A; Salem, M E; Abd-Alaaty, B M; Goda, S S; Eltaras, S M; Khalil, F O; Abou-Zeinah, S S; Sira, M M

    2018-02-03

    Fulminant hepatic failure is a life-threatening disease. Hepatitis A virus (HAV) can cause fulminant hepatic failure and death in about 0.2% of cases. Extensive destruction of infected hepatocytes by immune-mediated lysis is thought to be the cause. We aimed to evaluate the use of steroid therapy in children with fulminant HAV. This study included 33 children with fulminant HAV in two groups. Steroid group: comprised of 18 children who received prednisolone (1 mg/kg/d) or its equivalent dose of methylprednisolone, and the nonsteroid group: comprised another 15 children who did not receive steroid therapy. Age and sex were matched for both groups (P > .05), and they were comparable regarding baseline clinical and laboratory characteristics. Of the steroid group, 15 patients survived and 3 died, while in the nonsteroid group, 4 patients survived and 11 died (P = .001). Of the living patients, 15 of 19 (78.9%) received steroids while only 3 of 14 (21.4%) of the dead patients received steroids (P = .001). Stepwise regression analysis showed that steroid therapy was the only independent variable associated with recovery (P = .001). Steroid therapy in children with fulminant HAV associated significantly with improved outcome and survival. Future studies on a larger population size are strongly recommended. © 2018 John Wiley & Sons Ltd.

  9. In Silico Assessment of Literature Insulin Bolus Calculation Methods Accounting for Glucose Rate of Change.

    PubMed

    Cappon, Giacomo; Marturano, Francesca; Vettoretti, Martina; Facchinetti, Andrea; Sparacino, Giovanni

    2018-05-01

    The standard formula (SF) used in bolus calculators (BCs) determines meal insulin bolus using "static" measurement of blood glucose concentration (BG) obtained by self-monitoring of blood glucose (SMBG) fingerprick device. Some methods have been proposed to improve efficacy of SF using "dynamic" information provided by continuous glucose monitoring (CGM), and, in particular, glucose rate of change (ROC). This article compares, in silico and in an ideal framework limiting the exposition to possibly confounding factors (such as CGM noise), the performance of three popular techniques devised for such a scope, that is, the methods of Buckingham et al (BU), Scheiner (SC), and Pettus and Edelman (PE). Using the UVa/Padova Type 1 diabetes simulator we generated data of 100 virtual subjects in noise-free, single-meal scenarios having different preprandial BG and ROC values. Meal insulin bolus was computed using SF, BU, SC, and PE. Performance was assessed with the blood glucose risk index (BGRI) on the 9 hours after meal. On average, BU, SC, and PE improve BGRI compared to SF. When BG is rapidly decreasing, PE obtains the best performance. In the other ROC scenarios, none of the considered methods prevails in all the preprandial BG conditions tested. Our study showed that, at least in the considered ideal framework, none of the methods to correct SF according to ROC is globally better than the others. Critical analysis of the results also suggests that further investigations are needed to develop more effective formulas to account for ROC information in BCs.

  10. Prevalence of Eosinophilic Esophagitis and Lymphocytic Esophagitis in Adults with Esophageal Food Bolus Impaction.

    PubMed

    Truskaite, Kotryna; Dlugosz, Aldona

    2016-01-01

    Background. The relation of esophageal food bolus impaction (FBI) to eosinophilic esophagitis (EoE) and lymphocytic esophagitis (LyE) is unclear. The aim of this study was to determine the prevalence of EoE and LyE among adults with FBI. Methods. In this retrospective study we analyzed data from all patients referred for gastroscopy during the past 5 years, because of a present or recent episode of FBI. Results. We found 238 patients with FBI (median age 51 (17-96), 71% males). Endoscopic therapy was required in 143 patients. Esophageal biopsies were obtained in 185 (78%) patients. All biopsies were assessed for numbers of eosinophils and lymphocytes. EoE was found in 18% of patients who underwent biopsy. We found 41 patients (22%) who fulfilled the criteria for both EoE and LyE (EoE/LyE). LyE was found in the 9% of patients with FBI. EoE together with EoE/LyE was the leading cause of FBI in patients ≤50 years (64%). GERD was the leading cause of FBI among patients older than 50 years (42%). Conclusions. Our study showed that EoE was the leading cause of FBI in particular among young adults. Our study highlights the need for esophageal biopsies in any patient with FBI.

  11. Clinical findings for fungal infections caused by methylprednisolone injections.

    PubMed

    Chiller, Tom M; Roy, Monika; Nguyen, Duc; Guh, Alice; Malani, Anurag N; Latham, Robert; Peglow, Sheree; Kerkering, Tom; Kaufman, David; McFadden, Jevon; Collins, Jim; Kainer, Marion; Duwve, Joan; Trump, David; Blackmore, Carina; Tan, Christina; Cleveland, Angela A; MacCannell, Tara; Muehlenbachs, Atis; Zaki, Sherif R; Brandt, Mary E; Jernigan, John A

    2013-10-24

    Since September 18, 2012, public health officials have been investigating a large outbreak of fungal meningitis and other infections in patients who received epidural, paraspinal, or joint injections with contaminated lots of methylprednisolone acetate. Little is known about infections caused by Exserohilum rostratum, the predominant outbreak-associated pathogen. We describe the early clinical course of outbreak-associated infections. We reviewed medical records for outbreak cases reported to the Centers for Disease Control and Prevention before November 19, 2012, from the six states with the most reported cases (Florida, Indiana, Michigan, New Jersey, Tennessee, and Virginia). Polymerase-chain-reaction assays and immunohistochemical testing were performed on clinical isolates and tissue specimens for pathogen identification. Of 328 patients without peripheral-joint infection who were included in this investigation, 265 (81%) had central nervous system (CNS) infection and 63 (19%) had non-CNS infections only. Laboratory evidence of E. rostratum was found in 96 of 268 patients (36%) for whom samples were available. Among patients with CNS infections, strokes were associated with an increased severity of abnormalities in cerebrospinal fluid (P<0.001). Non-CNS infections were more frequent later in the course of the outbreak (median interval from last injection to diagnosis, 39 days for epidural abscess and 21 days for stroke; P<0.001), and such infections developed in patients with and in those without meningitis. The initial clinical findings from this outbreak suggest that fungal infections caused by epidural and paraspinal injection of a contaminated glucocorticoid product can result in a broad spectrum of clinical disease, reflecting possible variations in the pathogenic mechanism and in host and exposure risk factors. (Funded by the Centers for Disease Control and Prevention.).

  12. Utility of Operative Glaucoma Tube Shunt Viscoelastic Bolus Flush.

    PubMed

    Groth, Sylvia L; Greider, Kelsi L; Sponsel, William Eric

    2015-01-01

    To assess the utility of viscoelastic injection to induce bleb expansion and decrease intraocular pressure (IOP) in eyes with encapsulated glaucoma tube shunt blebs. Case series. Forty-three glaucomatous eyes, including 13 eyes with congenital, 13 uveitic, 5 neovascular, 5 open angle, 4 narrow angle and 3 traumatic glaucomas. Methods, interventions or testing: All patients underwent viscoelastic flush procedure. A pre-bent 27 or 30-gauge cannula was passed through a 25-gauge paracentesis, advanced over the iris across the anterior chamber, and insinuated into the tube shunt lumen. Once the cannula was firmly lodged in position, 0.45 to 0.85 ml of viscoelastic was injected to hyperinflate the bleb. Paired t-tests were performed comparing preoperative IOP and number of medications used preoperatively vs levels measured at 1, 6, 12, 18 and 24 months. Intraocular pressure was reduced from a mean preoperative level of 26.0 ± 1.2 (sem) mm Hg to 15.8 ± 1.0 at 1 month, remaining stable thereafter at each 6-month interval with 15.1 ± 1.1 mm Hg at 24 months (p < 0.0001). Medication use did not vary significantly from baseline. Pressure remained < 21 mm Hg after 2 years in 85% of eyes cannulated within 1 year of primary tube shunt implantation (n = 23), and in 62% of eyes cannulated more than 1 year after tube shunt placement (n = 20). Tube shunt expansion with bolus viscoelastic flush successfully restored encapsulated bleb function, providing a substantial (~10 mm Hg) IOP decrease into the mid-normal pressure range. This persisted in the majority of treated eyes for the entire study period. How to cite this article: Groth SL, Greider KL, Sponsel WE. Utility of Operative Glaucoma Tube Shunt Viscoelastic Bolus Flush. J Curr Glaucoma Pract 2015;9(3):73-76.

  13. Effect of bolus fluid intake on energy expenditure values as determined by the doubly labeled water method

    NASA Technical Reports Server (NTRS)

    Drews, D.; Stein, T. P.

    1992-01-01

    The doubly labeled water (DLW, 2H(2)18O) method is a highly accurate method for measuring energy expenditure (EE). A possible source of error is bolus fluid intake before body water sampling. If there is bolus fluid intake immediately before body water sampling, the saliva may reflect the ingested water disproportionately, because the ingested water may not have had time to mix fully with the body water pool. To ascertain the magnitude of this problem, EE was measured over a 5-day period by the DLW method. Six subjects were dosed with 2H2(18)O. After the reference salivas for the two-point determination were obtained, subjects drank water (700-1,000 ml), and serial saliva samples were collected for the next 3 h. Expressing the postbolus saliva enrichments as a percentage of the prebolus value, we found 1) a minimum in the saliva isotopic enrichments were reached at approximately 30 min with the minimum for 2H (95.48 +/- 0.43%) being significantly lower than the minimum for 18O (97.55 +/- 0.44, P less than 0.05) and 2) EE values calculated using the postbolus isotopic enrichments are appreciably higher (19.9 +/- 7.5%) than the prebolus reference values. In conclusion, it is not advisable to collect saliva samples for DLW measurements within approximately 1 h of bolus fluid intake.

  14. Economic Synergy between Dry Cow Diet Improvement and Monensin Bolus Use to Prevent Subclinical Ketosis: An Experimental Demonstration Based on Available Literature

    PubMed Central

    Raboisson, Didier; Barbier, Maxime

    2017-01-01

    The prevention of subclinical ketosis (SCK) is based on maintaining adequate nutrition in dairy cows during the dry period and close to calving. Recently, an oral-route monensin bolus to prevent SCK was approved in Europe. The present study aims to define the allocation of resources for SCK management at the herd level and evaluate the profitability of administering monensin boluses in cows at risk for SCK. A stochastic model was used to calculate the total cost of SCK for a population with a given prevalence of cows at risk for SCK. This model included the ability of the farmer to correctly target and preventatively treat these cows at risk for SCK. The results clearly demonstrated economic synergy between two management practices. First, reducing the prevalence of cows at risk for SCK dramatically reduces the total cost of SCK and seems profitable in most situations. Second, monensin bolus use to reduce the occurrence of SCK in cows already at risk for SCK is cost-effective. The results also highlighted three economic strategies to manage SCK in the dairy industry in Europe. First, monensin bolus use throughout an entire herd when the prevalence of cows at risk for SCK is high is only profitable in the short-term as a tool to correct acute deterioration at the herd level. Second, decreasing the prevalence of cows at risk for SCK through adequate feeding in the dry period is of financial interest as a baseline strategy when prevalence is high, assuming moderate additional cost linked to the new diet. Third, monensin bolus use when the prevalence of cows at risk for SCK is low is also profitable as a long-term strategy when only cows at high risk for SCK (such as cows that are over-conditioned, old, or have a previous history of SCK-related disorders) are targeted for preventative treatment. Authors suggest to use the present results considering that farmers have a correct, but not perfect, ability to target animals to be preventively targeted with the monensin

  15. Economic Synergy between Dry Cow Diet Improvement and Monensin Bolus Use to Prevent Subclinical Ketosis: An Experimental Demonstration Based on Available Literature.

    PubMed

    Raboisson, Didier; Barbier, Maxime

    2017-01-01

    The prevention of subclinical ketosis (SCK) is based on maintaining adequate nutrition in dairy cows during the dry period and close to calving. Recently, an oral-route monensin bolus to prevent SCK was approved in Europe. The present study aims to define the allocation of resources for SCK management at the herd level and evaluate the profitability of administering monensin boluses in cows at risk for SCK. A stochastic model was used to calculate the total cost of SCK for a population with a given prevalence of cows at risk for SCK. This model included the ability of the farmer to correctly target and preventatively treat these cows at risk for SCK. The results clearly demonstrated economic synergy between two management practices. First, reducing the prevalence of cows at risk for SCK dramatically reduces the total cost of SCK and seems profitable in most situations. Second, monensin bolus use to reduce the occurrence of SCK in cows already at risk for SCK is cost-effective. The results also highlighted three economic strategies to manage SCK in the dairy industry in Europe. First, monensin bolus use throughout an entire herd when the prevalence of cows at risk for SCK is high is only profitable in the short-term as a tool to correct acute deterioration at the herd level. Second, decreasing the prevalence of cows at risk for SCK through adequate feeding in the dry period is of financial interest as a baseline strategy when prevalence is high, assuming moderate additional cost linked to the new diet. Third, monensin bolus use when the prevalence of cows at risk for SCK is low is also profitable as a long-term strategy when only cows at high risk for SCK (such as cows that are over-conditioned, old, or have a previous history of SCK-related disorders) are targeted for preventative treatment. Authors suggest to use the present results considering that farmers have a correct, but not perfect, ability to target animals to be preventively targeted with the monensin

  16. Doxorubicin: Comparison between 3-h continuous and bolus intravenous administration paradigms on cardio-renal axis, mitochondrial sphingolipids and pathology

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kamendi, Harriet, E-mail: harriet_kamendi@kandih.com; Zhou, Ying, E-mail: yingzhou526@gmail.com; Crosby, Meredith, E-mail: Meredith.crosby@astrazeneca.com

    Doxorubicin (DOX) is a potent and effective broad-spectrum anthracycline antitumor agent, but its clinical usefulness is restricted by cardiotoxicity. This study compared pharmacokinetic, functional, structural and biochemical effects of single dose DOX bolus or 3-h continuous iv infusion (3-h iv) in the Han–Wistar rat to characterize possible treatment-related differences in drug safety over a 72 h observation period. Both DOX dosing paradigms significantly altered blood pressure, core body temperature and QA interval (indirect measure of cardiac contractility); however, there was no recovery observed in the bolus iv treatment group. Following the 3-h iv treatment, blood pressures and QA interval normalizedmore » by 36 h then rose above baseline levels over 72 h. Both treatments induced biphasic changes in heart rate with initial increases followed by sustained decreases. Cardiac injury biomarkers in plasma were elevated only in the bolus iv treatment group. Tissue cardiac injury biomarkers, cardiac mitochondrial complexes I, III and V and cardiac mitochondrial sphingolipids were decreased only in the bolus iv treatment group. Results indicate that each DOX dosing paradigm deregulates sinus rhythm. However, slowing the rate of infusion allows for functional compensation of blood pressure and may decrease the likelihood of cardiac myocyte necrosis via a mechanism associated with reduced mitochondrial damage. - Highlights: • Despite damaging cardiomyocytes, continuous iv doxorubicin improves cardiovascular outcomes. • This study supports administration of doxorubicin via slow continuous iv infusion limits acute cardio-toxicity. • This study supports use of metabolomic-derived lipid biomarkers for improved quantification of cardiovascular risk. • This study supports systems-based physiological approach to generate a data that can greatly inform risk assessments.« less

  17. High-dose, single-bolus eptifibatide: a safe and cost-effective alternative to conventional glycoprotein IIb/IIIa inhibitor use for elective coronary interventions.

    PubMed

    Fischell, Tim A; Attia, Tamer; Rane, Santosh; Salman, Waddah

    2006-10-01

    Adjunctive pharmacotherapy with eptifibatide, a glycoprotein (GP) IIb/IIIa inhibitor, as an intravenous bolus followed by infusion has been shown to improve outcomes in elective coronary interventions (PCI). However, bleeding complications and costs have limited the routine adoption of this regimen. The goal of this study was to examine the safety, efficacy and cost-effectiveness of high-dose, single-bolus eptifibatide, without post-intervention infusion, in "real-world" patients undergoing elective PCI. We studied 401 patients with stable and unstable angina who were treated with a high-dose (20 mg), single bolus of eptifibatide plus heparin prior to the start of elective PCI. Exclusion criteria included recent MI, stenting of bypass graft(s), rotational atherectomy and/or brachytherapy. The primary study endpoints were major adverse clinical events (MACE), defined as the in-hospital and 30-day incidence of death from any cause, Q-wave or non-Q-wave MI, repeat target vessel revascularization and/or major bleeding complications. Relevant demographic and procedural characteristics included mean age: 66.4 +/- 11.2; male gender: 242/401 (61%); number of vessels treated per patient: 1.46 +/- 0.42; and number of stents deployed per patient: 1.82 +/- 0.65. In-hospital non-Q-wave MI (CPK and/or CPK-MB > 3 times the upper limit of normal) occurred in 7/401 patients (1.75%) and MACE was 2.25%. Major bleeding complications were seen in 2/401 patients (0.49%). There were 4 additional MACE events at 30-day follow up (total MACE and bleeding = 3.25%). The average anticoagulation cost was 66 dollars/patient. Intravenous eptifibatide, administered as a high-dose (20 mg) single-vial bolus, is a safe, effective and highly cost-effective alternative to the conventional regimens of bolus plus prolonged intravenous GP IIb/IIIa inhibitor infusion for patients undergoing elective PCI.

  18. [Linear IgA disease with ocular involvement associated with ulcerative colitis].

    PubMed

    Klein, A; Wenzel, S M; Messmer, E M; Landthaler, M; Vogt, T

    2010-01-01

    The association of linear IgA disease (LAD), ulcerative colitis and scarring ocular involvement is very rare and represents a considerable therapeutic challenge. We report a 48-year-old male diagnosed with ulcerative colitis in 1995, who received long-term methylprednisolone therapy. Later, he developed ocular inflammation with conjunctival scarring and synechiae formation as well as episodes of vesicles. Although azathioprine was added to his regimen, the disease was not controlled. After the diagnosis of LAD was established, dapsone was added. With this therapy, the ocular inflammation decreased significantly and the methylprednisolone dose could be successfully tapered slowly without reappearance of vesicles.

  19. Lidocaine bolus may facilitate computed tomographic coronary angiography in patients with frequent premature ventricular contractions

    PubMed Central

    Jastrzębski, Jan; Kępka, Cezary; Kruk, Mariusz; Demkow, Marcin; Kalińczuk, Łukasz; Wolny, Rafał; Ciszewski, Michał; Michałowska, Ilona; Witkowski, Adam

    2013-01-01

    Introduction Heart rate irregularities are the major limitations of computed tomographic coronary angiography (CTCA) due to severe motion artifacts. Aim To evaluate the safety and efficacy of a lidocaine intravenous bolus in preserving good image quality by the transient suppression of premature ventricular contractions (PVC) during the CTCA scan. Material and methods The study group comprised 67 consecutive patients with sinus rhythm and numerous PVC scheduled for CTCA. Intravenous boluses of 25–50 mg lidocaine were given after calcium score assessment and immediately before CTCA. The control group comprised 67 patients with sinus rhythm without PVC matched according to the body mass index (BMI), age, sex, and calcium score. All coronary vessel segments were assessed for image quality and presence of significant stenosis. Results As compared with calcium score assessment, after administration of lidocaine and during the CTCA scan PVC were completely suppressed in 22 (40%), reduced in 10 (18%), unchanged in 18 (32%), and intensified in 5 (10%) patients. Overall, there were 32 (58%) patients with sinus rhythm during CTCA as compared with only 11 (20%) patients free from PVC during calcium score assessment (p < 0.001). Image quality in 871 coronary segments including both the study group and control patients was worse in patients with PVC (p < 0.0001). However, there was no statistically significant difference in the number of patients with at least one segment of non-diagnostic quality (6% vs. 12%, p = 0.36; respectively). Conclusions Single lidocaine bolus given prior to CTCA is safe, may temporarily eliminate or reduce the intensity of arrhythmia, and hence results in improved quality of CTCA in patients with numerous PVC. PMID:24570719

  20. Intravenous bolus of 125I labeled meglumine diatrizoate. Early extravascular distribution.

    PubMed

    Dean, P B; Kormano, M

    1977-05-01

    A mixture of 125I labeled meglumine diatrizoate and 131I labeled human serum albumin was injected into the femoral vein of 26 anesthetized male rats. Measurements of the activities in cardiac blood and in different tissues of the lower extremity and in the testis were performed at time intervals ranging from 5 s to 5 min after injection. The determination of tissue uptake and distribution volumes of diatrizoate showed widely differing accumulation of contrast medium. Over 50 per cent of the intravenous bolus of diatrizoate was extravascular at 40 s.

  1. Effect of bromocriptine-QR therapy on glycemic control in subjects with type 2 diabetes mellitus whose dysglycemia is inadequately controlled on insulin.

    PubMed

    Chamarthi, Bindu; Cincotta, Anthony H

    2017-05-01

    The concurrent use of an insulin sensitizer in type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control on basal-bolus insulin may help improve glycemic control while limiting further insulin requirement. Bromocriptine-QR (B-QR), a quick release, sympatholytic, dopamine D2 receptor agonist therapy for T2DM, is a postprandial insulin sensitizer. This study evaluated the effect of B-QR on dysglycemia in T2DM subjects with suboptimal glycemic control on basal-bolus insulin plus metformin. The effect of once-daily morning administration of B-QR on dysglycemia was evaluated in 60 T2DM subjects derived from the Cycloset Safety Trial, with HbA1c >7% on basal-bolus insulin plus metformin at baseline, randomized to B-QR (N = 44) versus placebo (N = 16) and completed 12 weeks of study drug treatment. The analyses also included a subset of subjects on high-dose insulin (total daily insulin dose (TDID) ≥70 units; N = 36: 27 B-QR; 9 placebo). Subjects were well matched at baseline. After 12 weeks of B-QR treatment, mean % HbA1c decreased by -0.73% relative to baseline (p < 0.001) and by -1.13 relative to placebo (p < 0.001). In the high-dose insulin subset, B-QR therapy resulted in % HbA1c reductions of -0.95 and -1.49 relative to baseline (p < 0.001) and placebo (p = 0.001) respectively. Secondary analyses of treatment effect at 24 and 52 weeks demonstrated similar influences of B-QR on HbA1c. The fasting plasma glucose (FPG) and TDID changes within each treatment group were not significant. More subjects achieved HbA1c ≤7 at 12 weeks with B-QR relative to placebo (36.4% B-QR vs 0% placebo, Fisher's exact 2-sided p = 0.003 in the entire cohort and 37% vs 0%, 2-sided p = 0.039 in the high-dose insulin subset). B-QR therapy improves glycemic control in T2DM subjects whose glycemia is poorly controlled on metformin plus basal-bolus insulin, including individuals on high-dose basal-bolus insulin. This glycemic impact occurred without

  2. Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study.

    PubMed

    Lomonte, Andrea Barranjard Vannucci; de Morais, Marina Gonçalves Veras; de Carvalho, Lina Oliveira; Zerbini, Cristiano Augusto de Freitas

    2015-09-01

    Intraarticular (IA) corticosteroid injections are broadly used in knee osteoarthritis (OA); however, the best corticosteroid agent is not well defined. The aim of the present study was to compare the efficacy of triamcinolone hexacetonide (TH) and methylprednisolone acetate (MA) injections in knee OA. Patients with symptomatic knee OA and Kellgren-Lawrence grade II or III were randomized to receive 40 mg of IA TH or MA. Evaluations were performed at 4, 12, and 24 weeks. The primary outcome was a change in the patient's assessment of pain by visual analog scale from baseline to Week 4. Secondary outcomes included a global assessment of the disease by patients and physicians, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index (LI), and Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria of response. Generalized estimating equations were used in statistical analysis. The intention-to-treat population included 100 patients; 50 in each study arm. A significant improvement in pain was observed at Week 4 for both groups (p < 0.0001), with no difference between them (p = 0.352). This improvement was sustained up to Week 24. A significant improvement from the baseline was observed for both the patient's and the physician's global assessments, WOMAC questionnaire, and LI, with no differences between the groups. Improvements in the secondary outcomes were sustained during the study. The OMERACT-OARSI criteria of response was achieved by 74% and 72% of patients in the TH and the MA groups, respectively. Both IA therapies are equally effective, and improvement in pain and function can be sustained for up to 24 weeks. Controlled-trials.com identifier: ISRCTN15077843.

  3. Patients with Spinal Cord Injuries Favor Administration of Methylprednisolone

    PubMed Central

    Bowers, Christian A.; Kundu, Bornali; Rosenbluth, Jeffrey; Hawryluk, Gregory W. J.

    2016-01-01

    Methylprednisolone sodium succinate (MPSS) for treatment of acute spinal cord injury (SCI) has been associated with both benefits and adverse events. MPSS administration was the standard of care for acute SCI until recently when its use has become controversial. Patients with SCI have had little input in the debate, thus we sought to learn their opinions regarding administration of MPSS. A summary of the published literature to date on MPSS use for acute SCI was created and adjudicated by 28 SCI experts. This summary was then emailed to 384 chronic SCI patients along with a survey that interrogated the patients’ neurological deficits, communication with physicians and their views on MPSS administration. 77 out of 384 patients completed the survey. 28 respondents indicated being able to speak early after injury and of these 24 reported arriving at the hospital within 8 hours of injury. One recalled a physician speaking to them about MPSS and one patient reported choosing whether or not to receive MPSS. 59.4% felt that the small neurological benefits associated with MPSS were ‘very important’ to them (p<0.0001). Patients had ‘little concern’ for potential side-effects of MPSS (p = 0.001). Only 1.4% felt that MPSS should not be given to SCI patients regardless of degree of injury (p<0.0001). This is the first study to report SCI patients’ preferences regarding MPSS treatment for acute SCI. Patients favor the administration of MPSS for acute SCI, however few had input into whether or not it was administered. Conscious patients should be given greater opportunity to decide their treatment. These results also provide some guidance regarding MPSS administration in patients unable to communicate. PMID:26789007

  4. Bolus versus continuous low dose of enalaprilat in congestive heart failure with acute refractory decompensation.

    PubMed

    Podbregar, M; Voga, G; Horvat, M; Zuran, I; Krivec, B; Skale, R; Pareznik, R

    1999-01-01

    The first dose of angiotensin-converting enzyme (ACE) inhibitors may trigger a considerable fall of blood pressure in chronic heart failure. The response may be dose-related. To determine hemodynamic and systemic oxygenation effects of low-dose enalaprilat, we administered intravenous enalaprilat (0.004 mg/kg) as bolus (group B) or continuous 1-hour infusion (group C) in 20 patients with congestive heart failure due to ischemic heart disease with acute decompensation refractory to inotropic, vasodilator and diuretic therapy. Hemodynamic and systemic oxygenation variables were recorded at baseline (+0 min), +30, +60, +120, +180, and +360 min after the start of intervention. Mean arterial pressure (MAP) (p < 0. 001), mean pulmonary artery pressure (MPAP) (p < 0.001), pulmonary artery occlusion pressure (PAOP) (p < 0.001), oxygen extraction ratio (ER) (p < 0.026) decreased regardless of enalaprilat application. Compared to group B, there was in group C prolonged decrease of MAP, MPAP, PAOP, ER and increase of pulmonary artery oxyhemoglobin saturation in regard to baseline values. Cardiac index, heart rate, central venous pressure and oxygen consumption index did not change. A low dose of intravenous enalaprilat (0.004 mg/kg) can be used to safely improve hemodynamics and systemic oxygenation in congestive heart failure due to ischemic heart disease with acute refractory decompensation.

  5. SU-E-T-72: Commissioning of a Standardized SRS Cone Set: Determination of the Bolus Gap Factors in a Passively Scattered Proton Beam

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Simpson, R; Gordon, I; Ghebremedhin, A

    2014-06-01

    Purpose: To determine the proton output factors for an SRS cone set using standardized apertures and varied range compensators (bolus blanks); specifically, to determine the best method for modeling the bolus gap factor (BGF) and eliminate the need for patient specific calibrations. Methods: A Standard Imaging A-16 chamber was placed in a Plastic Water phantom to measure the change in dose/MU with different treatment combinations for a proton SRS cone, using standardized apertures and range compensators. Measurements were made with all apertures in the SRS cone set, with four different range compensator thicknesses and five different air gaps between themore » end of the SRS cone and the surface of the phantom. The chamber was located at iso-center and maintained at a constant depth at the center of modulation for all measurements. Each aperture was placed in the cone to measure the change in MU needed to maintain constant dose at the chamber, as the air gap was increased with different thicknesses of bolus. Results: The dose/MU varied significantly with decreasing aperture size, increasing bolus thickness, or increasing air gap. The measured data was fitted with the lowest order polynomials that accurately described the data, to create a model for determining the change in output for any potential combination of devices used to treat a patient. For a given standardized aperture, the BGF could be described by its constituent factors: the bolus thickness factor (BTF) and the nozzle extension factor (NEF). Conclusion: The methods used to model the dose at the calibration point could be used to accurately predict the change in output for SRS proton beams due to the BGF, eliminating the need for patient specific calibrations. This method for modeling SRS treatments could also be applied to model other treatments using passively scattered proton beams.« less

  6. Wedge-shaped slice-selective adiabatic inversion pulse for controlling temporal width of bolus in pulsed arterial spin labeling

    PubMed Central

    Guo, Jia; Buxton, Richard B.; Wong, Eric C.

    2015-01-01

    Purpose In pulsed arterial spin labeling (PASL) methods, arterial blood is labeled via inverting a slab with uniform thickness, resulting in different temporal widths of boluses in vessels with different flow velocities. This limits the temporal resolution and signal-to-noise ratio (SNR) efficiency gains in PASL-based methods intended for high temporal resolution and SNR efficiency, such as Turbo-ASL and Turbo-QUASAR. Theory and Methods A novel wedge-shaped (WS) adiabatic inversion pulse is developed by adding in-plane gradient pulses to a slice-selective (SS) adiabatic inversion pulse to linearly modulate the inversion thicknesses at different locations while maintaining the adiabatic properties of the original pulse. A hyperbolic secant (HS) based WS inversion pulse was implemented. Its performance was tested in simulations, phantom and human experiments, and compared to an SS HS inversion pulse. Results Compared to the SS inversion pulse, the WS inversion pulse is capable of inducing different inversion thicknesses at different locations. It can be adjusted to generate a uniform temporal width of boluses in arteries at locations with different flow velocities. Conclusion The WS inversion pulse can be used to control the temporal widths of labeled boluses in PASL experiments. This should benefit PASL experiments by maximizing labeling duty cycle, and improving temporal resolution and SNR efficiency. PMID:26451521

  7. Comparative effects of rapid bolus administration of aqueous amiodarone versus 10-minute cordarone I.v. infusion on mean arterial blood pressure in conscious dogs.

    PubMed

    Somberg, John Charin; Cvetanovic, Ivana; Ranade, Vasant; Molnar, Janos

    2004-09-01

    This study was designed to test the hypothesis that rapid bolus administration of an aqueous formulation of intravenous amiodarone causes less hypotension than a 10-minute infusion of the standard formulation, Cordarone IV. Hypotension was the most common adverse event reported with Cordarone IV. The hypotension was not dose related, but related to the rate of infusion. Therefore, product labeling calls Cordarone and its generic formulations to be administered over 10 minutes. Cordarone IV contains polysorbate 80 and benzyl alcohol, each causes hypotension. A new aqueous formulation of amiodarone (Amio-Aqueous) does not contain these agents and therefore may cause less hypotension. Six conscious beagle dogs were instrumented with a telemetric device for blood pressure monitoring. The study was conducted on 5 days. On the first 2 days, a 10-min infusion or a bolus of D(5)W was administered (placebo). Over the following 3 days, the dogs received (in randomized order, one per day) a 10-min infusion of 2.5 mg/kg Cordarone IV and boluses of 2.5 mg/kg and 5.0 mg/kg Amio-Aqueous injected over 2 to 5 sec. The dogs were monitored for 2 hrs after dosing. Compared to placebo, boluses of aqueous amiodarone produced no significant changes in the mean arterial blood pressure (MABP). In contrast, Cordarone infusion produced significant decreases in MABP that lasted for at least 2 hrs (p < 0.001). Amio-Aqueous had significantly better hemodynamic profile permitting rapid intravenous administration. This is a significant advantage over the standard formulation, because Cordarone cannot be administered by rapid bolus due to excipient-related hypotension.

  8. Safety and effectiveness of biphasic insulin aspart 30 in people with type 2 diabetes switching from basal-bolus insulin regimens in the A1chieve study.

    PubMed

    Dieuzeide, Guillermo; Chuang, Lee-Ming; Almaghamsi, Abdulrahman; Zilov, Alexey; Chen, Jian-Wen; Lavalle-González, Fernando J

    2014-07-01

    Biphasic insulin aspart 30 allows fewer daily injections versus basal-bolus insulin regimens, which may improve adherence and treatment outcome. This sub-analysis of the observational A1chieve study assessed clinical safety and effectiveness of biphasic insulin aspart 30 in people with type 2 diabetes previously receiving basal-bolus insulin regimens. A1chieve was an international, open-label, 24-week study in people with type 2 diabetes starting/switching to biphasic insulin aspart 30, insulin detemir or insulin aspart. This sub-analysis assessed patients switching from insulin glargine- or neutral protamine Hagedorn insulin-based basal-bolus insulin regimens to biphasic insulin aspart 30. 1024 patients were included. At 24 weeks, glycated haemoglobin and fasting plasma glucose were significantly reduced from baseline in both cohorts (all p<0.001). The proportion reporting any hypoglycaemia, major hypoglycaemia or nocturnal hypoglycaemia was significantly reduced after 24 weeks (all p<0.05). No serious adverse drug reactions were reported. Both cohorts had significantly improved health-related quality of life (HRQoL; p<0.001). 24 weeks after switching from basal-bolus insulin regimens to biphasic insulin aspart 30, glycaemic control and HRQoL were significantly improved, and hypoglycaemia was significantly reduced. This suggests that people with type 2 diabetes inadequately controlled on basal-bolus insulin regimens can consider biphasic insulin aspart 30. Copyright © 2013 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

  9. Effect of phenylephrine bolus administration on left ventricular function during postural hypotension in anesthetized patients.

    PubMed

    Goertz, A W; Schmidt, M; Lindner, K H; Seefelder, C; Georgieff, M

    1993-01-01

    To investigate the effect of intravenous (IV) phenylephrine (PHE) bolus administration on left ventricular function in patients who developed postural hypotension during isoflurane anesthesia in the head-up tilt (reverse Trendelenburg) position. Prospective "before-after" trial. Operation theater of a university medical center. 15 ASA physical status I and II patients without cardiovascular disorders. The anesthetized patients were tilted from a supine horizontal to a 30-degree reverse-Trendelenburg position. Once a steady state was achieved, PHE 3 micrograms/kg was administered as an IV bolus dose. Transesophageal echocardiography was used to assess left ventricular function. We measured blood pressure (BP); heart rate; left ventricular end-systolic and end-diastolic area, diameter, and wall thickness; and ejection time at baseline and after tilt, immediately before and for a period of 3 minutes after PHE injection. We calculated fractional area change (FAC), mean velocity of circumferential fiber shortening (mVcf), and end-systolic wall stress. Head-up tilt caused a reduction of mean arterial pressure [from 68 to 54 mmHg (mean)], end-systolic and end-diastolic left ventricular area (from 9.7 to 6.5 cm2 and from 19.2 to 13.1 cm2, respectively) and end-systolic wall stress (from 56 to 33 10(3).dyne/cm2). FAC and mVcf remained unaltered. PHE administration restored baseline values or overcompensated the changes caused by tilt. FAC slightly decreased in response to PHE (from 0.51 to 0.43), end-systolic wall stress increased to 83 10(3).dyne/cm2, and mVcf remained unchanged. PHE bolus administration effectively restored BP and cardiac filling, which were reduced after head-up tilt, without causing a relevant impairment of left ventricular function or an increase in end-systolic wall stress above the upper normal limit.

  10. Once-weekly exenatide as adjunct treatment of type 1 diabetes mellitus in patients receiving continuous subcutaneous insulin infusion therapy.

