Knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings: a systematic review.

PubMed

Tarabay, Rami; El Rassi, Rola; Dakik, Abeer; Harb, Alain; Ballout, Rami A; Diab, Batoul; Khamassi, Selma; Akl, Elie A

2016-07-13

Adopting technologies such as injection safety devices in healthcare settings can enhance injection safety. Developing guidelines for appropriate adoption of such technologies need to consider factors beyond evidence for their health effects. The objective of this study is to systematically review the published literature for evidence among healthcare workers and patients about knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings. We included both qualitative and quantitative studies conducted with the general public, patients, and healthcare workers, administrators, or policy makers. We searched MEDLINE, EMBASE, CINHAL and CENTRAL. We used a duplicate and independent approach to title and abstract screening, full text screening, data abstraction and risk of bias assessment. Out of a total of 6568 identified citations, we judged fourteen studies as eligible for this systematic review. All these studies were surveys, conducted with healthcare workers in high-income countries. We did not identify any qualitative study, or a study of the general public, patients, healthcare administrators or policy makers. We did not identify any study assessing knowledge, or values assigned to outcomes relevant to injection safety devices. Each of the included studies suffered from methodological limitations, which lowers our confidence in their findings. Based on the findings of six studies, the injection safety devices were generally perceived as easy to use and as an improvement compared with conventional syringes. Some of these studies reported few technical problems while using the devices. In three studies assessing perceived safety, the majority of participants judged the devices as safe. Two studies reported positive perceptions of healthcare workers regarding patient tolerance of these injection safety devices. One study found that less than half the nurses felt comfortable using the

Safety of Lienal Polypeptide Injection Combined with Chemotherapy in Treating Patients with Advanced Cancer.

PubMed

Huang, Xin-En; Wang, Lin; Ji, Zhu-Qing; Liu, Meng-Yan; Qian, Ting; Li, Li

2015-01-01

To assess the safety of Liena polypeptide injection (produced by JILIN FSENS PHARMACEUTICAL CO.,LTD) combined with chemotherapy in treating patients with advanced cancers. A consecutive cohort of patients with advanced cancers were treated with Liena polypeptide injection combined with chemotherapy. And chemotherapy for patients with advanced cancers were adopted from regimens suggested by NCCN guideline. Liena polypeptide injection was intravenously injected at a dosage of 2 ml plus 100ml normal saline for continuous 7 days during chemotherapy as one course. After at least two courses of treatment, safety and side effects were evaluated. There were 20 female and 14 male patients with advanced cancer recruited into this study, including 10 patients with breast, 8 patients with colorectal, 8 patients with lung, 4 patients with gastric, and 1 patient with esophageal cancer, as well as 1 patient with non-Hodgkin's lymphoma, 1 patient with low pharyngeal and 1 patient with urethral cancer. The median age of patients was 59 (40-82) years. Incidences of Grade 1 to 2 myelosuppression was observed in 5/34 patients, and Grade 1 to 2 elevation of hepatic enzyme was recorded in 3/34 patients. Adverse effects on the gastrointestinal tract were documented in 5/34 patients, and were Grade 1. No Grade 3-4 toxicities were diagnosed. No treatment related death was found. Liena polypeptide injection combined with chemotherapy was safe in treating several sites of tumors, that mainly included lung, colorectal and breast cancer. However, further study should be conducted to clarify the effectiveness of this treatment.

Safety and tolerability of injectable lipid-lowering drugs: a review of available clinical data.

PubMed

Cicero, Arrigo F G; Tartagni, Elisa; Ertek, Sibel

2014-08-01

To answer the need of a better low-density lipoprotein (LDL) cholesterol control in statin-treated patients at high risk for cardiovascular disease, new injectable lipid-lowering drugs with innovative mechanisms of action are in advanced phase of development or have just been approved. Evolocumab and alirocumab are fully human monoclonal antibodies inhibiting the proprotein convertase subtilisin/kexin type 9 (PCSK9) that binds to hepatic LDL receptor and prevents it from normal recycling by targeting it for degradation. Mipomersen specifically binds to a segment of the human apolipoprotein B100 messenger RNA, blocking the translation of the gene product. Phase II (for evolocumab and alirocumab) and III (for evolocumab) trials show that PCSK9 inhibitors are equally well tolerated, with adverse events mainly limited to mild-to-moderate nasopharyngitis, injection-site pain, arthralgia and back pain. Mipomersen use is mainly associated to hepatosteatosis, increased transaminases (> 3 times the upper limit of normal), mild-to-moderate injection-site reactions and flu-like symptoms. PCSK9 inhibitors have demonstrated their good safety and tolerability in a large number of subjects with different clinical conditions, including statin-intolerance, enlarging their potential use in a broader range of patients. Further data on long-term mipomersen safety are required.

Safety and Efficacy of Permacol Injection in the Treatment of Fecal Incontinence.

PubMed

Al-Abed, Yahya A; Ayers, Jennifer; Ayantunde, Abraham; Praveen, Bandipalyam V

2016-04-01

Permacol has been gaining popularity in recent times for the treatment of fecal incontinence (FI). This study aims to evaluate the safety and efficacy of anal submucosal Permacol injection in the treatment of FI. All consecutive patients who underwent Permacol injection for FI over a 3-year period were included. Patients' data relating to obstetric history, anorectal/pelvic operations, type of FI, preoperative anorectal physiology results and follow-up details for outcome measures were collected. Preoperative and postoperative Cleveland Clinic Florida Incontinence Scores (CCFISs) were noted. Patients were surveyed by using a telephone questionnaire to assess the quality of life and other outcome measures. Data were analysed using SPSS ver.19.0. Thirty patients (28 females and 2 males) with a median age of 67 years were included in the study. Of those patients, 37%, 50%, and 13% were noted to have passive, mixed and urge FI, respectively. Six of the patients (20%) had repeat Permacol injections, 5 of whom had sustained responses to the first Permacol injection for a mean of 11 months. There was a significant improvement in the CCFIS from a baseline median of 12.5, mean 12.8 interquartile range [IQR], 6-20), to a median of 3.5, mean 4.8 (IQR, 0-20), P < 0.001. Of the patients surveyed by telephone 89% were satisfied with their overall experience and the improvement in their symptoms following Permacol injections. This study has demonstrated that Permacol injection for the treatment of FI is safe and effective and has no associated major complications. However, the results are not permanent; consequently, a significant proportion of the patients with an initial response may require repeat injections.

Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases

PubMed Central

Li, Xue-Lin; Tang, Jin-Fa; Li, Wei-Xia; Li, Chun-Xiao; Zhao, Tao; Zhao, Bu-Chang; Wang, Yong; Zhang, Hui; Chen, Xiao-Fei; Xu, Tao; Zhu, Ming-Jun

2015-01-01

Traditional Chinese medicine injections (TCMIs) have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI) is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus) accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. The main disposition of ADRs of DHI was drug withdrawal and without any treatments. The results can provide basis for amendment and improvement of the instructions of DHI, as well as demonstration and reference for the postmarketing safety surveillance and reevaluation of other TCMIs. And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved. PMID:26508981

Prevalence of injections and knowledge of safe injections among rural residents in Central China.

PubMed

Yan, Y W; Yan, J; Zhang, G P; Gao, Z L; Jian, H X

2007-08-01

Abuse of the injection services, namely unnecessary injections and unsafe injections, exists extensively in developing countries. Unsafe injection practices contribute to the transmission of blood-borne pathogens. The aims of this study were to survey the prevalence of injections and knowledge of injection safety among the rural residents in Jingzhou district, Hubei, China and to provide scientific data for developing a health educational programme. A retrospective cross-sectional study was conducted in 12 villages, which were selected from the Jingzhou district by the random sampling method. 50 rural residents were interviewed per village using a questionnaire. Among the 595 residents studied, 192 had received at least one injection in the past three months, with an injection prevalence of 32.3 percent and an average of 0.93 injections. 90.3 percent of the rural residents knew that unsafe injections could transmit the following blood-borne pathogens: human immunodeficiency virus (74.4 percent), hepatitis B virus (55.8 percent) and hepatitis C virus (22.9 percent). Logistic regression analysis showed that the residents' age, educational level and residential area were important factors in influencing their knowledge about injection safety. The results indicated that the injection prevalence was high among rural residents in the study area, and their knowledge regarding injection safety should be further improved.

Epidural steroid injections: update on efficacy, safety, and newer medications for injection.

PubMed

Kozlov, N; Benzon, H T; Malik, K

2015-08-01

The best evidence for epidural injection appears to be in the setting of radicular pain with epidural steroid and non-steroid injections more efficacious than non-epidural injections. Studies showed the efficacy of non-particulate steroid to approach the efficacy of particulate steroid and very limited comparisons demonstrated no significant difference between epidural steroid and epidural non-steroid (local anesthetic) injection. Preliminary studies evaluating epidural injection of disease modifying anti-rheumatic drugs such etanercept and tocilizumab showed conflicting results and had significant limitations. Randomized studies support better efficacy of transforaminal injection due to greater incidence of ventral epidural spread of injectate when compared to interlaminar injection. Thus, the transforaminal approach is recommended when unilateral radicular pain is limited to one nerve root. However, the transforaminal approach is associated with greater incidence of central nervous system injury, including paraplegia, attributed to embolization of the particulate steroid. Recent studies showed that non-particulate steroids potentially last as long as particulate steroids. Therefore non-particulate steroid should be used in initial transforaminal epidural injection. Future studies should look into the role of adjunct diagnostic aids, including digital subtraction angiography, in detecting intravascular injection and the ideal site of needle placement, whether it is the safe triangle or the triangle of Kambin. Finally, the role of epidural disease -modifying antirheumatic drugs in the management of back pain needs to be better elucidated.

Safety and Efficacy of Permacol Injection in the Treatment of Fecal Incontinence

PubMed Central

Ayers, Jennifer; Ayantunde, Abraham; Praveen, Bandipalyam V

2016-01-01

Purpose Permacol has been gaining popularity in recent times for the treatment of fecal incontinence (FI). This study aims to evaluate the safety and efficacy of anal submucosal Permacol injection in the treatment of FI. Methods All consecutive patients who underwent Permacol injection for FI over a 3-year period were included. Patients' data relating to obstetric history, anorectal/pelvic operations, type of FI, preoperative anorectal physiology results and follow-up details for outcome measures were collected. Preoperative and postoperative Cleveland Clinic Florida Incontinence Scores (CCFISs) were noted. Patients were surveyed by using a telephone questionnaire to assess the quality of life and other outcome measures. Data were analysed using SPSS ver.19.0. Results Thirty patients (28 females and 2 males) with a median age of 67 years were included in the study. Of those patients, 37%, 50%, and 13% were noted to have passive, mixed and urge FI, respectively. Six of the patients (20%) had repeat Permacol injections, 5 of whom had sustained responses to the first Permacol injection for a mean of 11 months. There was a significant improvement in the CCFIS from a baseline median of 12.5, mean 12.8 interquartile range [IQR], 6–20), to a median of 3.5, mean 4.8 (IQR, 0–20), P < 0.001. Of the patients surveyed by telephone 89% were satisfied with their overall experience and the improvement in their symptoms following Permacol injections. Conclusion This study has demonstrated that Permacol injection for the treatment of FI is safe and effective and has no associated major complications. However, the results are not permanent; consequently, a significant proportion of the patients with an initial response may require repeat injections. PMID:27218098

Efficacy and safety of acute injection laryngoplasty for vocal cord paralysis following thoracic surgery.

PubMed

Graboyes, Evan M; Bradley, Joseph P; Meyers, Bryan F; Nussenbaum, Brian

2011-11-01

The primary objective of this study was to evaluate the effectiveness and safety of injection laryngoplasty using a temporary injectable agent in the acute setting for patients with unilateral vocal cord paralysis following thoracic surgical procedures. Retrospective consecutive case series in an academic institution. Inclusion criteria included patients acutely treated with injection laryngoplasty from January 1, 2006, to March 31, 2010, for a unilateral vocal cord paralysis that occurred after a thoracic surgical procedure (N = 20). All patients were injected with Radiesse Voice Gel using microlaryngoscopy technique. The mean time to vocal cord injection from the time of thoracic surgery was 4.5 days. There was one operative-related complication of intraoperative bile reflux that caused a pneumonitis. Ninety percent of patients were recommended for strict nothing by mouth prior to injection. Of these, 94% were allowed an oral diet following injection, and 67% tolerated a regular diet. None of the patients required subsequent procedures for aspiration or dysphagia, and 25% required further intervention after discharge for persistent dysphonia. Patients with a known nerve transection had a higher rate of dysphonia requiring further surgical procedures than those who did not have a known nerve transection. Acute treatment of thoracic surgery-related unilateral vocal cord paralysis with injection laryngoplasty appears safe and effective at preventing postoperative aspiration pneumonia and improves swallowing function to allow resumption of an oral diet. A single injection is often the only required treatment. Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.

Epidural Steroid Injections are Safe and Effective: Multisociety Letter in Support of the Safety and Effectiveness of Epidural Steroid Injections.

PubMed

Kennedy, David J; Levin, Joshua; Rosenquist, Richard; Singh, Virtaj; Smith, Clark; Stojanovic, Milan P; Vorobeychik, Yakov

2015-05-01

In April 2014, the Food and Drug Administration (FDA) issued a Drug Safety Communication requesting that corticosteroid labeling include warnings that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The International Spine Intervention Society spearheaded a collaboration of more than a dozen other medical societies in submitting the letter below to the FDA on November 7, 2014. We are publishing the letter to ensure that the readership of Pain Medicine is aware of the multisociety support for the safety and effectiveness of these procedures. A special note of thanks to all of the societies who signed on in support of the message. Wiley Periodicals, Inc.

Efficiency and safety of subconjunctival injection of anti-VEGF agent - bevacizumab - in treating dry eye.

PubMed

Jiang, Xiaodan; Lv, Huibin; Qiu, Weiqiang; Liu, Ziyuan; Li, Xuemin; Wang, Wei

2015-01-01

Dry eye is a chronic inflammatory ocular surface disease with high prevalence. The current therapies for dry eye remain to be unspecific and notcomprehensive. This study aims to explore safety and efficacy of a novel treatment - subconjunctival injection of bevacizumab - in dry eye patients. Sixty-four eyes of 32 dry eye patients received subconjunctival injection of 100 μL 25 mg/mL bevacizumab. Dry eye symptoms, signs (corrected visual acuity, intraocular pressure, conjunctival vascularity, corneal staining, tear break-up time, Marx line score, and blood pressure), and conjunctival impression cytology were evaluated 3 days before and 1 week, 1 month, and 3 months after injection. Significant improvements were observed in dry eye symptoms, tear break-up time, and conjunctival vascularization area at all the visits after injection compared to the baseline (P<0.05). The density of the goblet cell increased significantly at 1 month and 3 months after injection (P<0.05). There was no visual and systemic threat observed in any patient. Subconjunctival injection of 100 μL 25 mg/mL bevacizumab is a safe and efficient treatment for ocular surface inflammation of dry eye disease.

Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men.

PubMed

Behre, Hermann M; Zitzmann, Michael; Anderson, Richard A; Handelsman, David J; Lestari, Silvia W; McLachlan, Robert I; Meriggiola, M Cristina; Misro, Man Mohan; Noe, Gabriela; Wu, Frederick C W; Festin, Mario Philip R; Habib, Ndema A; Vogelsong, Kirsten M; Callahan, Marianne M; Linton, Kim A; Colvard, Doug S

2016-12-01

The development of a safe and effective reversible method of male contraception is still an unmet need. Evaluation of suppression of spermatogenesis and contraceptive protection by coadministered im injections of progestogen and testosterone. Prospective multicentre study. Ten study centers. Healthy men, aged 18-45 years, and their 18- to 38-year-old female partners, both without known fertility problems. Intramuscular injections of 200-mg norethisterone enanthate combined with 1000-mg testosterone undecanoate, administered every 8 weeks. Suppression of spermatogenesis by ejaculate analysis, contraceptive protection by pregnancy rate. Of the 320 participants, 95.9 of 100 continuing users (95% confidence interval [CI], 92.8-97.9) suppressed to a sperm concentration less than or equal to 1 million/mL within 24 weeks (Kaplan-Meier method). During the efficacy phase of up to 56 weeks, 4 pregnancies occurred among the partners of the 266 male participants, with the rate of 1.57 per 100 continuing users (95% CI, 0.59-4.14). The cumulative reversibility of suppression of spermatogenesis after 52 weeks of recovery was 94.8 per 100 continuing users (95% CI, 91.5-97.1). The most common adverse events were acne, injection site pain, increased libido, and mood disorders. Following the recommendation of an external safety review committee the recruitment and hormone injections were terminated early. The study regimen led to near-complete and reversible suppression of spermatogenesis. The contraceptive efficacy was relatively good compared with other reversible methods available for men. The frequencies of mild to moderate mood disorders were relatively high.

Safety and Efficacy of Intratumoral Injections of Chimeric Antigen Receptor (CAR) T Cells in Metastatic Breast Cancer.