    PubMed

    Traina, Andrea N; Lull, Melinda E; Hui, Adrian C; Zahorian, Toni M; Lyons-Patterson, Jane

    2014-08-01

    The use of once-weekly exenatide in type 2 diabetes mellitus is well supported, but little is known about its effectiveness in type 1 diabetes. The objective of this study was to determine the clinical efficacy of once-weekly exenatide on glycemic control in patients with type 1 diabetes when added to basal-bolus insulin therapy. For this retrospective study, patients with type 1 diabetes, aged 18 years and older, receiving continuous subcutaneous insulin infusion, using a continuous glucose monitoring device or regularly measuring blood glucose levels and receiving 2 mg of exenatide once weekly for at least 3 months were included. Demographic information, glycated hemoglobin (A1C), body weight, body mass index, systolic and diastolic blood pressures, total daily insulin dose, basal and bolus insulin doses, 28-day continuous subcutaneous insulin infusion glucose average and incidence of hypoglycemia were collected at baseline and 3 months after beginning therapy with once-weekly exenatide. An electronic medical record search identified 11 patients with type 1 diabetes who met the inclusion criteria. Comparing baseline and 3 months after initiation of once-weekly exenatide revealed reductions of 0.6% in A1C (p=0.013), 3.7% in body weight (p=0.008), 1.7 kg/m(2) in body mass index (p=0.003), 13% in total daily insulin dose (p=0.011) and 9.3 units in bolus insulin dose (p=0.015). This study revealed that the addition of once-weekly exenatide to insulin therapy for type 1 diabetes patients leads to significant improvements in A1C, body weight, body mass index and insulin doses. Copyright © 2014 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

  11. Continuous infusion or bolus injection of loop diuretics for congestive heart failure?

    PubMed

    Zepeda, Patricio; Rain, Carmen; Sepúlveda, Paola

    2016-04-22

    Loop diuretics are widely used in acute heart failure. However, there is controversy about the superiority of continuous infusion over bolus administration. Searching in Epistemonikos database, which is maintained by screening 30 databases, we identified four systematic reviews including 11 pertinent randomized controlled trials overall. We combined the evidence using meta-analysis and generated a summary of findings following the GRADE approach. We concluded continuous administration of loop diuretics probably reduces mortality and length of stay compared to intermittent administration in patients with acute heart failure.

  12. Estimation of contrast agent bolus arrival delays for improved reproducibility of liver DCE MRI

    NASA Astrophysics Data System (ADS)

    Chouhan, Manil D.; Bainbridge, Alan; Atkinson, David; Punwani, Shonit; Mookerjee, Rajeshwar P.; Lythgoe, Mark F.; Taylor, Stuart A.

    2016-10-01

    Delays between contrast agent (CA) arrival at the site of vascular input function (VIF) sampling and the tissue of interest affect dynamic contrast enhanced (DCE) MRI pharmacokinetic modelling. We investigate effects of altering VIF CA bolus arrival delays on liver DCE MRI perfusion parameters, propose an alternative approach to estimating delays and evaluate reproducibility. Thirteen healthy volunteers (28.7  ±  1.9 years, seven males) underwent liver DCE MRI using dual-input single compartment modelling, with reproducibility (n  =  9) measured at 7 days. Effects of VIF CA bolus arrival delays were assessed for arterial and portal venous input functions. Delays were pre-estimated using linear regression, with restricted free modelling around the pre-estimated delay. Perfusion parameters and 7 days reproducibility were compared using this method, freely modelled delays and no delays using one-way ANOVA. Reproducibility was assessed using Bland-Altman analysis of agreement. Maximum percent change relative to parameters obtained using zero delays, were  -31% for portal venous (PV) perfusion, +43% for total liver blood flow (TLBF), +3247% for hepatic arterial (HA) fraction, +150% for mean transit time and  -10% for distribution volume. Differences were demonstrated between the 3 methods for PV perfusion (p  =  0.0085) and HA fraction (p  <  0.0001), but not other parameters. Improved mean differences and Bland-Altman 95% Limits-of-Agreement for reproducibility of PV perfusion (9.3 ml/min/100 g, ±506.1 ml/min/100 g) and TLBF (43.8 ml/min/100 g, ±586.7 ml/min/100 g) were demonstrated using pre-estimated delays with constrained free modelling. CA bolus arrival delays cause profound differences in liver DCE MRI quantification. Pre-estimation of delays with constrained free modelling improved 7 days reproducibility of perfusion parameters in volunteers.

  13. Quantitative measurement of regional blood flow with gadolinium diethylenetriaminepentaacetate bolus track NMR imaging in cerebral infarcts in rats: validation with the iodo[14C]antipyrine technique.

    PubMed Central

    Wittlich, F; Kohno, K; Mies, G; Norris, D G; Hoehn-Berlage, M

    1995-01-01

    NMR bolus track measurements were correlated with autoradiographically determined regional cerebral blood flow (rCBF). The NMR method is based on bolus infusion of the contrast agent gadolinium diethylenetriaminepentaacetate and high-speed T*2-sensitive NMR imaging. The first pass of the contrast agent through the image plane causes a transient decrease of the signal intensity. This time course of the signal intensity is transformed into relative concentrations of the contrast agent in each pixel. The mean transit time and relative blood flow and volume are calculated from such indicator dilution curves. We investigated whether this NMR technique correctly expresses the relative rCBF. The relative blood flow data, calculated from NMR bolus track experiments, and the absolute values of iodo[14C]antipyrine autoradiography were compared. A linear relationship was observed, indicating the proportionality of the transient NMR signal change with CBF. Excellent interindividual reproducibility of calibration constants is observed (r = 0.963). For a given NMR protocol, bolus track measurements calibrated with autoradiography after the experiment allow determination of absolute values for rCBF and regional blood volume. Images Fig. 2 Fig. 3 PMID:7892189

  14. Methylprednisolone Administration Following Spinal Cord Injury Reduces Aquaporin 4 Expression and Exacerbates Edema

    PubMed Central

    Martínez-Cruz, Angelina; Reyes-Sánchez, Alejandro; Guizar-Sahagún, Gabriel

    2017-01-01

    Spinal cord injury (SCI) is an incapacitating condition that affects motor, sensory, and autonomic functions. Since 1990, the only treatment administered in the acute phase of SCI has been methylprednisolone (MP), a synthetic corticosteroid that has anti-inflammatory effects; however, its efficacy remains controversial. Although MP has been thought to help in the resolution of edema, there are no scientific grounds to support this assertion. Aquaporin 4 (AQP4), the most abundant component of water channels in the CNS, participates in the formation and elimination of edema, but it is not clear whether the modulation of AQP4 expression by MP plays any role in the physiopathology of SCI. We studied the functional expression of AQP4 modulated by MP following SCI in an experimental model in rats along with the associated changes in the permeability of the blood-spinal cord barrier. We analyzed these effects in male and female rats and found that SCI increased AQP4 expression in the spinal cord white matter and that MP diminished such increase to baseline levels. Moreover, MP increased the extravasation of plasma components after SCI and enhanced tissue swelling and edema. Our results lend scientific support to the increasing motion to avoid MP treatment after SCI. PMID:28572712

  15. Measurements of the contact force from myenteric contractions on a solid bolus.

    PubMed

    Terry, Benjamin S; Schoen, Jonathan A; Rentschler, Mark E

    2013-03-01

    The development of robotic capsule endoscopes (RCEs) is one avenue presently investigated by multiple research groups to minimize invasiveness and enhance outcomes of enteroscopic procedures. Understanding the biomechanical response of the small bowel to RCEs is needed for design optimization of these devices. In previous work, the authors developed, characterized, and tested the migrating motor complex force sensor (MFS), a novel sensor for quantifying the contact forces per unit of axial length exerted by the myenteron on a solid bolus. This work is a continuation, in which the MFS is used to quantify the contractile strength in the small intestine proximal, middle, and distal regions of five live porcine models. The MFSs are surgically implanted in a generally anesthetized animal, and force data from 5 min of dwell time are analyzed. The mean myenteric contact force from all porcine models and locations within the bowel is 1.9 ± 1.0 N cm(-1). Examining the results based on the small bowel region shows a statistically significant strengthening trend in the contractile force from proximal to middle to distal with mean forces of 1.2 ± 0.5, 1.9 ± 0.9, and 2.3 ± 1.0 N cm(-1), respectively (mean ± one standard deviation). Quantification of the contact force against a solid bolus provides developers of RCEs with a valuable, experimentally derived parameter of the intraluminal environment.

  16. Impaired bolus clearance in combined high-resolution esophageal manometry and impedance measurement helps to differentiate between esophagogastric junction outflow obstruction and achalasia.

    PubMed

    Zizer, Eugen; Seufferlein, Thomas; Hänle, Mark Martin

    2017-02-01

    Introduction and aims  High-resolution esophageal manometry (HRM) has improved the diagnostic work-up of esophageal motility disorders. Simultaneous evaluation of bolus clearance delivers useful information about the function of tubular esophagus. We assessed bolus clearance in a combined HRM-impedance examination for esophagogastric junction outflow obstruction (EGJOO) in comparison to achalasia patients. The collected data were assessed in a retrospective analysis. Patients and methods  After gastroscopy excluded a mechanical esophageal or gastric obstruction, 142 consecutive patients underwent combined HRM-impedance examination. The assessment and interpretation of the manometry results were done according to the Chicago Classification of esophageal motility disorders v3.0. After classifying the motility disorder, the evaluation of bolus clearance was done according to published studies. Results  All patients with achalasia (n = 24) showed a significantly impaired bolus clearance (< 80 %). Patients with unaffected peristalsis (n = 56) or patients with EGJOO (n = 14) each showed impaired clearance in 7 %, respectively. The evidence of axial hernia was not associated with impaired clearance. Conclusion  Our results demonstrate a significant difference in impedance measurements between EGJOO and achalasia cases. This might be helpful as an additional tool to differentiate between achalasia and EGJOO patients. Furthermore, the role of the combined impedance-HRM investigation for early diagnosis of achalasia in "pre-achalasia" condition or in evaluation of potential progress of EGJOO to achalasia should be evaluated in a prospective study. © Georg Thieme Verlag KG Stuttgart · New York.

  17. Comparison of liraglutide plus basal insulin and basal-bolus insulin therapy (BBIT) for glycemic control, body weight stability, and treatment satisfaction in patients treated using BBIT for type 2 diabetes without severe insulin deficiency: A randomized prospective pilot study.

    PubMed

    Yamamoto, Saki; Hayashi, Toshiyuki; Ohara, Makoto; Goto, Satoshi; Sato, Jun; Nagaike, Hiroe; Fukase, Ayako; Sato, Nobuko; Hiromura, Munenori; Tomoyasu, Masako; Nakanishi, Noriko; Lee, Soushou; Osamura, Anna; Yamamoto, Takeshi; Fukui, Tomoyasu; Hirano, Tsutomu

    2018-03-26

    We examined whether 0.9 mg/day liraglutide plus basal insulin (Lira-basal) is superior to basal-bolus insulin therapy (BBIT) for type 2 diabetes (T2DM) without severe insulin deficiency as determined by glucagon stimulation. Fifty patients receiving BBIT were enrolled in this 24-week, prospective, randomized, open-labeled study. After excluding subjects with fasting C-peptide immunoreactivity (CPR) < 1.0 ng/mL and CPR increase < 1.0 ng/mL at 6 min post glucagon injection, 25 were randomly allocated to receive Lira-basal (n = 12) or continued BBIT (n = 13). Primary endpoint was change in HbA1c. Secondary endpoints were changes in body weight (BW), 7-point self-monitored blood glucose (SMBG), and Diabetes Treatment Satisfaction Questionnaire status (DTSQs) scores. The Lira-basal group demonstrated reduced HbA1c, whereas the BBIT group showed no change. BW was reduced in the Lira-basal group but increased in the BBIT group. The Lira-basal group also exhibited significantly reduced pre-breakfast and pre-lunch SMBG. DTSQs scores improved in the Lira-basal group but not the BBIT group. Plasma lipids, liver function, and kidney function were not significantly changed in either group. Lira-basal therapy is superior to BBIT for T2DM without severe insulin deficiency. This study was registered with UMIN Clinical Trials Registry (UMIN000028313). Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

  18. Dynamic microbubble contrast-enhanced US to measure tumor response to targeted therapy: a proposed clinical protocol with results from renal cell carcinoma patients receiving antiangiogenic therapy.

    PubMed

    Williams, Ross; Hudson, John M; Lloyd, Brendan A; Sureshkumar, Ahthavan R; Lueck, Gordon; Milot, Laurent; Atri, Mostafa; Bjarnason, Georg A; Burns, Peter N

    2011-08-01

    To develop and implement an evidence-based protocol for characterizing vascular response of renal cell carcinoma (RCC) to targeted therapy by using dynamic contrast material-enhanced (DCE) ultrasonography (US). The study was approved by the institutional research ethics board; written informed consent was obtained from all patients. Seventeen patients (four women; median age, 58 years; range, 42-72 years; 13 men, median age, 62 years; range, 45-81 years) with metastatic RCC were examined by using DCE US before and after 2 weeks of treatment with sunitinib (May 2007 to October 2009). Two contrast agent techniques--bolus injection and disruption-replenishment infusion of microbubbles--were compared. Changes in tumor blood velocity and fractional blood volume were measured with both methods, together with reproducibility and effect of compensation for respiratory motion. Tumor changes were assessed with computed tomography, by using the best response with the Response Evaluation Criteria in Solid Tumors (RECIST) and progression-free survival (PFS). Follow-up RECIST measurements were performed at 6-week intervals until progressive disease was detected. In response to treatment, median tumor fractional blood volume measured with the disruption-replenishment infusion method decreased by 73.2% (interquartile range, 46%-87%) (P < .002), with repeated-measure reproducibility of 9%-15%. Significant decreases were also seen with the bolus method, but with poor correlation of changes in bolus peak (r = 0.46, P = .066) and area under the curve (r = 0.47, P = .058), compared with infusion measurements. Changes in DCE US parameters over 2 weeks did not correlate with PFS and could not be used to predict long-term assessment of best response by using RECIST. Follow-up times ranged 28-501 days; the median was 164 days. DCE US provides reproducible and sensitive assessment of vascular changes in response to antiangiogenic therapy. The disruption-replenishment infusion protocol is a

  19. Traitement de la neuromyélite optique de Devic durant de la grossesse

    PubMed Central

    Daouda, Moussa Toudou; Obenda, Norlin Samuel; Assadeck, Hamid; Camara, Diankanagbe; Djibo, Fatimata Hassane

    2016-01-01

    La neuromyélite optique de Devic est une pathologie inflammatoire démyélinisante du système nerveux central qui affecte électivement la moelle spinale, le nerf optique et les régions cérébrales à haute expression d’antigènes aquaporine 4. Il s’agit d’une pathologie auto-immune sévère due à des auto-anticorps dirigés contre l’aquaporine 4, à taux de morbidité et de mortalité élevé. Contrairement à d’autres pathologies inflammatoires notamment la sclérose en plaques ou polyarthrite rhumatoïde, la grossesse n’exerce aucune influence sur l’activité de la neuromyélite optique d’où la nécessité d’instaurer un traitement de fond durant toute la grossesse. La corticothérapie représente le traitement de premier choix de la neuromyélite optique durant la grossesse. D’autres traitements peuvent également être utilisés notamment le rituximab, certains immunosuppresseurs, les immunoglobulines. Le traitement par immunosuppresseurs ou rituximab est proposé lorsque la corticothérapie au long cours est contre-indiquée ou en cas d’inefficacité à celle-ci ou encore lorsque les effets secondaires sont intolérables. Les immunoglobulines sont administrées en cas de poussées sévères de la neuromyélite optique qui ne répondent pas aux bolus de methylprednisolone. Les immunoglobulines peuvent également être poursuivies seules à la dose 0,4g/kg/j toutes les 6 à 8 semaines jusqu’à l’accouchement. La plasmaphérèse est également une bonne alternative aux bolus de methylprednisolone lorsque les poussées sont très sévères. PMID:27800085

  20. Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children.

    PubMed

    Hauber, John A; Davis, Peter J; Bendel, Laima P; Martyn, Slava V; McCarthy, Denise L; Evans, Minh-Chau; Cladis, Franklyn P; Cunningham, Sarah; Lang, Robert Scott; Campbell, Neal F; Tuchman, Jay B; Young, Michael C

    2015-11-01

    Administration of dexmedetomidine (DEX) in the pediatric population for its sedative, analgesic, and anxiolytic properties has been widely reported, despite there being no label indication approved by the U.S. Food and Drug Administration for pediatric patients. Infusions of DEX, rather than bolus administration, are recommended to attenuate the hemodynamic response caused by the α2-adrenoreceptor agonist. In this prospective, double-blind, randomized study, we examined the effect of rapid IV bolus injection of DEX on emergence agitation and the hemodynamic response in a large sample of children undergoing tonsillectomy with or without adenoidectomy, with or without myringotomy, and/or tympanostomy tube insertion. Four hundred patients, aged 4 to 10 years, undergoing tonsillectomy with or without adenoidectomy, with or without myringotomy, and/or tympanostomy tube insertion, were randomized at a 1:1 ratio into 1 of the 2 treatment groups in a double-blinded fashion. After a standardized anesthetic regimen and approximately 5 minutes before the end of surgery, patients in group DEX were administered a rapid IV bolus of 4 μg·mL DEX at a dose of 0.5 μg·kg, whereas patients in group saline received a rapid IV bolus of equivalent volume saline. Baseline measurements of heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, and blood oxygen saturation were collected immediately before study drug administration and every minute thereafter for 5 minutes. In the postanesthesia care unit, vital signs were measured, emergence agitation (EA) was assessed using the Pediatric Anesthesia Emergence Delirium scale, and postoperative opioid use and complications were recorded. The incidence of EA in group DEX was significantly lower than that in group saline, regardless of whether EA was defined as a Pediatric Anesthesia Emergence Delirium score >10 (36% vs 66%, respectively; P < 0.0001; relative risk [95% confidence interval] = 0.527 [0

  1. Development of a bolus injection system for regional deposition studies of nanoparticles in the human respiratory system

    NASA Astrophysics Data System (ADS)

    Koujalagi, V.; Ramesh, S. L.; Gunarathne, G. P. P.; Semple, S.; Ayres, J. G.

    2009-02-01

    This study presents the work carried out in developing a precision bolus injection system in order to understand the regional deposition of nanoparticles (NP) in human lung. A real-time control system has been developed that is capable of storing graphite NP, assessing human breathing pattern and delivering a bolus of the stored NP at a pre-determined instance of the inhalation phase of breathing. This will form the basis for further development of a system to deliver radioactive nanoparticles to enable 3-dimensional lung imaging using techniques such as positron emission tomography (PET). The system may then be used to better understand the actual regional deposition in human lung, which could validate or challenge the current computational lung models such as that published by the International Commission for Radiation Protection (ICRP-1994). A dose related response to inhaled PM can possibly be shown, which can be used to review the current workplace exposure limits (WELs).

  2. Eosinophilic esophagitis in children needing emergency endoscopy for foreign body and food bolus impaction.

    PubMed

    El-Matary, Wael; El-Hakim, Hamdy; Popel, Jillian

    2012-07-01

    The objective of this study was to examine the prevalence of eosinophilic esophagitis (EoE) in children presenting with esophageal foreign body (FB)/food bolus impaction. A retrospective chart review for all children who underwent endoscopic esophageal FB extraction at the Stollery Children's Hospital between January 2005 and December 2008 was performed. The prevalence of EoE and characteristics of children who had EoE were documented. A total of 140 children (mean age, 4.98 [SD, 4] years; range, 0.3-16.9 years; 81 boys) had esophageal FB/food impaction and needed endoscopic removal over the study period. Eleven children (mean age, 9.38 [SD, 5.35] years; range, 1.9-16.2 years; 8 boys) were diagnosed with EoE (8%). Seven (39%) of 18 children with food impaction were diagnosed with EoE. Four (3%) of 122 children with esophageal foreign bodies other than food had EoE. Considerable number of children with esophageal FB/food bolus impaction may have EoE. Routine sampling of esophageal mucosa at different levels during esophageal FB extraction may be considered. Well-designed prospective studies with multiple-level esophageal biopsies taken from all children with FB/food impaction are needed to confirm our results.

  3. Comparison of bolus transit patterns identified by esophageal impedance to barium esophagram in patients with dysphagia.

    PubMed

    Cho, Y K; Choi, M-G; Oh, S N; Baik, C N; Park, J M; Lee, I S; Kim, S W; Choi, K Y; Chung, I-S

    2012-01-01

    Bolus transit through the esophagus has not been validated by videoesophagram in patients with dysphagia and changes in impedance with abnormal barium transit have not been described in those patients. The aim of this study was to compare esophageal impedance findings with barium esophagram measurements in patients with dysphagia. The consecutive patients with dysphagia underwent conventional multichannel esophageal impedance manometry, after which a barium videoesophagram was performed simultaneously with multichannel esophageal impedance manometry using a mean of three swallows of barium. Esophageal emptying patterns shown in the esophagogram were classified by the degree of intraesophageal stasis and presence of intraesophageal reflux. Bolus transit patterns in impedance were classified as complete and incomplete transit. Sixteen patients (M : F = 8 : 8, mean age, 47 years) were enrolled. Their manometric diagnosis were normal (n= 6), ineffective esophageal motility (n= 1), diffuse esophageal spasm (DES; n= 2), and achalasia (n= 7). Sixty-three swallows were analyzed. According to impedance analysis, 21/22 swallows with normal barium emptying showed complete transit (96%) and 31/32 swallows with severe stasis showed incomplete transit (97%). Nine swallows with mild stasis showed either complete or incomplete transit patterns in impedance. Swallows with mild barium stasis and complete transit in impedance were observed in patients who had received treatment (two patients with achalasia with history of esophageal balloonplasty and a patient with DES after nifedipine administration). Impedance reflected severe stasis with retrograde barium movement and described typical bolus transit patterns in patients with achalasia and DES. In conclusion, impedance-barium esophagram concordance is high for swallows with normal esophageal emptying and for severe barium stasis in patients with dysphagia. © 2011 Copyright the Authors. Journal compilation © 2011, Wiley

  4. Dual-energy CT iodine maps as an alternative quantitative imaging biomarker to abdominal CT perfusion: determination of appropriate trigger delays for acquisition using bolus tracking.

    PubMed

    Skornitzke, Stephan; Fritz, Franziska; Mayer, Philipp; Koell, Marco; Hansen, Jens; Pahn, Gregor; Hackert, Thilo; Kauczor, Hans-Ulrich; Stiller, Wolfram

    2018-05-01

    Quantitative evaluation of different bolus tracking trigger delays for acquisition of dual energy (DE) CT iodine maps as an alternative to CT perfusion. Prior to this retrospective analysis of prospectively acquired data, DECT perfusion sequences were dynamically acquired in 22 patients with pancreatic carcinoma using dual source CT at 80/140 kV p with tin filtration. After deformable motion-correction, perfusion maps of blood flow (BF) were calculated from 80 kV p image series of DECT, and iodine maps were calculated for each of the 34 DECT acquisitions per patient. BF and iodine concentrations were measured in healthy pancreatic tissue and carcinoma. To evaluate potential DECT acquisition triggered by bolus tracking, measured iodine concentrations from the 34 DECT acquisitions per patient corresponding to different trigger delays were assessed for correlation to BF and intergroup differences between tissue types depending on acquisition time. Average BF measured in healthy pancreatic tissue and carcinoma was 87.6 ± 28.4 and 38.6 ± 22.2 ml/100 ml min -1 , respectively. Correlation between iodine concentrations and BF was statistically significant for bolus tracking with trigger delay greater than 0 s (r max = 0.89; p < 0.05). Differences in iodine concentrations between healthy pancreatic tissue and carcinoma were statistically significant for DECT acquisitions corresponding to trigger delays of 15-21 s (p < 0.05). An acquisition window between 15 and 21 s after exceeding bolus tracking threshold shows promising results for acquisition of DECT iodine maps as an alternative to CT perfusion measurements of BF. Advances in knowledge: After clinical validation, DECT iodine maps of pancreas acquired using bolus tracking with appropriate trigger delay as determined in this study could offer an alternative quantitative imaging biomarker providing functional information for tumor assessment at reduced patient radiation exposure compared to CT

  5. Methylprednisolone prevents nerve injury-induced hyperalgesia in neprilysin knockout mice.

    PubMed

    He, Lan; Uçeyler, Nurcan; Krämer, Heidrun H; Colaço, Maria Nandini; Lu, Bao; Birklein, Frank; Sommer, Claudia

    2014-03-01

    The pathophysiology of the complex regional pain syndrome involves enhanced neurogenic inflammation mediated by neuropeptides. Neutral endopeptidase (neprilysin, NEP) is a key enzyme in neuropeptide catabolism. Our previous work revealed that NEP knock out (ko) mice develop more severe hypersensitivity to thermal and mechanical stimuli after chronic constriction injury (CCI) of the sciatic nerve than wild-type (wt) mice. Because treatment with glucocorticoids is effective in early complex regional pain syndrome, we investigated whether methylprednisolone (MP) reduces pain and sciatic nerve neuropeptide content in NEP ko and wt mice with nerve injury. After CCI, NEP ko mice developed more severe thermal and mechanical hypersensitivity and hind paw edema than wt mice, confirming previous findings. Hypersensitivity was prevented by MP treatment in NEP ko but not in wt mice. MP treatment had no effect on protein levels of calcitonin-gene related peptide, substance P, and bradykinin in sciatic nerves of NEP ko mice. Endothelin-1 (ET-1) levels were higher in naïve and nerve-injured NEP ko than in wt mice, without an effect of MP treatment. Gene expression of the ET-1 receptors ETAR and ETBR was not different between genotypes and was not altered after CCI, but was increased after additional MP treatment. The ETBR agonist IRL-1620 was analgesic in NEP ko mice after CCI, and the ETBR antagonist BQ-788 showed a trend to reduce the analgesic effect of MP. The results provide evidence that MP reduces CCI-induced hyperalgesia in NEP ko mice, and that this may be related to ET-1 via analgesic actions of ETBR. Copyright © 2013 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  6. Comparison of the effects of 2 doses of methylprednisolone on pain, swelling, and trismus after third molar surgery.

    PubMed

    UStün, Yakup; Erdogan, Ozgür; Esen, Emin; Karsli, Ebru Deniz

    2003-11-01

    The aim of this study was to compare the effects of intravenous administration of 1.5 mg/kg and 3 mg/kg of methylprednisolone sodium succinate (MP) on pain, swelling, and trismus after third molar surgery. Twenty-six healthy patients with symmetrically impacted mandibular third molars were included in this double-blind, cross-over study. Either 1.5 mg/kg or 3 mg/kg of MP was administered by intravenous route one hour prior to the first operation. At the second operation the other dose was applied. Trismus was determined by measuring maximum interincisal opening and facial swelling was evaluated using a tape measuring method. Pain was determined using visual analogue scale and recording the number of pain pills taken. There was no statistically significant difference in trismus, facial swelling, and pain between the two groups. No clinical benefit of the higher dose of MP was demonstrated.

  7. SU-E-T-275: Dose Build Up and Bolusing Characteristics for Total Body Irradiation Dosimetry

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Butson, M; Pope, D; Whitaker, M

    2015-06-15

    Purpose: Total Body Irradiation (TBI) treatments are mainly used in a preparative regimen for haematopoietic stem cell (or bone marrow) transplantation. Our standard regimen is a 12 Gy / 6 fraction bi-daily technique. To evaluate the delivered dose homogeneity to the patient, EBT3 Gafchromic film is positioned at the head, neck, chest, pelvis and groin for all fractions. This work investigates and quantifies the build-up dose characteristics at TBI distances and requirements for in-vivo dosimetry bolusing. Methods: Percentage dose build up characteristics of photon beams have been investigated at large extended SSD’s using parallel plate ionisations chambers (Attix) and EBT3more » Gafchromic film. Measurements were made to open fields at different field sizes as well as large 40cm × 40cm fields with differing scatter conditions such as the introduction of standard Perspex scattering plates at different distances to the measurement point. Results: Percentage surface dose measured values for open fields at 300 cm SSD were found to range from 20 % up to 65.5 % for fields of 5 cm × 5 cm to 40 cm × 40 cm. With the introduction of 1cm Perspex scattering plates used in TBI treatments the surface dose values increased up to 83% to 90%, depending on the position of the Perspex scattering plate compared to the measurement point. Our work showed that at least 3mm water equivalent bolus / scatter material should be placed over the EBT3 for accurate dose assessment for TBI treatments. Conclusion: Build up dose characteristics exist at long (300cm) SSD’s including treatments using Perspex scattering plates placed at various distances form the patient during TBI treatment. Top accurately assess the applied dose during treatment, in-vivo dosimeters such as Gafchromic EBT3 should have at least 3mm bolus / scatter material placed over them to measure actual applied doses.« less

  8. Autoimmune hepatitis during intravenous glucocorticoid pulse therapy for Graves' ophthalmopathy treated successfully with glucocorticoids themselves.

    PubMed

    Marinò, M; Morabito, E; Altea, M A; Ambrogini, E; Oliveri, F; Brunetto, M R; Pollina, L E; Campani, D; Vitti, P; Bartalena, L; Pincheral, A; Marcocci, C

    2005-03-01

    We report a case of acute hepatitis of autoimmune origin which occurred in a 43-yr-old woman during iv glucocorticoid (GC) pulse therapy for Graves' ophthalmopathy (GO). Prior to therapy, liver function tests were normal with no previous history of liver disorders or conditions predisposing to GC-associated liver damage. After the administration of a 4.7-g cumulative dose of methylprednisolone acetate, there was a marked increase of liver enzymes, prompting immediate discontinuation of iv GC. Nevertheless, liver enzymes increased further, reaching a peak 45 days later, with values 30- to 50-fold greater than those prior to therapy, associated with evidence of impaired liver function. Liver biopsy showed a marked lymphocytic infiltration, likely indicating an autoimmune hepatitis. Based on the assumption that following GC-induced immune suppression, autoimmune hepatitis might have been precipitated by sudden re-activation of the immune system during interpulse periods, we treated the patient with im and then oral GC, in order to re-induce immune suppression. Within three days from re-institution of GC therapy, there was a marked reduction of liver enzymes and amelioration of liver function. Complete normalization was achieved two months later, while the patient was still receiving a low maintenance dose of oral prednisone.

  9. Changing epidemiology of food bolus impaction: is eosinophilic esophagitis to blame?

    PubMed

    Mahesh, Venkat N; Holloway, Richard H; Nguyen, Nam Quoc

    2013-06-01

    Data on the relationship between epidemiological changes in food bolus impaction (FBI) and its relationship to eosinophilic esophagitis (EoE) are limited. The aim of this study was to evaluate changes in the prevalence and etiology of FBI at the Royal Adelaide Hospital over 15 years. Details of all patients who presented with FBI to Royal Adelaide Hospital (1996-2010) were reviewed from a prospective database. Detailed endoscopic and histological findings were examined for patients admitted under the Gastroenterology team. From 1996-2010, 539 patients were admitted. Prevalence of FBI increased overtime, with a male preponderance. The age at presentation was significantly lower in 2006-2010 (56.2 ± 1.6 years) compared with 2001-2005 (61.6 ± 1.9 years, P=0.03). There was a reduction in the proportion of patients with peptic-related stricture (from 75% [1996-2000] to 41% [2006-2010] [P<0.001]) and an increase in the prevalence of EoE (from 0% [1996-2000] to 35% [2006-2010], P<0.001). The proportion of patients who had esophageal biopsies taken at the index endoscopy also increased (8% [1996-2000] vs 28% [2001-2005] and 61% [2006-2010], P<0.01). There were no significant changes in rate of malignancy or post-surgical strictures. Endoscopic removal of food bolus was required in 86% of cases and, of these, 98% were successful with no complication or death. The prevalence of FBI has increased over the last 15 years. This was associated with an increased prevalence of EoE and a reduction in age of presentation and peptic-related strictures. These findings suggest that EoE is an important cause of FBI and that esophageal mucosal biopsy should be performed in all cases of FBI. © 2013 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

  10. Hypothermia in the sepsis syndrome and clinical outcome. The Methylprednisolone Severe Sepsis Study Group.

    PubMed

    Clemmer, T P; Fisher, C J; Bone, R C; Slotman, G J; Metz, C A; Thomas, F O

    1992-10-01

    To evaluate the consequences of clinical hypothermia associated with sepsis syndrome and septic shock. Analysis of data from a multi-institutional, randomized, placebo-controlled, prospective study with predetermined end-point analysis of development of shock, recovery from shock, hospital length of stay, and death. Multi-institutional medical and surgical ICUs. Patients meeting predetermined criteria for severe sepsis syndrome. Appropriate sepsis and shock care with 50% of patients receiving methylprednisolone and 50% receiving placebo. The occurrence rate of hypothermia (< 35.5 degrees C) is 9% in this population. When compared with febrile patients, hypothermic patients had a higher frequency of central nervous system dysfunction (88% vs. 60%), increased serum bilirubin concentration (35% vs. 15%), prolonged prothrombin times (50% vs. 23%), shock (94% vs. 61%), failure to recover from shock (66% vs. 26%), and death (62% vs. 26%). The hypothermic patients were also more likely to be classified as having a rapidly or ultimately fatal disease upon study admission. This prospective study confirms that hypothermia associated with sepsis syndrome has a significant relationship to outcome manifest by increased frequency of shock and death from shock. This finding is in sharp contrast to the protective effects of induced hypothermia in septic animals and perhaps man.

  11. Switching to multiple daily injection therapy with glulisine improves glycaemic control, vascular damage and treatment satisfaction in basal insulin glargine-injected diabetic patients.

    PubMed

    Yanagisawa, Katsuyuki; Ashihara, Junya; Obara, Shinji; Wada, Norio; Takeuchi, Masayoshi; Nishino, Yuri; Maeda, Sayaka; Ishibashi, Yuji; Yamagishi, Sho-ichi

    2014-11-01

    Basal and bolus insulin therapy is required for strict blood control in diabetic patients, which could lead to prevention of vascular complications in diabetes. However, the optimal combination regimen is not well established. Fifty-nine diabetic patients (49 type 1 and 10 type 2; 52.9 ± 13.3 years old) whose blood glucose levels were uncontrolled (HbA1c  > 6.2%) by combination treatment of basal insulin glargine with multiple daily pre-meal injections of bolus short-acting insulin [aspart (n = 19), lispro (n = 37) and regular human insulin (n = 3)] for at least 8 weeks were enrolled in this study. We examined whether glycaemic control and vascular injury were improved by replacement of short-acting insulin with glulisine. Patient satisfaction was assessed with Diabetes Treatment Satisfaction Questionnaire. Although bolus and basal insulin doses were almost unchanged before and after replacement therapy, switching to glulisine insulin for 24 weeks significantly decreased level of HbA1c , advanced glycation end products (AGEs), soluble receptor for AGEs (sRAGE), monocyte chemoattractant protein-1 (MCP-1) and urinary albumin excretion. In multiple stepwise regression analysis, change in MCP-1 values from baseline (ΔMCP-1) was a sole determinant of log urinary albumin excretion. ΔAGEs and ΔsRAGE were independently correlated with each other. The relationship between ΔMCP-1 and ΔsRAGE was marginally significant (p = 0.05). Replacement of short-acting insulin by glulisine significantly increased Diabetes Treatment Satisfaction Questionnaire scores. Our present study suggests that combination therapy of glargine with multiple daily pre-meal injections of glulisine might show superior efficacy in controlling blood glucose, preventing vascular damage and improving treatment satisfaction in diabetic patients. Copyright © 2014 John Wiley & Sons, Ltd.

  12. BET 1: use of glucagon for oesophageal food bolus impaction.

    PubMed

    2015-01-01

    A shortcut review was carried out to establish whether intravenous glucagon is a safe and effective treatment for patients with suspected lower oesophageal food bolus impaction. Seven studies were directly relevant to the question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of these papers are tabulated. The clinical bottom line is that there is no evidence for the effectiveness of glucagon in this situation. Its use may be associated with adverse effects such as vomiting, with the potential risk of oesophageal perforation. Intravenous glucagon should therefore be avoided. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  13. Preliminary Laboratory Report of Fungal Infections Associated with Contaminated Methylprednisolone Injections

    PubMed Central

    Pham, Cau D.; Gade, Lalitha; Iqbal, Naureen; Scheel, Christina M.; Cleveland, Angela A.; Whitney, Anne M.; Noble-Wang, Judith; Chiller, Tom M.; Park, Benjamin J.; Litvintseva, Anastasia P.; Brandt, Mary E.

    2013-01-01

    In September 2012, the Centers for Disease Control and Prevention (CDC) initiated an outbreak investigation of fungal infections linked to injection of contaminated methylprednisolone acetate (MPA). Between 2 October 2012 and 14 February 2013, the CDC laboratory received 799 fungal isolates or human specimens, including cerebrospinal fluid (CSF), synovial fluid, and abscess tissue, from 469 case patients in 19 states. A novel broad-range PCR assay and DNA sequencing were used to evaluate these specimens. Although Aspergillus fumigatus was recovered from the index case, Exserohilum rostratum was the primary pathogen in this outbreak and was also confirmed from unopened MPA vials. Exserohilum rostratum was detected or confirmed in 191 specimens or isolates from 150 case patients, primarily from Michigan (n = 67 patients), Tennessee (n = 26), Virginia (n = 20), and Indiana (n = 16). Positive specimens from Michigan were primarily abscess tissues, while positive specimens from Tennessee, Virginia, and Indiana were primarily CSF. E. rostratum antifungal susceptibility MIC50 and MIC90 values were determined for voriconazole (1 and 2 μg/ml, respectively), itraconazole (0.5 and 1 μg/ml), posaconazole (0.5 and 1 μg/ml), isavuconazole (4 and 4 μg/ml), and amphotericin B (0.25 and 0.5 μg/ml). Thirteen other mold species were identified among case patients, and four other fungal genera were isolated from the implicated MPA vials. The clinical significance of these other fungal species remains under investigation. The laboratory response provided significant support to case confirmation, enabled linkage between clinical isolates and injected vials of MPA, and described significant features of the fungal agents involved in this large multistate outbreak. PMID:23761142

  14. Best Practices for Intrathecal Baclofen Therapy: Dosing and Long-Term Management.

    PubMed

    Boster, Aaron L; Adair, Roy L; Gooch, Judith L; Nelson, Mary Elizabeth S; Toomer, Andrea; Urquidez, Joe; Saulino, Michael

    2016-08-01

    Intrathecal baclofen (ITB) therapy aims to reduce spasticity and provide functional control. An expert panel consulted on best practices. Pump fill and drug delivery can be started intraoperatively, with monitoring for at least eight hours. Initiate with the 500 mcg/mL concentration. The starting daily dose should be twice the effective bolus screening dose, or the screening dose if the patient had a prolonged response (greater than eight hours) or negative reactions. Oral antispasmodics can be weaned, one drug at a time beginning with oral baclofen after ITB begins. Assessment should occur within 24 hours of a dose change. For adults, daily dose increases may be 5% to 15% once every 24 hours for cerebral-origin spasticity and 10% to 30% once every 24 hours for spinal-origin spasticity. Daily dose increases can be 5% to 15% once every 24 hours for children. Inpatients should be assessed at least every 24 hours and receive rehabilitation. Step dosing can be used for outpatients who cannot return daily. Dosing options include simple continuous dosing, variable 24-hour flex dosing, or regularly scheduled boluses. Patients/caregivers should understand the care plan, responsibilities, and possible side-effects. Low-reservoir alarm dates and refill schedules should be written down, along with emergency contact information. A higher concentration at refill can extend refill intervals, and a bridge bolus must be programmed. Time changes may affect flex dosing. Pump replacement should be scheduled at least three months in advance. ITB dosing is multistep and individualized. © 2016 International Neuromodulation Society.

  15. Single-phase Whole-body 64-MDCT Split-bolus Protocol for Pediatric Oncology: Diagnostic Efficacy and Dose Radiation.

    PubMed

    Scialpi, Michele; Schiavone, Raffaele; D'Andrea, Alfredo; Palumbo, Isabella; Magli, Michelle; Gravante, Sabrina; Falcone, Giuseppe; De Filippi, Claudio; Manganaro, Lucia; Palumbo, Barbara

    2015-05-01

    To evaluate the image quality and the diagnostic efficacy by single-phase whole-body 64-slice multidetector CT (MDCT) for pediatric oncology. Chest-abdomen-pelvis CT examinations with single-phase split-bolus technique were evaluated for T: detection and delineation of primary tumor (assessment of the extent of the lesion to neighboring tissues), N: regional lymph nodes and M: distant metastasis. Quality scores (5-point scale) were assessed by two radiologists on parenchymal and vascular enhancement. Accurate TNM staging in term of detection and delineation of primary tumor, regional lymph nodes and distant metastasis was obtained in all cases. On the image quality and severity artifact, the Kappa value for the interobserver agreement measure obtained from the analysis was 0.754, (p<0.001), characterizing a very good agreement between observers. Single-pass total body CT split-bolus technique reached the highest overall image quality and an accurate TNM staging in pediatric patients with cancer. Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  16. Effect of oral calcium bolus administration on milk production, concentrations of minerals and metabolites in serum, early-lactation health status, and reproductive performance of Holstein dairy cows.

    PubMed

    Jahani-Moghadam, M; Chashnidel, Y; Teimouri-Yansari, A; Mahjoubi, E; Dirandeh, E

    2018-05-01

    To determine the effects of oral Ca bolus administration in the early postpartum period of cows on milk yield and composition, blood metabolites, early-lactation health status, and reproductive performance. Multiparous Holstein dry cows (n=66) with a mean parity of 3.1 (SD 0.35) were fed a diet with a positive dietary cation-anion difference (DCAD) prior to calving. They were randomly assigned to receive no treatment (Control; n=33) or two oral Ca boluses (n=33, 45 g of Ca per bolus); one was administered immediately after calving (Day 0) and the second 24 hours (±30 minutes) later. Blood samples were collected at calving, and on Days 2 and 7 to determine concentrations in serum of Ca, P, Mg, glucose, non-esterified fatty acids (NEFA), and β-hydroxybutyric acid (BHBA). Milk yield was recorded daily and milk composition was determined weekly from calving until 28 day postpartum. Health and outcomes were determined during the first 30 days postpartum and reproductive outcomes to 180 days postpartum. Mean milk yields and composition over the first month of lactation were similar between cows in the two treatment groups (p>0.1). Mean concentrations of Ca in serum were not different between treatment groups on Day 0, but were higher on Day 2 for cows that received oral Ca boluses (1.77 (SE 0.07)) compared with Control cows (1.54 (SE 0.08)) (p=0.04). Concentrations in serum of P, Mg, glucose, NEFA and ΒHBA did not differ between treatment groups on any day of measurement. Fewer cows that received oral Ca were diagnosed with hypocalcaemia (total concentrations of Ca in serum <1.5 mmol/L) by Day 2 (2/33; 6%) compared with Control cows (12/33; 36%) (p=0.01). There was no difference in the prevalence of other health outcomes between treatment groups. The proportion of cows conceiving to first insemination was greater in cows that received an oral Ca bolus (19/29; 65%) than Control cows (12/29; 41%) (p=0.01). Oral Ca bolus administration increased concentrations of Ca

  17. Closed-Loop- and Decision-Assist-Guided Fluid Therapy of Human Hemorrhage.

    PubMed

    Hundeshagen, Gabriel; Kramer, George C; Ribeiro Marques, Nicole; Salter, Michael G; Koutrouvelis, Aristides K; Li, Husong; Solanki, Daneshvari R; Indrikovs, Alexander; Seeton, Roger; Henkel, Sheryl N; Kinsky, Michael P

    2017-10-01

    We sought to evaluate the efficacy, efficiency, and physiologic consequences of automated, endpoint-directed resuscitation systems and compare them to formula-based bolus resuscitation. Experimental human hemorrhage and resuscitation. Clinical research laboratory. Healthy volunteers. Subjects (n = 7) were subjected to hemorrhage and underwent a randomized fluid resuscitation scheme on separate visits 1) formula-based bolus resuscitation; 2) semiautonomous (decision assist) fluid administration; and 3) fully autonomous (closed loop) resuscitation. Hemodynamic variables, volume shifts, fluid balance, and cardiac function were monitored during hemorrhage and resuscitation. Treatment modalities were compared based on resuscitation efficacy and efficiency. All approaches achieved target blood pressure by 60 minutes. Following hemorrhage, the total amount of infused fluid (bolus resuscitation: 30 mL/kg, decision assist: 5.6 ± 3 mL/kg, closed loop: 4.2 ± 2 mL/kg; p < 0.001), plasma volume, extravascular volume (bolus resuscitation: 17 ± 4 mL/kg, decision assist: 3 ± 1 mL/kg, closed loop: -0.3 ± 0.3 mL/kg; p < 0.001), body weight, and urinary output remained stable under decision assist and closed loop and were significantly increased under bolus resuscitation. Mean arterial pressure initially decreased further under bolus resuscitation (-10 mm Hg; p < 0.001) and was lower under bolus resuscitation than closed loop at 20 minutes (bolus resuscitation: 57 ± 2 mm Hg, closed loop: 69 ± 4 mm Hg; p = 0.036). Colloid osmotic pressure (bolus resuscitation: 19.3 ± 2 mm Hg, decision assist, closed loop: 24 ± 0.4 mm Hg; p < 0.05) and hemoglobin concentration were significantly decreased after bolus fluid administration. We define efficacy of decision-assist and closed-loop resuscitation in human hemorrhage. In comparison with formula-based bolus resuscitation, both semiautonomous and autonomous approaches were more

  18. Micropropagation of Gerbera (Gerbera jamesonii Bolus).

    PubMed

    Minerva, Ghani; Kumar, Surinder

    2013-01-01

    Gerbera (Gerbera jamesonii Bolus) is one of the most popular ornamental flowers worldwide and used both as cut flower and potted plant. Some of them show excellent agronomic characters such as color, floral diameter, stem length, and vigor, which make this plant of commercial importance. Conventionally, multiplication is done through seeds or rhizome cuttings. Rapid multiplication of elite cultivars of Gerbera, with improved agronomic traits, has been achieved by using both direct and indirect tissue culture methods. Direct shoot regeneration was accomplished from stem apices on MS medium supplemented with 1 mg/L 6-benzyladenine (BA) and 1 mg/L kinetin. Indirect shoot induction succeeded from callus differentiation has been achieved on MS medium containing 2 mg/L 2,4-dichlorophenoxyacetic acid, 0.5 mg/L indole-3-acetic acid, and 2 mg/L BA. The in vitro shoots, 4-5 cm long, were rooted by quick dipping the shoot bases for 3-5 s in 2,000 mg/L indole-3-butyric acid solution followed by transfer to the pots containing farmyard manure, soil, and sand (1:1:1 by volume). Initially, in vitro plantlets were covered with glass jars to maintain a high relative humidity (85-90%). As soon as new shoot growth begins, relative humidity is decreased by exposing them to the open environmental conditions prior transferring to the glasshouse. Indirect shoot regeneration increased the frequency of somaclonal variations. The selected somaclones were used in developing new and novel cultivars.

  19. Patient-controlled Intermittent Epidural Bolus Versus Epidural Infusion for Posterior Spinal Fusion After Adolescent Idiopathic Scoliosis: Prospective, Randomized, Double-blinded Study.

    PubMed

    Erdogan, Mehmet Ali; Ozgul, Ulku; Ucar, Muharrem; Korkmaz, Mehmet Fatih; Aydogan, Mustafa Said; Ozkan, Ahmet Selim; Colak, Cemil; Durmus, Mahmut

    2017-06-15

    A prospective, randomized, double-blinded study. The aim of this study was to compare the efficacy and side effects of patient-controlled intermittent bolus epidural analgesia (PCIEA) and patient-controlled continuous epidural analgesia (PCCEA) for postoperative pain control in adolescent idiopathic scoliosis. Epidural analgesia is an accepted efficacious and safe procedure for postoperative pain management in scoliosis surgery. However, the PCIEA has not been adequately investigated for postoperative pain control in adolescent idiopathic scoliosis. Forty-seven patients, 8 to 18 years of age, who were undergoing posterior spinal fusion for idiopathic scoliosis were randomized to either the PCIEA or PCCEA group. An epidural catheter was inserted by a surgeon under direct visualization. The PCIEA group received 0.2 mg/mL of morphine, 0.25 mL/kg of morphine bolus, additional doses of 0.25 mL/kg morphine with a 1-hour lockout given by patient-controlled demand, and no infusion. The PCCEA group received the following: 0.2 mg/mL morphine, an initial morphine loading set at 0.1 mL/kg, followed by a 0.05 mL/kg/h continuous infusion of morphine, and a 0.025 mL/kg bolus dose of morphine. There was a 30-minute lockout interval. The primary outcome was morphine usage. The secondary outcomes were pain score, postoperative nausea and vomiting, and pruritus. Cumulative morphine consumption was lower in the PCIEA group than in the PCCEA group. Both methods provided effective pain control. There were no differences in pain scores between the groups. Postoperative nausea, vomiting, and pruritus were lower in the PCIEA group. The two epidural analgesia techniques studied are both safe and effective methods for postoperative pain control after posterior spinal fusion in idiopathic scoliosis. Nausea, vomiting and pruritus were considerably higher in the PCCEA group. Concerns regarding side effects associated with epidural opioids can be avoided by an intermittent bolus

  20. SU-D-18C-05: Variable Bolus Arterial Spin Labeling MRI for Accurate Cerebral Blood Flow and Arterial Transit Time Mapping

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Johnston, M; Jung, Y

    2014-06-01

    Purpose: Arterial spin labeling (ASL) is an MRI perfusion imaging method from which quantitative cerebral blood flow (CBF) maps can be calculated. Acquisition with variable post-labeling delays (PLD) and variable TRs allows for arterial transit time (ATT) mapping and leads to more accurate CBF quantification with a scan time saving of 48%. In addition, T1 and M0 maps can be obtained without a separate scan. In order to accurately estimate ATT and T1 of brain tissue from the ASL data, variable labeling durations were invented, entitled variable-bolus ASL. Methods: All images were collected on a healthy subject with a 3Tmore » Siemens Skyra scanner. Variable-bolus Psuedo-continuous ASL (PCASL) images were collected with 7 TI times ranging 100-4300ms in increments of 700ms with TR ranging 1000-5200ms. All boluses were 1600ms when the TI allowed, otherwise the bolus duration was 100ms shorter than the TI. All TI times were interleaved to reduce sensitivity to motion. Voxel-wise T1 and M0 maps were estimated using a linear least squares fitting routine from the average singal from each TI time. Then pairwise subtraction of each label/control pair and averaging for each TI time was performed. CBF and ATT maps were created using the standard model by Buxton et al. with a nonlinear fitting routine using the T1 tissue map. Results: CBF maps insensitive to ATT were produced along with ATT maps. Both maps show patterns and averages consistent with literature. The T1 map also shows typical T1 contrast. Conclusion: It has been demonstrated that variablebolus ASL produces CBF maps free from the errors due to ATT and tissue T1 variations and provides M0, T1, and ATT maps which have potential utility. This is accomplished with a single scan in a feasible scan time (under 6 minutes) with low sensivity to motion.« less

  1. SU-F-T-87: Comparison of Advanced Radiotherapy Techniques for Post- Mastectomy Breast Cancer Patients

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Heins, D; Zhang, R; Hogstrom, K

    2016-06-15

    Purpose: To determine if bolus electron conformal therapy (Bolus-ECT) combined with intensity modulated x-ray therapy (IMXT) and flattening filter free volumetric modulated arc therapy (FFF-VMAT (6x and 10x)) can maintain equal or better dose coverage than standard volumetric modulated arc therapy (Std-VMAT) while reducing doses to organs at risk (OARs). Methods: Bolus-ECT with IMXT, FFF-VMAT, and Std-VMAT treatment plans were produced for ten post-mastectomy radiotherapy (PMRT) patients previously treated at our clinic. The treatment plans were created on commercially available treatment planning system (TPS) and all completed treatment plans were reviewed and approved by a radiation oncologist. The plans weremore » evaluated based on planning target volume (PTV) coverage, tumor control probability (TCP), dose homogeneity index (DHI), conformity index (CI), and dose to organs at risk (OAR). Results: All techniques produced clinically acceptable PMRT plans. Overall, Bolus-ECT with IMXT exhibited higher maximum dose compared to all VMAT techniques. Bolus-ECT with IMXT and FFF-VMAT10x had slightly improved TCP over FFF-VMAT6x and Std-VMAT. However, all VMAT techniques showed improved CI and DHI over Bolus-ECT with IMXT. All techniques showed very similar mean lung dose. Bolus-ECT with IMXT exhibited a reduced mean heart dose over Std-VMAT. Both FFF-VMAT techniques had higher mean heart dose compared to Std-VMAT. In addition, Bolus-ECT with IMXT was able to reduce mean dose to the contralateral breast compared to Std-VMAT and both FFF-VMAT techniques had comparable but slightly reduced dose compared to Std-VMAT. Conclusion: This work has shown that Bolus-ECT with IMXT produces clinically acceptable plans while reducing OAR doses. Both FFF-VMAT techniques are comparable to Std-VMAT with slight improvements. Even though all VMAT techniques produce more homogenous and conformal dose distributions, Bolus-ECT with IMXT is a viable option for treating post

  2. Methylprednisolone as a memory enhancer in rats: Effects on aversive memory, long-term potentiation and calcium influx.

    PubMed

    de Vargas, Liane da Silva; Gonçalves, Rithiele; Lara, Marcus Vinícius S; Costa-Ferro, Zaquer S M; Salamoni, Simone Denise; Domingues, Michelle Flores; Piovesan, Angela Regina; de Assis, Dênis Reis; Vinade, Lucia; Corrado, Alexandre P; Alves-Do-Prado, Wilson; Correia-de-Sá, Paulo; da Costa, Jaderson Costa; Izquierdo, Ivan; Dal Belo, Cháriston A; Mello-Carpes, Pâmela B

    2017-09-01

    It is well recognized that stress or glucocorticoids hormones treatment can modulate memory performance in both directions, either impairing or enhancing it. Despite the high number of studies aiming at explaining the effects of glucocorticoids on memory, this has not yet been completely elucidated. Here, we demonstrate that a low daily dose of methylprednisolone (MP, 5mg/kg, i.p.) administered for 10-days favors aversive memory persistence in adult rats, without any effect on the exploring behavior, locomotor activity, anxiety levels and pain perception. Enhanced performance on the inhibitory avoidance task was correlated with long-term potentiation (LTP), a phenomenon that was strengthen in hippocampal slices of rats injected with MP (5mg/kg) during 10days. Additionally, in vitro incubation with MP (30-300µM) concentration-dependently increased intracellular [Ca 2+ ] i in cultured hippocampal neurons depolarized by KCl (35mM). In conclusion, a low daily dose of MP for 10days may promote aversive memory persistence in rats. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Closed-loop double-vasopressor automated system vs manual bolus vasopressor to treat hypotension during spinal anaesthesia for caesarean section: a randomised controlled trial.

    PubMed

    Sng, B L; Tan, H S; Sia, A T H

    2014-01-01

    Hypotension necessitating vasopressor administration occurs commonly during caesarean section under spinal anaesthesia. We developed a novel vasopressor delivery system that automatically administers phenylephrine or ephedrine based on continuous non-invasive arterial pressure monitoring. A phenylephrine bolus of 50 μg was given at 30-s intervals when systolic blood pressure fell < 90% of baseline; an ephedrine bolus of 4 mg was given instead if systolic pressure fell < 90% of baseline together with a heart rate < 60 beats.min(-1). The control group used manual boluses of either phenylephrine 100 μg or ephedrine 8 mg, administered at 1-min intervals based on the same thresholds for systolic pressure and heart rate. This randomised, controlled, double-blinded trial involved 213 healthy women who underwent elective caesarean delivery under spinal anaesthesia using 11 mg hyperbaric bupivacaine with 15 μg fentanyl and 100 μg morphine. The automated vasopressor group had better systolic pressure control, with 37/106 (34.9%) having any beat-to-beat systolic pressure reading < 80% of baseline compared with 63/107 (58.9%) in the control group (p < 0.001). There was no difference in the incidence of reactive hypertension, defined as systolic pressure > 120% of baseline, with 8/106 (7.5%) in the automated vasopressor group vs 14/107 (13.1%) in the control group, or total dose of vasopressors. The automated vasopressor group had lower median absolute performance error of 8.5% vs control of 9.8% (p = 0.013), and reduced incidence of nausea (1/106 (0.9%) vs 11/107 (10.3%), p = 0.005). Neonatal umbilical cord pH, umbilical lactate and Apgar scores were similar. Hence, our system afforded better control of maternal blood pressure and reduced nausea with no increase in reactive hypertension when compared with manual boluses. © 2013 The Association of Anaesthetists of Great Britain and Ireland.

  4. Pulse pressure variation-guided fluid therapy after cardiac surgery: a pilot before-and-after trial.

    PubMed

    Suzuki, Satoshi; Woinarski, Nicholas C Z; Lipcsey, Miklos; Candal, Cristina Lluch; Schneider, Antoine G; Glassford, Neil J; Eastwood, Glenn M; Bellomo, Rinaldo

    2014-12-01

    The aim of this study is to study the feasibility, safety, and physiological effects of pulse pressure variation (PPV)-guided fluid therapy in patients after cardiac surgery. We conducted a pilot prospective before-and-after study during mandatory ventilation after cardiac surgery in a tertiary intensive care unit. We introduced a protocol to deliver a fluid bolus for a PPV≥13% for at least >10 minutes during the intervention period. We studied 45 control patients and 53 intervention patients. During the intervention period, clinicians administered a fluid bolus on 79% of the defined PPV trigger episodes. Median total fluid intake was similar between 2 groups during mandatory ventilation (1297 mL [interquartile range 549-1968] vs 1481 mL [807-2563]; P=.17) and the first 24 hours (3046 mL [interquartile range 2317-3982] vs 3017 mL [2192-4028]; P=.73). After adjusting for several baseline factors, PPV-guided fluid management significantly increased fluid intake during mandatory ventilation (P=.004) but not during the first 24 hours (P=.47). Pulse pressure variation-guided fluid therapy, however, did not significantly affect hemodynamic, renal, and metabolic variables. No serious adverse events were noted. Pulse pressure variation-guided fluid management was feasible and safe during mandatory ventilation after cardiac surgery. However, its advantages may be clinically small. Copyright © 2014 Elsevier Inc. All rights reserved.

  5. Pharmacokinetic and pharmacodynamic assessment of bioavailability for two prodrugs of methylprednisolone

    PubMed Central

    Daley-Yates, P. T.; Gregory, A. J.; Brooks, C. D.

    1997-01-01

    Aims The aim of this study was to establish whether pharmacokinetic differences between two pro-drugs of methylprednisolone (MP) are likely to be of clinical significance. Methods This study was a single-blind, randomized, crossover design comparing the bioequivalence of MP released from the pro-drugs Promedrol (MP suleptanate) and Solu-Medrol (MP succinate) after a single 250 mg (MP equivalent) intramuscular injection to 20 healthy male volunteers. Bioequivalence was assessed by conventional pharmacokinetic analysis, by measuring pharmacodynamic responses plus a novel approach using pharmacokinetic/pharmacodynamic modeling. The main measure of pharmacodynamic response was whole blood histamine (WBH), a measure of basophil numbers. Results The MP Cmax was less for MP suleptanate due to a longer absorption half-life of the prodrug from the intramuscular injection site. The bioavailability of MP was equivalent when based on AUC with a MP suleptanate median 108% of the MP succinate value (90% CI: 102–114%). For Cmax the MP suleptanate median was 81% of the MP succinate value (90% CI: 75–88%). The tmax for MP from MP suleptanate was delayed relative to MP succinate. The median difference was 200% (90% non-parametric CI: 141–283%). The area under the WBH effect-time curve (AUEC) and the maximum response (Emax ) were found to be equivalent (90% CI: 98–113% and 93–109% respectively). The maximum changes in other white blood cell counts, blood glucose concentration and the parameters of the pharmacodynamic sigmoid Emax model (EC50, Emax and γ) were also not significantly different between prodrugs. Conclusions MP suleptanate is an acceptable pharmaceutical alternative to MP succinate. The use of both pharmacokinetic and pharmacodynamic response data together gives greater confidence in the conclusions compared with those based only on conventional pharmacokinetic bioequivalence analysis. PMID:9205819

  6. Adrenal steroidogenesis after B lymphocyte depletion therapy in new-onset Addison's disease.

    PubMed

    Pearce, Simon H S; Mitchell, Anna L; Bennett, Stuart; King, Phil; Chandran, Sukesh; Nag, Sath; Chen, Shu; Smith, Bernard Rees; Isaacs, John D; Vaidya, Bijay

    2012-10-01

    A diagnosis of Addison's disease means lifelong dependence on daily glucocorticoid and mineralocorticoid therapy and is associated with increased morbidity and mortality as well as a risk of unexpected adrenal crisis. The objective of the study was to determine whether immunomodulatory therapy at an early stage of autoimmune Addison's disease could lead to preservation or improvement in adrenal steroidogenesis. This was an open-label, pilot study of B lymphocyte depletion therapy in new-onset idiopathic primary adrenal failure. Doses of iv rituximab (1 g) were given on d 1 and 15, after pretreatment with 125 mg iv methylprednisolone. Six patients (aged 17-47 yr; four females) were treated within 4 wk of the first diagnosis of idiopathic primary adrenal failure. Dynamic testing of adrenal function was performed every 3 months for at least 12 months. Serum cortisol levels declined rapidly and were less than 100 nmol/liter (3.6 μg/dl) in all patients by 3 months after B lymphocyte depletion. Serum cortisol and aldosterone concentrations remained low in five of the six patients throughout the follow-up period. However, a single patient had sustained improvement in both serum cortisol [peak 434 nmol/liter (15.7 μg/dl)] and aldosterone [peak 434 pmol/liter (15.7 ng/dl)] secretion. This patient was able to discontinue steroid medications 15 months after therapy and remains well, with improving serum cortisol levels 27 months after therapy. New-onset autoimmune Addison's disease should be considered as a potentially reversible condition in some patients. Future studies of immunomodulation in autoimmune Addison's disease may be warranted.

  7. ANALGESIC EFFECT OF INTRATHECAL BACLOFEN BOLUS ON NEUROPATHIC PAIN IN SPINAL CORD INJURY PATIENTS.

    PubMed

    Kumru, Hatice; Benito-Penalva, Jesus; Kofler, Markus; Vidal, Joan

    2018-05-18

    GABA-ergic neurons are widely distributed throughout the central nervous system, including the spinal cord which is important for the transmission of pain impulses to the brain. Here we hypothesized that intrathecal baclofen (ITB) which is a GABA analogue might exert analgesic effects on neuropathic pain, which could be related to subtypes of pain in spinal cord injury (SCI). SCI patients with a cervical or thoracic lesion and neuropathic pain were randomized to receive either a single ITB bolus or placebo. Numerical Rating Scale (NRS), Neuropathic Pain Symptom Inventory (NPSI), and Brief Pain Inventory (BPI) were obtained for assessment of neuropathic pain. Spasticity was assessed using Modified Ashworth Scale and visual analogue scale. Evaluations were performed at baseline, and 4, 8, and 24 hours after application of ITB or placebo. Eight patients received ITB, 5 placebo. Neuropathic pain improved significantly in the ITB group based on NRS, BPI, and NPSI, which revealed an effect on all subtypes of pain. Spasticity declined significantly. In the placebo group, there was neither significant change in pain nor in spasticity. An ITB bolus exerted a significant analgesic effect on all subtypes of neuropathic pain in SCI patients. ITB has analgesic effects on all subtypes of neuropathic pain and can improve interference of neuropathic pain with activities of daily living. ITB might be a promising analgesic treatment to control neuropathic pain. Copyright © 2018. Published by Elsevier Inc.

  8. Paradoxically aggressive multiple sclerosis in the face of natalizumab therapy.

    PubMed

    Berger, J R

    2008-06-01

    In the pivotal trials of natalizumab in the treatment of relapsing-remitting multiple sclerosis (AFFIRM and SENTINEL), a dramatic reduction in relapse rate, new or enlarging T2-hyperintense lesions, and mean number of gadolinium-enhancing lesions was observed. While both relapses and new MRI lesions were observed in these trials, there has been no comment on the presence of aggressive disease in the face of natalizumab treatment. I report a 31-year-old woman with relapsing remitting MS of 12 years duration who developed aggressive demyelinating disease four months after the initiation of natalizumab. The clinical worsening was accompanied by a significant increase in new large T2-hyperintense signal abnormalities and in both solid and C-shaped contrast-enhancing lesions. Neither the clinical severity nor the striking MRI abnormalities had been noted earlier in her disease course. Neutralizing antibodies to natalizumab were not detected. She subsequently responded to combination therapy of pulsed methylprednisolone and daily glatiramer acetate.

  9. Nonlinear pharmacokinetics of visnagin in rats after intravenous bolus administration.

    PubMed

    Haug, Karin G; Weber, Benjamin; Hochhaus, Guenther; Butterweck, Veronika

    2012-01-23

    Ammi visnaga L. (syn. Khella, Apiaceae) preparations have traditionally been used in the Middle East for the treatment of kidney stone disease. Visnagin, a furanocoumarin derivative, is one of the main compounds of Ammi visnaga with potential effects on kidney stone prevention. To date, no information is available about the pharmacokinetic (PK) properties of visnagin. It was the aim of the study to characterize the PK properties of visnagin after intravenous (i.v.) bolus administration in rats and to develop an adequate model for the description of the observed data, including model parameter estimates. Therefore, three doses of visnagin (1.25, 2.5, and 5mg/kg) solubilized in 25% Captisol® were administered by i.v. bolus injection to male Sprague-Dawley rats. Plasma samples were extracted and subsequently analyzed using a validated LC-MS/MS method. Both non-compartmental and compartmental PK analyses were performed. A stepwise model building approach was applied including nonlinear mixed effect modeling for final model selection and to obtain final model estimates in NONMEM VI. The average areas under the curve (AUC(0-last)) after doses of 1.25, 2.5, and 5mg/kg were 1.03, 3.61, and 12.6 mg *h/l, respectively. The shape of the plasma concentration-time profiles and the observed disproportionate increase in AUC(0-last) with increasing dose suggested nonlinearity in the elimination of visnagin. A two-compartment Michaelis-Menten model provided the best fit with following typical values of the parameter estimates: 2.09 mg/(l*h) (V(max)), 0.08 mg/l (K(M)), 0.175 l (V(C)), 1.0 h⁻¹ (k₁₂), and 1.22 h⁻¹ (k₂₁). Associated inter-subject variability estimates (% CV) for V(max), K(M) and V(C) were 21.8, 70.9, and 9.2, respectively. Intra-subject variability (constant CV error model) was estimated to be 7.0%. The results suggest the involvement of a saturable process in the elimination of visnagin, possibly an enzyme or transporter system. Copyright © 2011

  10. When enough is enough: how the decision was made to stop the FEAST trial: data and safety monitoring in an African trial of Fluid Expansion As Supportive Therapy (FEAST) for critically ill children

    PubMed Central

    2013-01-01

    In resource-rich countries, bolus fluid expansion is routinely used for the treatment of poor perfusion and shock, but is less commonly used in many African settings. Controversial results from the recently completed FEAST (Fluid Expansion As Supportive Therapy) trial in African children have raised questions about the use of intravenous bolus fluid for the treatment of shock. Prior to the start of the trial, the Independent data monitoring committee (IDMC) developed stopping rules for the proof of benefit that bolus fluid resuscitation would bring. Although careful safety monitoring was put in place, there was less expectation that bolus fluid expansion would be harmful and differential stopping rules for harm were not formulated. In July 2010, two protocol amendments were agreed to increase the sample size from 2,880 to 3,600 children, and to increase bolus fluid administration. There was a non-significant trend against bolus treatment, but although the implications were discussed, the IDMC did not comment on the results, or on the amendments, in order to avoid inadvertent partial unblinding of the study. In January 2011, the trial was stopped for futility, as the combined intervention arms had significantly higher mortality (relative risk 1.46, 95% CI 1.13 to 1.90, P = 0.004) than the control arm. The stopping rule for proof of benefit was not achieved, and the IDMC stopped the trial with a lower level of significance (P = 0.01) due to futility and an increased risk of mortality from bolus fluid expansion in children enrolled in the trial. The basis for this decision was that the local standard of care was not to use bolus fluid for the care of children with shock in these African countries, and this was a different standard of care to that used in the UK. These decisions emphasize two important principles: firstly, the IDMC should avoid inadvertent unblinding of the trial by commenting on amendments, and secondly, when considering stopping a trial, the IDMC

  11. When enough is enough: how the decision was made to stop the FEAST trial: data and safety monitoring in an African trial of Fluid Expansion As Supportive Therapy (FEAST) for critically ill children.

    PubMed

    Todd, Jim; Heyderman, Robert S; Musoke, Philippa; Peto, Tim

    2013-03-26

    In resource-rich countries, bolus fluid expansion is routinely used for the treatment of poor perfusion and shock, but is less commonly used in many African settings. Controversial results from the recently completed FEAST (Fluid Expansion As Supportive Therapy) trial in African children have raised questions about the use of intravenous bolus fluid for the treatment of shock. Prior to the start of the trial, the Independent data monitoring committee (IDMC) developed stopping rules for the proof of benefit that bolus fluid resuscitation would bring. Although careful safety monitoring was put in place, there was less expectation that bolus fluid expansion would be harmful and differential stopping rules for harm were not formulated.In July 2010, two protocol amendments were agreed to increase the sample size from 2,880 to 3,600 children, and to increase bolus fluid administration. There was a non-significant trend against bolus treatment, but although the implications were discussed, the IDMC did not comment on the results, or on the amendments, in order to avoid inadvertent partial unblinding of the study.In January 2011, the trial was stopped for futility, as the combined intervention arms had significantly higher mortality (relative risk 1.46, 95% CI 1.13 to 1.90, P = 0.004) than the control arm. The stopping rule for proof of benefit was not achieved, and the IDMC stopped the trial with a lower level of significance (P = 0.01) due to futility and an increased risk of mortality from bolus fluid expansion in children enrolled in the trial. The basis for this decision was that the local standard of care was not to use bolus fluid for the care of children with shock in these African countries, and this was a different standard of care to that used in the UK. These decisions emphasize two important principles: firstly, the IDMC should avoid inadvertent unblinding of the trial by commenting on amendments, and secondly, when considering stopping a trial, the IDMC

  12. Use of the bolus tracking technique for the tomographic evaluation of the uretero-vesicular junction in dogs and assessment of dose records.

    PubMed

    Longo, Maurizio; Andreis, Maria Elena; Pettinato, Cinzia; Ravasio, Giuliano; Rabbogliatti, Vanessa; De Zani, Donatella; Di Giancamillo, Mauro; Zani, Davide Danilo

    2016-03-29

    The aim of the work is the application of a bolus tracking technique for tomographic evaluation of the uretero-vesicular junction in dogs. Ten adult dogs (8-14 years) with variable body weight (2,8-32 kg) were enrolled in the prospective study. The patients were placed in sternal recumbency with a 10° elevated pelvis and the visualization of the uretero-vesicular junction was obtained with the bolus tracking technique after intravenous administration of non-ionic contrast medium. In the post-contrast late phase a region of interest was placed within the lumen of the distal ureters and the density values were monitored before starting the helical scan. The uretero-vesicular junction was clearly visible in 100% of patients with the visualization of the endoluminal ureteral contrast enhancement and bladder washout. At the end of the tomographic study an evaluation of the dose records was performed and compared to human exposures reported in literature for the pelvic region. The effective dose estimated for each patient (37,5-138 mSv) proved to be elevated, when compared to those reported in human patients. The bolus tracking technique could be applied for the visualization of the uretero-vesicular junction in non-pathological patients, placing the region of interest in the distal ureters. The high effective doses recorded in our study support the need of specific thresholds for veterinary patients, pointing out the attention for paediatric patient's exposure also in veterinary imaging.

  13. A Randomized Study Comparing the Shaker Exercise with Traditional Therapy: A Preliminary Study

    PubMed Central

    Rademaker, Alfred; Pauloski, Barbara Roa; Kelly, Amy; Stangl-McBreen, Carrie; Antinoja, Jodi; Grande, Barbara; Farquharson, Julie; Kern, Mark; Easterling, Caryn; Shaker, Reza

    2010-01-01

    Seven institutions participated in this small clinical trial that included 19 patients who exhibited oropharyngeal dysphagia on videofluorography (VFG) involving the upper esophageal sphincter (UES) and who had a 3-month history of aspiration. All patients were randomized to either traditional swallowing therapy or the Shaker exercise for 6 weeks. Each patient received a modified barium swallow pre- and post-therapy, including two swallows each of 3 ml and 5 ml liquid barium and 3 ml barium pudding. Each videofluorographic study was sent to a central laboratory and digitized in order to measure hyoid and larynx movement as well as UES opening. Fourteen patients received both pre-and post-therapy VFG studies. There was significantly less aspiration post-therapy in patients in the Shaker group. Residue in the various oral and pharyngeal locations did not differ between the groups. With traditional therapy, there were several significant increases from pre- to post-therapy, including superior laryngeal movement and superior hyoid movement on 3-ml pudding swallows and anterior laryngeal movement on 3-ml liquid boluses, indicating significant improvement in swallowing physiology. After both types of therapy there is a significant increase in UES opening width on 3-ml paste swallows. PMID:19472007

  14. [Diuretic therapy in acute heart failure].