PubMed

Tchou, Julia; Zhao, Yangbing; Levine, Bruce L; Zhang, Paul J; Davis, Megan M; Melenhorst, Jan Joseph; Kulikovskaya, Irina; Brennan, Andrea L; Liu, Xiaojun; Lacey, Simon F; Posey, Avery D; Williams, Austin D; So, Alycia; Conejo-Garcia, Jose R; Plesa, Gabriela; Young, Regina M; McGettigan, Shannon; Campbell, Jean; Pierce, Robert H; Matro, Jennifer M; DeMichele, Angela M; Clark, Amy S; Cooper, Laurence J; Schuchter, Lynn M; Vonderheide, Robert H; June, Carl H

2017-12-01

Chimeric antigen receptors (CAR) are synthetic molecules that provide new specificities to T cells. Although successful in treatment of hematologic malignancies, CAR T cells are ineffective for solid tumors to date. We found that the cell-surface molecule c-Met was expressed in ∼50% of breast tumors, prompting the construction of a CAR T cell specific for c-Met, which halted tumor growth in immune-incompetent mice with tumor xenografts. We then evaluated the safety and feasibility of treating metastatic breast cancer with intratumoral administration of mRNA-transfected c-Met-CAR T cells in a phase 0 clinical trial (NCT01837602). Introducing the CAR construct via mRNA ensured safety by limiting the nontumor cell effects (on-target/off-tumor) of targeting c-Met. Patients with metastatic breast cancer with accessible cutaneous or lymph node metastases received a single intratumoral injection of 3 × 10 7 or 3 × 10 8 cells. CAR T mRNA was detectable in peripheral blood and in the injected tumor tissues after intratumoral injection in 2 and 4 patients, respectively. mRNA c-Met-CAR T cell injections were well tolerated, as none of the patients had study drug-related adverse effects greater than grade 1. Tumors treated with intratumoral injected mRNA c-Met-CAR T cells were excised and analyzed by immunohistochemistry, revealing extensive tumor necrosis at the injection site, cellular debris, loss of c-Met immunoreactivity, all surrounded by macrophages at the leading edges and within necrotic zones. We conclude that intratumoral injections of mRNA c-Met-CAR T cells are well tolerated and evoke an inflammatory response within tumors. Cancer Immunol Res; 5(12); 1152-61. ©2017 AACR . ©2017 American Association for Cancer Research.

Knowledge and Practice on Injection Safety among Primary Health Care Workers in Kaski District, Western Nepal

PubMed Central

Gyawali, Sudesh; Rathore, Devendra Singh; Shankar, P Ravi; Kc, Vikash Kumar; Jha, Nisha; Sharma, Damodar

2016-01-01

Background Unsafe injection practice can transmit various blood borne infections. The aim of this study was to assess the knowledge and practice of injection safety among injection providers, to obtain information about disposal of injectable devices, and to compare the knowledge and practices of urban and rural injection providers. Methods The study was conducted with injection providers working at primary health care facilities within Kaski district, Nepal. Ninety-six health care workers from 69 primary health care facilities were studied and 132 injection events observed. A semi-structured checklist was used for observing injection practice and a questionnaire for the survey. Respondents were interviewed to complete the questionnaire and obtain possible explanations for certain observed behaviors. Results All injection providers knew of at least one pathogen transmitted through use/re-use of unsterile syringes. Proportion of injection providers naming hepatitis/jaundice as one of the diseases transmitted by unsafe injection practice was significantly higher in urban (75.6%) than in rural (39.2%) area. However, compared to urban respondents (13.3%), a significantly higher proportion of rural respondents (37.3%) named Hepatitis B specifically as one of the diseases transmitted. Median (inter-quartile range) number of therapeutic injection and injectable vaccine administered per day by the injection providers were 2 (1) and 1 (1), respectively. Two handed recapping by injection providers was significantly higher in urban area (33.3%) than in rural areas (21.6%). Most providers were not aware of the post exposure prophylaxis guideline. Conclusion The knowledge of the injection providers about safe injection practice was acceptable. The use of safe injection practice by providers in urban and rural health care facilities was almost similar. The deficiencies noted in the practice must be addressed. PMID:27540325

Safety of Repeated-Dose Intratympanic Injections with AM-101 in Acute Inner Ear Tinnitus.

PubMed

Staecker, Hinrich; Morelock, Michael; Kramer, Timothy; Chrbolka, Pavel; Ahn, Joong Ho; Meyer, Thomas

2017-09-01

Objective To evaluate the safety and tolerability of repeated intratympanic administration of the gel-formulated NMDA receptor antagonist AM-101 in acute patients with inner ear tinnitus. Study Design Prospective, double-blind, randomized, placebo-controlled study. Setting Sixty-nine secondary and tertiary sites in North America, Europe, and Asia. Subjects and Methods In total, 343 subjects with persistent acute tinnitus after traumatic cochlear injury or otitis media were randomized to receive 3 intratympanic doses of either AM-101 0.87 mg/mL or placebo over 3 to 5 days. They were followed for 84 days. The primary safety end point was the incidence of a clinically meaningful hearing deterioration from baseline to study day 35. Further safety assessments included tympanic membrane closure rates, analysis of adverse events, hematology, blood chemistry, and vital signs. In addition, data were collected on applied anesthetics and injection techniques. Results The treatment was well tolerated, with no intervention-related serious adverse events. The incidence of clinically meaningful hearing deterioration was low, comparable between treatment groups ( P = .82 for the primary safety end point) and not different between treated and untreated ears in unilaterally treated subjects. The rate of treatment and procedure-related adverse events was similar among treatment groups. The tympanic membrane was closed in 92% of subjects within 1 week and in all subjects by study day 84. Blood values and vital signs were inconspicuous. Conclusion Repeated intratympanic injections of AM-101 over a 3- to 5-day period appear to be safe and well tolerated, demonstrating the ability to potentially use this delivery approach over longer time periods.

Safety and efficacy of bi-annual intra-articular LBSA0103 injections in patients with knee osteoarthritis.

PubMed

Lee, Jin Kyu; Choi, Chong-Hyuk; Oh, Kwang-Jun; Kyung, Hee-Soo; Yoo, Ju-Hyung; Ha, Chul-Won; Bin, Seong-Il; Kang, Seung-Baik; Kim, Myung Ku; Lee, Ju-Hong; Lee, Myung Chul

2017-11-01

The objective of this study is to assess the safety and efficacy of repeated intra-articular injection of high molecular weight hyaluronic acid (LBSA0103) at a 26-week interval, in patients with osteoarthritis of the knee. The study was an open-label, single arm, multicentre prospective trial conducted in patients with symptomatic knee osteoarthritis. The intervention consisted of two intra-articular injections of LBSA0103, with the second injection performed 26 weeks after the first injection. The primary outcome was the incidence of adverse drug reactions related to each injection. Assessment of efficacy of repeated injections in terms of maintenance of pain relief was a secondary objective of this study. Of the 185 patients screened, 174 patients received the first injection and 153 patients received both injections of LBSA0103. Nine adverse drug reactions occurred in seven patients (4.02%) after the first injection, while only one adverse drug reaction occurred (0.65%) after the second injection. As a secondary outcome measure, the improvements in the efficacy parameters including total WOMAC score and weight-bearing pain were all significant at both week 13 and 39 compared to the baseline value (P < 0.001), and improvements after the second injection were consistent with those after the initial injection of LBSA0103 (between week 26 and week 39, P < 0.001). Repeated intra-articular injection of LBSA0103 at a 26-week interval is safe without increased risk of adverse drug reactions. Additionally, LBSA0103 is effective in reduction of osteoarthritis knee pain and in maintenance of pain reduction for a 39-week period when a second injection is administered.

Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations.

PubMed

Wang, Can; Shi, Qing-Ping; Ding, Feng; Jiang, Xiao-Dong; Tang, Wei; Yu, Mei-Ling; Zhu, Jian-Hua

2018-01-01

To evaluate the factors influencing suspected hypersensitivity and adverse systemic reactions after Shuxuening injection and to provide innovative ideas and methods for the reevaluation of post-marketing safety of Shuxuening. This study used a prospective, nested case-control study design, combined with a prescription sequence analysis design method. It classified patients who exhibited trigger signals after administration of Shuxuening injection as suspected allergic patients and made comparisons with patients who did not report adverse effects to calculate the correlation between relevant risk factors and suspected allergic reactions. Randomized controlled studies and cohort studies of the adverse drug reaction (ADR) of Shuxuening were performed using a computer database. Data retrieval was carried out by the foundation governing the individual database. Meta-analysis was performed by using R3.2.3 software to evaluate the ADRs of Shuxuening. The results of real-world study showed that administration of Shuxuening in combination with potassium aspartate and magnesium, atorvastatin calcium, Shengmai injection, pantoprazole sodium, or high-dose medication was a risk factor for suspected allergic reactions. Meta-analysis showed that the incidence of adverse events was 5.84% (95% CI 0.0499; 0.0674), and serious adverse reaction rate was 4.36% (95% CI 0.0188; 0.0760) when Shuxuening was used in combination with these drugs. The incidence of allergic reaction was also influenced by the vehicle, duration of treatment, single dose, and indicated vs off-label use. Risk factors for adverse reaction following the use of Shuxuening injection in patients are associated with a single dose, vehicle, type of disease, and combination with potassium aspartate, atorvastatin calcium, Shengmai injection, injection with pantoprazole sodium, and other drugs. Physicians should be careful to follow guidelines when administering this drug. We further propose that the unique methodology

Safety of radiofrequency treatment over human skin previously injected with medium-term injectable soft-tissue augmentation materials: a controlled pilot trial.