    PubMed

    Trullàs, Joan Carles; Morales-Rull, José Luis; Formiga, Francesc

    2014-03-01

    Diuretics are widely recommended in patients with acute heart failure (AHF). Unfortunately, despite their widespread use, limited data are available from randomized clinical trials to guide clinicians on the appropriate management of diuretic therapy. Loop diuretics are considered the first-line diuretic therapy, especially intravenous furosemide, but the best mode of administration (high-dose versus low-dose and continuous infusion versus bolus) is unclear. When diuretic resistance develops, different therapeutic strategies can be adopted, including combined diuretic therapy with thiazide diuretics and/or aldosterone antagonists. Low or "non-diuretic" doses (25-50mg QD) of aldosterone antagonists have been demonstrated to confer a survival benefit in patients with heart failure and reduced ejection fraction and consequently should be prescribed in all such patients, unless contraindicated by potassium and/or renal function values. There is less evidence on the use of aldosterone antagonists at higher or "diuretic" doses (≥ 100mg QD) but these drugs could be useful in relieving congestive symptoms in combination with furosemide. Thiazide diuretics can also be helpful as they have synergic effects with loop diuretics by inhibiting sodium reabsorption in distal parts of the nephron. The effect of diuretic therapy in AHF should be monitored with careful observation of clinical signs and symptoms of congestion. Serum electrolytes and kidney function should also be monitored during the use of intravenous diuretics. Copyright © 2014 Elsevier España, S.L. All rights reserved.

  15. A retrospective comparison of smart prep and test bolus multi-detector CT pulmonary angiography protocols

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Suckling, Tara; Smith, Tony; Reed, Warren

    2013-06-15

    Optimal arterial opacification is crucial in imaging the pulmonary arteries using computed tomography (CT). This poses the challenge of precisely timing data acquisition to coincide with the transit of the contrast bolus through the pulmonary vasculature. The aim of this quality assurance exercise was to investigate if a change in CT pulmonary angiography (CTPA) scanning protocol resulted in improved opacification of the pulmonary arteries. Comparison was made between the smart prep protocol (SPP) and the test bolus protocol (TBP) for opacification in the pulmonary trunk. A total of 160 CTPA examinations (80 using each protocol) performed between January 2010 andmore » February 2011 were assessed retrospectively. CT attenuation coefficients were measured in Hounsfield Units (HU) using regions of interest at the level of the pulmonary trunk. The average pixel value, standard deviation (SD), maximum, and minimum were recorded. For each of these variables a mean value was then calculated and compared for these two CTPA protocols. Minimum opacification of 200 HU was achieved in 98% of the TBP sample but only 90% of the SPP sample. The average CT attenuation over the pulmonary trunk for the SPP was 329 (SD = ±21) HU, whereas for the TBP it was 396 (SD = ±22) HU (P = 0.0017). The TBP also recorded higher maximum (P = 0.0024) and minimum (P = 0.0039) levels of opacification. This study has found that a TBP resulted in significantly better opacification of the pulmonary trunk than the SPP.« less

  16. Pronounced reversible hyperammonemic encephalopathy associated with combined valproate-topiramate therapy in a 7-year-old girl.

    PubMed

    Weise, Sebastian; Syrbe, Steffen; Preuss, Matthias; Bertsche, Astrid; Merkenschlager, Andreas; Bernhard, Matthias K

    2015-01-01

    Valproate is one of the most frequently used anticonvulsive drugs in children and adults. Valproate is a generally well tolerated medication. However, encephalopathy with or without hyperammonemia is one of its rare adverse events. We present a 7-year-old girl who suffered from epilepsy with generalized tonic-clonic seizures and absence epilepsy. She was initially treated with topiramate. Methylprednisolone pulse therapy and long-term therapy with valproate were initiated due to an increase of seizure frequency. At day 5 of therapy, a further increase of seizure frequency was observed followed by lethargy and somnolence. Liver enzymes remained within normal range, but ammonia serum levels increased to a maximum of 544 mmol/l. Discontinuing valproate and starting potassium-benzoate and sodium-phenylbutyrate improved the clinical condition and ammonia serum levels. Haemodialysis was not required. Cranial magnetic resonance imaging ruled out brain edema. The patient was further on successfully treated with a combination of both, topiramate and levetiracetam. Seizures did not recur and development was normal until now (3 years later). To the best of our knowledge, we observed the highest ammonia serum levels ever reported in valproate-induced hyperammonemia with a complete remission of the subsequent encephalopathy. Topiramate might increase the risk of valproate-induced encephalopathy by carbonic anhydrase inhibition.

  17. Safety Profile and Effects of Pulsed Methylprednisolone on Vital Signs in Thyroid Eye Disease.

    PubMed

    Yong, Kai-Ling; Chng, Chiaw Ling; Htoon, Hla Myint; Lim, Lee Hooi; Seah, Lay Leng

    2015-01-01

    Objective. To analyze changes in vital signs (heart rate (HR), systolic (SBP), and diastolic blood pressure (DBP)) during and after intravenous methylprednisolone (IVMP) and any other adverse effects. Methods. Retrospective review of charts of patients who received IVMP as treatment regime for thyroid eye disease. All subjects had vital signs charted during and after infusions. Results. This study included 38 subjects and a total of 242 infusions administered. IVMP resulted in a small but significant percentage drop in mean SBP at 30 min (p < 0.001) and 60 min (p = 0.03) but no difference at 90 min. There was also small but significant percentage drop in mean DBP and HR (DBP: p < 0.001 for 30 min, p = 0.001 for 60 min, and p = 0.02 for 90 min and HR: p < 0.001 for 30 min, 60 min, and 90 min). There were no cumulative effects on change of blood pressure or HR. There were 6 episodes of bradycardia (2.5%) and 12 episodes of moderate to severe hypertension (5%). No significant cardiovascular or hepatic toxicity was found. Conclusion. IVMP is relatively safe and efficacious. IVMP demonstrated mild and noncumulative effects on vital signs. Severe hypertension may occur in susceptible individuals such as those with underlying hypertension and uncontrolled thyroid dysfunction, whereas bradycardia may be more likely in those on beta-blockers.

  18. Surfactant protein-A nanobody-conjugated liposomes loaded with methylprednisolone increase lung-targeting specificity and therapeutic effect for acute lung injury.

    PubMed

    Li, Nan; Weng, Dong; Wang, Shan-Mei; Zhang, Yuan; Chen, Shan-Shan; Yin, Zhao-Fang; Zhai, Jiali; Scoble, Judy; Williams, Charlotte C; Chen, Tao; Qiu, Hui; Wu, Qin; Zhao, Meng-Meng; Lu, Li-Qin; Mulet, Xavier; Li, Hui-Ping

    2017-11-01

    The advent of nanomedicine requires novel delivery vehicles to actively target their site of action. Here, we demonstrate the development of lung-targeting drug-loaded liposomes and their efficacy, specificity and safety. Our study focuses on glucocorticoids methylprednisolone (MPS), a commonly used drug to treat lung injuries. The steroidal molecule was loaded into functionalized nano-sterically stabilized unilamellar liposomes (NSSLs). Targeting functionality was performed through conjugation of surfactant protein A (SPANb) nanobodies to form MPS-NSSLs-SPANb. MPS-NSSLs-SPANb exhibited good size distribution, morphology, and encapsulation efficiency. Animal experiments demonstrated the high specificity of MPS-NSSLs-SPANb to the lung. Treatment with MPS-NSSLs-SPANb reduced the levels of TNF-α, IL-8, and TGF-β1 in rat bronchoalveolar lavage fluid and the expression of NK-κB in the lung tissues, thereby alleviating lung injuries and increasing rat survival. The nanobody functionalized nanoparticles demonstrate superior performance to treat lung injury when compared to that of antibody functionalized systems.

  19. Lung disease severity in idiopathic pulmonary fibrosis is more strongly associated with impedance measures of bolus reflux than pH parameters of acid reflux alone.

    PubMed

    Gavini, S; Borges, L F; Finn, R T; Lo, W-K; Goldberg, H J; Burakoff, R; Feldman, N; Chan, W W

    2017-05-01

    Gastroesophageal reflux (GER) has been associated with idiopathic pulmonary fibrosis (IPF). Pathogenesis may be related to chronic micro-aspiration. We aimed to assess objective measures of GER on multichannel intraluminal impedance and pH study (MII-pH) and their relationship with pulmonary function testing (PFT) results, and to compare the performance of pH/acid reflux parameters vs corresponding MII/bolus parameters in predicting pulmonary dysfunction in IPF. This was a retrospective cohort study of IPF patients undergoing prelung transplant evaluation with MII-pH off acid suppression, and having received PFT within 3 months. Patients with prior fundoplication were excluded. Severe pulmonary dysfunction was defined using diffusion capacity of the lung for carbon monoxide (DLCO) ≤40%. Six pH/acid reflux parameters with corresponding MII/bolus reflux measures were specified a priori. Multivariate analyses were applied using forward stepwise logistic regression. Predictive value of each parameter for severe pulmonary dysfunction was calculated by area-under-the-receiver-operating-characteristic-curve or c-statistic. Forty-five subjects (67% M, age 59, 15 mild-moderate vs 30 severe) met criteria for inclusion. Patient demographics and clinical characteristics were similar between pulmonary dysfunction groups. Abnormal total reflux episodes and prolonged bolus clearance time were significantly associated with pulmonary dysfunction severity on univariate and multivariate analyses. No pH parameters were significant. The c-statistic of each pH parameter was lower than its MII counterpart in predicting pulmonary dysfunction. MII/bolus reflux, but not pH/acid reflux, was associated with pulmonary dysfunction in prelung transplant patients with IPF. MII-pH may be more valuable than pH testing alone in characterizing GER in IPF. © 2016 John Wiley & Sons Ltd.

  20. Use of glucocorticoids in rheumatoid arthritis - pratical modalities of glucocorticoid therapy: recommendations for clinical practice based on data from the literature and expert opinion.

    PubMed

    Dernis, Emmanuelle; Ruyssen-Witrand, Adeline; Mouterde, Gaël; Maillefert, Jean-Francis; Tebib, Jacques; Cantagrel, Alain; Claudepierre, Pascal; Fautrel, Bruno; Gaudin, Philippe; Pham, Thao; Schaeverbeke, Thierry; Wendling, Daniel; Saraux, Alain; Loët, Xavier Le

    2010-10-01

    To develop recommendations about the use of glucocorticoids in patients with established rheumatoid arthritis (RA) managed in everyday practice, using the evidence-based approach and expert opinion. A three-step procedure was used: a scientific committee used a Delphi procedure to select five questions, which formed the basis for developing the recommendations; a systematic literature review was conducted by searching the Medline and Embase databases and the abstracts of meetings held by the Société Française de Rhumatologie (SFR), American College of Rheumatology (ACR), and European League Against Rheumatism (EULAR); and recommendations were developed and validated by a panel of experts based on the data from the literature review and on their experience. For each recommendation, the level of evidence and extent of agreement among experts were determined. The five questions pertained to the use of glucocorticoids in RA patients: role for intravenous glucocorticoid bolus therapy, role for intraarticular injections, and practical modalities of glucocorticoid administration and discontinuation. From the literature search, 93 articles were selected based on their titles and abstracts. Of these, 50 were selected for the literature review. Eight recommendations about the use of glucocorticoid therapy in everyday practice in patients with established RA were validated by a vote among all participating experts: bolus glucocorticoid therapy should be reserved for highly selected situations; triamcinolone hexacetonide is the preferred glucocorticoid for intraarticular therapy, and the joint should be rested for about 24h after the injection; for oral glucocorticoid therapy, agents with a short half-life taken once daily should be preferred; and when discontinuing glucocorticoid therapy, the patient and usual physician should be informed of the risk of adrenal insufficiency. Copyright © 2010 Société française de rhumatologie. Published by Elsevier SAS. All rights

  1. Entering the Era of Targeted Therapy for Chronic Lymphocytic Leukemia: Impact on the Practicing Clinician

    PubMed Central

    Byrd, John C.; Jones, Jeffrey J.; Woyach, Jennifer A.; Johnson, Amy J.; Flynn, Joseph M.

    2014-01-01

    Purpose Chemoimmunotherapy has been the standard of care for chronic lymphocytic leukemia (CLL). However, the introduction of B-cell receptor (BCR) kinase inhibitors such as ibrutinib has the potential to eliminate the role of chemotherapy in the treatment of CLL. How to best incorporate old and new therapies for CLL in this landscape is increasingly complex. Methods This article reviews current data available to clinicians and integrates these data to provide a strategy that can be used to approach the treatment of CLL in the era of BCR signaling inhibitors. Results Current strategies separate patients based on age or functional status as well as genetics [presence or absence of del(17)(p13.1)]. In the era of targeted therapy, this will likely continue based on current available data. Phase III studies support chemoimmunotherapy as the initial standard therapy for patients without del(17)(p13.1). Choice of chemotherapy (fludarabine plus cyclophosphamide, bendamustine, or chlorambucil) and anti-CD20 antibody (rituximab, ofatumumab, or obinutuzumab) varies based on regimen and patient status. For patients with del(17)(p13.1), no standard initial therapy exists, although several options supported by phase II clinical trials (methylprednisolone plus alemtuzumab or ibrutinib) seem better than chemoimmunotherapy. Treatment of relapsed CLL seems to be best supported by ibrutinib-based therapy. Completion of trials with ibrutinib and other new agents in the near future will offer opportunity for chemotherapy-free treatment across all groups of CLL. Conclusion Therapy for CLL has evolved significantly over the past decade with introduction of targeted therapy for CLL. This has the potential to completely transform how CLL is treated in the future. PMID:25049322

  2. Methylprednisolone acetate induces, and Δ7-dafachronic acid suppresses, Strongyloides stercoralis hyperinfection in NSG mice.

    PubMed

    Patton, John B; Bonne-Année, Sandra; Deckman, Jessica; Hess, Jessica A; Torigian, April; Nolan, Thomas J; Wang, Zhu; Kliewer, Steven A; Durham, Amy C; Lee, James J; Eberhard, Mark L; Mangelsdorf, David J; Lok, James B; Abraham, David

    2018-01-02

    Strongyloides stercoralis hyperinfection causes high mortality rates in humans, and, while hyperinfection can be induced by immunosuppressive glucocorticoids, the pathogenesis remains unknown. Since immunocompetent mice are resistant to infection with S. stercoralis , we hypothesized that NSG mice, which have a reduced innate immune response and lack adaptive immunity, would be susceptible to the infection and develop hyperinfection. Interestingly, despite the presence of large numbers of adult and first-stage larvae in S. stercoralis -infected NSG mice, no hyperinfection was observed even when the mice were treated with a monoclonal antibody to eliminate residual granulocyte activity. NSG mice were then infected with third-stage larvae and treated for 6 wk with methylprednisolone acetate (MPA), a synthetic glucocorticoid. MPA treatment of infected mice resulted in 50% mortality and caused a significant >10-fold increase in the number of parasitic female worms compared with infected untreated mice. In addition, autoinfective third-stage larvae, which initiate hyperinfection, were found in high numbers in MPA-treated, but not untreated, mice. Remarkably, treatment with Δ7-dafachronic acid, an agonist of the parasite nuclear receptor Ss -DAF-12, significantly reduced the worm burden in MPA-treated mice undergoing hyperinfection with S. stercoralis Overall, this study provides a useful mouse model for S. stercoralis autoinfection and suggests a therapeutic strategy for treating lethal hyperinfection.

  3. Adrenal Steroidogenesis after B Lymphocyte Depletion Therapy in New-Onset Addison's Disease

    PubMed Central

    Mitchell, Anna L.; Bennett, Stuart; King, Phil; Chandran, Sukesh; Nag, Sath; Chen, Shu; Smith, Bernard Rees; Isaacs, John D.; Vaidya, Bijay

    2012-01-01

    Context: A diagnosis of Addison's disease means lifelong dependence on daily glucocorticoid and mineralocorticoid therapy and is associated with increased morbidity and mortality as well as a risk of unexpected adrenal crisis. Objective: The objective of the study was to determine whether immunomodulatory therapy at an early stage of autoimmune Addison's disease could lead to preservation or improvement in adrenal steroidogenesis. Design and Intervention: This was an open-label, pilot study of B lymphocyte depletion therapy in new-onset idiopathic primary adrenal failure. Doses of iv rituximab (1 g) were given on d 1 and 15, after pretreatment with 125 mg iv methylprednisolone. Patients and Main Outcome Measures: Six patients (aged 17–47 yr; four females) were treated within 4 wk of the first diagnosis of idiopathic primary adrenal failure. Dynamic testing of adrenal function was performed every 3 months for at least 12 months. Results: Serum cortisol levels declined rapidly and were less than 100 nmol/liter (3.6 μg/dl) in all patients by 3 months after B lymphocyte depletion. Serum cortisol and aldosterone concentrations remained low in five of the six patients throughout the follow-up period. However, a single patient had sustained improvement in both serum cortisol [peak 434 nmol/liter (15.7 μg/dl)] and aldosterone [peak 434 pmol/liter (15.7 ng/dl)] secretion. This patient was able to discontinue steroid medications 15 months after therapy and remains well, with improving serum cortisol levels 27 months after therapy. Conclusion: New-onset autoimmune Addison's disease should be considered as a potentially reversible condition in some patients. Future studies of immunomodulation in autoimmune Addison's disease may be warranted. PMID:22767640

  4. Bolus oral or continuous intestinal amino acids reduce hypothermia during anesthesia in rats.

    PubMed

    Imoto, Akinobu; Yokoyama, Takeshi; Suwa, Kunio; Yamasaki, Fumiyasu; Yatabe, Tomoaki; Yokoyama, Reiko; Yamashita, Koichi; Selldén, Eva

    2010-01-01

    We hypothesized that, with oral or intestinal administration of amino acids (AA), we may reduce hypothermia during general anesthesia as effectively as with intravenous AA. We, therefore, examined the effect of bolus oral and continuous intestinal AA in preventing hypothermia in rats. Male Wistar rats were anesthetized with sevoflurane for induction and with propofol for maintenance. In the first experiment, 30 min before anesthesia, rats received one bolus 42 mL/kg of AA solution (100 g/L) or saline orally. Then for the next 3 h during anesthesia, they received 14 mL/kg/h of AA and/or saline intravenously. They were in 4 groups: I-A/A, both AA; I-A/S, oral AA and intravenous saline; I-S/A, oral saline and intravenous AA; I-S/S, both saline. In the second experiment, rats received 14 mL/kg/h duodenal AA and/or saline for 2 h. They were in 3 groups: II-A/S, duodenal AA and intravenous saline; II-S/A, duodenal saline and intravenous AA; II-S/S, both saline. Core body temperature was measured rectally. After the second experiment, serum electrolytes were examined. In both experiments, rectal temperature decreased in all groups during anesthesia. However, the decrease in rectal temperature was significantly less in groups receiving AA than in groups receiving only saline. In the second experiment, although there was no significant difference in the decrease in body temperature between II-A/S and II-S/A, Na(+) concentration was significantly lower in II-S/A. In conclusion, AA, administered orally or intestinally, tended to keep the body temperature stable during anesthesia without disturbing electrolyte balance. These results suggest that oral or enteral AA may be useful for prevention of hypothermia in patients.

  5. Efficacy, distribution and faecal excretion of copper oxide wire particles in a novel bolus in red deer (Cervus elaphus).

    PubMed

    Castillo-Alcala, F; Wilson, P R; Molenaar, R; Lopez-Villalobos, N

    2007-04-01

    To determine the efficacy of a novel copper oxide wire particle (COWP) formulation in elevating concentrations of copper (Cu) in the liver and serum of red deer (Cervus elaphus), and to investigate the distribution of particles in the gastrointestinal tract and the rate of their excretion in faeces. Mixed-age red deer hinds were allocated to three groups (n=10 per group) on the basis of pre-treatment liver Cu concentrations. Groups 1 and 2 were treated orally with a 10-g COWP bolus on Days 0 and 30, respectively, while the remaining group served as an untreated control. Animals were slaughtered on Day 60, when blood and liver samples were collected for determination of Cu concentrations. An additional group of 18-month-old red deer hinds (n=20) were treated orally with a 10-g COWP bolus, and four were slaughtered on each of Days 1, 5, 15, 30 and 60 after treatment. The gastrointestinal tract was secured between compartments below the oesophagus and contents rinsed until sedimentation of particles was complete. The sediment was oven-dried and COWP were separated and weighed. Faeces were collected continuously from four additional animals held in metabolism cages for 4 days after treatment, sub-sampled daily, and COWP recovered. Mean liver Cu concentrations at slaughter were 80, 597 and 447 micromol/kg for controls and hinds treated 30, and 60 days previously, respectively. Corresponding mean serum Cu concentrations were 7.7, 12.9 and 11.9 micromol/L, respectively. Liver and serum Cu concentrations were higher in both treatment groups than in untreated control animals (p<0.001). COWP were found in all compartments of the gastrointestinal tract measured, for at least 15 days, and in the rumen/reticulum and abomasum for at least 60 days post-administration. The highest rate of recovery overall was from the rumen/reticulum. Mean weight of COWP recovered from faeces was 0.09 g during the first 24 h and 0.94 g over the first 4 days following administration. The COWP bolus

  6. Serum of patients with oral pemphigus vulgaris impairs keratinocyte wound repair in vitro: a time-lapse study on the efficacy of methylprednisolone and pyridostigmine bromide.

    PubMed

    Lanza, A; Stellavato, A; Heulfe, I; Landi, C; Gombos, F; Cirillo, N

    2009-10-01

    Pemphigus vulgaris (PV) is an autoimmune blistering disease affecting primarily oral mucosa and skin. Among the drugs used for the therapy of pemphigus, both methylprednisolone (MP) and pyridostigmine bromide (PBr) can prevent acantholysis in vitro. However, their putative therapeutic properties in regenerating PV-like lesions and promoting the healing process still remain to be demonstrated. To address this issue, here we have developed a model for studying the process of epithelial cleft regeneration in PV by artificially wounding keratinocyte monolayers. The experimental model was established by scratching confluent monolayers to simulate the epithelial cleft; then, wound regeneration in the presence of submaximal concentrations of PV sera was studied by time-lapse microscopy, with or without the addition of MP and PBr in the culture medium. Pemphigus vulgaris serum inhibited epithelial cleft repair of wounded monolayers. Indeed, in the presence of 10% (v/v) PV serum, keratinocytes reached only 2% confluence within 72 h vs an almost complete healing of controls. When administered together with PV sera, MP significantly (P < 0.01) enhanced wound fill by 30% after 72 h. PV-associated wound repair was significantly (P < 0.05) ameliorated by PBr by 24 h and keratinocytes reached 20% confluence after 72 h. Interestingly, neither MP nor PBr could accelerate wound healing when compared with untreated control monolayers. In PV, MP and PBr exert their curative effects in part by enhancing the regeneration properties of keratinocytes. Indeed, our data suggest that both drugs can specifically counterbalance the detrimental effects of PV serum on keratinocyte wound healing. These findings provide an explanation for the efficacy of MP and PBr in the treatment of PV lesions in human skin and oral mucosa.

  7. A randomised comparative study of the short term clinical and biological effects of intravenous pulse methylprednisolone and infliximab in patients with active rheumatoid arthritis despite methotrexate treatment.

    PubMed

    Durez, P; Nzeusseu Toukap, A; Lauwerys, B R; Manicourt, D H; Verschueren, P; Westhovens, R; Devogelaer, J-P; Houssiau, F A

    2004-09-01

    To compare the short term clinical and biological effects of intravenous (i.v.) pulse methylprednisolone (MP) and infliximab (IFX) in patients with severe active rheumatoid arthritis (RA) despite methotrexate (MTX) treatment. Patients with active RA despite MTX treatment were randomly allocated to receive a single i.v. infusion of MP (1 g) or three i.v. infusions of IFX (3 mg/kg) on weeks 0, 2, and 6. Patients were "blindly" evaluated for disease activity measures. Quality of life (QoL) was evaluated through the SF-36 health survey. Serum matrix metalloproteinase-3 (MMP-3) titres were measured at baseline, weeks 2 and 6. Compared with baseline, significant improvement was noted in all activity measures, including serum C reactive protein (CRP) titres, in the IFX group only. At week 14, 6/9 (67%) and 4/9 (44%) IFX patients met the ACR20 and 50 response criteria, while this was the case in only 1/12 (8%) and 0/12 (0%) MP patients, respectively (p<0.05). None of the QoL scales improved with MP treatment, whereas some did so in the IFX group. Serum MMP-3 titres significantly decreased (41% drop) at week 6 in the IFX group, while no changes were seen in patients given MP. This short term randomised comparative study demonstrates that TNF blockade is better than MP pulse therapy in a subset of patients with severe refractory RA, with improvement in not only clinical parameters of disease activity but also biological inflammatory indices, such as serum CRP and MMP-3 titres.

  8. Pharmacokinetic Analysis of Ziconotide (SNX-111), an Intrathecal N-type Calcium Channel Blocking Analgesic, Delivered by Bolus and Infusion in the Dog

    PubMed Central

    Yaksh, Tony L.; de Kater, Annelies; Dean, Robin; Best, Brookie M.; Miljanich, George P.

    2012-01-01

    SUMMARY Background and purpose Ziconotide is a peptide that blocks N-type calcium channels and is anti-hyperalgesic after intrathecal delivery. We here characterize the spinal kinetics of intrathecal bolus and infused ziconotide in dog. Experimental approach Male beagle dogs (N = 5) were prepared with chronic intrathecal (IT) lumbar injection and cerebrospinal fluid (LCSF) sampling catheters connected to vest-mounted pumps. Each dog received: i) IT bolus ziconotide (10 µg + 1 µCi 3H-inulin), ii) IT infusion for 48 hr of ziconotide (1 µg/100 µL/hr), iii) IT infusion for 48 hr of ziconotide (5 µg/100 µL/hr), and iv) intravenous injection of ziconotide (0.1 mg/kg). After IT bolus, LCSF ziconotide and inulin showed an initial peak and biphasic (distribtution/elimination) clearance (ziconotide T1/2 α / ß = 0.14 and 1.77 hr, and inulin T1/2 α / ß = 0.16 and 3.88 hr, respectively). The LCSF: plasma ziconotide concentration ratio was 20,000: 1 at 30 min, and 30: 1 at 8 hr. IT infusion of 1 and then 5 µg/hr resulted in LCSF concentrations that peaked by 8 hr and remained stable at 343 and 1380 ng/mL, respectively, to the end of the 48-hr infusions. Terminal elimination T1/2 after termination of continuous infusion was 2.47 hr. Ziconotide LCSF: cisternal CSF: plasma concentration ratios after infusion of 1 µg/hr and 5 µg/hr were 1: 0.017: 0.001 and 1: 0.015: 0.003, respectively. IT infusion of ziconotide at 1 µg/hr inhibited thermal skin twitch by 24 hr, and produced modest trembling, ataxia, and decreased arousal. Effects continued through the 48-hr infusion period, increased in magnitude during the subsequent 5 µg/hr infusion periods, and disappeared after drug clearance. Conclusions and Implications After intrathecal bolus or infusion, ziconotide displays linear kinetics that are consistent with a hydrophilic molecule of approximately 2500 Da that is cleared slightly more rapidly than inulin from the LCSF. Behavioral effects were dose dependent and

  9. Early treatment with infliximab in bilateral occlusive vasculitis as a presenting manifestation of Behçet' disease.

    PubMed

    Bañeros-Rojas, P; Berrozpe-Villabona, C; Peraza-Nieves, J E; Díaz-Valle, D

    2015-06-01

    A 24 year old woman who complained of maculo-papulo rash, genital and bucal aphthous ulcers, abdominal pain, minor dyspnea and visual loss in both eyes. Funduscopy revealed a bilateral occlusive vasculitis including central vessels. Treatment was initiated with a methylprednisolone bolus (1 g/24h) and infliximab 5mg/kg/day (0-2-6 weeks and every 8 weeks). The treatment prescribed induced a fast remission. Visual acuity improved. The patient did not suffer any other relapse after one year of follow-up. An initial treatment with Infliximab should be considered in Behçet disease for serious outbreaks, such as macular occlusive vasculitis with ischemia. Copyright © 2013 Sociedad Española de Oftalmología. Published by Elsevier España, S.L.U. All rights reserved.

  10. Effect of Bolus Viscosity on the Safety and Efficacy of Swallowing and the Kinematics of the Swallow Response in Patients with Oropharyngeal Dysphagia: White Paper by the European Society for Swallowing Disorders (ESSD).

    PubMed

    Newman, Roger; Vilardell, Natàlia; Clavé, Pere; Speyer, Renée

    2016-04-01

    Fluid thickening is a well-established management strategy for oropharyngeal dysphagia (OD). However, the effects of thickening agents on the physiology of impaired swallow responses are not fully understood, and there is no agreement on the degree of bolus thickening. To review the literature and to produce a white paper of the European Society for Swallowing Disorders (ESSD) describing the evidence in the literature on the effect that bolus modification has upon the physiology, efficacy and safety of swallowing in adults with OD. A systematic search was performed using the electronic Pubmed and Embase databases. Articles in English available up to July 2015 were considered. The inclusion criteria swallowing studies on adults over 18 years of age; healthy people or patients with oropharyngeal dysphagia; bolus modification; effects of bolus modification on swallow safety (penetration/aspiration) and efficacy; and/or physiology and original articles written in English. The exclusion criteria consisted of oesophageal dysphagia and conference abstracts or presentations. The quality of the selected papers and the level of research evidence were assessed by standard quality assessments. At the end of the selection process, 33 articles were considered. The quality of all included studies was assessed using systematic, reproducible, and quantitative tools (Kmet and NHMRC) concluding that all the selected articles reached a valid level of evidence. The literature search gathered data from various sources, ranging from double-blind randomised control trials to systematic reviews focused on changes occurring in swallowing physiology caused by thickened fluids. Main results suggest that increasing bolus viscosity (a) results in increased safety of swallowing, (b) also results in increased amounts of oral and/or pharyngeal residue which may result in post-swallow airway invasion, (c) impacts the physiology with increased lingual pressure patterns, no major changes in impaired

  11. Safely Converting an Entire Academic Medical Center From Sliding Scale to Basal Bolus Insulin via Implementation of the eGlycemic Management System.

    PubMed

    Newsom, Rosalina; Patty, Christopher; Camarena, Emma; Sawyer, Regina; McFarland, Raymie; Gray, Thomas; Mabrey, Melanie

    2018-01-01

    Hyperglycemia is common in the inpatient setting and providers frequently rely on sliding scale insulin. This case study reviews the experience of one hospital moving from high utilization of sliding scale to basal bolus insulin therapy. This Retrospective Quality Improvement Study describes the journey of clinicians at a 580-bed hospital to convert from high usage of SSI to BBI. Hyperglycemic adult patients prescribed insulin, with/without a diagnosis of diabetes, were included. Data over the first year showed that patients treated with Glucommander (GM) spent more time in the target range of 70-180 mg/dL than patients treated with non-Glucommander (non-GM), with 2,434 fewer hypoglycemic events and 40,589 fewer hyperglycemic events. Prior to implementation of GM, SSI was close to 95%, BBI at 5%. Within the first month of use, 96% usage of BBI was achieved. Reduction of hypoglycemic events (% of BG < 70 mg/dL) by 21% with 2.16% non-GM compared to GM at 1.74% and severe Hypoglycemia (% of BG < 50 mg/dL) by 50% in the ICU 3% non-GM compared to GM at 1.5%. In addition, patients treated with GM had a shorter LOS than patients treated with non-GM by 3.18 days and used 47.4% less point of care tests per patient. Glycemic management improved with use of eGMS. The conversion from SSI to BBI enhanced overall patient safety, eliminated the time and effort otherwise required when manually titrating insulin and reduced overall cost of care for patients on insulin therapy.

  12. The Effects of Bolus Volume and Texture on Pharyngeal Pressure Events Using High-resolution Manometry and Its Comparison with Videofluoroscopic Swallowing Study

    PubMed Central

    Ryu, Ju Seok; Park, Donghwi; Oh, Yoongul; Lee, Seok Tae; Kang, Jin Young

    2016-01-01

    Background/Aims The purpose of this study was to develop new parameters of high-resolution manometry (HRM) and to applicate these to quantify the effect of bolus volume and texture on pharyngeal swallowing. Methods Ten healthy subjects prospectively swallowed dry, thin fluid 2 mL, thin fluid 5 mL, thin fluid 10 mL, and drinking twice to compare effects of bolus volume. To compare effect of texture, subjects swallowed thin fluid 5 mL, yogurt 5 mL, and bread twice. A 32-sensor HRM catheter and BioVIEW ANALYSIS software were used for data collection and analysis. HRM data were synchronized with kinematic analysis of videofluoroscopic swallowing study (VFSS) using epiglottis tilting. Results Linear correlation analysis for volume showed significant correlation for area of velopharynx, duration of velopharynx, pre-upper esophageal sphincter (UES) maximal pressure, minimal UES pressure, UES activity time, and nadir UES duration. In the correlation with texture, all parameters were not significantly different. The contraction of the velopharynx was faster than laryngeal elevation. The durations of UES relaxation was shorter in the kinematic analysis than HRM. Conclusions The bolus volume was shown to have significant effect on pharyngeal pressure and timing, but the texture did not show any effect on pharyngeal swallowing. The parameters of HRM were more sensitive than those of kinematic analysis. As the parameters of HRM are based on precise anatomic structure and the kinematic analysis reflects the actions of multiple anatomic structures, HRM and VFSS should be used according to their purposes. PMID:26598598

  13. A multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin compared with standard therapy for the treatment of transverse myelitis in adults and children (STRIVE).

    PubMed

    Absoud, Michael; Brex, Peter; Ciccarelli, Olga; Diribe, Onyinye; Giovannoni, Gavin; Hellier, Jennifer; Howe, Rosemary; Holland, Rachel; Kelly, Joanna; McCrone, Paul; Murphy, Caroline; Palace, Jackie; Pickles, Andrew; Pike, Michael; Robertson, Neil; Jacob, Anu; Lim, Ming

    2017-05-01

    Transverse myelitis (TM) is an immune-mediated disorder of the spinal cord that affects adults and children and that causes motor, sensory and autonomic dysfunction. There is a prolonged recovery phase, which may continue for many years. Neuromyelitis optica (NMO) is an uncommon relapsing inflammatory central nervous system condition in which TM can be the first presenting symptom. As TM and NMO affect many patients in the prime of their working life, the disorder can impose a significant demand on health resources. There are currently no robust controlled trials in children or adults to inform the optimal treatment of TM. However, treatment with intravenous immunoglobulin (IVIG) is being effectively used in the management of a range of neurological conditions. Although other interventions such as plasma exchange (PLEX) in addition to intravenous (IV) methylprednisolone therapy can be beneficial in TM, PLEX is costly and technically challenging to deliver in the acute setting. IVIG is more readily accessible and less costly. To evaluate whether additional and early treatment with IVIG is of extra benefit in TM compared with standard therapy with IV steroids. A multicentre, single-blind, parallel-group randomised controlled trial of IVIG compared with standard therapy for the treatment of TM in adults and children. Patients aged ≥ 1 year diagnosed with either acute first-onset TM or first presentation of NMO. Target recruitment was 170 participants (85 participants per arm). Participants were randomised 1 : 1 to treatment with IV methylprednisolone only or treatment with IV methylprednisolone plus 2 g/kg of IVIG in divided doses within 5 days of the first commencement of steroid therapy. Primary outcome measure - American Spinal Injury Association (ASIA) Impairment Scale at 6 months post randomisation, with a good outcome defined by a two-grade change. Secondary and tertiary outcome measures - ASIA motor and sensory scales, Expanded Disability Status Scale

  14. Hyponatremia induced by hyperinsulinemia-euglycemia therapy.

    PubMed

    Beavers, Jennifer R; Stollings, Joanna L; Rice, Todd W

    2017-07-15

    A case of symptomatic hyponatremia induced by hyperinsulinemia-euglycemia (HIE) therapy is reported. A 59-year-old, 81.65-kg woman with hypertension, major depressive disorder, and anxiety arrived at a tertiary medical center 1.5 hours after an intentional overdose of oral amlodipine 200 mg, metoprolol tartrate 2,000 mg, and isosorbide mononitrate 1,200 mg. Upon arrival, her pulse was 63 beats/min and blood pressure was 106/56 mm Hg. The patient's blood pressure was refractory to fluids, calcium gluconate, and norepinephrine, resulting in initiation of HIE therapy. She had recurrent episodes of hypoglycemia, which required increases of the dextrose infusion and resulted in the patient receiving a total of 6.9 L of dextrose with free water. Seventeen hours into the hospitalization, the patient became obtunded due to hyponatremia (serum sodium concentration, 121 mmol/L). HIE therapy was discontinued, an infusion of 5% dextrose injection with sodium bicarbonate added was started, and a bolus of 3% sodium chloride was administered. Nine hours after the presentation of hyponatremia, the patient's serum sodium concentration normalized (137 mmol/L), and her symptoms resolved. The patient's blood pressure, pulse, and mental status continued to improve, and the patient was transferred out of the medical intensive care unit 41 hours after her arrival at the hospital. A woman who overdosed on amlodipine, metoprolol tartrate, and isosorbide mononitrate was treated with HIE therapy and developed symptomatic hyponatremia. Hyponatremia resolved after administration of dextrose with sodium bicarbonate infusion and 3% sodium chloride infusion and cessation of HIE therapy. Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  15. Pharmacokinetics of ketamine and norketamine enantiomers after racemic or S-ketamine IV bolus administration in dogs during sevoflurane anaesthesia.

    PubMed

    Romagnoli, Noemi; Bektas, Rima N; Kutter, Annette P; Barbarossa, Andrea; Roncada, Paola; Hartnack, Sonja; Bettschart-Wolfensberger, Regula

    2017-06-01

    The aims of this study were to measure plasma levels of R- and S-ketamine and their major metabolites R- and S-norketamine following single intravenous bolus administration of racemic or S-ketamine in sevoflurane anaesthetised dogs and to calculate the relevant pharmacokinetic profiles. Six adult healthy beagle dogs were used in the study. An intravenous bolus of 4mg/kg racemic ketamine (RS-KET) or 2mg/kg S-ketamine (S-KET) was administered, with a three-weeks washout period between treatments. Venous blood samples were collected at fixed times until 900min and R- and S-ketamine as well as R- and S-norketamine plasma levels determined by liquid chromatography coupled with tandem mass spectrometry. Cardiovascular parameters were recorded during the anaesthesia until 240min. All dogs recovered well from anaesthesia. No statistical differences between groups were detected in any cardiovascular parameter. The pharmacokinetics of S-ketamine did not differ when injected intravenously alone or as part of the racemic mixture in dogs anaesthetised with sevoflurane. Following racemic ketamine, the area under the curve of R-norketamine was statistically higher than the one of S-norketamine. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. [Effective combination therapy of plasma exchange and subsequent cyclophosphamide pulses for catastrophic antiphospholipid antibody syndrome: a case report].

    PubMed

    Miyamae, T; Imagawa, T; Ito, S; Katakura, S; Mori, M; Ibe, M; Mitsuda, T; Aihara, Y; Nakanishi, S; Kohri, T; Yokota, S

    1999-06-01

    A 7-year-old girl with catastrophic antiphospholipid antibody syndrome was described. She firstly admitted to the local hospital with the complaints of persistent fever and abdominal pain, and was diagnosed as systemic lupus erythematosus with the laboratory findings as follows; positive for antinuclear antibody, anti-DNA antibody, and platelet-associated IgG, thrombocytopenia, and hypocomplementemia. 10 days after the initiation of oral prednisolone, she suddenly manifested tonic convulsion and unconsciousness accompanied by high fever. Because of the unresponsiveness to the methylprednisolone pulse therapy for supposed CNS lupus, she was transferred to our hospital. Her unconsciousness persisted, and pulsation on dorsalis pedis was not palpable on admission. Laboratory investigation revealed the falsely positive VDRL, a prolonged aPTT, positive for lupus-anticoagulant and antiphospholipid antibody. The magnetic resonance image demonstrated multiple spotty hyperintensity (T2) in the brain consistent with multiple hemorrhagic infarcts. Arteriogram demonstrated the infarct of dorsalis pedis, and coronary aneurysms. These findings were compatible with the criteria of catastrophic antiphospholipid antibody syndrome, she was diagnosed as catastrophic antiphospholipid antibody syndrome. The plasma exchange and subsequent cyclophosphamide-pulse therapy, which was given once a month for first 6 months, and later, at 3 months intervals, was effectively administered. This combination and oral anti-thrombotic therapy revealed effective for this kind of fatal disorder.

  17. Addition of rapid-acting insulin to basal insulin therapy in type 2 diabetes: indications and modalities.

    PubMed

    Monnier, L; Colette, C

    2006-02-01

    There are many reasons to believe that in the near future, the treatment of patients with Type 2 diabetes will be characterised by an increased use of insulin therapy. To ensure that insulin regimens are acceptable to patients, and implemented by physicians, they should be as simple and efficient as possible. Simplicity is synonymous with the regimen of once-daily basal insulin glargine given at any time of the day (at the same time each day). With such a strategy, the dose is adjusted by titrating to target fasting blood glucose values of 5.0 - 7.2 mmol/L (90 - 130 mg/dL). When these targets can no longer be achieved with reasonable doses of long-acting insulin, a rapid-acting insulin analogue should be added at meal times. A step-by-step strategy can be used; it is recommended that initially, a single daily prandial bolus of a rapid-acting insulin analogue is administered before the meal that leads to the highest post-meal blood glucose excursions. Further boluses can be added at other meal times as necessary, i.e, when post-meal blood glucose values remain above 10.0 mmol/L (180 mg/dL) and 7.8 mmol/L (140 mg/dL) at mid-morning and 2h-post-lunch or post-dinner times, respectively. This stepwise strategy may eventually lead to a standard basal-bolus regimen with 3 pre-meal injections of rapid-acting insulin analogues, a potentially small trade-off for achieving fairly-well controlled diabetes.

  18. Perceptions and experiences of using automated bolus advisors amongst people with type 1 diabetes: a longitudinal qualitative investigation.

    PubMed

    Lawton, J; Kirkham, J; Rankin, D; Barnard, K; Cooper, C L; Taylor, C; Heller, S; Elliott, J

    2014-12-01

    We explored people's reasons for, and experiences of, using bolus advisors to determine insulin doses; and, their likes/dislikes of this technology. 42 people with type 1 diabetes who had received instruction in use of bolus advisors during a structured education course were interviewed post-course and 6 months later. Data were analysed thematically. Participants who considered themselves to have poor mathematical skills highlighted a gratitude for, and heavy reliance on, advisors. Others liked and chose to use advisors because they saved time and effort calculating doses and/or had a data storage facility. Follow-up interviews highlighted that, by virtue of no longer calculating their doses, participants could become deskilled and increasingly dependent on advisors. Some forgot what their mealtime ratios were; others reported a misperception that, because they were pre-programmed during courses, these parameters never needed changing. Use of data storage facilities could hinder effective review of blood glucose data and some participants reported an adverse impact on glycaemic control. While participants liked and perceived benefits to using advisors, there may be unintended consequences to giving people access to this technology. To promote effective use, on-going input and education from trained health professionals may be necessary. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  19. Intravenous cyclophosphamide pulse therapy in Japanese children with systemic lupus erythematosus.

    PubMed

    Igarashi, Toru; Igarashi, Tsutomu; Shimizu, Akira; Itoh, Yasuhiko

    2013-01-01

    Intravenous cyclophosphamide (IVCY) pulse therapy has been used for lupus nephritis since the latter half of the 1980s; it has been shown to be effective for lupus nephritis and vasculitis and has become a standard therapy for the diffuse proliferative type of lupus nephritis in adults. IVCY therapy has also come to be used in children. This paper reports the long-term outcomes of IVCY therapy in children. Six female patients (age range, 13 to 18 years) with systemic lupus erythematosus (SLE) were enrolled in this retrospective study. Three patients had lupus nephritis (World Health Organization class IIb, IVa, IVc), 2 had central nervous system (CNS) lupus, and 1 had neither lupus nephritis nor CNS lupus. The mean pretreatment SLE disease activity index (SLEDAI) score was 18.8 ± 4.6. Cyclophosphamide (initial dose, 500 mg/m(2)) was administered intravenously each month for 6 months and then given every 3 months for maintenance. Prednisolone was given in dosages ranging from 5 to 60 mg/day, adjusted according to laboratory data and clinical symptoms. Levels of C3, C4, CH50, and creatinine; the SLEDAI score; and the SLE responder index were monitored and evaluated. The SLE responder index was considered to have improved if the SLEDAI score had decreased by 4 points or more after 52 weeks. Prednisolone doses were reduced in all patients. Because methylprednisolone pulse therapy was administered before IVCY therapy, some patients had low titers of immunoglobin G antibodies against double-stranded DNA at the start of IVCY therapy. All patients had low serum creatinine levels. Proteinuria resolved in 1 of the 3 patients with lupus nephritis. The SLEDAI scores improved after 52 weeks in 5 of 6 patients (mean, 5.2 ± 2.6). No patients had severe bone marrow suppression or hemorrhagic cystitis during IVCY pulse therapy. IVCY pulse therapy for SLE in children achieved good long-term outcomes with no serious adverse effects, such as digestive symptoms, bone marrow

  20. Comparative Efficacy of Platelet Rich Plasma Injection, Corticosteroid Injection and Ultrasonic Therapy in the Treatment of Periarthritis Shoulder.

    PubMed

    Kothari, Shashank Yeshwant; Srikumar, Venkataraman; Singh, Neha

    2017-05-01

    Periarthritis (PA) shoulder characterised by pain and restricted range of motion has a plethora of treatment options with inconclusive evidence. Platelet Rich Plasma (PRP) is an emerging treatment option and its efficacy needs to be examined and compared with other routine interventions. To assess the efficacy of PRP injection and compare it with corticosteroid injection and ultrasonic therapy in the treatment of PA shoulder. Patients with PA shoulder (n=195) were randomised to receive single injection of PRP (2 ml) or corticosteroid (80 mg of methylprednisolone) or ultrasonic therapy (seven sittings in two weeks; 1.5 W/cm 2 , 1 MHz, continuous mode). All participants were also advised to perform a home based 10 minute exercise therapy. The primary outcome measure was active range of motion of the shoulder. Secondary outcome measures used were Visual Analogue Scale (VAS) for pain and a shortened version of Disabilities of the Arm, Shoulder and Hand (QuickDASH) for function. Participants were evaluated at 0, 3, 6 and 12 weeks. Chi-square test, one way and repeated measures of ANOVA tests were used to determine significant differences. PRP treatment resulted in statistically significant improvements over corticosteroid and ultrasonic therapy in active as well as passive range of motion of shoulder, VAS and QuickDASH at 12 weeks. At six weeks, PRP treatment resulted in statistically significant improvements over ultrasonic therapy in VAS and QuickDASH. No major adverse effects were observed. This study demonstrates that single injection of PRP is effective and better than corticosteroid injection or ultrasonic therapy in treatment of PA shoulder.

  1. Comparing the Effectiveness of Patient Control Analgesia Pump and Bolus Morphine in Controlling Pain After Cardiopulmonary Bypass Graft Surgery.

    PubMed

    Imantalab, Vali; Mirmansouri, Ali; Mohammadzadeh Jouryabi, Ali; Naderi Nabi, Bahram; Kanani, Gholamreza; Nassiri Sheikhani, Nassir; Atrkarroushan, Zahra; Ghazanfar Tehran, Samaneh; Samadpour, Nastaran

    2017-10-01

    Postoperative pain is a complex process commonly caused by surgical trauma. It is one of the major concerns of patients undergoing heart surgery. Despite new techniques and modern analgesic treatments, postoperative pain is still one of the most important controversial issues. 68 patients scheduled for elective CABG with CPB were included in a prospective, double-blind clinical trial. They were randomly divided into two groups. One group received PCA pump including morphine (group P) with underlying infusion of 0.02 mg/kg/Qh, bolus dose of 1 mg, lockout time of 15 minutes, and a maximum of 4 bolus of 0.02 mg/kg for one hour and the other group received morphine bolus (group B). Three patients were excluded from the study, and 33 and 32 patients participated in the groups P and B, respectively. Variables including age, gender, pump time, aortic clamp time, duration of surgery, complications (nausea and vomiting, GI Bleeding, and hypoxia), level of pain based on VAS, opioid consumption, hemodynamic, and sedation status were measured in both groups. There was no significant difference between the groups regarding age, gender, pump time, clamp time, duration of surgery, complication, sedation score, and hemodynamic status in most of the assessment periods. By assessing the pain severity in the groups at different periods, results showed a significant difference between the groups except at enrollment, and a lower severity of pain was noted in the group P compared to the group B. The consumed opioid was significantly higher in the group P than in the group B. However, higher doses of diclofenac and paracetamol were administered in the group B compared to the group P. Results showed that higher morphine would be used in patients with PCA pump after extubation following heart surgery, and this increased dose of opioid was associated with better pain control and lack of complication. Therefore, PCA pump with underlying infusion could be effectively used in patients

  2. Comparing the Effectiveness of Patient Control Analgesia Pump and Bolus Morphine in Controlling Pain After Cardiopulmonary Bypass Graft Surgery

    PubMed Central

    Imantalab, Vali; Mirmansouri, Ali; Mohammadzadeh Jouryabi, Ali; Naderi Nabi, Bahram; Kanani, Gholamreza; Nassiri Sheikhani, Nassir; Atrkarroushan, Zahra; Ghazanfar Tehran, Samaneh; Samadpour, Nastaran

    2017-01-01

    Background Postoperative pain is a complex process commonly caused by surgical trauma. It is one of the major concerns of patients undergoing heart surgery. Despite new techniques and modern analgesic treatments, postoperative pain is still one of the most important controversial issues. Methods 68 patients scheduled for elective CABG with CPB were included in a prospective, double-blind clinical trial. They were randomly divided into two groups. One group received PCA pump including morphine (group P) with underlying infusion of 0.02 mg/kg/Qh, bolus dose of 1 mg, lockout time of 15 minutes, and a maximum of 4 bolus of 0.02 mg/kg for one hour and the other group received morphine bolus (group B). Three patients were excluded from the study, and 33 and 32 patients participated in the groups P and B, respectively. Variables including age, gender, pump time, aortic clamp time, duration of surgery, complications (nausea and vomiting, GI Bleeding, and hypoxia), level of pain based on VAS, opioid consumption, hemodynamic, and sedation status were measured in both groups. Results There was no significant difference between the groups regarding age, gender, pump time, clamp time, duration of surgery, complication, sedation score, and hemodynamic status in most of the assessment periods. By assessing the pain severity in the groups at different periods, results showed a significant difference between the groups except at enrollment, and a lower severity of pain was noted in the group P compared to the group B. The consumed opioid was significantly higher in the group P than in the group B. However, higher doses of diclofenac and paracetamol were administered in the group B compared to the group P. Conclusions Results showed that higher morphine would be used in patients with PCA pump after extubation following heart surgery, and this increased dose of opioid was associated with better pain control and lack of complication. Therefore, PCA pump with underlying infusion could

  3. Automated mandatory bolus versus basal infusion for maintenance of epidural analgesia in labour.

    PubMed

    Sng, Ban Leong; Zeng, Yanzhi; de Souza, Nurun Nisa A; Leong, Wan Ling; Oh, Ting Ting; Siddiqui, Fahad Javaid; Assam, Pryseley N; Han, Nian-Lin R; Chan, Edwin Sy; Sia, Alex T

    2018-05-17

    Childbirth may cause the most severe pain some women experience in their lifetime. Epidural analgesia is an effective form of pain relief during labour and is considered to be the reference standard. Traditionally epidural analgesia has been delivered as a continuous infusion via a catheter in the epidural space, with or without the ability for the patient to supplement the analgesia received by activating a programmable pump to deliver additional top-up doses, known as patient-controlled epidural analgesia (PCEA). There has been interest in delivering maintenance analgesic medication via bolus dosing (automated mandatory bolus - AMB) instead of the traditional continuous basal infusion (BI); recent randomized controlled trials (RCTs) have shown that the AMB technique leads to improved analgesia and maternal satisfaction. To assess the effects of automated mandatory bolus versus basal infusion for maintaining epidural analgesia in labour. We searched CENTRAL, MEDLINE, Embase, the World Health Organization International Clinial Trials Registry Platform (WHO-ICTRP) and ClinicalTrials.gov on 16 January 2018. We screened the reference lists of all eligible trials and reviews. We also contacted authors of included studies in this field in order to identify unpublished research and trials still underway, and we screened the reference lists of the included articles for potentially relevant articles. We included all RCTs that compared the use of bolus dosing AMB with continuous BI for providing pain relief during epidural analgesia for labour in women. We used the standard methodological procedures expected by Cochrane. Our primary outcomes were: risk of breakthrough pain with the need for anaesthetic intervention; risk of caesarean delivery; risk of instrumental delivery. Secondary outcomes included: duration of labour; local anaesthetic consumption. We used GRADE to assess the certainty of evidence for each outcome. We included 12 studies with a total of 1121 women. Ten

  4. Comparison of double intravenous vasopressor automated system using nexfin versus manual vasopressor bolus administration for maintenance of haemodynamic stability during spinal anaesthesia for caesarean delivery: A randomised double-blind controlled trial.

    PubMed

    Sng, Ban Leong; Du, Wei; Lee, Man Xin; Ithnin, Farida; Mathur, Deepak; Leong, Wan Ling; Sultana, Rehena; Han, Nian-Lin R; Sia, Alex Tiong Heng

    2018-05-01

    Hypotension is a common side effect of spinal anaesthesia during caesarean delivery and is associated with maternal and foetal adverse effects. We developed an updated double intravenous vasopressor automated (DIVA) system that administers phenylephrine or ephedrine based on continuous noninvasive haemodynamic monitoring using the Nexfin device. The aim of our present study is to compare the performance and reliability of the DIVA system against Manual Vasopressor Bolus administration. A randomised, double-blind controlled trial. Single-centre, KK Women's and Children's Hospital, Singapore. Two hundred and thirty-six healthy women undergoing elective caesarean delivery under spinal anaesthesia. The primary outcome was the incidence of maternal hypotension. The secondary outcome measures were reactive hypertension, total vasopressor requirement and maternal and neonatal outcomes. The DIVA group had a significantly lower incidence of maternal hypotension, with 39.3% (46 of 117) patients having any SBP reading less than 80% of baseline compared with 57.5% (65 of 113) in the manual vasopressor bolus group (P = 0.008). The DIVA group also had fewer hypotensive episodes than the manual vasopressor bolus group (4.67 versus 7.77%; P < 0.0001). There was no difference in the incidence of reactive hypertension or the total vasopressor requirement. The DIVA group had less wobble in system performance. Maternal and neonatal outcomes were similar. The DIVA system achieved better control of maternal blood pressure after spinal anaesthesia than manual vasopressor bolus administration. Clinicaltrials.gov identifier: NCT02277730.

  5. SU-F-T-387: A Novel Optimization Technique for Field in Field (FIF) Chestwall Radiation Therapy Using a Single Plan to Improve Delivery Safety and Treatment Planning Efficiency

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Tabibian, A; Kim, A; Rose, J

    Purpose: A novel optimization technique was developed for field-in-field (FIF) chestwall radiotherapy using bolus every other day. The dosimetry was compared to currently used optimization. Methods: The prior five patients treated at our clinic to the chestwall and supraclavicular nodes with a mono-isocentric four-field arrangement were selected for this study. The prescription was 5040 cGy in 28 fractions, 5 mm bolus every other day on the tangent fields, 6 and/or 10 MV x-rays, and multileaf collimation.Novelly, tangents FIF segments were forward planned optimized based on the composite bolus and non-bolus dose distribution simultaneously. The prescription was spilt into 14 fractionsmore » for both bolus and non-bolus tangents. The same segments and monitor units were used for the bolus and non-bolus treatment. The plan was optimized until the desired coverage was achieved, minimized 105% hotspots, and a maximum dose of less than 108%. Each tangential field had less than 5 segments.Comparison plans were generated using FIF optimization with the same dosimetric goals, but using only the non-bolus calculation for FIF optimization. The non-bolus fields were then copied and bolus was applied. The same segments and monitor units were used for the bolus and non-bolus segments. Results: The prescription coverage of the chestwall, as defined by RTOG guidelines, was on average 51.8% for the plans that optimized bolus and non-bolus treatments simultaneous (SB) and 43.8% for the plans optimized to the non-bolus treatments (NB). Chestwall coverage of 90% prescription averaged to 80.4% for SB and 79.6% for NB plans. The volume receiving 105% of the prescription was 1.9% for SB and 0.8% for NB plans on average. Conclusion: Simultaneously optimizing for bolus and non-bolus treatments noticeably improves prescription coverage of the chestwall while maintaining similar hotspots and 90% prescription coverage in comparison to optimizing only to non-bolus treatments.« less

  6. Comparison of treatment with continuous subcutaneous insulin infusion versus multiple daily insulin injections with bolus calculator in patients with type 1 diabetes.

    PubMed

    Pérez-García, L; Goñi-Iriarte, M J; García-Mouriz, M

    2015-01-01

    A study of the glycemic control, quality of life, and fear and perception of hypoglycemia by comparing continuous subcutaneous insulin infusion (CSII) group with multiple daily inyections (MDI) with bolus calculator group. This is a retrospective cohort study with following up during the first 12 months that CSII group (n=30) begins the use of "bolus wizard" and the MDI-calculator (n=30) group begins the use of the bolus calculator (Accu-Chek(®) Aviva Expert). HbA1c (3, 6 and 12 months). Questionnaires used: EsDQOL (quality of life), FH-15 (fear of hypoglycemia), and Clarke (perception of hypoglycemia). T Student and nonparametric tests. The average reduction in HbA1c during the study was significantly higher in CSII group (-0.56±0.84%) compared with the MDI group (0.097±0.94%), P=.028. The average basal insulin dose was significantly higher in the MDI group (at baseline, 6 and 12 months). No significant differences were found between the 2 treatment groups after analyzing the EsDQOL, FH-15 and Clarke questionnaires. In the CSII group, perceived quality of life assessed by the EsDQOL questionnaire was found to be better at the end of the study than at the beginning of using the insulin pump. The average reduction in HbA1c was significantly higher in the CSII group. In the CSII group, perceived quality of life was better at the end of the study than at the beginning. Copyright © 2014 SEEN. Published by Elsevier España, S.L.U. All rights reserved.

  7. Observational 6-month open-label study of Japanese type 2 diabetes patients switching from NPH insulin to insulin detemir in basal-bolus regimen: 23rd article of the Japan Diabetes Clinical Data Management Study Group (JDDM23).

    PubMed

    Oishi, M; Abe, N; Yokoyama, H; Kuribayashi, N; Tomonaga, O; Matoba, K; Kobayashi, M

    2012-01-01

    Glycaemic control is critical to prevent diabetic complications and mortality. This 6-month, open-label, observational study assessed the efficacy and safety of switching Japanese patients with type 2 diabetes from neutral protamine Hagedorn (NPH) insulin to insulin detemir. Patients with type 2 diabetes (n = 126) receiving basal-bolus insulin therapy with NPH insulin plus rapid-acting insulin analogues were recruited. NPH insulin was replaced with insulin detemir for 6 months. Glycosylated haemoglobin (HbA(1c)), fasting plasma glucose (FPG), daily glucose levels and hypoglycaemia were monitored. Nocturnal quality of life was assessed by insulin therapy related quality of life at night questionnaire. HbA(1c), FPG and body weight were all significantly reduced after treatment with insulin detemir for 6 months, without increasing severe hypoglycaemia. Insulin dose increased significantly over the same time. There were significant improvements in overall nocturnal quality of life, as well as well-being. Treatment with insulin detemir for 6 months resulted in substantial benefits, including reduced HbA(1c), FPG and body weight, and improvements in nocturnal quality of life, without increasing hypoglycaemia.

  8. Assessment of the Prevalence and Risk Factors Associated With Glucocorticoid-Induced Diabetes Mellitus in Pemphigus Vulgaris Patients.

    PubMed

    Darjani, Abbas; Nickhah, Nahid; Hedayati Emami, Mohammad Hassan; Alizadeh, Narges; Rafiei, Rana; Eftekhari, Hojat; Gharaei Nejad, Kaveh

    2017-06-01

    Pemphigus vulgaris is a chronic autoimmune disease and glucocorticoids are one of the main treatments. Our study investigates the prevalence and associated factors of glucocorticoid-induced diabetes mellitus in these patients under different glucocorticoid regimens. 36 patients with first diagnosed Pemphigus vulgaris based on pathological and direct immunofluorescence findings who had received different glucocorticoid regimens (1-2 mg/kg oral or 1-2 mg/kg oral with 1g methylprednisolone pulse daily for 3 consecutive days with or without azathioprine) were evaluated during 2014-2016. Our study found that 22.2% of patients had impaired fasting glucose and incidence of corticosteroid-induced diabetes mellitus was 22.2% with no difference between oral and pulse therapy of corticosteroid. The first day after pulse therapy 19 patients of 21 had post bolus hyperglycemia that 36% of them became diabetic after 8 weeks. None of the variables, including age, BMI, HbA1c, LDL, HDL, TG, cholesterol, family history and blood pressure were associated with diabetes. Pretreatment FBS was the factor that would increase the likelihood of glucocorticoid-induced diabetes mellitus, 42.2% of patients with pretreatment FBS 100-126 developed diabetes in comparison with 17.2% in normal pretreatment FBS. Although the group who received azathioprine was associated with increased incidence of diabetes, the overall corticosteroid dose in this group was significantly higher than the other group (P=0.012), and controversy with other studies could be because of difference in corticosteroid dosage and small number of patients. The incidence of diabetes was not different between the group with glucocorticoid pulses and oral prednisolone without pulse therapy. Higher pretreatment FBS can be related to increased incidence of diabetes, but results from this study due to small number of patients are preliminary and multicenter studies are needed.

  9. Preliminary Evaluation of a New Semi-Closed-Loop Insulin Therapy System Over the Prandial Period in Adult Patients With Type 1 Diabetes

    PubMed Central

    Quemerais, Marie Aude; Doron, Maeva; Dutrech, Florent; Melki, Vincent; Franc, Sylvia; Antonakios, Michel; Charpentier, Guillaume; Hanaire, Helene; Charpentier, Guillaume

    2014-01-01

    There is room for improvement in the algorithms used in closed-loop insulin therapy during the prandial period. This pilot study evaluated the efficacy and safety of the Diabeloop algorithm (model predictive control type) during the postprandial period. This 2-center clinical trial compared interstitial glucose levels over two 5-hour periods (with/without the algorithm) following a calibrated lunch. On the control day, the amount of insulin delivered by the pump was determined according to the patient’s usual parameters. On the test day, 50% or 75% of the theoretical bolus required was delivered, while the algorithm, informed of carbohydrate intake, proposed changes to insulin delivery every 15 minutes using modeling to forecast glucose levels. The primary endpoint was percentage of time spent at near normoglycemia (70-180 mg/dl). Twelve patients with type 1 diabetes (9 men, age 35.6 ± 12.7 years, HbA1c 7.3 ± 0.8%) were included. The percentage of time spent in the target range was 84.5 ± 20.8 (test day) versus 69.2 ± 33.9% (control day, P = .11). The percentage of time spent in hypoglycemia < 70 mg/dl was 0.2 ± 0.8 (test) versus 4.4 ± 8.2% (control, P = .18). Interstitial glucose at the end of the test (5 hours) was 127.5 ± 40.1 (test) versus 146 ± 53.5 mg/dl (control, P = .25). The insulin doses did not differ, and no differences were observed between the 50% and 75% boluses. In a semi-closed-loop configuration with manual priming boluses (25% or 50% reduction), the Diabeloop v1 algorithm was as successful as the manual method in determining the prandial bolus, without any exposure to excessive hypoglycemic risk. PMID:25097057

  10. Therapy for unhealed gastrocutaneous fistulas in rats as a model for analogous healing of persistent skin wounds and persistent gastric ulcers: stable gastric pentadecapeptide BPC 157, atropine, ranitidine, and omeprazole.

    PubMed

    Skorjanec, Sandra; Dolovski, Zdravko; Kocman, Ivan; Brcic, Luka; Blagaic Boban, Alenka; Batelja, Lovorka; Coric, Marjana; Sever, Marko; Klicek, Robert; Berkopic, Lidija; Radic, Bozo; Drmic, Domagoj; Kolenc, Danijela; Ilic, Spomenko; Cesarec, Vedran; Tonkic, Ante; Zoricic, Ivan; Mise, Stjepan; Staresinic, Mario; Ivica, Mihovil; Lovric Bencic, Martina; Anic, Tomislav; Seiwerth, Sven; Sikiric, Predrag

    2009-01-01

    This study focused on unhealed gastrocutaneous fistulas to resolve whether standard drugs that promote healing of gastric ulcers may simultaneously have the same effect on cutaneous wounds, and corticosteroid aggravation, and to demonstrate why peptides such as BPC 157 exhibit a greater healing effect. Therefore, with the fistulas therapy, we challenge the wound/growth factors theory of the analogous nonhealing of wounds and persistent gastric ulcers. The healing rate of gastrocutaneous fistula in rat (2-mm-diameter stomach defect, 3-mm-diameter skin defect) validates macro/microscopically and biomechanically a direct skin wound/stomach ulcer relation, and identifies a potential therapy consisting of: (i) stable gastric pentadecapeptide BPC 157 [in drinking water (10 microg/kg) (12 ml/rat/day) or intraperitoneally (10 microg/kg, 10 ng/kg, 10 pg/kg)], (ii) atropine (10 mg/kg), ranitidine (50 mg/kg), and omeprazole (50 mg/kg), (iii) 6-alpha-methylprednisolone (1 mg/kg) [intraperitoneally, once daily, first application at 30 min following surgery; last 24 h before sacrifice (at postoperative days 1, 2, 3, 7, 14, and 21)]. Greater anti-ulcer potential and efficiency in wound healing compared with standard agents favor BPC 157, efficient in inflammatory bowel disease (PL-14736, Pliva), given in drinking water or intraperitoneally. Even after 6-alpha-methylprednisolone aggravation, BPC 157 promptly improves both skin and stomach mucosa healing, and closure of fistulas, with no leakage after up to 20 ml water intragastrically. Standard anti-ulcer agents, after a delay, improve firstly skin healing and then stomach mucosal healing, but not fistula leaking and bursting strength (except for atropine). We conclude that BPC 157 may resolve analogous nonhealing of wounds and persistent gastric ulcers better than standard agents.

  11. MO-D-213-04: The Proximity to the Skin of PTV Affects PTV Coverage and Skin Dose for TomoTherapy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Reynolds, T; Higgins, P; Watanabe, Y

    Purpose: The proximity to the skin surface of the PTV for the patients with skin disease could be a concern in terms of the PTV coverage and actual surface dose (SD). IMRT optimization algorithms increase the beam intensity close to the skin in order to compensate for lack of scattering material, leading to enhanced SD but potential hot spots. This study aims to investigate the effect of PTV proximity to the skin on planning and measured SD Methods: All measurements were done for 6 MV X-ray beam of Helical TomoTherapy. An anthropomorphic phantom was scanned in a CT simulator inmore » a routine manner with thermoplastic mask immobilization. PTVs were created with varying distances to the skin of 0 mm -(PTV1), 1 mm- (PTV2), 2 mm-(PTV3) and 3 mm-(PTV4). Also, a 5 mm bolus was used with PTV1 (PTV5). All planning constraints were kept the same in all studies (hard constraint: 95% of the prescription dose covered 95% of the PTV). Gafchromic film (EBT3) was placed under the mask on the phantom surface, and the resulting dose was estimated using RIT software. Results: Optimizing the dose using different PTVs lead to average planned target doses of 10.8, 10.3, 10.2, 10.3 and 10.0 Gy, with maximum doses 12.2, 11.2, 11.1, 11.1 and 10.0 Gy for PTV1, PTV2, PTV3, PTV4 and PTV5, respectively. EBT3 measurements indicated a significant decrease of SD with skin distance by 12.7% (PTV1), 21.9% (PTV2), 24.8% (PTV3) and 28.4% (PTV4) comparing to prescription dose. Placement of a 5 mm bolus on the phantom surface resulted in a SD close to prescribed (+0.5%). Conclusion: This work provides a clear demonstration of the relationship between the skin dose and the PTV to the skin distance. The results indicate the necessity of a bolus even for TomoTherapy when high skin dose is required.« less

  12. SU-F-T-189: Dosimetric Comparison of Spot-Scanning Proton Therapy Techniques for Liver Tumors Close to the Skin Surface

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Takao, S; Matsuzaki, Y; Matsuura, T

    Purpose: Spot-scanning technique has been utilized to achieve conformal dose distribution to large and complicated tumors. This technique generally does not require patient-specific devices such as aperture and compensator. The commercially available spot-scanning proton therapy (SSPT) systems, however, cannot deliver proton beams to the region shallower than 4 g/cm2. Therefore some range compensation device is required to treat superficial tumors with SSPT. This study shows dosimetric comparison of the following treatment techniques: (i) with a tabletop bolus, (ii) with a nozzle-mounted applicator, and (iii) without any devices and using intensity-modulated proton therapy (IMPT) technique. Methods: The applicator composed of amore » combination of a mini-ridge filter and a range shifter has been manufactured by Hitachi, Ltd., and the tabletop bolus was made by .decimal, Inc. Both devices have been clinically implemented in our facility. Three patients with liver tumors close to the skin surface were examined in this study. Each treatment plan was optimized so that the prescription dose of 76 Gy(RBE) or 66 Gy(RBE) would be delivered to 99% of the clinical target volume in 20 fractions. Three beams were used for tabletop bolus plan and IMPT plan, whereas two beams were used in the applicator plan because the gantry angle available was limited due to potential collision to patient and couch. The normal liver, colon, and skin were considered as organs at risk (OARs). Results: The target heterogeneity index (HI = D{sub 5}/D{sub 95}) was 1.03 on average in each planning technique. The mean dose to the normal liver was considerably less than 20 Gy(RBE) in all cases. The dose to the skin could be reduced by 20 Gy(RBE) on average in the IMPT plan compared to the applicator plan. Conclusion: It has been confirmed that all treatment techniques met the dosimetric criteria for the OARs and could be implemented clinically.« less

  13. Clinical experience with induction therapy in renal transplantation.

    PubMed

    Muntean, Adriana; Lucan, Mihai; Barbos, Adrian; Elec, Alina; Iacob, Gheorghita; Loga, Luminita; Dican, Lucia

    2013-01-01

    Acute rejection (AR) is a major determinant of renal allograft survival. The incorporation of new immunosuppressive agents explains the improvement seen in the results of transplantation in recent years. To assess the optimal immunosuppression regimen according to the immunological risk of renal transplant patients. We performed a retrospective study of 977 consecutive patients transplanted in our institution between January 2000 and December 2011. Recipients were classified according to the immunological risk (high, intermediate and low) and the type of induction therapy received. We evaluated the incidence of early acute rejection (eAR) and late acute rejection (lAR) and their influence on graft and patients survival in relation to the immunological risk and induction regimen used. The incidence of eAR was 5.4%, 6.4% and 1.4% in relation with the immunological risk, high, intermediate and low respectively. The most commonly used induction immunosuppression was rabbit antithymocyte globulin (ATG), followed by methylprednisolone and basiliximab. No statistical difference was found between the incidence of eAR according to the type of induction therapy and immunological risk. The graft survival was significantly better for the cases without eAR at 1 year (98.6% versus 94.4%, p=0.019), and 3 years (94.9% versus 88.9%, p=0.056). The patients survival was significantly better for those without eAR at 1 year after transplant (95.7% vs. 88.9%, p=0.051), 3 years (93.1% vs. 83.3%, p=0.008) and 5 years (92.2% vs. 79.6%, p=0.001). The incidence of lAR was between 0 and 7.1% according to the induction therapy, lacking any statistical significance (p=0.450). Tailoring the induction immunosuppression according to the immunological risk reduces the incidence of early acute rejection.

  14. Clinical experience with induction therapy in renal transplantation

    PubMed Central

    MUNTEAN, ADRIANA; LUCAN, MIHAI; BARBOS, ADRIAN; ELEC, ALINA; IACOB, GHEORGHITA; LOGA, LUMINITA; DICAN, LUCIA

    2013-01-01

    Introduction Acute rejection (AR) is a major determinant of renal allograft survival. The incorporation of new immunosuppressive agents explains the improvement seen in the results of transplantation in recent years. Objective To assess the optimal immunosuppression regimen according to the immunological risk of renal transplant patients. Method We performed a retrospective study of 977 consecutive patients transplanted in our institution between January 2000 and December 2011. Recipients were classified according to the immunological risk (high, intermediate and low) and the type of induction therapy received. We evaluated the incidence of early acute rejection (eAR) and late acute rejection (lAR) and their influence on graft and patients survival in relation to the immunological risk and induction regimen used. Results The incidence of eAR was 5.4%, 6.4% and 1.4% in relation with the immunological risk, high, intermediate and low respectively. The most commonly used induction immunosuppression was rabbit antithymocyte globulin (ATG), followed by methylprednisolone and basiliximab. No statistical difference was found between the incidence of eAR according to the type of induction therapy and immunological risk. The graft survival was significantly better for the cases without eAR at 1 year (98.6% versus 94.4%, p=0.019), and 3 years (94.9% versus 88.9%, p=0.056). The patients survival was significantly better for those without eAR at 1 year after transplant (95.7% vs. 88.9%, p=0.051), 3 years (93.1% vs. 83.3%, p=0.008) and 5 years (92.2% vs. 79.6%, p=0.001). The incidence of lAR was between 0 and 7.1% according to the induction therapy, lacking any statistical significance (p=0.450). Conclusion Tailoring the induction immunosuppression according to the immunological risk reduces the incidence of early acute rejection. PMID:26527980

  15. Inter-device differences in monitoring for goal-directed fluid therapy.

    PubMed

    Thiele, Robert H; Bartels, Karsten; Gan, Tong-Joo

    2015-02-01

    Goal-directed fluid therapy is an integral component of many Enhanced Recovery After Surgery (ERAS) protocols currently in use. The perioperative clinician is faced with a myriad of devices promising to deliver relevant physiologic data to better guide fluid therapy. The goal of this review is to provide concise information to enable the clinician to make an informed decision when choosing a device to guide goal-directed fluid therapy. The focus of many devices used for advanced hemodynamic monitoring is on providing measurements of cardiac output, while other, more recent, devices include estimates of fluid responsiveness based on dynamic indices that better predict an individual's response to a fluid bolus. Currently available technologies include the pulmonary artery catheter, esophageal Doppler, arterial waveform analysis, photoplethysmography, venous oxygen saturation, as well as bioimpedance and bioreactance. The underlying mechanistic principles for each device are presented as well as their performance in clinical trials relevant for goal-directed therapy in ERAS. The ERAS protocols typically involve a multipronged regimen to facilitate early recovery after surgery. Optimizing perioperative fluid therapy is a key component of these efforts. While no technology is without limitations, the majority of the currently available literature suggests esophageal Doppler and arterial waveform analysis to be the most desirable choices to guide fluid administration. Their performance is dependent, in part, on the interpretation of dynamic changes resulting from intrathoracic pressure fluctuations encountered during mechanical ventilation. Evolving practice patterns, such as low tidal volume ventilation as well as the necessity to guide fluid therapy in spontaneously breathing patients, will require further investigation.