PubMed

Alam, Murad; Levy, Ross; Pajvani, Urvi; Pavjani, Urvi; Ramierez, James A; Guitart, Joan; Veen, Heather; Gladstone, Hayes B

2006-03-01

Several soft-tissue augmentation materials are now available for reduction of nasolabial fold creases and perioral rhytides. Nasolabial folds and perioral rhytides can also be improved by skin tightening delivered by non-ablative radiofrequency (RF) treatment. The purpose of this study was to assess the safety of RF treatment over skin areas recently injected with medium-term injectable soft-tissue augmentation materials. Five subjects were assigned to the experimental arm (augmentation materials plus RF) and one to the control arm (augmentation materials alone). Each subject received injections of 0.3 mL of hyaluronic acid derivative (Restylane) and calcium hydroxylapatite (Radiesse) 3 cm apart on the upper inner arm. Two weeks later, two non-overlapping passes of RF (Thermage ThermaCool TC) were delivered at 63.5 setting with medium-fast 1.5 cm2 tip over injected sites in all of the experimental subjects. Punch skin biopsies were obtained 3 days later from each of the two injection sites on each subject. Light microscopy and digital photomicrographs obtained at low, medium, and high power showed no difference between filler materials in experimental and control subjects. In both cases filler was evident at the deep dermal-subcutaneous junction. Nodule formation, foreign body extravasation, or hemorrhage/clot was not observed grossly or histologically. Subjects and physicians did not report any difference in signs and symptoms between the experimental and control arms. Slightly increased transitory pain was noted when RF was delivered over filler versus over normal skin. Applying RF treatment over the same area 2 weeks after deep dermal injection with hyaluronic acid derivatives or calcium hydroxylapatite does not appear to cause gross morphological changes in the filler material or surrounding skin. Further studies with different parameters are necessary to confirm these findings. 2006 Wiley-Liss, Inc.

A global health partnership's use of time-limited support to catalyze health practice change: the case of GAVI's Injection Safety Support.

PubMed

Levin, Ann; Fang, Arnold; Hansen, Peter M; Pyle, David; Dia, Ousmane; Schwalbe, Nina

2010-09-27

This paper presents the findings of a study to assess the effectiveness and sustainability of a GAVI (Global Alliance of Vaccines and Immunization) sponsored, time-limited Injection Safety (INS) support. The support came in two forms: 1) in-kind, in the form of AD syringes and safety boxes, and 2) in cash, for those countries that already had a secure, multi-year source of AD syringes and safety boxes, but proposed to use INS support to strengthen their injection safety activities. In total, GAVI gave INS support for a three-year period to 58 countries: 46 with commodities and 12 with cash support. To identify variables that might be associated with financial sustainability, frequencies and cross-tabulations were run against various programmatic and socio-economic variables in the 58 countries. All but two of the 46 commodity-recipient countries were able to replace and sustain the use of AD syringes and safety boxes after the end of their GAVI INS support despite the fact that standard disposable syringes are less costly than ADs (10-15 percent differential). In addition, all 12 cash-recipient countries continued to use AD syringes and safety boxes in their immunization programs in the years following GAVI INS assistance. At the same time, countries were often not prepared for the increased waste management requirements associated with the use of the syringes, suggesting the importance of anticipating challenges with the introduction of new technologies. The sustained use of AD syringes in countries receiving injection safety support from GAVI, in a majority of cases through government financing, following the completion of three years of time-limited support, represents an early indication of how GHPs can contribute to improved health outcomes in immunization safety in the world's poorest countries in a sustainable way.

Deltoid Injections of Risperidone Long-acting Injectable in Patients with Schizophrenia

PubMed Central

Quiroz, Jorge A.; Rusch, Sarah; Thyssen, An; Kushner, Stuart

2011-01-01

Background Risperidone long-acting injectable was previously approved for treatment of schizophrenia as biweekly injections in the gluteal muscle only. We present data on local injection-site tolerability and safety of risperidone long-acting injectable and comparability of systemic exposure of deltoid versus gluteal injections. Methods Risperidone long-acting injectable was administered in an open-label, single-dose, two-way crossover study, with patients randomized to receive either 25mg gluteal/37.5mg deltoid crossover in two treatment periods or 50mg gluteal/50mg deltoid injections crossover; each treatment period was separated by an 85-day observation period (Study 1) and an open-label, multiple-dose study (4 sequential 37.5mg or 50mg deltoid injections every 2 weeks) (Study 2). The pharmacokinetic results from both the studies have already been published. Results In Study 1 (n=170), the majority of patients had no local injection-site findings, based on investigator and patient-rated evaluations. In Study 2 (n=53), seven of the 51 patients who received at least two deltoid injections discontinued (primary endpoint). However, none of the discontinuations were due to injection-site related reasons. The 90-percent upper confidence limit of the true proportion of injection-site issue withdrawals was 5.7 percent. No moderate or severe injection-site reactions were reported. Conclusion Intramuscular injections via the deltoid and gluteal sites are equivalent routes of administration of risperidone long-acting injectable with respect to local injection-site tolerability. The overall safety and tolerability profile of risperidone long-acting injectable was comparable when administered as an intramuscular injection in the deltoid (37.5mg and 50mg) and gluteal (25mg and 50mg) sites. PMID:21779538

Efficacy and safety of flurbiprofen axetil in the prevention of pain on propofol injection: a systematic review and meta-analysis.

PubMed

Zhang, Lieliang; Zhu, Juan; Xu, Lei; Zhang, Xunlei; Wang, Hongyu; Luo, Zhonghua; Zhao, Yamei; Yu, Yi; Zhang, Yong; Shi, Hongwei; Bao, Hongguang

2014-06-17

Pain on injection is an acknowledged adverse effect (AE) of propofol administration for the induction of general anesthesia. Flurbiprofen axetil has been reported to reduce the pain of injection. However, results of published papers on the efficacy of flurbiprofen axetil in managing pain on injection of propofol are inconsistent. We conducted a comprehensive meta-analysis of studies to appraise the efficacy and safety of flurbiprofen axetil for controlling pain induced by propofol injection. The pooled risk ratio (RR) with corresponding 95% confidence intervals (CI) was calculated employing fixed- or random-effects models, depending upon the heterogeneity of the included trials. Compared with the placebo group, flurbiprofen axetil allows more patients to have no pain (RR 3.51, 95% CI 2.22-5.55, p=0.000), and decreases the cumulative number of patients with mild, moderate, and severe pain on injecting propofol (RR 0.70, 95% CI 0.58-0.86, p=0.000; RR 0.59, 95% CI 0.46-0.75, p=0.000; RR 0.25, 95% CI 0.16-0.38, p=0.000, respectively). In the stratified analysis by the doses, flurbiprofen axetil at a dose of over 50 mg was found to be effective in reducing propofol-induced pain on injection; however, there were no significant differences in relieving pain between treatment and placebo groups with flurbiprofen axetil at a dose of 25 mg. In terms of drug safety, there were no adverse effects (AEs) reported between flurbiprofen axetil-based regimens and placebo regimens. Flurbiprofen axetil, an injectable prodrug of flurbiprofen, can significantly prevent or relieve the pain induced by propofol injection. More studies are required to assess its adverse effects.

Evaluation of performance, safety, subject acceptance, and compliance of a disposable autoinjector for subcutaneous injections in healthy volunteers.

PubMed

Berteau, Cecile; Schwarzenbach, Florence; Donazzolo, Yves; Latreille, Mathilde; Berube, Julie; Abry, Herve; Cotten, Joël; Feger, Celine; Laurent, Philippe E

2010-10-05

A disposable autoinjector was developed for subcutaneous (SC) self-injection by patients with chronic diseases. To verify its performance and evaluate its acceptance, a clinical study was conducted in healthy volunteers, comparing SC injections performed by subjects using the autoinjector with SC injections performed by nurses using a syringe. This was a randomized, single-center, crossover study comparing SC self-injection using an autoinjector with SC nurse-administered injection using a syringe. Two volumes (0.2 mL and 1 mL) were injected into healthy volunteers. Study objectives included assessment of the accuracy and consistency of the volume injected by the injection systems, and skin reaction and pain associated with the injection. The fluid depot in the SC tissue layer was evaluated by ultrasound. Subject acceptance was evaluated using questionnaires on attitudes and emotions towards the injection technique, and challenged by seeking the subjects' preferred system for a final study injection or future treatment. A total of 960 injections (480 with autoinjector, 480 with syringe) were performed in 40 subjects. There were no significant differences in mean fluid leakage and injected volumes between the systems. Pain associated with the injection was significantly lower with the auto-injector than with the syringe. Local skin reaction at the injection site was overall satisfactory. Injections were appropriately performed by all subjects. At study end, all 40 subjects preferred the autoinjector for a final study injection and for future treatment. This study indicated that the autoinjector used by the subject was similar to a syringe used by a nurse in terms of performance and safety in administering the injections, and better in terms of pain, overall acceptance, and preference.

Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study.

PubMed

Bashaireh, Khaldoon; Naser, Ziad; Hawadya, Khaled Al; Sorour, Sorour; Al-Khateeb, Rami Nabeel

2015-01-01

The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period. The study was a post-marketing Phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1-4) in the tibio-femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection. An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated. The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3.36, the stiffness score was 0.42, and the physical performance score was 11.5. All side effects were local and transient, and included pain, swelling, and redness of the knee. Most side effects were treated. Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce their required doses, and delay potential future surgical intervention.

Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study

PubMed Central

Bashaireh, Khaldoon; Naser, Ziad; Hawadya, Khaled Al; Sorour, Sorour; Al-Khateeb, Rami Nabeel

2015-01-01

Purpose The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period. Materials and methods The study was a post-marketing Phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1–4) in the tibio–femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection. Main outcome measure(s) An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated. Main results The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3.36, the stiffness score was 0.42, and the physical performance score was 11.5. All side effects were local and transient, and included pain, swelling, and redness of the knee. Most side effects were treated. Conclusion Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce

Safety Study: Intraventricular Injection of a Modified Oncolytic Measles Virus into Measles-Immune, hCD46-Transgenic, IFNαRko Mice.

PubMed

Lal, Sangeet; Peng, Kah-Whye; Steele, Michael B; Jenks, Nathan; Ma, Hong; Kohanbash, Gary; Phillips, Joanna J; Raffel, Corey

2016-12-01

The modified Edmonston vaccine strain of measles virus (MV) has shown potent oncolytic efficacy against various tumor types and is being investigated in clinical trials. Our laboratory showed that MV effectively kills medulloblastoma tumor cells in both localized disease and when tumor cells are disseminated through cerebrospinal fluid (CSF). Although the safety of repeated intracerebral injection of modified MV in rhesus macaques has been established, the safety of administering MV into CSF has not been adequately investigated. In this study, we assessed the safety of MV-NIS (MV modified to express the human sodium iodide symporter protein) injected into the CSF of measles-immunized and measles virus-susceptible transgenic (CD46, IFNαRko) mice. Treated animals were administered a single intraventricular injection of 1 × 10 5 or 1 × 10 6 TCID 50 (50% tissue culture infective dose) of MV-NIS. Detailed clinical observation was performed over a 90-day period. Clinically, we did not observe any measles-related toxic effects or behavioral abnormality in animals of any treated cohort. The complete blood count and blood chemistry analysis results were found to be within normal range for all the cohorts. Histologic examination of brains and spinal cords revealed inflammatory changes, mostly related to the needle track; these resolved by day 21 postinjection. To assess viral biodistribution, quantitative RT-PCR to detect the measles virus N-protein was performed on blood and brain samples. Viral RNA was not detectable in the blood as soon as 2 days after injection, and virus cleared from the brain by 45 days postadministration in all treatment cohorts. In conclusion, our data suggest that a single injection of modified MV into the CSF is safe and can be used in future therapeutic applications.

Assistive Device for Efficient Intravitreal Injections.

PubMed

Ullrich, Franziska; Michels, Stephan; Lehmann, Daniel; Pieters, Roel S; Becker, Matthias; Nelson, Bradley J

2016-08-01

Intravitreal therapy is the most common treatment for many chronic ophthalmic diseases, such as age-related macular degeneration. Due to the increasing worldwide demand for intravitreal injections, there exists a need to render this medical procedure more time- and cost-efficient while increasing patient safety. The authors propose a medical assistive device that injects medication intravitreally. Compared to the manual intravitreal injection procedure, an automated device has the potential to increase safety for patients, decrease procedure times, allow for integrated data storage and documentation, and reduce costs for medical staff and expensive operating rooms. This work demonstrates the development of an assistive injection system that is coarsely positioned over the patient's head by the human operator, followed by automatic fine positioning and intravitreal injection through the pars plana. Several safety features, such as continuous eye tracking and iris recognition, have been implemented. The functioning system is demonstrated through ex vivo experiments with porcine eyes. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:752-762.]. Copyright 2016, SLACK Incorporated.

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

Evaluation of the acute and chronic safety of the biosense injection catheter system in porcine hearts.

PubMed

Kornowski, R; Fuchs, S; Tio, F O; Pierre, A; Epstein, S E; Leon, M B

1999-12-01

Direct myocardial injection of therapeutic agents has been explored as a new method for myocardial revascularization. The integration of a 3D electromechanical mapping catheter with a retractable injection needle should allow for intramyocardial injection to identified sites, obviating the need for open heart surgery. This study assessed the procedural safety and performance characteristics of a novel guided catheter-based transendocardial injection system. The electromagnetic guidance system was coupled with a retrievable 27G needle for left ventricular endocardial injection. Using this system, we injected, transendocardially, methylene-blue (MB) dye tracer at a volume of 0.1 or 0.2 ml per injection in eight normal pigs. Animals were sacrificed acutely, at 1, 3, and 7 days (two animal in each time). Three animals served as controls. The injections were followed by coronary angiography and echocardiogram to assess possible ventricular or coronary perforation and wall motion abnormalities. CK-MB levels were measured up to 24 hr following the procedure. The animals were sacrificed at the assigned time for gross and histopathology evaluation. A total of 101 injections were made in all regions of the heart except the apex and the mitral valve. No animal died as a result of the mapping or injection procedures. Vital signs did not change relative to baseline after the mapping and injection procedures. CK-MB values did not increase over time and there was no evidence of sustained arrhythmia or hemodynamic compromise. There was no evidence of left ventricular or coronary perforation, global or regional wall motion abnormalities, or hemopericardium. On histologic evaluation, the estimated volume of tissue staining was greater than the volume of the injected MB dye due to dispersion of the injectate in the interstitial and intracellular fluid compartments. It is concluded that using this magnetic guidance catheter-based navigational system, it is feasible and safe to perform

Efficacy and safety of repeated courses of hyaluronic acid injections for knee osteoarthritis: A systematic review.

PubMed

Altman, Roy; Hackel, Josh; Niazi, Faizan; Shaw, Peter; Nicholls, Mathew

2018-01-31

Hyaluronic acid (HA) is a commonly prescribed intra-articular (IA) therapy for knee osteoarthritis (OA). While a single series of IA-HA has been well studied, the efficacy and safety of repeated courses of IA-HA injection therapy in knee OA patients have not been evaluated as frequently. A literature search was conducted using MEDLINE, EMBASE and PubMed databases. The primary outcome measure was knee pain reduction after each treatment course and/or last reported follow-up visit. Secondary outcomes were treatment-related adverse events (AEs) and serious adverse events (SAEs). A total of 17 articles (7 RCTs and 10 cohort studies) met the pre-defined inclusion criteria. Of the RCTs, six were double-blind with two trials including open label extension studies, and one was single-blind. Studies ranged from investigating a single reinjection cycle to four repeat injection cycles. Eleven studies evaluated one reinjection, five studies evaluated ≥2 repeated courses of IA-HA, and one study allowed either one or two repeated courses. All studies reported pain reduction from baseline in the IA-HA treatment group throughout the initial treatment cycle, and either sustained or further reduced pain throughout the repeated courses of treatment. The study with the longest follow-up repeated IA-HA injection every 6 months for 25 months. Pain decreased after the first course and continued to decrease until the end of the study, with an approximate 55% reduction in pain compared to baseline. Common AEs were joint swelling and arthralgia; there were no reported SAEs. All repeated courses were well tolerated, and the number of documented AEs and SAEs was similar to the primary injection regimens. Repeated courses of IA-HA injections are an effective and safe treatment for knee OA. Repeat courses were demonstrated to maintain or further improve pain reduction while introducing no increased safety risk. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study.

PubMed

Ha, Chul-Won; Park, Yong-Beom; Choi, Chong-Hyuk; Kyung, Hee-Soo; Lee, Ju-Hong; Yoo, Jae Doo; Yoo, Ju-Hyung; Choi, Choong-Hyeok; Kim, Chang-Wan; Kim, Hee-Chun; Oh, Kwang-Jun; Bin, Seong-Il; Lee, Myung Chul

2017-05-26

This randomized, double-blind, multi-center, non-inferiority trial was conducted to assess the efficacy and safety of a cross-linked hyaluronate (XLHA, single injection form) compared with a linear high molecular hyaluronate (HMWHA, thrice injection form) in patients with symptomatic knee osteoarthritis. Two hundred eighty seven patients with osteoarthritis (Kellgren-Lawrence grade I to III) were randomized to each group. Three weekly injections were given in both groups but two times of saline injections preceded XLHA injection to maintain double-blindness. Primary endpoint was the change of weight-bearing pain (WBP) at 12 weeks after the last injection. Secondary endpoints included Western Ontario and McMaster Universities Osteoarthritis index; patient's and investigator's global assessment; pain at rest, at night, or in motion; OMERACT-OARSI responder rate; proportion of patients achieving at least 20 mm or 40% decrease in WBP; and rate of rescue medicine use and its total consumption. Mean changes of WBP at 12 weeks after the last injection were -33.3 mm with XLHA and -29.2 mm with HMWHA, proving non-inferiority of XLHA to HMWHA as the lower bound of 95% CI (-1.9 mm, 10.1 mm) was well above the predefined margin (-10 mm). There were no significant between-group differences in all secondary endpoints. Injection site pain was the most common adverse event and no remarkable safety issue was identified. This study demonstrated that a single injection of XLHA was non-inferior to three weekly injections of HMWHA in terms of WBP reduction, and supports XLHA as an effective and safe treatment for knee osteoarthritis. ClinicalTrials.gov ( NCT01510535 ). This trial was registered on January 6, 2012.