  16. Continuous right thoracic paravertebral block following bolus initiation reduced postoperative pain after right-lobe hepatectomy: a randomized, double-blind, placebo-controlled trial.

    PubMed

    Chen, Hexiang; Liao, Zhipin; Fang, Yan; Niu, Ben; Chen, Amber; Cao, Fei; Mei, Wei; Tian, Yuke

    2014-01-01

    We hypothesized that continuous right thoracic paravertebral block, following bolus initiation, decreases opioid consumption after right-lobe hepatectomy in patients receiving patient-controlled intravenous analgesia with sufentanil. Patients undergoing right-lobe hepatectomy with a right thoracic paravertebral catheter placed at T7 30 minutes before surgery were randomly assigned to receive through this catheter either a 10-mL bolus of 0.2% ropivacaine before emergence, followed by a continuous infusion of 6 mL/h for 24 hours (PVB group), or saline at the same scheme of administration (control group). All patients were started on patient-controlled intravenous analgesia with sufentanil in the postanesthesia care unit. The primary outcome measure was total sufentanil consumption during the first 24 postoperative hours. P = 0.05 was considered as significant. For the multiple comparisons of data at 5 different time points, the P value for the 0.05 level of significance was adjusted to 0.01. Sixty-six patients were assessed for eligibility, and a PVB catheter was successfully placed for 48 patients. Data were analyzed on 22 patients in group PVB and 22 patients in the control group. The cumulative sufentanil consumption in the PVB group (54.3 ± 12.1 μg) at 24 postoperative hours was more than 20% less than that of the control group (68.1 ± 9.9 μg) (P < 0.001). There was also a significant difference in pain scores (numerical rating scale) between groups, where the PVB group had lower scores than did the control group at rest and with coughing for the first 24 hours (P < 0.001). Continuous right thoracic paravertebral block, following bolus initiation, has an opioid-sparing effect on sufentanil patient-controlled intravenous analgesia for right-lobe hepatectomy patients and reduces numerical rating scale pain scores at rest and with coughing in the first 24 postoperative hours.

  17. Clinical applications of 3-dimensional printing in radiation therapy.

    PubMed

    Zhao, Yizhou; Moran, Kathryn; Yewondwossen, Mammo; Allan, James; Clarke, Scott; Rajaraman, Murali; Wilke, Derek; Joseph, Paul; Robar, James L

    2017-01-01

    Three-dimensional (3D) printing is suitable for the fabrication of complex radiotherapy bolus. Although investigated from dosimetric and feasibility standpoints, there are few reports to date of its use for actual patient treatment. This study illustrates the versatile applications of 3D printing in clinical radiation oncology through a selection of patient cases, namely, to create bolus for photon and modulated electron radiotherapy (MERT), as well as applicators for surface high-dose rate (HDR) brachytherapy. Photon boluses were 3D-printed to treat a recurrent squamous cell carcinoma (SCC) of the nasal septum and a basal cell carcinoma (BCC) of the posterior pinna. For a patient with a mycosis fungoides involving the upper face, a 3D-printed MERT bolus was used. To treat an SCC of the nose, a 3D-printed applicator for surface brachytherapy was made. The structures' fit to the anatomy and the radiotherapy treatment plans were assessed. Based on the treatment planning computed tomography (CT), the size of the largest air gap at the interface of the 3D-printed structure was 3 mm for the SCC of the nasal septum, 3 mm for the BCC of the pinna, 2 mm for the mycosis fungoides of the face, and 2 mm for the SCC of the nose. Acceptable treatment plans were obtained for the SCC of the nasal septum (95% isodose to 99.8% of planning target volume [PTV]), the BCC of the pinna (95% isodose to 97.7% of PTV), and the mycosis fungoides of the face (90% isodose to 92.5% of PTV). For the latter, compared with a plan with a uniform thickness bolus, the one featuring the MERT bolus achieved relative sparing of all the organs at risk (OARs) distal to the target volume, while maintaining similar target volume coverage. The surface brachytherapy plan for the SCC of the nose had adequate coverage (95% isodose to 95.6% of clinical target volume [CTV]), but a relatively high dose to the left eye, owing to its proximity to the tumor. 3D printing can be implemented effectively in the

  18. Model-Based Sensor-Augmented Pump Therapy

    PubMed Central

    Grosman, Benyamin; Voskanyan, Gayane; Loutseiko, Mikhail; Roy, Anirban; Mehta, Aloke; Kurtz, Natalie; Parikh, Neha; Kaufman, Francine R.; Mastrototaro, John J.; Keenan, Barry

    2013-01-01

    Background In insulin pump therapy, optimization of bolus and basal insulin dose settings is a challenge. We introduce a new algorithm that provides individualized basal rates and new carbohydrate ratio and correction factor recommendations. The algorithm utilizes a mathematical model of blood glucose (BG) as a function of carbohydrate intake and delivered insulin, which includes individualized parameters derived from sensor BG and insulin delivery data downloaded from a patient’s pump. Methods A mathematical model of BG as a function of carbohydrate intake and delivered insulin was developed. The model includes fixed parameters and several individualized parameters derived from the subject’s BG measurements and pump data. Performance of the new algorithm was assessed using n = 4 diabetic canine experiments over a 32 h duration. In addition, 10 in silico adults from the University of Virginia/Padova type 1 diabetes mellitus metabolic simulator were tested. Results The percentage of time in glucose range 80–180 mg/dl was 86%, 85%, 61%, and 30% using model-based therapy and [78%, 100%] (brackets denote multiple experiments conducted under the same therapy and animal model), [75%, 67%], 47%, and 86% for the control experiments for dogs 1 to 4, respectively. The BG measurements obtained in the simulation using our individualized algorithm were in 61–231 mg/dl min–max envelope, whereas use of the simulator’s default treatment resulted in BG measurements 90–210 mg/dl min–max envelope. Conclusions The study results demonstrate the potential of this method, which could serve as a platform for improving, facilitating, and standardizing insulin pump therapy based on a single download of data. PMID:23567006

  19. Comparative Efficacy of Platelet Rich Plasma Injection, Corticosteroid Injection and Ultrasonic Therapy in the Treatment of Periarthritis Shoulder

    PubMed Central

    Srikumar, Venkataraman; Singh, Neha

    2017-01-01

    Introduction Periarthritis (PA) shoulder characterised by pain and restricted range of motion has a plethora of treatment options with inconclusive evidence. Platelet Rich Plasma (PRP) is an emerging treatment option and its efficacy needs to be examined and compared with other routine interventions. Aim To assess the efficacy of PRP injection and compare it with corticosteroid injection and ultrasonic therapy in the treatment of PA shoulder. Materials and Methods Patients with PA shoulder (n=195) were randomised to receive single injection of PRP (2 ml) or corticosteroid (80 mg of methylprednisolone) or ultrasonic therapy (seven sittings in two weeks; 1.5 W/cm2, 1 MHz, continuous mode). All participants were also advised to perform a home based 10 minute exercise therapy. The primary outcome measure was active range of motion of the shoulder. Secondary outcome measures used were Visual Analogue Scale (VAS) for pain and a shortened version of Disabilities of the Arm, Shoulder and Hand (QuickDASH) for function. Participants were evaluated at 0, 3, 6 and 12 weeks. Chi-square test, one way and repeated measures of ANOVA tests were used to determine significant differences. Results PRP treatment resulted in statistically significant improvements over corticosteroid and ultrasonic therapy in active as well as passive range of motion of shoulder, VAS and QuickDASH at 12 weeks. At six weeks, PRP treatment resulted in statistically significant improvements over ultrasonic therapy in VAS and QuickDASH. No major adverse effects were observed. Conclusion This study demonstrates that single injection of PRP is effective and better than corticosteroid injection or ultrasonic therapy in treatment of PA shoulder. PMID:28658861

  20. Crystalloids versus colloids for goal-directed fluid therapy in major surgery

    PubMed Central

    Hiltebrand, Luzius B; Kimberger, Oliver; Arnberger, Michael; Brandt, Sebastian; Kurz, Andrea; Sigurdsson, Gisli H

    2009-01-01

    Introduction Perioperative hypovolemia arises frequently and contributes to intestinal hypoperfusion and subsequent postoperative complications. Goal-directed fluid therapy might reduce these complications. The aim of this study was to compare the effects of goal-directed administration of crystalloids and colloids on the distribution of systemic, hepatosplanchnic, and microcirculatory (small intestine) blood flow after major abdominal surgery in a clinically relevant pig model. Methods Twenty-seven pigs were anesthetized and mechanically ventilated and underwent open laparotomy. They were randomly assigned to one of three treatment groups: the restricted Ringer lactate (R-RL) group (n = 9) received 3 mL/kg per hour of RL, the goal-directed RL (GD-RL) group (n = 9) received 3 mL/kg per hour of RL and intermittent boluses of 250 mL of RL, and the goal-directed colloid (GD-C) group (n = 9) received 3 mL/kg per hour of RL and boluses of 250 mL of 6% hydroxyethyl starch (130/0.4). The latter two groups received a bolus infusion when mixed venous oxygen saturation was below 60% ('lockout' time of 30 minutes). Regional blood flow was measured in the superior mesenteric artery and the celiac trunk. In the small bowel, microcirculatory blood flow was measured using laser Doppler flowmetry. Intestinal tissue oxygen tension was measured with intramural Clark-type electrodes. Results After 4 hours of treatment, arterial blood pressure, cardiac output, mesenteric artery flow, and mixed oxygen saturation were significantly higher in the GD-C and GD-RL groups than in the R-RL group. Microcirculatory flow in the intestinal mucosa increased by 50% in the GD-C group but remained unchanged in the other two groups. Likewise, tissue oxygen tension in the intestine increased by 30% in the GD-C group but remained unchanged in the GD-RL group and decreased by 18% in the R-RL group. Mesenteric venous glucose concentrations were higher and lactate levels were lower in the GD-C group

  1. The management of oesophageal soft food bolus obstruction: a systematic review.

    PubMed

    Leopard, D; Fishpool, S; Winter, S

    2011-09-01

    Oesophageal soft food bolus obstruction (OSFBO) is a surgical emergency. However, no national guidelines exist regarding its management. This paper systematically reviews the literature with respect to the management of OSFBO. Relevant studies included were identified from the the Cochrane Library, the National Center for Biotechnology Information and the US National Library of Medicine resources. A systematic review was performed on 8 November 2010. This systematic review of the management of OSFBO shows no evidence that any medical intervention is more effective than a 'watch and wait' policy in enabling spontaneous disimpaction. Furthermore, the use of hyoscine butylbromide for OSFBO probably stems from a misquoted textbook. Surgical removal of an OSFBO is effective but not without potential risk. There is some evidence to support surgical intervention within 24 hours to prevent complications deriving from the initial obstruction. There is a need for large double-blind, randomised, placebo controlled trials of drugs used in the medical management of OSFBO. Until the results from such trials are available, the treatment of OSFBO will remain based on inconsistent clinical judgement.

  2. Management of type 2 diabetes with Fixed-Ratio combination insulin degludec/liraglutide (IDEGLIRA) versus Basal-Bolus therapy (INSULIN GLARGINE U100 PLUS INSULIN ASPART): A Short-Term Cost-Effectiveness analysis in the UK setting.

    PubMed

    Drummond, R S; Malkin, Sjp; Du Preez, M; Lee, X Y; Hunt, B

    2018-05-24

    Insulin degludec/liraglutide (IDegLira) is a once-daily, single-injection, fixed-ratio combination of insulin degludec, a basal insulin with a half-life of more than 24 hours, and GLP-1 receptor agonist liraglutide. The present analysis evaluated the cost-effectiveness of IDegLira versus basal-bolus therapy (BBT) with insulin glargine U100 plus up to four times daily insulin aspart for management of type 2 diabetes in the UK. A Microsoft Excel model was used to evaluate the cost-utility of IDegLira versus BBT over a 1-year time horizon. Clinical input data were taken from the treat-to-target DUAL VII trial, conducted in patients unable to achieve adequate glycaemic control (Hb A1c <7.0%) with basal insulin, with IDegLira associated with lower rates of hypoglycaemia and reduced body mass index (BMI) in comparison with BBT, with similar Hb A1c reductions. Costs (GBP) and event-related disutilities were taken from published sources. Extensive sensitivity analyses were performed. IDegLira was associated with an improvement of 0.05 quality-adjusted life years (QALYs) versus BBT, due to reductions in non-severe hypoglycaemic episodes and BMI with IDegLira. Costs were higher with IDegLira by GBP 303 per patient, leading to an incremental cost-effectiveness ratio (ICER) of GBP 5,924 per QALY gained for IDegLira versus BBT. ICERs remained below GBP 20,000 per QALY gained across a range of sensitivity analyses. IDegLira is a cost-effective alternative to BBT with insulin glargine U100 plus insulin aspart, providing equivalent glycaemic control with a simpler treatment regimen for patients with type 2 diabetes inadequately controlled on basal insulin in the UK. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  3. Intratracheal Milrinone Bolus Administration During Acute Right Ventricular Dysfunction After Cardiopulmonary Bypass.

    PubMed

    Gebhard, Caroline Eva; Desjardins, Georges; Gebhard, Cathérine; Gavra, Paul; Denault, André Y

    2017-04-01

    To evaluate intratracheal milrinone (tMil) administration for rapid treatment of right ventricular (RV) dysfunction as a novel route after cardiopulmonary bypass. Retrospective analysis. Single-center study. The study comprised 7 patients undergoing cardiac surgery who exhibited acute RV dysfunction after cardiopulmonary bypass. After difficult weaning caused by cardiopulmonary bypass-induced acute RV dysfunction, milrinone was administered as a 5-mg bolus inside the endotracheal tube. RV function improvement, as indicated by decreasing pulmonary artery pressure and changes of RV waveforms, was observed in all 7 patients. Adverse effects of tMil included dynamic RV outflow tract obstruction (2 patients) and a decrease in systemic mean arterial pressure (1 patient). tMil may be an effective, rapid, and easily applicable therapeutic alternative to inhaled milrinone for the treatment of acute RV failure during cardiac surgery. However, sufficiently powered clinical trials are needed to confirm these findings. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. Randomized controlled trial of reduced-dose bolus fluorouracil plus leucovorin and irinotecan or infused fluorouracil plus leucovorin and oxaliplatin in patients with previously untreated metastatic colorectal cancer: a North American Intergroup Trial.

    PubMed

    Goldberg, Richard M; Sargent, Daniel J; Morton, Roscoe F; Fuchs, Charles S; Ramanathan, Ramesh K; Williamson, Stephen K; Findlay, Brian P; Pitot, Henry C; Alberts, Steven

    2006-07-20

    Previously, we reported results of Intergroup N9741, which compared standard bolus fluorouracil (FU), leucovorin, plus irinotecan (IFL) with infused FU, leucovorin, plus oxaliplatin (FOLFOX4) and irinotecan plus oxaliplatin in patients with untreated metastatic colorectal cancer. High rates of grade > or = 3 toxicity on IFL (resulting in some deaths) led us to reduce the starting doses of both irinotecan and FU by 20% (rIFL). This article compares rIFL with FOLFOX4. The primary comparison was time to progression, with secondary end points of response rate (RR), overall survival, and toxicity. Three hundred five patients were randomly assigned. The North Central Cancer Treatment Group Data Safety Monitoring Committee interrupted enrollment at a planned interim analysis when outcomes crossed predetermined stopping boundaries. The results were significantly superior for FOLFOX4 compared with rIFL for time to progression (9.7 v 5.5 months, respectively; P < .0001), RR (48% v 32%, respectively; P = .006), and overall survival (19.0 v 16.3 months, respectively; P = .026). Toxicity profiles were not significantly different between regimens for nausea, vomiting, diarrhea, febrile neutropenia, dehydration, or 60-day all-cause mortality. Sensory neuropathy and neutropenia were significantly more common with FOLFOX4. Approximately 75% of patients in both arms received second-line therapy; 58% of rIFL patients received oxaliplatin-based second-line therapy, and 55% of FOLFOX4 patients received irinotecan-based regimens as second-line therapy. FOLFOX4 led to superior RR, time to progression, and overall survival compared with rIFL. The survival benefit for FOLFOX4 observed in the earlier stage of the study was preserved with equal use of either irinotecan or oxaliplatin as second-line therapy.

  5. Successful treatment with adalimumab for severe multifocal choroiditis and panuveitis in presumed (early-onset) ocular sarcoidosis.

    PubMed

    Achille, Marino; Ilaria, Pagnini; Teresa, Giani; Roberto, Caputo; Ilir, Arapi; Piergiorgio, Neri; Rolando, Cimaz; Gabriele, Simonini

    2016-02-01

    Early-onset sarcoidosis (EOS) and Blau syndrome are rare auto-inflammatory diseases characterized by a triad of skin rash, granulomatous uveitis, and symmetrical polyarthritis occurring in early childhood. In this paper, we describe a case report very interesting for the multidisciplinary management (pediatric rheumatologist and ophthalmologist), the challenging diagnosis and the difficult choice of the best treatment. We describe a case report of an 8-year old with recurrent episodes of acute uveitis that developed bilateral granulomatous panuveitis initially treated with topical and systemic steroids. Genetic testing for NOD2/CARD15 revealed a heterozygous mutation on exon 4 in the NBD domain (P268S/SNP5). Therefore, an incomplete EOS was suspected. Because uveitis worsening with multifocal chorioretinitis aggravation, intravenous boluses of methylprednisolone were administered. During the steroids tapering, she flared again, and methotrexate was started along with corticosteroids pulse therapy. However, new ocular granuloma appeared, macular oedema with poor visual outcome occurred, and therefore, adalimumab was added to MTX and steroids. After 6 months since the new therapy started, she had a complete visual recovery, and she was able to stop steroid treatment. At 2 years of follow-up, she is still in remission on treatment, and her visual acuity is normal. No side effects were observed. In our patient, we found a heterozygous mutation on exon 4 in the NBD domain (P268S/SNP5) of NOD2/CARD15 gene and an incomplete EOS was hypothesized. The role of this variant is currently under study. Adalimumab use dramatically changed the course of eye disease, prompting to stop steroid treatment and preserving visual acuity.

  6. Ultrasound-mediated gene delivery of naked plasmid DNA in skeletal muscles: a case for bolus injections.

    PubMed

    Sanches, Pedro Gomes; Mühlmeister, Mareike; Seip, Ralf; Kaijzel, Eric; Löwik, Clemens; Böhmer, Marcel; Tiemann, Klaus; Grüll, Holger

    2014-12-10

    Localized gene delivery has many potential clinical applications. However, the nucleic acids (e.g. pDNA and siRNA) are incapable of passively crossing the endothelium, cell membranes and other biological barriers which must be crossed to reach their intracellular targets. A possible solution is the use of ultrasound to burst circulating microbubbles inducing transient permeabilization of surrounding tissues which mediates nucleic acid extravasation and cellular uptake. In this study we report on an optimization of the ultrasound gene delivery technique. Naked pDNA (200 μg) encoding luciferase and SonoVue® microbubbles were co-injected intravenously in mice. The hindlimb skeletal muscles were exposed to ultrasound from a non-focused transducer (1 MHz, 1.25 MPa, PRI 30s) and injection protocols and total amounts as well as ultrasound parameters were systemically varied. Gene expression was quantified relative to a control using a bioluminescence camera system at day 7 after sonication. Bioluminescence ratios in sonicated/control muscles of up to 101× were obtained. In conclusion, we were able to specifically deliver genetic material to the selected skeletal muscles and overall, the use of bolus injections and high microbubble numbers resulted in increased gene expression reflected by stronger bioluminescence signals. Based on our data, bolus injections seem to be required in order to achieve transient highly concentrated levels of nucleic acids and microbubbles at the tissue of interest which upon ultrasound exposure should lead to increased levels of gene delivery. Thus, ultrasound mediated gene delivery is a promising technique for the clinical translation of localized drug delivery. Copyright © 2014 Elsevier B.V. All rights reserved.

  7. Comparison of Gavage, Water Bottle, and a High-Moisture Diet Bolus as Dosing Methods for Quantitative D-xylose Administration to B6D2F1 (Mus musculus) Mice

    NASA Technical Reports Server (NTRS)

    Zimmer, J. Paul; Lewis, Sherry M.; Moyer, Jerry L.

    1993-01-01

    Gavage, water bottle, and diet incorporation are 3 dosing methods used orally to administer test compounds to rodents. These 3 methods were compared in mice to determine which represented the most quantitative delivery system. For dietary incorporation, a high-moisture bolus form of NIH-31 rodent meal was developed using hydroxypropyl methylcellulose as an autoclave-stable binding agent. A high-moisture bolus were selected to increase the acceptability of the dosed diet and to promote quantitative consumption through reduced wastage. The test compound used was D-xylose, a pentose sugar that may be quantitatively detected, colorimetrically, in urine following oral dosing. Six male and 6 female B6D2FI mice were placed in metabolism cages and dosed with a known quantity of D-xylose by each of the 3 methods. Urine was collected before and after each method of administration and analysed for total D-xylose; the per cent recovery was based upon the amount of D-xylose consumed. Quantitative consumption was apparently greatest for water bottle dosing with an average recovery of 56.0% of the original D-xylose dose. High-moisture bolus incorporation ranked second with 50.0% D-xylose recovery, and gavage was third with 41.0% D-xylose recovery.

  8. SU-F-T-323: A Post-Mastectomy Radiation Therapy Dose Distribution Study Using Nanodots and Films

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Qian, X; Vaidya, K; Puckett, L

    Purpose: In post-mastectomy radiation therapy (RT), skin dose must be accurately estimated to assess skin reactions such as erythema, desquamation and necrosis. Planning systems cannot always provide accurate dosimetry for target volumes distal to skin. Therefore, in-vivo dosimetry is necessary. A female anthropomorphic phantom was used with optically stimulated luminescence dosimeters (nanoDots) to measure dose to chest wall skin. In addition, EBT2 films was employed to measure dose to left lung and heart in post-mastectomy RT. Methods: Films and nanoDots were calibrated under full buildup conditions at 100cm SAD for 6MV photons. Five pieces of films were placed between slabsmore » of Rando phantom to assess dose to left lung and heart. Two layers of 0.5cm thick bolus were used to cover the whole left chest. Six pairs of nanoDots were placed at medical and lateral aspects on the bolus surface, between the 0.5cm bolus layers, and under the bolus. Three control nanoDots were placed on chest wall to quantify imaging dose. The phantom was CT scanned with all dosimeters in place, and treatment planning was performed with tangential fields (200cGy). All dosimeters were contoured on CT and dose was extracted. NanoDots were read using nanoDot reader and films were scanned using film scanner. The measured and calculated doses were tabulated. Results: Dose to 12 nanoDots were evaluated. Dose variance for surface nanoDots were +3.8%, +2.7%, −5% and −9.8%. Those at lateral positions, with greater beam obliquity had larger variance than the medial positions. A similar trend was observed for other nanoDots (Table1). Point doses from films for heart and the left lung were 112.7cGy and 108.7cGy, with +10.2% and +9.04% deviation from calculated values, respectively. Conclusion: Dosimetry provided by the advanced planning system was verified using NanoDots and films. Both nanoDots and films provided good estimation of dose distribution in post-mastectomy RT.« less

  9. Continuous Transversus Abdominis Plane Nerve Blocks: Does Varying Local Anesthetic Delivery Method-Automatic Repeated Bolus Versus Continuous Basal Infusion-Influence the Extent of Sensation to Cold?: A Randomized, Triple-Masked, Crossover Study in Volunteers.

    PubMed

    Khatibi, Bahareh; Said, Engy T; Sztain, Jacklynn F; Monahan, Amanda M; Gabriel, Rodney A; Furnish, Timothy J; Tran, Johnathan T; Donohue, Michael C; Ilfeld, Brian M

    2017-04-01

    It remains unknown whether continuous or scheduled intermittent bolus local anesthetic administration is preferable for transversus abdominis plane (TAP) catheters. We therefore tested the hypothesis that when using TAP catheters, providing local anesthetic in repeated bolus doses increases the cephalad-caudad cutaneous effects compared with a basal-only infusion. Bilateral TAP catheters (posterior approach) were inserted in 24 healthy volunteers followed by ropivacaine 2 mg/mL administration for a total of 6 hours. The right side was randomly assigned to either a basal infusion (8 mL/h) or bolus doses (24 mL administered every 3 hours for a total of 2 bolus doses) in a double-masked manner. The left side received the alternate treatment. The primary end point was the extent of sensory deficit as measured by cool roller along the axillary line at hour 6 (6 hours after the local anesthetic administration was initiated). Secondary end points included the extent of sensory deficit as measured by cool roller and Von Frey filaments along the axillary line and along a transverse line at the level of the anterior superior iliac spine at hours 0 to 6. Although there were statistically significant differences between treatments within the earlier part of the administration period, by hour 6 the difference in extent of sensory deficit to cold failed to reach statistical significance along the axillary line (mean = 0.9 cm; SD = 6.8; 95% confidence interval -2.0 to 3.8; P = .515) and transverse line (mean = 2.5 cm; SD = 10.1; 95% confidence interval -1.8 to 6.8; P = .244). Although the difference between treatments was statistically significant at various early time points for the horizontal, vertical, and estimated area measurements of both cold and mechanical pressure sensory deficits, no comparison remained statistically significant by hour 6. No evidence was found in this study involving healthy volunteers to support the hypothesis that changing the local anesthetic

  10. Graft-versus-host disease after radiation therapy in patients who have undergone allogeneic stem cell transplantation: two case reports.

    PubMed

    Milgrom, Sarah A; Nieto, Yago; Pinnix, Chelsea C; Smith, Grace L; Wogan, Christine F; Rondon, Gabriela; Medeiros, L Jeffrey; Kebriaei, Partow; Dabaja, Bouthaina S

    2016-07-28

    Patients who undergo allogeneic stem cell transplantation and subsequent radiation therapy uncommonly develop graft-versus-host disease within the irradiated area. We quantified the incidence of this complication, which is a novel contribution to the field. From 2010 to 2014, 1849 patients underwent allogeneic stem cell transplantation, and 41 (2 %) received radiation therapy afterward. Of these, two patients (5 %) developed graft-versus-host disease within the irradiated tissues during or immediately after radiation therapy. The first patient is a 37-year-old white man who had Hodgkin lymphoma; he underwent allogeneic stem cell transplantation from a matched unrelated donor and received radiation therapy for an abdominal and pelvic nodal recurrence. After 28.8 Gy, he developed grade 4 gastrointestinal graft-versus-host disease, refractory to tacrolimus and steroids, but responsive to pentostatin and photopheresis. The other patient is a 24-year-old white man who had acute leukemia; he underwent allogeneic stem cell transplantation from a matched related donor and received craniospinal irradiation for a central nervous system relapse. After 24 cobalt Gy equivalent, he developed severe cutaneous graft-versus-host disease, sharply delineated within the radiation therapy field, which was responsive to tacrolimus and methylprednisolone. We conclude that graft-versus-host disease within irradiated tissues is an uncommon but potentially serious complication that may follow radiation therapy in patients who have undergone allogeneic stem cell transplantation. Clinicians must be aware of this complication and prepared with strategies to mitigate risk. Patients who have undergone allogeneic stem cell transplantation represent a unique population that may offer novel insight into the pathways involved in radiation-related inflammation.

  11. Preoperative methylprednisolone does not reduce loss of knee-extension strength after total knee arthroplasty

    PubMed Central

    Lindberg-Larsen, Viktoria; Bandholm, Thomas Q; Zilmer, Camilla K; Bagger, Jens; Hornsleth, Mette; Kehlet, Henrik

    2017-01-01

    Background and purpose Patients undergoing total knee arthroplasty (TKA) face challenges related to postoperative reduction in knee-extension strength. We evaluated whether inhibition of the inflammatory response by a single preoperative dose of methylprednisolone (MP) reduces the pronounced loss of knee-extension strength at discharge after fast-track TKA. Patients and methods 70 patients undergoing elective unilateral TKA were randomized (1:1) to preoperative intravenous (IV) MP 125 mg (group MP) or isotonic saline IV (group C). All procedures were performed under spinal anesthesia without tourniquet, and with a standardized multimodal analgesic regime. The primary outcome was change in knee-extension strength from baseline to 48 hours postoperatively. Secondary outcomes were knee joint circumference, functional performance using the Timed Up and Go (TUG) test, pain during the aforementioned tests, rescue analgesic requirements, and plasma C-reactive protein (CRP) changes. Results 61 patients completed the follow-up. The loss in quadriceps muscle strength was similar between groups; group MP 1.04 (0.22–1.91) Nm/kg (–89%) vs. group C 1.02 (0.22–1.57) Nm/kg (–88%). Also between-group differences were similar for knee circumference, TUG test, and pain scores. MP reduced the inflammatory response (CRP) at 24 hours postoperatively; group MP 33 (IQR 21–50) mg/L vs. group C 72 (IQR 58–92) mg/L (p < 0.001), and 48 hours postoperatively; group MP 83 (IQR 56–125) mg/L vs. group C 192 (IQR 147–265) mg/L (p < 0.001), respectively. Interpretation Preoperative systemic administration of MP 125 mg did not reduce the pronounced loss of knee-extension strength or other functional outcomes at discharge after fast-track TKA despite a reduced systemic inflammatory response. PMID:28657396

  12. Three-Station Three-dimensional Bolus-Chase MR Angiography with Real-time Fluoroscopic Tracking

    PubMed Central

    Johnson, Casey P.; Weavers, Paul T.; Borisch, Eric A.; Grimm, Roger C.; Hulshizer, Thomas C.; LaPlante, Christine C.; Rossman, Phillip J.; Glockner, James F.; Young, Phillip M.

    2014-01-01

    Purpose To determine the feasibility of using real-time fluoroscopic tracking for bolus-chase magnetic resonance (MR) angiography of peripheral vasculature to image three stations from the aortoiliac bifurcation to the pedal arteries. Materials and Methods This prospective study was institutional review board approved and HIPAA compliant. Eight healthy volunteers (three men; mean age, 48 years; age range, 30–81 years) and 13 patients suspected of having peripheral arterial disease (five men; mean age, 67 years; age range, 47–81 years) were enrolled and provided informed consent. All subjects were imaged with the fluoroscopic tracking MR angiographic protocol. Ten patients also underwent a clinical computed tomographic (CT) angiographic runoff examination. Two readers scored the MR angiographic studies for vessel signal intensity and sharpness and presence of confounding artifacts and venous contamination at 35 arterial segments. Mean aggregate scores were assessed. The paired MR angiographic and CT angiographic studies also were scored for visualization of disease, reader confidence, and overall diagnostic quality and were compared by using a Wilcoxon signed rank test. Results Real-time fluoroscopic tracking performed well technically in all studies. Vessel segments were scored good to excellent in all but the following categories: For vessel signal intensity and sharpness, the abdominal aorta, iliac arteries, distal plantar arteries, and plantar arch were scored as fair to good; and for presence of confounding artifacts, the abdominal aorta and iliac arteries were scored as fair. The MR angiograms and CT angiograms did not differ significantly in any scoring category (reader 1: P = .50, .39, and .39; reader 2: P = .41, .61, and .33, respectively). CT scores were substantially better in 20% (four of 20) and 25% (five of 20) of the pooled evaluations for the visualization of disease and overall image quality categories, respectively, versus 5% (one of 20) for MR

  13. Role of Acid and Weakly Acidic Reflux in Gastroesophageal Reflux Disease Off Proton Pump Inhibitor Therapy

    PubMed Central

    Sung, Hea Jung; Moon, Sung Jin; Kim, Jin Su; Lim, Chul Hyun; Park, Jae Myung; Lee, In Seok; Kim, Sang Woo; Choi, Myung-Gye

    2012-01-01

    Background/Aims Available data about reflux patterns and symptom determinants in the gastroesophageal reflux disease (GERD) subtypes off proton pump inhibitor (PPI) therapy are lacking. We aimed to evaluate reflux patterns and determinants of symptom perception in patients with GERD off PPI therapy by impedance-pH monitoring. Methods We retrospectively reviewed the impedance-pH data in patients diagnosed as GERD based on results of impedance-pH monitoring, endoscopy and/or typical symptoms. The characteristics of acid and weakly acidic reflux were evaluated. Symptomatic and asymptomatic reflux were compared according to GERD subtypes and individual symptoms. Results Forty-two patients (22 males, mean age 46 years) were diagnosed as GERD (17 erosive reflux disease, 9 pH(+) non-erosive reflux disease [NERD], 9 hypersensitive esophagus and 7 symptomatic NERD). A total of 1,725 reflux episodes were detected (855 acid [50%], 857 weakly acidic [50%] and 13 weakly alkaline reflux [< 1%]). Acid reflux was more frequently symptomatic and bolus clearance was longer compared with weakly acidic reflux. In terms of globus, weakly acidic reflux was more symptomatic. Symptomatic reflux was more frequently acid and mixed reflux; these associations were more pronounced in erosive reflux disease and symptomatic NERD. The perception of regurgitation was related to acid reflux, while that of globus was more related to weakly acidic reflux. Conclusions In patients not taking PPI, acid reflux was more frequently symptomatic and had longer bolus clearance. Symptomatic reflux was more frequently acid and mixed type; however, weakly acidic reflux was associated more with globus. These data suggest a role for impedance-pH data in the evaluation of globus. PMID:22837877

  14. Role of Acid and weakly acidic reflux in gastroesophageal reflux disease off proton pump inhibitor therapy.

    PubMed

    Sung, Hea Jung; Cho, Yu Kyung; Moon, Sung Jin; Kim, Jin Su; Lim, Chul Hyun; Park, Jae Myung; Lee, In Seok; Kim, Sang Woo; Choi, Myung-Gye

    2012-07-01

    Available data about reflux patterns and symptom determinants in the gastroesophageal reflux disease (GERD) subtypes off proton pump inhibitor (PPI) therapy are lacking. We aimed to evaluate reflux patterns and determinants of symptom perception in patients with GERD off PPI therapy by impedance-pH monitoring. We retrospectively reviewed the impedance-pH data in patients diagnosed as GERD based on results of impedance-pH monitoring, endoscopy and/or typical symptoms. The characteristics of acid and weakly acidic reflux were evaluated. Symptomatic and asymptomatic reflux were compared according to GERD subtypes and individual symptoms. Forty-two patients (22 males, mean age 46 years) were diagnosed as GERD (17 erosive reflux disease, 9 pH(+) non-erosive reflux disease [NERD], 9 hypersensitive esophagus and 7 symptomatic NERD). A total of 1,725 reflux episodes were detected (855 acid [50%], 857 weakly acidic [50%] and 13 weakly alkaline reflux [< 1%]). Acid reflux was more frequently symptomatic and bolus clearance was longer compared with weakly acidic reflux. In terms of globus, weakly acidic reflux was more symptomatic. Symptomatic reflux was more frequently acid and mixed reflux; these associations were more pronounced in erosive reflux disease and symptomatic NERD. The perception of regurgitation was related to acid reflux, while that of globus was more related to weakly acidic reflux. In patients not taking PPI, acid reflux was more frequently symptomatic and had longer bolus clearance. Symptomatic reflux was more frequently acid and mixed type; however, weakly acidic reflux was associated more with globus. These data suggest a role for impedance-pH data in the evaluation of globus.