Safety and Efficacy of Intra-articular Injection of Platelet-Rich Plasma in Patients With Ankle Osteoarthritis.

PubMed

Fukawa, Taisuke; Yamaguchi, Satoshi; Akatsu, Yorikazu; Yamamoto, Yohei; Akagi, Ryuichiro; Sasho, Takahisa

2017-06-01

An intra-articular injection of platelet-rich plasma (PRP) may be an effective treatment for osteoarthritis (OA). However, its efficacy in ankle OA has not been investigated yet. The purpose of this study was to assess the safety and efficacy of an intra-articular injection of PRP in patients with ankle OA during a 24-week period. Twenty ankles of 20 patients with varus-type ankle OA who received intra-articular injections of PRP were evaluated. PRP was extracted from whole blood by using the double-spin technique. Three injections of 2-mL PRP were administered to the ankle at an interval of 2 weeks under ultrasonographic guidance. Adverse events and efficacy were assessed at 4, 12, and 24 weeks after the last injection. Clinical outcomes were assessed by using the visual analog scale (VAS) for pain, the Japanese Society for Surgery of the Foot (JSSF) ankle/hindfoot scale, and the Self-Administered Foot Evaluation Questionnaire (SAFE-Q). No serious adverse effects were observed during the follow-up period. The VAS and JSSF scale scores significantly decreased from baseline to 4, 12, and 24 weeks after treatment ( P < .001). The mean score in the pain-related subscale of the SAFE-Q significantly improved from baseline to 12 weeks after treatment ( P = .04). Overall, the amount of pain reduction was maximal at 12 weeks after the last injection, and the effect was reduced at 24 weeks. The patients with late-stage OA had worse scores in all outcomes than those with early-stage OA. Intra-articular injections of PRP resulted in no serious adverse effects and significantly reduced pain in the patients with ankle OA. PRP treatment can be safe and effective and may be an option in the treatment of ankle OA. Level IV, case series.

Strategies for safe injections.

PubMed Central

Battersby, A.; Feilden, R.; Stoeckel, P.; Da Silva, A.; Nelson, C.; Bass, A.

1999-01-01

In 1998, faced with growing international concern, WHO set out an approach for achieving injection safety that encompassed all elements from patients' expectations and doctors' prescribing habits to waste disposal. This article follows that lead and describes the implications of the approach for two injection technologies: sterilizable and disposable. It argues that focusing on any single technology diverts attention from the more fundamental need for health services to develop their own comprehensive strategies for safe injections. National health authorities will only be able to ensure that injections are administered safely if they take an approach that encompasses the whole system, and choose injection technologies that fit their circumstances. PMID:10680247

Poly(ortho ester) nanoparticles targeted for chronic intraocular diseases: ocular safety and localization after intravitreal injection.

PubMed

Li, Huiling; Palamoor, Mallika; Jablonski, Monica M

2016-10-01

Treatment of posterior eye diseases is more challenging than the anterior segment ailments due to a series of anatomical barriers and physiological constraints confronted by drug delivery to the back of the eye. In recent years, concerted efforts in drug delivery have been made to prolong the residence time of drugs injected in the vitreous humor of the eye. Our previous studies demonstrated that poly(ortho ester) (POE) nanoparticles were biodegradable/biocompatible and were capable of long-term sustained release. The objective of the present study was to investigate the safety and localization of POE nanoparticles in New Zealand white rabbits and C57BL/6 mice after intravitreal administration for the treatment of chronic posterior ocular diseases. Two concentration levels of POE nanoparticles solution were chosen for intravitreal injection: 1.5 mg/ml and 10 mg/ml. Our results demonstrate that POE nanoparticles were distributed throughout the vitreous cavity by optical coherence tomography (OCT) examination 14 days post-intravitreal injection. Intraocular pressure was not changed from baseline. Inflammatory or adverse effects were undetectable by slit lamp biomicroscopy. Furthermore, we demonstrate that POE nanoparticles have negligible toxicity assessed at the cellular level evidenced by a lack of glia activation or apoptosis estimation after intravitreal injection. Collectively, POE nanoparticles are a novel and nontoxic as an ocular drug delivery system for the treatment of posterior ocular diseases.

The Efficacy and Safety of HA IDF Plus (with Lidocaine) Versus HA IDF (Without Lidocaine) in Nasolabial Folds Injection: A Randomized, Multicenter, Double-Blind, Split-Face Study.

PubMed

Lee, Jong-Hun; Kim, Seok-Hwan; Park, Eun-Soo

2017-04-01

Injection-related pain of dermal fillers is a consistent and bothersome problem for patients undergoing soft tissue augmentation. Reducing the pain could improve overall patient satisfaction. The purpose of this study was to compare the pain relief, efficacy, and safety of HA IDF plus containing lidocaine with HA IDF without lidocaine during correction of nasolabial folds (NLFs). Sixty-two subjects were enrolled in a randomized, multicenter, double-blind, split-face study of HA IDF plus and HA IDF for NLF correction. For split-face study, HA IDF plus was injected to one side of NLF, and HA IDF was injected to the other side. The first evaluation variable was the injection site pain measured using a 100-mm visual analogue scale (VAS). The second evaluation variables included the global aesthetic improvement scale, wrinkle severity rating scale, and adverse events. Immediately after injection, 91.94% of subjects experienced at least 10 mm decrease in VAS scores at the side injected with HA IDF plus compared with HA IDF, and the rate of subjects is statistically significant. The two fillers were not significantly different in safety profile or wrinkle correction during the follow-up visit. HA IDF plus significantly reduced the injection-related pain during NLFs correction compared with HA IDF without altering clinical outcomes or safety. Both HA IDF plus and HA IDF were considerably tolerated and most adverse reactions were mild and transient. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Safety and Acceptability of Community-Based Distribution of Injectable Contraceptives: A Pilot Project in Mozambique

PubMed Central

Jacinto, Ana; Mobaracaly, Mahomed Riaz; Ustáb, Momade Bay; Bique, Cassimo; Blazer, Cassandra; Weidert, Karen; Prata, Ndola

2016-01-01

ABSTRACT Mozambique has witnessed a climbing total fertility rate in the last 20 years. Nearly one-third of married women have an unmet need for family planning, but the supply of family planning services is not meeting the demand. This study aimed to explore the safety and effectiveness of training 2 cadres of community health workers—traditional birth attendants (TBAs) and agentes polivalentes elementares (APEs) (polyvalent elementary health workers)—to administer the injectable contraceptive depot-medroxyprogesterone acetate (DMPA), and to provide evidence to policy makers on the feasibility of expanding community-based distribution of DMPA in areas where TBAs and APEs are present. A total of 1,432 women enrolled in the study between February 2014 and April 2015. The majority (63% to 66%) of women in the study started using contraception for the first time during the study period, and most women (over 66%) did not report side effects at the 3-month and 6-month follow-up visits. Very few (less than 0.5%) experienced morbidities at the injection site on the arm. Satisfaction with the performance of TBAs and APEs was high and improved over the study period. Overall, the project showed a high continuation rate (81.1%) after 3 injections, with TBA clients having significantly higher continuation rates than APE clients after 3 months and after 6 months. Clients’ reported willingness to pay for DMPA (64%) highlights the latent demand for modern contraceptives. Given Mozambique’s largely rural population and critical health care workforce shortage, community-based provision of family planning in general and of injectable contraceptives in particular, which has been shown to be safe, effective, and acceptable, is of crucial importance. This study demonstrates that community-based distribution of injectable contraceptives can provide access to family planning to a large group of women that previously had little or no access. PMID:27651076

Safety and Acceptability of Community-Based Distribution of Injectable Contraceptives: A Pilot Project in Mozambique.