  15. [Clinical and biological evolution of nephrotic syndrome patients and corticotherapy].

    PubMed

    Fongoro, S; Diallo, D; Maiga, M K

    2009-01-01

    This study was aimed to follow clinical and biological data of patients presenting a nephrotic syndrom apparently primitiv, devided in two groups. The study was prospectiv including 50 patients hospitalized from January 1999 to January 2001. The first group received prednison tablets according to their body weight, and the second group received firstly a bolus of methyl prednisone to the cumulative dose of 20mg/kg divided on 3 days; relayed by the 20mg/day of prednison tablets. The Chi2 test was estimated (pbolus group, and in the prednisone tablets group from 115/72 mmHg to 123/80 mmHg. The average hospitalisation was 5 weeks in first groups and 8 weeks in second before proteinuria disappeared in the urine. We concluted that methylprednisolon contributed to a faster normalisation of proteinuria and shorter hospitalisation time.

  16. Regional differences in insulin therapy regimens in five European countries
.

    PubMed

    Rathmann, Wolfgang; Czech, Marcin; Franek, Edward; Kostev, Karel

    2017-05-01

    The purpose of this study was to investigate differences of insulin therapy regimens in five European countries. Proportions of basal bolus therapy (intensified insulin therapy (ICT), basal insulin supported oral therapy (BOT), conventional therapy (CT), and short-acting prandial insulin (SIT) among insulin-treated diabetes patients in Germany (n = 64,055), the UK (n = 6,740), and France (n = 4,779) were estimated using representative general medicine practice databases (Disease Analyzer: 2014). Insulin regimens in Hungary (n = 40,769) and Poland (n = 68,136) were analyzed based on nationwide prescription databases (LRx: 2014). ICT was the most frequent insulin regimen (46 - 81%) in all countries except France (BOT > ICT). SIT showed the lowest use, ranging from 2.5% in the UK to 11.2% in Germany. BOT was more frequently used than CT in Germany and Hungary, which was just the opposite in the UK and Poland. The share of insulin analogs among all prescriptions was higher in Germany, the UK, and France (short-acting insulins: 59 - 98%; basal insulins: 70 - 93%) than in Hungary and Poland (short-acting insulins: 41 - 57%; basal insulins: 23 - 46%) (all p < 0.001). Despite national and international guidelines, insulin regimens differ substantially between European countries. Our results most likely reflect differences in regulations and reimbursement systems, national diabetes care systems as well as patient characteristics and expectations.
.

  17. Push versus gravity for intermittent bolus gavage tube feeding of premature and low birth weight infants.

    PubMed

    Dawson, Jennifer A; Summan, Ravinder; Badawi, Nadia; Foster, Jann P

    2012-11-14

    Many small, sick and premature infants are unable to coordinate sucking, swallowing and breathing, and therefore, require gavage feeding. In gavage feeding, milk feeds are delivered through a tube passed via the nose or mouth into the stomach. Intermittent bolus milk feeds may be administered using a syringe to gently push milk into the infant's stomach (push feed). Alternatively, milk can be poured into a syringe attached to the tube and allowed to drip in by gravity (gravity feed). To determine whether the use of push compared with gravity gavage feeding results in a more rapid establishment of full gavage feeds without increasing adverse events in preterm or low birth weight, infants who require intermittent bolus gavage feeding. We searched the following electronic databases to locate randomised controlled or quasi-randomised trials: Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, 2012, Issue 5), MEDLINE (from 1966 to May 2012), EMBASE (from 1980 to May 2012), and CINAHL (from 1982 to May 2012). We used the standard search strategy of the Cochrane Neonatal Review Group. Randomised or quasi-randomised controlled trials comparing push versus gravity intermittent gavage tube feeding in premature or low birth weight, or both, infants. We assessed the methodology of trials regarding blinding of randomisation and outcome measurement. We evaluated treatment effect with a fixed-effect model using risk ratio (RR), relative risk reduction, risk difference (RD) and number needed to treat (NNT) for categorical data; and using mean, standard deviation and weighted mean difference (WMD) for continuous data. We analysed outcomes measured as count data, for example frequency of apnoea, bradycardia and episodes of pulse oximeter oxygen (SpO(2)) desaturation, by comparing rates of events and the rate ratio. We evaluated heterogeneity to help determine the suitability of pooling results. Only one small cross-over trial met the criteria for inclusion

  18. Continuous nasogastric milk feeding versus intermittent bolus milk feeding for premature infants less than 1500 grams.

    PubMed

    Premji, Shahirose S; Chessell, Lorraine

    2011-11-09

    Milk feedings can be given via nasogastric tube either intermittently, typically over 10 to 20 minutes every two or three hours, or continuously, using an infusion pump. Although theoretical benefits and risks of each method have been proposed, effects on clinically important outcomes remain uncertain. To examine the evidence regarding the effectiveness of continuous versus intermittent bolus nasogastric milk feeding in premature infants less than 1500 grams. Searches were performed of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2011), MEDLINE, CINAHL and HealthSTAR up to July 2011. Randomised and quasi-randomised clinical trials comparing continuous versus intermittent bolus nasogastric milk feeding in premature infants less than 1500 grams. Two review authors independently assessed all trials for relevance and methodologic quality. The standard methods of the Cochrane Neonatal Review Group were used to extract data. Overall, the seven included trials, involving 511 infants, found no differences in time to achieve full enteral feeds between feeding methods (weighted mean difference (WMD) 2 days; 95% CI -0.3 to 3.9) . In the subgroup analysis of those studies comparing continuous nasogastric versus intermittent bolus nasogastric milk feedings the findings remained unchanged (WMD 2 days, 95% CI -0.4 to 4.1). There was no significant difference in somatic growth and incidence of NEC between feeding methods irrespective of tube placement. One study noted a trend toward more apneas during the study period in infants fed by the continuous tube feeding method compared to those fed by intermittent feedings delivered predominantly by orogastric tube placements [mean difference (MD) 14.0 apneas during study period; 95% CI -0.2 to 28.2]. In subgroup analysis based on weight groups, one study suggested that infants less than 1000 grams and 1000 to 1250 grams birth weight gained weight faster when fed by the continuous

  19. A retrospective observational study of glucocorticoid-induced diabetes mellitus with IgA nephropathy treated with tonsillectomy plus methylprednisolone pulse therapy

    PubMed Central

    Katsuyama, Takayuki; Sada, Ken-Ei; Hiramatsu, Sumie; Ohashi, Keiji; Morishita, Michiko; Katsuyama, Eri; Watanabe, Haruki; Takano-Narazaki, Mariko; Toyota-Tatebe, Noriko; Sunahori-Watanabe, Katsue; Kawabata, Tomoko; Inoue, Tatsuyuki; Kinomura, Masaru; Sugiyama, Hitoshi; Wada, Jun

    2017-01-01

    Aims To evaluate the incidence of GC-DM among patients with immunoglobulin A nephropathy (IgAN) and to confirm the risk factors for the development of GC-DM. Methods The medical records of patients with IgAN newly treated with the protocol of tonsillectomy combined with steroid pulse therapy were reviewed. The primary outcome was the development of GC-DM within the hospitalization period and during one year of follow-up. Results During hospitalization, 19 of the 95 patients developed GC-DM (20.0%), and the patients with GC-DM were significantly older and had a higher rate of family history of diabetes and higher HbA1c levels. The prevalence of hypertension was higher and the eGFR was numerically lower in patients with GC-DM than in those without. Older age (≥45 years) and a family history of diabetes emerged as independent risk factors for the development of GC-DM (odds ratio [OR], 6.3 and 95% confidence interval [CI], 1.6–27.6; OR, 4.4 and 95% CI, 1.2–16.6, respectively). No patients were newly diagnosed with GC-DM during 1-year observation period at out-patient clinic. Conclusions Among the patients with IgAN, 20% developed GC-DM during the hospitalization period, confirming the family history of diabetes is clinically necessary before starting GC therapy. PMID:28562629

  20. Neuroprotective therapy for argon-laser-induced retinal injury

    NASA Astrophysics Data System (ADS)

    Belkin, Michael; Rosner, Mordechai; Solberg, Yoram; Turetz, Yosef

    1999-06-01

    Laser photocoagulation treatment of the central retina is often complicated by an immediate side effect of visual impairment, caused by the unavoidable laser-induced destruction of the normal tissue lying adjacent to the lesion and not affected directly by the laser beam. Furthermore, accidental laser injuries are at present untreatable. A neuroprotective therapy for salvaging the normal tissue might enhance the benefit obtained from treatment and allow safe perifoveal photocoagulation. We have developed a rat model for studying the efficacy of putative neuroprotective compounds in ameliorating laser-induced retinal damage. Four compounds were evaluated: the corticosteroid methylprednisolone, the glutamate-receptor blocker MK-801, the anti-oxidant enzyme superoxide dismutase, and the calcim-overload antagonist flunarizine. The study was carried out in two steps: in the first, the histopathological development of retinal laser injuries was studied. Argon laser lesions were inflicted in the retinas of 18 pigmented rats. The animals were sacrificed after 3, 20 or 60 days and their retinal lesions were evaluated under the light microscope. The laser injury mainly involved the outer layers of the retina, where it destroyed significant numbers of photoreceptor cells. Over time, evidence of two major histopathological processes was observed: traction of adjacent nomral retinal cells into the central area of the lesion forming an internal retinal bulging, and a retinal pigmented epithelial proliferative reaction associated with subretinal neovascularization and invations of the retinal lesion site by phagocytes. The neuroprotective effects of each of the four compounds were verified in a second step of the study. For each drug tested, 12 rats were irradiated wtih argon laser inflictions: six of them received the tested agent while the other six were treated with the corresponding vehicle. Twenty days after laser expsoure, the rats were sacrificed and their lesions were

  1. Urinary profile of methylprednisolone and its metabolites after oral and topical administrations.

    PubMed

    Matabosch, Xavier; Pozo, Oscar J; Monfort, Núria; Pérez-Mañá, Clara; Farré, Magi; Marcos, Josep; Segura, Jordi; Ventura, Rosa

    2013-11-01

    Methylprednisolone (MP) is prohibited in sports competitions when administered by systemic routes; however its use by topical administration is allowed. Therefore, analytical approaches to distinguish between these different administration pathways are required. A reporting level of 30ng/mL was established for this purpose. However, the suitability of that reporting level for MP is not known. In the present work, excretion profiles of MP and different metabolites after oral and topical administrations have been compared. A method for the quantification of MP and the qualitative detection of fifteen previously reported metabolites has been validated. The method involved an enzymatic hydrolysis, liquid-liquid extraction and analysis by liquid chromatography coupled to tandem mass spectrometry. The method was found to be linear, selective, precise and accurate. The high sensitivity (limit of detection 0.1ng/mL) and linear range (0.1-250ng/mL) achieved allowed for the quantification of MP at both the low concentrations present after topical administration and the high concentrations detected after oral intake. The method was applied to samples collected after oral (4 or 40mg) and topical administration (10mg of MP aceponate/day for 5 consecutive days) to healthy volunteers. After oral administration, MP and all metabolites were detected in urines collected up to at least 36h. Only MP and five metabolites were detected in samples obtained after topical treatment. As expected, concentrations of MP after topical administration were well below current reporting level (30ng/mL), however 3 out of 4 samples in range 8-24h after the low oral dose (4mg) were also below that concentration. Taking into account metabolites detected after both administration routes, metabolites 16β,17α,21-trihydroxy-6α-methylpregna-1,4-diene-3,11,20-trione (M8) and 17α,20α,21-trihydroxy-6α-methylpregna-1,4-diene-3,11-dione (M11) are best markers to differentiate between topical and oral

  2. A portable self-sensing rheometer for investigation and therapy of swallowing disorders.

    PubMed

    O'Leary, Mark T; Hanson, Ben

    2010-01-01

    Dysphagia is a medical condition in which the safety or efficiency of eating and drinking is compromised. Thin, watery fluids flow too quickly through the oral anatomy during an abnormal swallow, pre-empting airway protective mechanisms, and potentially resulting in fluid entry into the lung. Dysphagia therapy consists of reducing flow speed during swallowing by increasing fluid viscosity using thickeners. Bolus viscosity must be specified and presented to the patient within a well-defined range for effective therapy. Thickeners produce non-Newtonian fluids, rendering current subjective methods for fluid assessment unreliable. Widespread quantification of fluid viscosity is presently impractical as rheometers are costly and complicated to use. Alternative techniques also have disadvantages such as operation at shear rates inappropriate to fluid use. A simple and inexpensive rheometer has been constructed to remedy this situation using a self-sensing electromagnetic actuator. This avoids the need for separate force and displacement sensors, with benefits for simplicity and robustness. The actuator and fluid interface were designed for viscosities consistent with those used for dysphagia therapy. The self-sensing rheometer was found to be able to resolve the different dynamic viscosities obtained from three commonly used therapeutic fluid consistency levels in close agreement with results from a reference laboratory rheometer. Widespread use of the rheometer could remove the subjectivity of fluid assessment, increasing accuracy of fluid specification and therapy across all consistencies and fluid types.

  3. Prolonged infusion versus intermittent boluses of β-lactam antibiotics for treatment of acute infections: a meta-analysis.

    PubMed

    Teo, Jocelyn; Liew, Yixin; Lee, Winnie; Kwa, Andrea Lay-Hoon

    2014-05-01

    The clinical advantages of prolonged (extended/continuous) infusion remain controversial. Previous studies and reviews have failed to show consistent clinical benefits of extending the infusion time. This meta-analysis sought to determine whether prolonged β-lactam infusions were associated with a reduction in mortality and improvement in clinical success. A search of PubMed, EMBASE and The Cochrane Library for randomised controlled trials (RCTs) and observational studies comparing prolonged infusion with intermittent bolus administration of the same antibiotic in hospitalised adult patients was conducted. Primary outcomes evaluated were mortality and clinical success. A total of 29 studies with 2206 patients (18 RCTs and 11 observational studies) were included in the meta-analysis. Compared with intermittent boluses, use of prolonged infusion appeared to be associated with a significant reduction in mortality [pooled relative risk (RR) = 0.66, 95% confidence interval (CI) 0.53-0.83] and improvement in clinical success (RR = 1.12, 95% CI 1.03-1.21). Statistically significant benefit was supported by non-randomised studies (mortality, RR = 0.57, 95% CI 0.43-0.76; clinical success, RR = 1.34, 95% CI 1.02-1.76) but not by RCTs (mortality, RR = 0.83, 95% CI 0.57-1.21; clinical success, RR = 1.05, 95% CI 0.99-1.12). The positive results from observational studies, especially in the face of increasing antibiotic resistance, serve to justify the imperative need to conduct a large-scale, well-designed, multicentre RCT involving critically ill patients infected with high minimum inhibitory concentration pathogens to clearly substantiate this benefit. Copyright © 2014 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

  4. [Differentiation therapy for non-acidic gastroesophageal reflux disease].

    PubMed

    Lishchuk, N B; Simanenkov, V I; Tikhonov, S V

    2017-01-01

    To investigate the clinical and pathogenetic features of the non-acidic types of gastroesophageal reflux disease (GERD) and to evaluate the impact of combined therapy versus monotherapy on the course of this disease. The investigation enrolled 62 patients with non-acidic GERD. The follow-up period was 6 weeks. The patients were divided into 2 groups: 1) weakly acidic gastroesophageal refluxes (GER); 2) weakly alkaline GER. Then each group was distributed, thus making up 4 groups: 1) 19 patients with weakly acidic GER who received monotherapy with rabeprazole 20 mg/day; 2) 21 patients with weakly acidic GER had combined therapy with rabeprazole 20 mg and itopride; 3) 8 patients with weakly alkaline GER who received ursodeoxycholic acid (UDCA) monotherapy; and 4) 14 patients with weakly alkaline GER who had combined therapy with UDCA and itopride, The clinical symptoms of the disease, the endoscopic pattern of the upper gastrointestinal tract (GIT) mucosa, histological changes in the esophageal and gastric mucosa, and the results of 24-hour impedance pH monitoring were assessed over time. During differentiation therapy, the majority of patients reported positive clinical changes and an improved or unchanged endoscopic pattern. Assessment of impedance pH monitoring results revealed decreases in the overall number of GERs, the presence of a bolus in the esophagus, and the number of proximal refluxes. These changes were noted not only in patients taking proton pump inhibitors (PPIs), but also in those treated with UDCA monotherapy or combined PPI and prokinetic therapy. A differentiated approach to non-acidic GER treatment contributes to its efficiency. Adding the prokinetic itomed (itopride hydrochloride) to PPI therapy in a patient with weakly acidic GER enhances the efficiency of treatment, by positively affecting upper GIT motility. The mainstay of therapy for GERD with a predominance of weakly alkaline refluxes is UDCA, the combination of the latter and the

  5. Intraoperative anti-thymocyte globulin-Fresenius (ATG-F) administration as induction immunosuppressive therapy in kidney transplantation.

    PubMed

    Abou-Jaoude, Maroun M; Almawi, Wassim Y

    2003-07-01

    We reviewed 43 adult kidney transplant patients (32 males and 11 females, 14-68 years of age) performed at our center between July 1999 and February 2002. Donors (39 males and 4 females) comprised two cadaverics, five living-related and 36 living-unrelated; age 18-44 years. Indications for kidney transplantation (KT) were: chronic glomerulonephritis (8), re-transplantation (4) and chronic pyelonephritis (3); kidney disease was unknown in 15 cases. ATG-F was given as a single intra-operative bolus induction therapy in 26 patients; extended ATG-F dose was given in 17 patients because of a high sensitization status, slow graft function (SGF) or development of calcineurin inhibitors toxicity. ATG-F was stopped in seven out of 17 patients because of thrombocytopenia or severe anemia. ATG-F-related fever occurred in six patients. Acute rejection (AR) occurred in eight patients (18%) 5-11 days post-KT. ATG-F was given in three steroid-resistant AR. Infection occurred in 19 patients (44%) for a total of 32 infectious episodes comprising 24 bacterial infections (nine urinary, seven catheter-related and three respiratory), six viral infections (five CMV and one herpes) and two fungal infections (one pulmonary aspergillosis and one catheter-related candidiasis). The hospital stay was 8-75 days for a median of 13 days. The mean serum creatinine upon discharge, at 1 and 6 months after KT were: 2.04+/-0.37, 1.43+/-0.16 and 1.29+/-0.08, respectively. One patient lost his graft on day 9 because of graft microthrombi related to Factor V-Leiden mutation. The 6 months actuarial patient and graft survival were 100 and 97.6%, respectively. ATG-F as a bolus therapy is an effective and safe induction treatment in KT.

  6. The impact of highly concentrated Mo and Cu dietary supplements, fed as a bolus, on the efficacy of chelated versus inorganic Cu in cattle on a low-Cu diet.

    PubMed

    Grace, N D; West, D M; Smith, S L; Knowles, S O

    2013-11-01

    To compare the efficacy of chelated versus inorganic forms of dietary Cu supplements, fed as a bolus, when challenged by a daily bolus of dietary Mo in cattle on a low-Cu diet. Forty non-lactating, Friesian dairy cows of adequate Cu status were assigned to four groups and fed a basal diet of baled silage containing 5.3 mg Cu and 0.4 mg Mo/kg DM. The experimental design was a factorial of two chemical forms of supplemental Cu and two levels of Mo intake, provided as pelleted grain supplements made from crushed barley/molasses plus Cu and Mo. The supplements contained 140 mg Cu/kg as Cu sulphate pentahydrate (CS), 140 mg Cu/kg as Cu glycinate (CG), CS plus 38 mg Mo/kg as sodium molybdate (CS+Mo), or CG plus 38 mg Mo/kg (CG+Mo). Commencing on Day 0, supplements were fed once daily (offered 1-1.2 kg/cow) and were completely consumed within 5-10 minutes, which constitutes a bolus type of administration. Liver samples were collected by biopsy at Days -24, 13, 41 or 47, and 69 for Cu determinations. The diets fed to the Cu+Mo groups were roughly equivalent to 25 mg Cu and 5.7 mg Mo/kg DM. Mean initial concentration of Cu in liver for all groups was 516 (SE 54) μmol Cu/kg fresh tissue. In cows supplemented with CS and CG, the final (Day 69) concentrations increased (p<0.01) to 939 (SE 166) and 853 (SE 163) μmol Cu/kg, respectively. These values were not different (p=0.72). For groups CS+Mo and CG+Mo, the final concentrations of 535 (SE 122) and 453 (SE 102) μmol Cu/kg were not different from initial values or from each other (p>0.25). The rate of accumulation of Cu in liver following bolus Cu and Mo intake was highly variable but was not affected by initial concentration of Cu in liver (p>0.9) or by the form of Cu (p>0.6). Mean rates of accumulation of Cu in liver were 4.0 (SD 3.8) and 0.65 (SD 2.0) μmol Cu/kg fresh tissue/day for the Cu-only treatments and the Cu+Mo treatments, respectively. When fed together as a bolus, high Mo intake negated the effect

  7. Dosing of Milrinone in Preterm Neonates to Prevent Postligation Cardiac Syndrome: Simulation Study Suggests Need for Bolus Infusion.

    PubMed

    Hallik, Maarja; Tasa, Tõnis; Starkopf, Joel; Metsvaht, Tuuli

    2017-01-01

    Milrinone has been suggested as a possible first-line therapy for preterm neonates to prevent postligation cardiac syndrome (PLCS) through decreasing systemic vascular resistance and increasing cardiac contractility. The optimal dosing regimen, however, is not known. To model the dosing of milrinone in preterm infants for prevention of PLCS after surgical closure of patent ductus arteriosus (PDA). Milrinone time-concentration profiles were simulated for 1,000 subjects using the volume of distribution and clearance estimates based on one compartmental population pharmacokinetic model by Paradisis et al. [Arch Dis Child Fetal Neonatal Ed 2007;92:F204-F209]. Dose optimization was based on retrospectively collected demographic data from neonates undergoing PDA ligation in Estonian PICUs between 2012 and 2014 and existing pharmacodynamic data. The target plasma concentration was set at 150-200 ng/ml. The simulation study used demographic data from 31 neonates who underwent PDA ligation. The median postnatal age was 13 days (range: 3-29) and weight was 760 g (range: 500-2,351). With continuous infusion of milrinone 0.33 μg/kg/min, the proportion of subjects within the desired concentration range was 0% by 3 h, 36% by 6 h, and 61% by 8 h; 99% of subjects exceeded the range by 18 h. The maximum proportion of total simulated concentrations in the target range was attained with a bolus infusion of 0.73 μg/kg/min for 3 h followed by a 0.16-μg/kg/min maintenance infusion. Mathematical simulations suggest that in preterm neonates the plasma time-concentration profile of milrinone can be optimized with a slow loading dose followed by maintenance infusion. © 2016 S. Karger AG, Basel.

  8. Prospective Randomized Comparison of the Effectiveness of Radiation Therapy and Local Steroid Injection for the Treatment of Plantar Fasciitis

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Canyilmaz, Emine, E-mail: dremocan@ktu.edu.tr; Canyilmaz, Fatih; Aynaci, Ozlem

    2015-07-01

    Purpose: The purpose of this study was to conduct a randomized trial of radiation therapy for plantar fasciitis and to compare radiation therapy with local steroid injections. Methods and Materials: Between March 2013 and April 2014, 128 patients with plantar fasciitis were randomized to receive radiation therapy (total dose of 6.0 Gy applied in 6 fractions of 1.0 Gy three times a week) or local corticosteroid injections a 1 ml injection of 40 mg methylprednisolone and 0.5 ml 1% lidocaine under the guidance of palpation. The results were measured using a visual analog scale, a modified von Pannewitz scale, andmore » a 5-level function score. The fundamental phase of the study was 3 months, with a follow-up period of up to 6 months. Results: The median follow-up period for all patients was 12.5 months (range, 6.5-18.6 months). For the radiation therapy patients, the median follow-up period was 13 months (range, 6.5-18.5 months), whereas in the palpation-guided (PG) steroid injection arm, it was 12.1 months (range, 6.5-18.6 months). After 3 months, results in the radiation therapy arm were significantly superior to those in the PG steroid injection arm (visual analog scale, P<.001; modified von Pannewitz scale, P<.001; 5-level function score, P<.001). Requirements for a second treatment did not significantly differ between the 2 groups, but the time interval for the second treatment was significantly shorter in the PG steroid injection group (P=.045). Conclusion: This study confirms the superior analgesic effect of radiation therapy compared to mean PG steroid injection on plantar fasciitis for at least 6 months after treatment.« less

  9. Prospective Randomized Comparison of the Effectiveness of Radiation Therapy and Local Steroid Injection for the Treatment of Plantar Fasciitis.

    PubMed

    Canyilmaz, Emine; Canyilmaz, Fatih; Aynaci, Ozlem; Colak, Fatma; Serdar, Lasif; Uslu, Gonca Hanedan; Aynaci, Osman; Yoney, Adnan

    2015-07-01

    The purpose of this study was to conduct a randomized trial of radiation therapy for plantar fasciitis and to compare radiation therapy with local steroid injections. Between March 2013 and April 2014, 128 patients with plantar fasciitis were randomized to receive radiation therapy (total dose of 6.0 Gy applied in 6 fractions of 1.0 Gy three times a week) or local corticosteroid injections a 1 ml injection of 40 mg methylprednisolone and 0.5 ml 1% lidocaine under the guidance of palpation. The results were measured using a visual analog scale, a modified von Pannewitz scale, and a 5-level function score. The fundamental phase of the study was 3 months, with a follow-up period of up to 6 months. The median follow-up period for all patients was 12.5 months (range, 6.5-18.6 months). For the radiation therapy patients, the median follow-up period was 13 months (range, 6.5-18.5 months), whereas in the palpation-guided (PG) steroid injection arm, it was 12.1 months (range, 6.5-18.6 months). After 3 months, results in the radiation therapy arm were significantly superior to those in the PG steroid injection arm (visual analog scale, P<.001; modified von Pannewitz scale, P<.001; 5-level function score, P<.001). Requirements for a second treatment did not significantly differ between the 2 groups, but the time interval for the second treatment was significantly shorter in the PG steroid injection group (P=.045). This study confirms the superior analgesic effect of radiation therapy compared to mean PG steroid injection on plantar fasciitis for at least 6 months after treatment. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Current practice of methylprednisolone administration for acute spinal cord injury in Germany: a national survey.

    PubMed

    Druschel, Claudia; Schaser, Klaus-Dieter; Schwab, Jan M

    2013-05-15

    Written mail-out survey. To determine current practice in high-dose methylprednisolone succinate (MPSS) administration for treatment of acute spinal cord injury (SCI) in Germany. Reanalysis of the National Acute Spinal Cord Injury Studies (NASCIS) resulted in criticism of the use of high-dose MPSS for treatment of acute SCI. Subsequently, SCI treatment guidelines were revised leading to a reduction in MPSS use across North America. The impact of these revisions on SCI treatment in Germany is not known. A questionnaire was sent to all trauma, orthopedic and neurosurgical departments of German university centers, affiliated teaching hospitals, and specialized SCI care centers. Survey included 6 questions about the administration of MPSS after acute SCI. Three hundred seventy-two respondents completed the survey (response rate: 51% overall, 76% university hospitals, 85% specialized SCI care centers). Overall, 55% of departments that treat SCI prescribe MPSS. Among them, 73% are "frequent" users administering MPSS to more than 50% of their patients. Ten percent prescribe according to NASCIS I, 43% NASCIS II, 33% NASCIS III, and 13% "generic protocols." As justification for MPSS treatment, "effectiveness" ranked before "common practice" and "medicolegal reasons." "Specialized" SCI care centers differ in that (1) MPSS is administered less frequently, (2) NASCIS I doses are not used, and (3) during the past several years, practice patterns are more likely to have shifted away from the treatment of SCI with MPSS. About one-half of the institutions continue to prescribe MPSS in the setting of acute SCI. A need for further education in almost one-fourth of German departments treating acute SCI is demonstrated through responses indicating use of the outdated NASCIS I protocol, a "legal need" or "unchanged MPSS application during the last years." "Specialized" SCI centers are more likely to change their practice in accordance with evolving literature. 3.

  11. Intra-articular steroids in knee osteoarthritis: a comparative study of triamcinolone hexacetonide and methylprednisolone acetate.

    PubMed

    Pyne, Debasish; Ioannou, Yiannakis; Mootoo, Ramesh; Bhanji, Asgar

    2004-04-01

    The aim of this study was to compare the effectiveness of triamcinolone hexacetonide (THA) and methylprednisolone acetate (MPA), given via the intra-articular route at equipotent dosage to patients with symptomatic knee OA with effusion, in a double-blind randomized comparative trial. Consecutive hospital-referred patients who fulfilled the American College of Rheumatology criteria for knee OA (clinical and radiographic) were randomly allocated to receive either THA 20 mg (1 ml) or MPA 40 mg (1 ml). All patients had synovial fluid aspirated from their knee joint at the time of injection. Assessments were made at 0, 3 and 8 weeks by a second operator, thus blinding both patient and assessor. Outcomes measured at each visit were: knee pain in the previous 48 h (expressed on a 100 mm visual analog scale; VAS), stair climb time (SCT) and Lequesne index score (LEQ). Changes in VAS, SCT and LEQ were compared between the groups using a Student's paired t test. Fifty-seven patients were studied (44 female, 13 male) with a mean age of 62.5 years. Both steroids gave significant pain relief (VAS) at week 3 ( p<0.01) but only MPA showed an effect on VAS and LEQ scores at week 8 compared to baseline ( p<0.05). THA was more effective than MPA at pain reduction at week 3 ( p<0.01); this difference was lost at week 8 ( p=0.17). There was no significant difference between the two drugs in functional endpoints (SCT, LEQ) at either 3 or 8 weeks. Both THA and MPA offer at least temporary symptomatic benefit in knee OA. THA is more effective than MPA at week 3, but its effect is lost by week 8. MPA still has an effect at week 8.

  12. 21 CFR 520.540b - Dexamethasone tablets and boluses.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... therapy following its parenteral administration. The drug may be used as supportive therapy for management of inflammatory conditions such as acute arthritic lamenesses, and for various stress conditions...

  13. 21 CFR 520.540b - Dexamethasone tablets and boluses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... therapy following its parenteral administration. The drug may be used as supportive therapy for management of inflammatory conditions such as acute arthritic lamenesses, and for various stress conditions...

  14. 21 CFR 520.540b - Dexamethasone tablets and boluses.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... therapy following its parenteral administration. The drug may be used as supportive therapy for management of inflammatory conditions such as acute arthritic lamenesses, and for various stress conditions...

  15. 21 CFR 520.540b - Dexamethasone tablets and boluses.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... therapy following its parenteral administration. The drug may be used as supportive therapy for management of inflammatory conditions such as acute arthritic lamenesses, and for various stress conditions...

  16. 21 CFR 520.540b - Dexamethasone tablets and boluses.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... therapy following its parenteral administration. The drug may be used as supportive therapy for management of inflammatory conditions such as acute arthritic lamenesses, and for various stress conditions...

  17. Imaging of cerebral α4β2* nicotinic acetylcholine receptors with (-)-[(18)F]Flubatine PET: Implementation of bolus plus constant infusion and sensitivity to acetylcholine in human brain.

    PubMed

    Hillmer, A T; Esterlis, I; Gallezot, J D; Bois, F; Zheng, M Q; Nabulsi, N; Lin, S F; Papke, R L; Huang, Y; Sabri, O; Carson, R E; Cosgrove, K P

    2016-11-01

    The positron emission tomography (PET) radioligand (-)-[(18)F]flubatine is specific to α4β2(⁎) nicotinic acetylcholine receptors (nAChRs) and has promise for future investigation of the acetylcholine system in neuropathologies such as Alzheimer's disease, schizophrenia, and substance use disorders. The two goals of this work were to develop a simplified method for α4β2(⁎) nAChR quantification with bolus plus constant infusion (B/I) (-)-[(18)F]flubatine administration, and to assess the radioligand's sensitivity to acetylcholine fluctuations in humans. Healthy human subjects were imaged following either bolus injection (n=8) or B/I (n=4) administration of (-)-[(18)F]flubatine. The metabolite-corrected input function in arterial blood was measured. Free-fraction corrected distribution volumes (VT/fP) were estimated with modeling and graphical analysis techniques. Next, sensitivity to acetylcholine was assessed in two ways: 1. A bolus injection paradigm with two scans (n=6), baseline (scan 1) and physostigmine challenge (scan 2; 1.5mg over 60min beginning 5min prior to radiotracer injection); 2. A single scan B/I paradigm (n=7) lasting up to 240min with 1.5mg physostigmine administered over 60min beginning at 125min of radiotracer infusion. Changes in VT/fP were measured. Baseline VT/fP values were 33.8±3.3mL/cm(3) in thalamus, 12.9±1.6mL/cm(3) in cerebellum, and ranged from 9.8 to 12.5mL/cm(3) in other gray matter regions. The B/I paradigm with equilibrium analysis at 120min yielded comparable VT/fP values with compartment modeling analysis of bolus data in extrathalamic gray matter regions (regional means <4% different). Changes in VT/fP following physostigmine administration were small and most pronounced in cortical regions, ranging from 0.8 to 4.6% in the two-scan paradigm and 2.8 to 6.5% with the B/I paradigm. These results demonstrate the use of B/I administration for accurate quantification of (-)-[(18)F]flubatine VT/fP in 120min, and suggest

  18. Effect of short-term, high-dose methylprednisolone on oxidative stress in children with acute immune thrombocytopenia.

    PubMed

    Cura, Musa; Koç, Ahmet; Aksoy, Nurten; Özdemir, Zeynep Canan

    2016-12-01

    Immune thrombocytopenia (ITP) is the most common cause of acquired childhood thrombocytopenia and is characterized by increased immune-mediated destruction of circulating thrombocytes. Oxidative damage may be involved in ITP pathogenesis; paraoxonase (PON) and arylesterase (ARE) enzymes are closely associated with the cellular antioxidant system. We investigated the effect of short-term high-dose methylprednisolone (HDMP) treatment on the total oxidant status (TOS), total antioxidant capacity (TAC), oxidative stress index (OSI), and PON and ARE enzymatic activity in children with acute ITP. Thirty children with acute ITP constituted the study group and 30 healthy children constituted the control group. Children with acute ITP were treated with HDMP: 30 mg/kg for 3 days, then 20 mg/kg for 4 days. The TOS, TAC, OSI, PON, and ARE levels were determined before and after 7 days of HDMP treatment. The TAC level ( P <0.001), and PON ( P <0.001) and ARE (P=0.001) activities were lower and the TOS ( P =0.003) and OSI ( P <0.001) levels were higher in children with acute ITP than those in healthy children in the control group. We also observed statistically significant increases in the TAC ( P <0.01), PON ( P <0.001) and ARE levels ( P =0.001) and decreases in the TOS ( P <0.05) and OSI levels ( P <0.05) with 7 days of HDMP treatment compared to their values before treatment. Our study demonstrated increased oxidative stress (OSI and TOC) and decreased antioxidant capacity (TAC), PON, and ARE in ITP patients and that steroid treatment could be effective in reducing the oxidative stress.