PubMed

Jacinto, Ana; Mobaracaly, Mahomed Riaz; Ustáb, Momade Bay; Bique, Cassimo; Blazer, Cassandra; Weidert, Karen; Prata, Ndola

2016-09-28

Mozambique has witnessed a climbing total fertility rate in the last 20 years. Nearly one-third of married women have an unmet need for family planning, but the supply of family planning services is not meeting the demand. This study aimed to explore the safety and effectiveness of training 2 cadres of community health workers-traditional birth attendants (TBAs) and agentes polivalentes elementares (APEs) (polyvalent elementary health workers)-to administer the injectable contraceptive depot-medroxyprogesterone acetate (DMPA), and to provide evidence to policy makers on the feasibility of expanding community-based distribution of DMPA in areas where TBAs and APEs are present. A total of 1,432 women enrolled in the study between February 2014 and April 2015. The majority (63% to 66%) of women in the study started using contraception for the first time during the study period, and most women (over 66%) did not report side effects at the 3-month and 6-month follow-up visits. Very few (less than 0.5%) experienced morbidities at the injection site on the arm. Satisfaction with the performance of TBAs and APEs was high and improved over the study period. Overall, the project showed a high continuation rate (81.1%) after 3 injections, with TBA clients having significantly higher continuation rates than APE clients after 3 months and after 6 months. Clients' reported willingness to pay for DMPA (64%) highlights the latent demand for modern contraceptives. Given Mozambique's largely rural population and critical health care workforce shortage, community-based provision of family planning in general and of injectable contraceptives in particular, which has been shown to be safe, effective, and acceptable, is of crucial importance. This study demonstrates that community-based distribution of injectable contraceptives can provide access to family planning to a large group of women that previously had little or no access. © Jacinto et al.

[Post-marketing safety surveillance of Diemailing Kudiezi injection: real world study in 30 233 cases].

PubMed

Liao, Xing; Yu, Dan-Dan; Xie, Yan-Ming; Zhang, Yun-Ling; He, Yan; Zhang, Yin; Liu, Yan; Yi, Dan-Hui; Wang, Yong-Yan

2017-08-01

This study was aimed to obtain the incidence of adverse drug reaction (ADR) of Diemailing Kudiezi injection, explore its characteristics, related risk factors and application in real world. A prospective single cohort study was conducted from 25 hospitals (including Chinese medicine hospitals and Western medicine hospitals) for 4 years. 30 233 consecutive inpatients using Diemailing Kudiezi injection were observed. Their general information was analyzed by using statistic frequency description. Association rules were used to analyze the correlation between comorbidities or drug combinations; the influential factors for ADRs were initially screened by using cross contingency method and Chi-square test, and then Group LASSAO method was used for further analysis. 54 patients with adverse drug events and 30 patients with ADRs were reported among 30 233 patients, with a total ADR incidence of 0.099%[95%CI (0.06%, 0.13%)]. There were 27 patients identified as the "general" ADR, one patients with "severe" ADR (anaphylactic shock) and two patients with new ADRs. ADR occurred most in 30 min after using Diemailing Kudiezi injection, in a total of 16 patients. The most ADRs were palpitation, vomiting, chills, pruritus and rash, 6 times for each symptom. Diemailing Kudiezi injection was well tolerated in the general population. The overall incidence of adverse reactions was rare, with high safety. However, the real incidence of ADRs may be underestimated in this study, and the blood samples were not obtained for the patients, so further mechanism studies shall be conducted. Copyright© by the Chinese Pharmaceutical Association.

Efficacy and safety of concurrent collagenase clostridium histolyticum injections for multiple Dupuytren contractures.

PubMed

Coleman, Stephen; Gilpin, David; Kaplan, F Thomas D; Houston, Anthony; Kaufman, Gregory J; Cohen, Brian M; Jones, Nigel; Tursi, James P

2014-01-01

To assess the safety and efficacy of 2 concurrent injections of collagenase clostridium histolyticum (CCH) in the same hand to treat multiple Dupuytren flexion contractures. In a multicenter, open-label phase IIIb study, 60 patients received two 0.58-mg CCH doses injected into cords affecting 2 joints in the same hand during 1 visit, followed by finger extension approximately 24 hours later. Efficacy at postinjection day 30 (change in flexion contracture and active range of motion, patient satisfaction, physician-rated improvement, and rates of clinical success [flexion contracture 5° or less]) and adverse events were summarized. The concurrent injections were most commonly administered in cords affecting metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints on the same finger (47%) or 2 MCP joints on different fingers of the same hand (37%). Mean total (sum of the 2 treated joints) flexion contracture decreased 76%, from 87° to 24° (MCP joints: 86%; PIP joints: 66%). Mean total range of motion increased from 100° to 161°. Clinical success was 76% for MCP joints and 33% for PIP joints. Most patients were very satisfied (60%) or quite satisfied (28%) with treatment. Most investigators rated treated joints as very much improved (55%) or much improved (37%). The most common treatment-related adverse events (> 75% of patients) were contusion, pain in extremity, and edema peripheral (local edema). Most adverse events were mild to moderate in severity. Serious complications included 1 pulley rupture related to study medication and 1 flexor tendon rupture (following conclusion of the study). There were no systemic complications. Results suggest that 2 affected joints can be effectively and safely treated with concurrent CCH injections. There was an increased incidence of some adverse events with concurrent treatment (pruritus, lymphadenopathy, blood blister, and skin laceration) compared with treatment of a single joint. High degrees of patient

Safety of intracameral injection of gatifloxacin, levofloxacin on corneal endothelial structure and viability.

PubMed

Choi, Jin A; Chung, Sung Kun

2009-10-01

To investigate the safety of intracameral injection of gatifloxacin, levofloxacin in a rabbit model as prophylaxis against endophthalmitis. Twenty-four eyes of New Zealand white rabbits were randomly divided into 3 treatment groups: levofloxacin, gatifloxacin, and balanced salt solution (BSS) control groups. After 100 microL of each was injected into the anterior chamber, endothelial toxicity was evaluated by measuring the central corneal thicknesses and the clinical toxicity scores using a slit-lamp at post-procedure days 3 and 7. The percent of dead cells was determined by vital staining with alizarin red and trypan blue at 7 days after injection. Finally, in each group, scanning electron microscopy (SEM) and transmission electron microscopy (TEM) were performed for the evaluation of structural integrity. The toxicity scores were increased at post-procedure days 3 and 7, but the difference among the groups was not statistically significant (P = 0.661, 0.216, respectively). With regard to baseline corneal thickness, only the levofloxacin group exhibited a significant increase from baseline (P = 0.028), whereas the other treatment groups showed no difference from baseline (P = 0.128 in gatifloxacin, 0.161 in BSS group). The mean corneal endothelial damage was 0.81 +/- 0.31% in the levofloxacin group, 0.56 +/- 0.47% in the gatifloxacin group, and 0.53 +/- 0.52% in the BSS group, with no statistically significant difference noted among the groups (P = 0.582). SEM revealed a well-preserved hexagonal endothelial cell mosaic and normal microvilli on the endothelial cell surface in the gatifloxacin and control groups. However, the levofloxacin group showed slightly disintegrated cellular borders. TEM revealed that each group maintained normal intracellular organization, whereas the levofloxacin group exhibited slightly flat cell configuration with irregular folds on the apical cell surface. Intracameral injection of gatifloxacin and levofloxacin was nontoxic in terms of

Evaluation of Biodistribution and Safety of Adenovirus Vectors Containing Group B Fibers after Intravenous Injection into Baboons

PubMed Central

NI, SHAOHENG; BERNT, KATHRIN; GAGGAR, ANUJ; LI, ZONG-YI; KIEM, HANS-PETER; LIEBER, ANDRÉ

2005-01-01

Vectors containing group B adenovirus (Ad) fibers are able to efficiently transduce gene therapy targets that are refractory to infection with standard Ad serotype 5 (Ad5) vectors, including malignant tumor cells, hematopoietic stem cells, and dendritic cells. Preliminary studies in mice indicate that, after intravenous injection, B-group fiber-containing Ads do not efficiently transduce most organs and cause less acute toxicity than Ad5 vectors. However, biodistribution and safety studies in mice are of limited value because the mouse analog of the B-group Ad receptor, CD46, is expressed only in the testis, whereas in humans, CD46 is expressed on all nucleated cells. Unlike mice, baboons have CD46 expression patterns and levels that closely mimic those in humans. We conducted a biodistribution and toxicity study of group B Ad fiber-containing vectors in baboons. Animals received phosphate-buffered saline, Ad5-bGal (a first-generation Ad5 vector), or B-group fiber-containing Ads (Ad5/35-bGal and Ad5/11-bGal) at a dose of 2 × 1012 VP/kg, and vector biodistribution and safety was analyzed over 3 days. The amount of Ad5/35-bGal and Ad5/11-bGal vector genomes was in most tissues one to three orders of magnitude below that of Ad5. Significant Ad5/35- and Ad5/11-mediated transgene (β-galactosidase) expression was seen only in the marginal zone of splenic follicles. Compared with the animal that received Ad5-bGal, all animals injected with B-group fiber-containing Ad vectors had lower elevations in serum proinflammatory cytokine levels. Gross and histopathology were normal in animals that received B-group Ad fiber-containing Ads, in contrast to the Ad5-infused animal, which showed widespread endothelial damage and inflammation. In a further study, a chimeric Ad5/35 vector carrying proapoptotic TRAIL and Ad E1A genes under tumor-specific regulation was well tolerated in a 30-day toxicity study. No major clinical, serologic, or pathologic abnormalities were noticed in