  19. Polyarteritis nodosa clinically mimicking nonocclusive mesenteric ischemia

    PubMed Central

    Shirai, Tsuyoshi; Fujii, Hiroshi; Saito, Shinichiro; Ishii, Tomonori; Yamaya, Hideyuki; Miyagi, Shigehito; Sekiguchi, Satoshi; Kawagishi, Naoki; Nose, Masato; Harigae, Hideo

    2013-01-01

    Here, we present the case of a 74-year-old Japanese man with segmental intestinal necrosis, which developed after treatment with pulsed methylprednisolone for mononeuritis multiplex. The patient was weakly positive for myeloperoxidase (MPO)-anti-neutrophil cytoplasmic antibody (ANCA). Computed tomography and surgical findings were compatible with nonocclusive mesenteric ischemia (NOMI). He underwent small intestinal resection by emergency surgery and an intestinal fistula was made. Pathologically, necrotizing vasculitis with fibrinoid necrosis was present in medium to small-sized arteries, which was equivalent to Arkin’s classification II-IV. Most of the arteries had fibrous intimal thickening, which was considered to obstruct the arteries and thus cause segmental intestinal necrosis. A diagnosis of polyarteritis nodosa (PAN) was made, and intravenous cyclophosphamide pulse therapy was added to the therapeutic regimen. This patient was successfully treated with these multidisciplinary therapies and his stoma was finally closed. This is a very rare and indicative case of PAN weakly positive for MPO-ANCA and clinically mimicking NOMI, which occurred even after treatment with pulsed methylprednisolone. PMID:23801874

  20. Worsening of Asthma with Systemic Corticosteroids

    PubMed Central

    Sheth, Ankur; Reddymasu, Savio; Jackson, Robert

    2006-01-01

    Despite widespread use for treatment of asthma and allergies, glucocorticoids may cause allergic reactions, even anaphylaxis. The incidence of adverse reactions to systemic glucocorticoids is 0.3%. The most commonly reported corticosteroids causing anaphylaxis like reactions are hydrocortisone, prednisone, and methylprednisolone. Most authors agree that allergic reactions to systemic corticosteroids are possibly immunoglobulin E mediated. We report a patient with asthma, aspirin allergy, and nasal polyps who developed bronchospasm following the administration of intravenous methylprednisolone sodium succinate during an acute asthmatic attack. We discuss the differential diagnosis of worsening asthma despite adequate treatment, and suggest corticosteroid-induced bronchospasm in our patient. Corticosteroid-induced bronchospasm should be considered when asthmatics fail to improve, or frankly deteriorate with systemic corticosteroid therapy, particularly when a history of aspirin allergy is present. Teaching Point: Know the differential diagnosis for worsening of asthma despite adequate treatment.Consider corticosteroid-induced bronchospasm when asthmatics fail to improve, or frankly deteriorate with systemic corticosteroid therapy.Corticosteroid-induced bronchospasm is more commonly seen in asthmatics with a history of aspirin allergy. PMID:16606375

  1. Patient handling system for carbon ion beam scanning therapy

    PubMed Central

    Shirai, Toshiyuki; Takei, Yuka; Furukawa, Takuji; Inaniwa, Taku; Matsuzaki, Yuka; Kumagai, Motoki; Murakami, Takeshi; Noda, Koji

    2012-01-01

    Our institution established a new treatment facility for carbon ion beam scanning therapy in 2010. The major advantages of scanning beam treatment compared to the passive beam treatment are the following: high dose conformation with less excessive dose to the normal tissues, no bolus compensator and patient collimator/ multi‐leaf collimator, better dose efficiency by reducing the number of scatters. The new facility was designed to solve several problems encountered in the existing facility, at which several thousand patients were treated over more than 15 years. Here, we introduce the patient handling system in the new treatment facility. The new facility incorporates three main systems, a scanning irradiation system (S‐IR), treatment planning system (TPS), and patient handling system (PTH). The PTH covers a wide range of functions including imaging, geometrical/position accuracy including motion management (immobilization, robotic arm treatment bed), layout of the treatment room, treatment workflow, software, and others. The first clinical trials without respiratory gating have been successfully started. The PTH allows a reduction in patient stay in the treatment room to as few as 7 min. The PTH plays an important role in carbon ion beam scanning therapy at the new institution, particularly in the management of patient handling, application of image‐guided therapy, and improvement of treatment workflow, and thereby allows substantially better treatment at minimum cost. PACS numbers: 87.56.‐v; 87.57.‐s; 87.55.‐x PMID:23149784

  2. The effect of methylprednisolone on facial nerve paralysis with different etiologies.

    PubMed

    Yildirim, Mehmet Akif; Karlidag, Turgut; Akpolat, Nusret; Kaygusuz, Irfan; Keles, Erol; Yalcin, Sinasi; Akyigit, Abdulvahap

    2015-05-01

    The objective of this study was to evaluate the effectiveness of methylprednisolone (MP) in models of facial nerve paralysis obtained by nerve section, compression, or inoculation with herpes simplex virus (HSV). Experimental controlled animal study. Tertiary referral center. A total of 30 female New Zealand rabbits weighing 1200-3000 g were used for the study. They were randomly assigned to one of 6 groups of 5 animals each. A nerve section injury was realized in Groups 1a (section and MP) and 1b (section, control) rabbits. A compression-type injury was inflicted to rabbits in Groups 2a (compression and MP) and 2b (compression, control). As for animals in Groups 3a (Type 1 HSV and MP) and 3b (Type 1 HSV, controls), facial nerve paralysis resulting from viral infection was obtained. Animals in the 3 treatment groups, designated with the letter "a", were administered MP, 1 mg/kg/d, whereas those in control groups "b" received 1 mL normal saline, both during 3 weeks. All subjects were followed up for 2 months. At the end of this period, all animals had the buccal branch of the facial nerve excised on the operated side. Semi-thin sections of these specimens were evaluated under light microscopy for the following: perineural fibrosis, increase in collagen fibers, myelin degeneration, axonal degeneration, Schwann cell proliferation, and edema. No significant difference was observed (P > 0.05) between the MP treatment group and the control group with regard to perineural fibrosis, increase in collagen fibers, myelin degeneration, axonal degeneration, edema, or Schwann cell proliferation. In the group with a compressive lesion (Group 2), controls were no different from MP-treated animals as to perineural fibrosis, increase in collagen fibers, or Schwann cell proliferation, whereas axonal degeneration, myelin degeneration, and edema were significantly higher (P < 0.05) in the control group. When comparing the treatment and control groups among the animals inoculated with

  3. Qualitative assessment of user experiences of a novel smart phone application designed to support flexible intensive insulin therapy in type 1 diabetes.

    PubMed

    Knight, Brigid A; McIntyre, H David; Hickman, Ingrid J; Noud, Marina

    2016-09-15

    Modern flexible multiple daily injection (MDI) therapy requires people with diabetes to manage complex mathematical calculations to determine insulin doses on a day to day basis. Automated bolus calculators assist with these calculations, add additional functionality to protect against hypoglycaemia and enhance the record keeping process, however uptake and use depends on the devices meeting the needs of the user. We aimed to obtain user feedback on the usability of a mobile phone bolus calculator application in adults with T1DM to inform future development of mobile phone diabetes support applications. Adults with T1DM who had previously received education in flexible MDI therapy were invited to participate. Eligible respondents attended app education and one month later participated in a focus group to provide feedback on the features of the app in relation to usability for patient-based flexible MDI and future app development. Seven adults participated in the app training and follow up interview. App features that support dose adjustment to reduce hypoglycaemia risk and features that enable greater efficiency in dose calculation, record keeping and report generation were highly valued. Adults who are self managing flexible MDI found the Rapidcalc mobile phone app to be a useful self-management tool and additional features to further improve usability, such as connectivity with BG meter and food databases, shortcut options to economise data entry and web based storage of data, were identified. Further work is needed to ascertain specific features and benefit for those with lower health literacy.

  4. A Phase 1, Single-center, Double-blind, Placebo-controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Clinical Effects, and Pharmacokinetics-Pharmacodynamics of Intravenous Cyclopropyl-methoxycarbonylmetomidate (ABP-700) after a Single Ascending Bolus Dose.

    PubMed

    Struys, Michel M R F; Valk, Beatrijs I; Eleveld, Douglas J; Absalom, Anthony R; Meyer, Peter; Meier, Sascha; den Daas, Izaak; Chou, Thomas; van Amsterdam, Kai; Campagna, Jason A; Sweeney, Steven P

    2017-07-01

    Cyclopropyl-methoxycarbonylmetomidate (ABP-700) is a new "soft" etomidate analog. The primary objectives of this first-in-human study were to describe the safety and efficacy of ABP-700 and to determine its maximum tolerated dose. Secondary objectives were to characterize the pharmacokinetics of ABP-700 and its primary metabolite (cyclopropyl-methoxycarbonyl acid), to assess the clinical effects of ABP-700, and to investigate the dose-response and pharmacokinetic/pharmacodynamic relationships. Sixty subjects were divided into 10 cohorts and received an increasing, single bolus of either ABP-700 or placebo. Safety was assessed by clinical laboratory evaluations, infusion-site reactions, continuous monitoring of vital signs, physical examination, adverse event monitoring, and adrenocorticotropic hormone stimulation testing. Clinical effects were assessed with modified observer's assessment of alertness/sedation and Bispectral Index monitoring. Pharmacokinetic parameters were calculated. Stopping criteria were met at 1.00 mg/kg dose. No serious adverse events were reported. Adverse events were dose-dependent and comprised involuntary muscle movement, tachycardia, and ventilatory effects. Adrenocorticotropic hormone stimulation evoked a physiologic cortisol response in all subjects, no different from placebo. Pharmacokinetics were dose-proportional. A three-compartment pharmacokinetic model described the data well. A rapid onset of anesthesia/sedation after bolus administration and also a rapid recovery were observed. A quantitative concentration-effect relationship was described for the modified observer's assessment of alertness/sedation and Bispectral Index. This first-in-human study of ABP-700 shows that ABP-700 was safe and well tolerated after single-bolus injections up to 1.00 mg/kg. Bolus doses of 0.25 and 0.35 mg/kg were found to provide the most beneficial clinical effect versus side-effect profile.

  5. Regulatory T Cell Responses to High-Dose Methylprednisolone in Active Systemic Lupus Erythematosus.

    PubMed

    Mathian, Alexis; Jouenne, Romain; Chader, Driss; Cohen-Aubart, Fleur; Haroche, Julien; Fadlallah, Jehane; Claër, Laetitia; Musset, Lucile; Gorochov, Guy; Amoura, Zahir; Miyara, Makoto

    2015-01-01

    A slight increase in the proportion of circulating regulatory T (Treg) cells has been reported in systemic lupus erythematosus (SLE) patients taking oral prednisone. The effects of intravenous (IV) high dose methylprednisolone (MP) on Tregs have not yet been described, especially in active SLE. We prospectively analyzed the proportion of circulating CD4+ Treg cell subsets defined as follows: (1) naïve Treg (nTreg) FoxP3lowCD45RA+ cells; (2) effector Treg (eTreg) FoxP3highCD45RA- cells; and (3) non-suppressive FoxP3lowCD45RA- cells (non-regulatory Foxp3low T cells). Peripheral blood mononuclear cells of patients with active SLE were analyzed before the first infusion of IV high dose MP (day 0) and the following days (day 1, day 2, ±day 3 and ±day 8). The activity of SLE was assessed by the SLEDAI score. Seventeen patients were included. Following MP infusions, the median (range) percentage of eTregs significantly increased from 1.62% (0.53-8.43) at day 0 to 2.80% (0.83-14.60) at day 1 (p = 0.003 versus day 0), 4.64% (0.50-12.40) at day 2 (p = 0.06 versus day 1) and 7.50% (1.02-20.70) at day 3 (p = 0.008 versus day 2), and declined to baseline values at day 8. Expanding eTreg cells were actively proliferating, as they expressed Ki-67. The frequency of non-regulatory FoxP3low T cells decreased from 6.39% (3.20-17.70) at day 0 to 4.74% (1.03-9.72) at day 2 (p = 0.005); nTreg frequency did not change. All patients clinically improved immediately after MP pulses. The absence of flare after one year of follow up was associated with a higher frequency of eTregs at day 2. IV high dose MP induces a rapid, dramatic and transient increase in circulating regulatory T cells. This increase may participate in the preventive effect of MP on subsequent flares in SLE.

  6. Regulatory T Cell Responses to High-Dose Methylprednisolone in Active Systemic Lupus Erythematosus

    PubMed Central

    Chader, Driss; Cohen-Aubart, Fleur; Haroche, Julien; Fadlallah, Jehane; Claër, Laetitia; Musset, Lucile; Gorochov, Guy; Amoura, Zahir; Miyara, Makoto

    2015-01-01

    Background/Purpose A slight increase in the proportion of circulating regulatory T (Treg) cells has been reported in systemic lupus erythematosus (SLE) patients taking oral prednisone. The effects of intravenous (IV) high dose methylprednisolone (MP) on Tregs have not yet been described, especially in active SLE. Methods We prospectively analyzed the proportion of circulating CD4+ Treg cell subsets defined as follows: (1) naïve Treg (nTreg) FoxP3lowCD45RA+ cells; (2) effector Treg (eTreg) FoxP3highCD45RA− cells; and (3) non-suppressive FoxP3lowCD45RA− cells (non-regulatory Foxp3low T cells). Peripheral blood mononuclear cells of patients with active SLE were analyzed before the first infusion of IV high dose MP (day 0) and the following days (day 1, day 2, ±day 3 and ±day 8). The activity of SLE was assessed by the SLEDAI score. Results Seventeen patients were included. Following MP infusions, the median (range) percentage of eTregs significantly increased from 1.62% (0.53–8.43) at day 0 to 2.80% (0.83–14.60) at day 1 (p = 0.003 versus day 0), 4.64% (0.50–12.40) at day 2 (p = 0.06 versus day 1) and 7.50% (1.02–20.70) at day 3 (p = 0.008 versus day 2), and declined to baseline values at day 8. Expanding eTreg cells were actively proliferating, as they expressed Ki-67. The frequency of non-regulatory FoxP3low T cells decreased from 6.39% (3.20–17.70) at day 0 to 4.74% (1.03–9.72) at day 2 (p = 0.005); nTreg frequency did not change. All patients clinically improved immediately after MP pulses. The absence of flare after one year of follow up was associated with a higher frequency of eTregs at day 2. Conclusion IV high dose MP induces a rapid, dramatic and transient increase in circulating regulatory T cells. This increase may participate in the preventive effect of MP on subsequent flares in SLE. PMID:26629828

  7. Anterior horn syndrome: A rare manifestation of primary Sjögren's syndrome.

    PubMed

    Zahlane, Safaa; Louhab, Nissrine; El Mellakh, Meriem; Kissani, Najib

    2016-07-01

    The authors report an exceptional case of an anterior horn syndrome associated with Sjögren's syndrome in a 58-year-old patient with a flaccid tetraparesis revealed by asymmetric atrophy and diffuse fasciculations associated with xerostomia and xerophthalmia. The electroneuromyography objectified a diffuse anterior horn syndrome. The brain MRI and spinal cord were normal. Laboratory tests revealed positive anti-SSA and anti-SSB antibody. The salivary glands biopsy objectified lymphocytic sialadenitis grade 3 of Chisholm. The Schirmer's test was abnormally low. Diagnosis of anterior horn syndrome as part of Sjögren's syndrome was retained. The methylprednisolone bolus allowed partial clinical improvement after 12 months of evolution. Therefore, in patients with isolated anterior horn involvement, a correct diagnosis of the underlying SS is often delayed or overlooked entirely; in these instances, standard clinicoserological assessment is recommendable. Copyright © 2016 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

  8. Imaging of cerebral α4β2* nicotinic acetylcholine receptors with (−)-[18F]Flubatine PET: Implementation of bolus plus constant infusion and sensitivity to acetylcholine in human brain☆

    PubMed Central

    Hillmer, A.T.; Esterlis, I.; Gallezot, J.D.; Bois, F.; Zheng, M.Q.; Nabulsi, N.; Lin, S.F.; Papke, R.L.; Huang, Y.; Sabri, O.; Carson, R.E.; Cosgrove, K.P.

    2016-01-01

    The positron emission tomography (PET) radioligand (−)-[18F]flubatine is specific to α4β2∗ nicotinic acetylcholine receptors (nAChRs) and has promise for future investigation of the acetylcholine system in neuropathologies such as Alzheimer's disease, schizophrenia, and substance use disorders. The two goals of this work were to develop a simplified method for α4β2∗ nAChR quantification with bolus plus constant infusion (B/I) (−)-[18F]flubatine administration, and to assess the radioligand's sensitivity to acetylcholine fluctuations in humans. Healthy human subjects were imaged following either bolus injection (n = 8) or B/I (n = 4) administration of (−)-[18F]flubatine. The metabolite-corrected input function in arterial blood was measured. Free-fraction corrected distribution volumes (VT/fP) were estimated with modeling and graphical analysis techniques. Next, sensitivity to acetylcholine was assessed in two ways: 1. A bolus injection paradigm with two scans (n = 6), baseline (scan 1) and physostigmine challenge (scan 2; 1.5 mg over 60 min beginning 5 min prior to radiotracer injection); 2. A single scan B/I paradigm (n = 7) lasting up to 240 min with 1.5 mg physostigmine administered over 60 min beginning at 125 min of radiotracer infusion. Changes in VT/fP were measured. Baseline VT/fP values were 33.8 ± 3.3 mL/cm3 in thalamus, 12.9 ± 1.6 mL/cm3 in cerebellum, and ranged from 9.8 to 12.5 mL/cm3 in other gray matter regions. The B/I paradigm with equilibrium analysis at 120 min yielded comparable VT/fP values with compartment modeling analysis of bolus data in extrathalamic gray matter regions (regional means <4% different). Changes in VT/fP following physostigmine administration were small and most pronounced in cortical regions, ranging from 0.8 to 4.6% in the two-scan paradigm and 2.8 to 6.5% with the B/I paradigm. These results demonstrate the use of B/I administration for accurate quantification of (−)-[18F]flubatine VT/fP in 120 min, and

  9. Impact of CTLA-4 blockade in conjunction with metronomic chemotherapy on preclinical breast cancer growth

    PubMed Central

    Parra, Karla; Valenzuela, Paloma; Lerma, Natzidielly; Gallegos, Alejandra; Reza, Luis C; Rodriguez, Georgialina; Emmenegger, Urban; Di Desidero, Teresa; Bocci, Guido; Felder, Mitchell S; Manciu, Marian; Kirken, Robert A; Francia, Giulio

    2017-01-01

    Background: Although there are reports that metronomic cyclophosphamide (CTX) can be immune stimulating, the impact of its combination with anti-CTLA-4 immunotherapy for the treatment of cancer remains to be evaluated. Methods: Murine EMT-6/P breast cancer, or its cisplatin or CTX-resistant variants, or CT-26 colon, were implanted into Balb/c mice. Established tumours were monitored for relative growth following treatment with anti-CTLA-4 antibody alone or in combination with; (a) metronomic CTX (ldCTX; 20 mg kg−1 day−1), b) bolus (150 mg kg−1) plus ldCTX, or (c) sequential treatment with gemcitabine (160 mg kg−1 every 3 days). Results: EMT-6/P tumours responded to anti-CTLA-4 therapy, but this response was less effective when combined with bolus plus ldCTX. Anti-CTLA-4 could be effectively combined with either ldCTX (without a bolus), or with regimens of either sequential or concomitant gemcitabine, including in orthotopic EMT-6 tumours, and independently of the schedule of drug administration. Tumour responses were confirmed with CT-26 tumours but were less pronounced in drug-resistant EMT-6/CTX or EMT-6/DDP tumour models than in the parent tumour. A number of tumour bearing mice developed spontaneous metastases under continuous therapy. The majority of cured mice rejected tumour re-challenges. Conclusions: Metronomic CTX can be combined with anti-CTLA-4 therapy, but this therapy is impaired by concomitant bolus CTX. Sequential therapy of anti-CTLA-4 followed by gemcitabine is effective in chemotherapy-naive tumours, although tumour relapses can occur, in some cases accompanied by the development of spontaneous metastases. PMID:28056464

  10. Adjunctive Corticosteroid Treatment Against Yersinia pestis Improves Bacterial Clearance, Immunopathology, and Survival in the Mouse Model of Bubonic Plague.

    PubMed

    Levy, Yinon; Vagima, Yaron; Tidhar, Avital; Zauberman, Ayelet; Aftalion, Moshe; Gur, David; Fogel, Itay; Chitlaru, Theodor; Flashner, Yehuda; Mamroud, Emanuelle

    2016-09-15

    Plague is initiated by Yersinia pestis, a highly virulent bacterial pathogen. In late stages of the infection, bacteria proliferate extensively in the internal organs despite the massive infiltration of neutrophils. The ineffective inflammatory response associated with tissue damage may contribute to the low efficacy of antiplague therapies during late stages of the infection. In the present study, we address the possibility of improving therapeutic efficacy by combining corticosteroid administration with antibody therapy in the mouse model of bubonic plague. Mice were subcutaneously infected with a fully virulent Y. pestis strain and treated at progressive stages of the disease with anti-Y. pestis antibodies alone or in combination with the corticosteroid methylprednisolone. The addition of methylprednisolone to antibody therapy correlated with improved mouse survival, a significant decrease in the amount of neutrophils and matrix metalloproteinase 9 in the tissues, and the mitigation of tissue damage. Interestingly, the combined treatment led to a decrease in the bacterial loads in infected organs. Corticosteroids induce an unexpectedly effective antibacterial response apart from their antiinflammatory properties, thereby improving treatment efficacy. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  11. Day two post retrieval 1500 IUI hCG bolus, progesterone-free luteal support post GnRH agonist trigger - a proof of concept study.

    PubMed

    Vanetik, Sharon; Segal, Linoy; Breizman, Tatiana; Kol, Shahar

    2018-02-01

    Small dose of hCG (1500 IU) on the day of oocyte retrieval, followed by daily progesterone administration, is currently the preferred way to secure adequate luteal support following GnRH agonist trigger. In the current proof-of-concept study, we explored the possibility that a bolus of 1500 IU hCG, given two days after oocyte retrieval, may be sufficient to sustain adequate luteal support without additional progesterone treatment. From February 2015 to August 2016, we obtained 44 pregnancies following GnRHa trigger followed by day 2 hCG (1500 IU) support only (study group). Data from these 44 cycles were compared with the latest 44 pregnancies obtained following hCG (6500 IU) trigger followed by conventional progesterone luteal documented (control group). Mean progesterone levels (14 days postoocyte retrieval) in the study and control groups were 197 nmol/l and 173 nmol/l, respectively (NS). Mean E 2 levels (14 days post oocyte retrieval) in the study group was 6937 pmol/l, significantly higher (p < .001) than in the control group (3.276 pmol/l). We conclude that bolus of 1500 IU hCG, administered 2 days after retrieval, can provide excellent support, without the need to further supplement with progesterone.

  12. A Case of Clinically Amyopathic Dermatomyositis with Interstitial Pneumonia that Was Successfully Treated with Plasma Exchange.

    PubMed

    Yagishita, Mizuki; Kondo, Yuya; Terasaki, Toshihiko; Terasaki, Mayu; Shimizu, Masaru; Honda, Fumika; Oyama, Ayako; Takahashi, Hiroyuki; Yokosawa, Masahiro; Asashima, Hiromitsu; Hagiwara, Shinya; Tsuboi, Hiroto; Matsumoto, Isao; Sumida, Takayuki

    2018-02-28

    Patients with clinically amyopathic dermatomyositis (CADM), a subset of dermatomyositis characterized by a lack of muscle involvement, frequently develop rapidly progressive and treatment-resistant interstitial lung disease. We report the case of a 49-year-old man who was diagnosed with CADM. He developed interstitial pneumonia, which did not respond to combination therapy with methylprednisolone pulse therapy, cyclophosphamide, and cyclosporine. We therefore attempted plasma exchange. After 7 courses of therapeutic plasma exchange, the interstitial pneumonia gradually improved. This case suggests that plasma exchange might be an effective therapeutic option for patients with progressive interstitial lung disease in steroid- and immunosuppressive therapy-refractive CADM.

  13. Site Targeted Press Coated Delivery of Methylprednisolone Using Eudragit RS 100 and Chitosan for Treatment of Colitis.

    PubMed

    Jagdale, Swati; Chandekar, Apoorva

    2016-01-01

    Inflammatory bowel disease (IBD) is one of the five most prevalent gastrointestinal disease burdens which commonly require lifetime care. Worldwide incidence rate of ulcerative colitis and Crohn's disease is about 16.8% and 13.4% respectively. Colitis is an inflammation of the colon. Colon targeted drug delivery will direct the drug to the colon. The drug will reach at the site of action and hence its side effects as well as dose can be reduced. Recent patent describes treatment of ulcerative colitis using anti CD3 antibodies, with nicotine and anti-depressant drugs, budesonide foam etc. Present study deals with optimization of site targeted methylprednisolone delivery for treatment of colitis. Chitosan and Eudragit RS 100 were used as coating polymers. Tablets were prepared by press coated technology. The core tablets contain drug, avicel as binder, croscarmellose sodium as super disintegrant and dicalcium phosphate as diluent. Drug excipient compatibility was carried out using FTIR, UV and DSC. Design of experiment was used to optimize the formulation. Tablets were evaluated for thickness, weight variation, hardness, swelling index, in-vitro drug release and release of drug in simulated media. Optimized batch (B2) contained chitosan 40% and eudragit RS 100 17.5%. B2 showed in-vitro drug release 85.65 ± 7.6% in 6.8 pH phosphate buffer and 96.7 ±9.1% in simulated media after 7.5 hours. In-vivo x-ray placebo study for formulation B2 had shown that the tablet reached to the ascending colon after 5 hours. This indicated a potential site targeted delivery of optimized batch B2.

  14. Classification and discrimination of pediatric patients undergoing open heart surgery with and without methylprednisolone treatment by cytomics

    NASA Astrophysics Data System (ADS)

    Bocsi, Jozsef; Mittag, Anja; Pierzchalski, Arkadiusz; Osmancik, Pavel; Dähnert, Ingo; Tárnok, Attila

    2011-02-01

    Introduction: Methylprednisolone (MP) is frequently preoperatively administered in children undergoing open heart surgery. The aim of this medication is to inhibit overshooting immune responses. Earlier studies demonstrated cellular and humoral immunological changes in pediatric patients undergoing heart surgeries with and without MP administration. Here in a retrospective study we investigated the modulation of the cellular immune response by MP. The aim was to identify suitable parameters characterizing MP effects by cluster analysis. Methods: Blood samples were analysed from two aged matched groups with surgical correction of septum defects. Group without MP treatment consisted of 10 patients; MP was administered on 21 patients (median dose: 11mg/kg) before cardiopulmonary bypass (CPB). EDTA anticoagulated blood was obtained 24 h preoperatively, after anesthesia, at CPB begin and end (CPB2), 4h, 24h, 48h after surgery, at discharge and at out-patient followup (8.2; 3.3-12.2 month after surgery; median and IQR). Flow cytometry showed the biggest MP relevant changes at CPB2 and 4h postoperatively. They were used for clustering analysis. Classification was made by discriminant analysis and cluster analysis by means of Genes@work software. Results & conclusion: 146 parameters were obtained from analysis. Cross-validation revealed several parameters being able to discriminate between MP groups and to identify immune modulation. MP administration resulted in a delayed activation of monocytes, increased ratio of neutrophils, reduced T-lymphocytes counts. Cluster analysis demonstrated that classification of patients is possible based on the identified cytomics parameters. Further investigation of these parameters might help to understand the MP effects in pediatric open heart surgery.

  15. Treatment of local-anesthetic toxicity with lipid emulsion therapy.

    PubMed

    Burch, Melissa S; McAllister, Russell K; Meyer, Tricia A

    2011-01-15

    The use of lipid emulsion to treat local-anesthetic toxicity is discussed. Systemic toxicity from local anesthetics is a rare but potentially fatal complication of regional anesthesia. There is increasing evidence that lipid emulsion may be an effective treatment to reverse the cardiac and neurologic effects of local-anesthetic toxicity. A literature search identified seven case reports of local-anesthetic toxicity in which lipid emulsion was used. Lipid emulsion was found to be successful in the treatment of local-anesthetic toxicity associated with various regional anesthetic techniques and multiple local anesthetics. The majority of patients in the case reports reviewed were unresponsive to initial management of local-anesthetic toxicity with standard resuscitative measures, but all recovered completely after receiving lipid emulsion therapy. The initial dose of lipid emulsion administered varied among the case reports, as well as whether a lipid emulsion infusion was started and at what point during resuscitation. Based on the case reports reviewed, an initial bolus dose of 1.5 mL/kg followed by an infusion of 10 mL/min as soon as local-anesthetic toxicity is suspected seems most beneficial. The pharmacokinetics of lipid emulsion therapy in the treatment of local-anesthetic toxicity has not been fully elucidated but likely involves increasing metabolism, distribution, or partitioning of the local anesthetic away from receptors into lipid within tissues. Lipid emulsion has been reported useful in the treatment of systemic toxicity caused by local anesthetics. The mechanism of effect is unclear, and evidence for the benefit of lipid therapy in humans is from case reports only.

  16. Implications for paediatric shock management in resource-limited settings: a perspective from the FEAST trial.

    PubMed

    Houston, Kirsty Anne; George, Elizabeth C; Maitland, Kathryn

    2018-05-04

    Although the African "Fluid Expansion as Supportive therapy" (FEAST) trial showed fluid resuscitation was harmful in children with severe febrile illness managed in resource-limited hospitals, the most recent evidence reviewed World Health Organization (WHO) guidelines continue to recommend fluid boluses in children with shock according to WHO criteria "WHO shock", arguing that the numbers included in the FEAST trial were too small to provide reasonable certainty. We re-analysed the FEAST trial results for all international definitions for paediatric shock including hypotensive (or decompensated shock) and the WHO criteria. In addition, we examined the clinical relevance of the WHO criteria to published and unpublished observational studies reporting shock in resource-limited settings. We established that hypotension was rare in children with severe febrile illness complicating only 29/3170 trial participants (0.9%). We confirmed that fluid boluses were harmful irrespective of the definitions of shock including the very small number with WHO shock (n = 65). In this subgroup 48% of bolus recipients died at 48 h compared to 20% of the non-bolus control group, an increased absolute risk of 28%, but translating to an increased relative risk of 240% (p = 0.07 (two-sided Fisher's exact test)). Examining studies describing the prevalence of the stringent WHO shock criteria in children presenting to hospital we found this was rare (~ 0.1%) and in these children mortality was very high (41.5-100%). The updated WHO guidelines continue to recommend boluses for a very limited number of children presenting at hospital with the strict definition of WHO shock. Nevertheless, the 3% increased mortality from boluses seen across FEAST trial participants would also include this subgroup of children receiving boluses. Recommendations aiming to differentiate WHO shock from other definitions will invariably lead to "slippage" at the bedside, with the potential of exposing a wider group

  17. SU-E-T-541: Bolus Effect of Thermoplastic Masks in IMRT and VMAT Head and Neck Treatments

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Zhen, H; Nedzi, L; Chen, S

    2014-06-01

    Purpose: To quantitatively evaluate the bolus effect of thermoplalstic mask on patient skin dose during multi-field IMRT and VMAT treatment. Methods: The clinically approved target contours for five head and neck patients were deformably registered to an anthropomorphic Rando phantom. Two plans: Multifield IMRT plan with 7-9 beams and VMAT plan with 2-4 arcs were created for each patient following same dose constraints. 3mm skin was excluded from PTVs but not constrained during optimization. The prescription dose was 200-220 cGy/fraction. A thermoplastic head and shoulder mask was customized for the Rando phantom. Each plan was delivered to the phantom twicemore » with and without mask. During each delivery, two rectangular strips of EBT3 films (1cm x 6.8cm) were placed across the anterior upper and lower neck near PTVs to measure the surface dose. For consistency films were positioned at same locations for same patient. A total of 8 film strips were obtained for each patient. Film dose was calibrated in the range of 0-400cGy on the day of plan delivery. For dose comparison 3 regions of interests (ROIs) of 1×1 cm{sup 2} were selected at left, right and middle part of each film, resulting in 6 point doses at each plan delivery. Results: The films without mask show relatively uniform dose distribution while those with mask clearly show mesh pattern of mask, usually indicating an increase in skin dose. On average the increase in skin dose over all ROIs with mask was 31.9%(±14.8%) with a range of 11.4%- 58.4%. There is no statistically significant difference (p=0.44) between skin dose increase in VMAT (30.8%±15.3%) and IMRT delivery (33.0%±14.9%). Conclusion: Thermoplastic immobilization masks increase surface dose for HN patient by around 30%. The magnitude is comparable between multi-field IMRT and VMAT. Radiochromic EBT3 film serves as an effective tool to quantify bolus effect.« less

  18. Differences in self-monitored, blood glucose test strip utilization by therapy for type 2 diabetes mellitus.

    PubMed

    Tavares, Ruben; Duclos, Marc; Brabant, Marie-Josée; Checchin, Daniella; Bosnic, Nevzeta; Turvey, Katherine; Terres, Jorge Alfonso Ross

    2016-06-01

    To determine whether blood glucose test strip (BGTS) utilization in patients with type 2 diabetes (T2D) is associated with the type of diabetes therapy, classified according to hypoglycemic risk. A retrospective, longitudinal (2006-2012) study of Canadian private drug plans (PDP) and Ontario Public Drug Programs (OPDP) prescription claims was conducted. Analyses were restricted to patients with T2D with or without a claim for BGTS. Daily BGTS utilization (TS/patient/day) was evaluated by diabetes therapy classified by hypoglycemic risk. Multivariate analyses were conducted to identify determinants of BGTS utilization. The T2D cohort comprised 5,759,591 observations from 1,949,129 claimants. Mean BGTS utilization was 0.84 TS/patient/day and differed between PDP and OPDP (0.66 vs. 1.00). Daily utilization was greatest in patients receiving therapy associated with a pre-defined high risk of hypoglycemia [insulin: basal + bolus (2.16), premixed (1.65), basal (1.16), other insulin regimens (2.13), and sulfonylureas (0.74)] versus non-sulfonylurea non-insulin-based regimens (0.52). For non-insulin therapy, BGTS utilization was greater for patients on multiple non-insulin therapies versus monotherapy (0.74 vs. 0.53 TS/patient/day). In multivariate analyses, drivers for BGTS utilization included insulin use, previous BGTS use, and female gender. Previous diabetes therapy and duration of therapy were negatively correlated with BGTS utilization. BGTS utilization varies depending on the type of therapy used to treat T2D according to hypoglycemic risk. Decision making regarding BGTS needs to account for robust analyses of current utilization and its value in those settings, including in patients not receiving diabetes therapy and the prevalence of circumstances conducive to more intensive monitoring.

  19. Steroids and statins: an old and a new anti-inflammatory strategy compared.

    PubMed

    Vukovic, Petar M; Maravic-Stojkovic, Vera R; Peric, Miodrag S; Jovic, Miomir Dj; Cirkovic, Milan V; Gradinac, Sinisa Dj; Djukanovic, Bosko P; Milojevic, Predrag S

    2011-01-01

    This study compared the anti-inflammatory effects of methylprednisolone (MP) and atorvastatin and analysed their influences on clinical variables in patients undergoing coronary revascularization. Ninety patients with compromised left ventricular ejection fraction (≤30%) undergoing elective coronary surgery were equally randomized to one of three groups: statin group, treatment with atorvastatin (20 mg/day) 3 weeks before surgery; methylprednisolone group, a single shot of methylpredniosolone (10mg/kg); and control group. Postoperative IL-6 was higher in the control group when compared to the methylprednisolone and statin groups (p<0.01). IL-6 was higher in the statin-treated patients (p<0.05 versus methylprednisolone). Administration of methylprednisolone as well as statin treatment increased postoperative cardiac index, left ventricular stroke work index, decreased postoperative atrial fibrilation rate and reduced ICU stay (p<0.05 versus control). The number of patients requiring inotropic support was lower in the methylprednisolone group when compared with the other two groups (p<0.01). Tracheal intubation time was reduced in patients who received methylprednisolone (p<0.01 versus control). Preoperative administration of either methylprednisolone or atorvastatin reduced pro-inflammatory cytokine release, improved haemodynamics, decreased postoperative atrial fibrilation rate and reduced ICU stay in patients with significantly impaired cardiac function undergoing coronary revascularization. Treatment with methylprednisolone was associated with less inotropic support requirements and reduced mechanical ventilation time.

  20. Improved survival in severe paraquat poisoning with repeated pulse therapy of cyclophosphamide and steroids.

    PubMed

    Lin, Ja-Liang; Lin-Tan, Dan-Tzu; Chen, Kuan-Hsing; Huang, Wen-Hung; Hsu, Ching-Wei; Hsu, Hsiang-Hao; Yen, Tzung-Hai

    2011-06-01

    To clarify the efficacy of repeated methylprednisolone (MP) and cyclophosphamide (CP) pulse therapy and daily dexamethasone (DEX) therapy in patients with severe paraquat (PQ) poisoning. A total of 111 patients with severe PQ poisoning and dark-blue color in urine tests within 24 h of intoxication were included prospectively. The control group consisted of 52 patients who were admitted between 1998 and 2001 and who received high doses of CP (2 mg/kg per day) and DEX (5 mg every 6 h) for 14 days. The study group consisted of 59 patients who were admitted from 2002 to 2007 and who received initial MP (1 g) for 3 days and CP (15 mg/kg per day) for 2 days, followed by DEX (5 mg every 6 h) until a PaO(2) of >80 mmHg had been achieved, or treated with repeated 1 g MP for 3 days and 1 g CP for 1 day if the PaO(2) was <60 mmHg. There were no differences between the two groups with regard to baseline data and plasma PQ levels. The study group patients had a lower mortality rate (39/59, 66%) than the control group patients (48/52, 92%; P=0.003, log-rank test). Multivariate Cox regression analysis revealed that the repeated pulse therapy was correlated with decreased hazard ratios (HR) for all-cause mortality (HR=0.50, 95% CI 0.31-0.80; P=0.004) and death from lung fibrosis-related hypoxemia (HR=0.10, 95% CI 0.04-0.25; P<0.001) in severely PQ-intoxicated patients. Repeated pulses of CP and MP, rather than high doses of CP and DEX, may result in a lower mortality rate in patients with severe PQ poisoning. © Copyright jointly held by Springer and ESICM 2011