Efficacy and Safety of Intravesical OnabotulinumtoxinA Injection in Patients with Detrusor Hyperactivity and Impaired Contractility

PubMed Central

Wang, Chung-Cheng; Lee, Cheng-Ling; Kuo, Hann-Chorng

2016-01-01

We investigated the efficacy and safety of intravesical onabotulinumtoxinA injection in patients with detrusor hyperactivity and impaired contractility (DHIC). Twenty-one patients with urodynamically proven DHIC and 21 age-matched patients with overactive bladder (OAB) with urodynamic detrusor overactivity were treated with intravesical injections of 100 U of onabotulinumtoxinA. The overactive bladder symptom score, urgency severity score, patient perception of bladder condition, global response assessment, voiding diary, and procedure-related adverse events (AE) at baseline, two weeks, one, three, and six months after treatment were assessed. The results showed that the subjective symptom scores improved significantly in both groups, and the scores did not differ between the groups. The decrease in urgency episodes and urgency urinary incontinence were noted in OAB patients but not in DHIC patients. Although the incidence of AEs was comparable between the groups, the therapeutic efficacy lasted for a mean of 4.9 ± 4.8 months in DHIC patients and 7.2 ± 3.3 months in OAB patients (p = 0.03). We concluded that the efficacy of intravesical onabotulinumtoxinA injection for DHIC patients was limited and short-term. Nevertheless, AEs did not increase in DHIC. Intravesical onabotulinumtoxinA might not be a good indication in patients with DHIC and high post-voiding residual urine. Physicians should inform patients of the potential benefits and risks of onabotulinumtoxinA injection for treatment of DHIC. PMID:26999209

Safety evaluation of poly(lactic-co-glycolic acid)/poly(lactic-acid) microspheres through intravitreal injection in rabbits.

PubMed

Rong, Xianfang; Yuan, Weien; Lu, Yi; Mo, Xiaofen

2014-01-01

Poly(lactic-co-glycolic acid) (PLGA) and/or poly(lactic-acid) (PLA) microspheres are important drug delivery systems. This study investigated eye biocompatibility and safety of PLGA/PLA microspheres through intravitreal injection in rabbits. Normal New Zealand rabbits were randomly selected and received intravitreal administration of different doses (low, medium, or high) of PLGA/PLA microspheres and erythropoietin-loaded PLGA/PLA microspheres. The animals were clinically examined and sacrificed at 1, 2, 4, 8, and 12 weeks postadministration, and retinal tissues were prepared for analysis. Retinal reactions to the microspheres were evaluated by terminal deoxynucleotidyl transferase-mediated dUTP nick end staining and glial fibrillary acidic protein immunohistochemistry. Retinal structure changes were assessed by hematoxylin and eosin staining and transmission electron microscopy. Finally, retinal function influences were explored by the electroretinography test. Terminal deoxynucleotidyl transferase-mediated dUTP nick end staining revealed no apoptotic cells in the injected retinas; immunohistochemistry did not detect any increased glial fibrillary acidic protein expression. Hematoxylin and eosin staining and transmission electron microscopy revealed no micro- or ultrastructure changes in the retinas at different time points postintravitreal injection. The electroretinography test showed no significant influence of scotopic or photopic amplitudes. The results demonstrated that PLGA/PLA microspheres did not cause retinal histological changes or functional damage and were biocompatible and safe enough for intravitreal injection in rabbits for controlled drug delivery.

Efficacy and safety of point-of-care ultrasound-guided intra-articular corticosteroid joint injections in patients with haemophilic arthropathy.

PubMed

Martin, E J; Cooke, E J; Ceponis, A; Barnes, R F W; Moran, C M; Holle, S; Hughes, T H; Moore, R E; von Drygalski, A

2017-01-01

Intra-articular corticosteroid injections are standard of care for managing joint pain secondary to osteoarthritis or rheumatoid arthritis but are rarely used in haemophilic arthropathy. We have introduced and evaluated the efficacy and safety of ultrasound-guided corticosteroid injections for pain relief in patients with haemophilic arthropathy. Ultrasound-guided intra-articular injections performed on haemophilia patients at UCSD between March 2012 and January 2016 were analysed. Needle placement and injection (40 mg triamcinolone; 3-5 mL lidocaine) were performed with musculoskeletal ultrasound and Power Doppler. Analysis included patient demographics, joint-specific parameters such as tissue hypervascularity and effusions, pain relief, and procedure-associated complications. Forty-five injections (14 ankles, 13 elbows, 18 knees) were administered in 25 patients. Advanced arthropathy with hypervascularity and/or effusions was present in 91% and 61% of joints, respectively. Ninety-one per cent of injections resulted in pain relief which was significant in 84% (>30% reduction). Median pain score was reduced from 7 of 10 to 1 of 10 (P < 0.001), usually within 24 h. Median duration of pain relief was 8 weeks (range 1-16 weeks). Haemophilia B patients experienced longer periods of relief, and high Pettersson scores were associated with shorter duration of relief. There were no procedure-associated complications. Repeat ultrasound of eight joints within 4 weeks of injection demonstrated nearly complete resolution of hypervascularity. Point-of-care ultrasound enabled intra-articular corticosteroid injections that provided highly effective, safe, and relatively long-lasting pain relief in haemophilic arthropathy. This approach should be used to improve pain management in haemophilic arthropathy. © 2016 John Wiley & Sons Ltd.

The Efficacy and Safety of Concurrent Collagenase Clostridium Histolyticum Injections for 2 Dupuytren Contractures in the Same Hand: A Prospective, Multicenter Study.

PubMed

Gaston, R Glenn; Larsen, Søren Erik; Pess, Gary M; Coleman, Stephen; Dean, Brian; Cohen, Brian M; Kaufman, Gregory J; Tursi, James P; Hurst, Lawrence C

2015-10-01

To evaluate efficacy and safety of concurrent administration of 2 collagenase clostridium histolyticum (CCH) injections to treat 2 joints in the same hand with Dupuytren fixed flexion contractures (FFCs). Patients with 2 or more contractures in the same hand caused by palpable cords participated in a 60-day, multicenter, open-label, phase 3b study. Two 0.58 mg CCH doses were injected into 1 or 2 cords in the same hand (1 injection per affected joint) during the same visit. Finger extension was performed approximately 24, 48, or 72 or more hours later. Changes in FFC and range of motion, incidence of clinical success (FFC ≤ 5°), and adverse events (AEs) were summarized. The study enrolled 715 patients (725 treated joint pairs), and 714 patients (724 joint pairs) were analyzed for efficacy. At day 31, mean total FFC (sum of 2 treated joints) decreased 74%, from 98° to 27°. Mean total range of motion increased from 90° to 156°. The incidence of clinical success was 65% in metacarpophalangeal joints and 29% in proximal interphalangeal joints. Most treatment-related AEs were mild to moderate, resolving without intervention; the most common were swelling of treated extremity, contusion, and pain in extremity. The incidence of skin lacerations was 22% (160 of 715). Efficacy and safety were similar regardless of time to finger extension. Collagenase clostridium histolyticum can be used to effectively treat 2 affected joints concurrently without a greater risk of AEs than treatment of a single joint, with the exception of skin laceration. The incidence of clinical success in this study after 1 injection per joint was comparable to phase 3 study results after 3 or more injections per joint. Two concurrent CCH injections may allow more rapid overall treatment of multiple affected joints, and the ability to vary the time between CCH injection and finger extension may allow physicians and patients greater flexibility with scheduling treatment. Copyright © 2015 American

Efficacy and safety of injection with poly-L-lactic acid compared with hyaluronic acid for correction of nasolabial fold: a randomized, evaluator-blinded, comparative study.

PubMed

Hyun, M Y; Lee, Y; No, Y A; Yoo, K H; Kim, M N; Hong, C K; Chang, S E; Won, C H; Kim, B J

2015-03-01

Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles. To compare the efficacy and safety of a novel injectable poly-L-lactic acid (PLA) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds. In this multicentre, randomized, evaluator-blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events. At week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases. PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds. © 2014 British Association of Dermatologists.

[Safety and effectiveness of large dose compound Sophora flavescens Ait injection in the treatment of advanced malignant tumors].

PubMed

Li, Dao-rui; Lin, Hong-sheng

2011-04-01

To evaluate the effectiveness and safety of large dose compound Sophora flavescens Ait injection in the treatment of advanced malignant tumors. A non-randomized case control trial was conducted. Ninety six patients with pathologically confirmed advanced non-small-cell lung cancer, gastric cancer and colorectal cancer were divided into traditional Chinese medicine group and chemotherapy group, 48 cases each. Patients of the traditional Chinese medicine group received treatment with large dose of compound Sophora flavescens Ait injection (20 ml/d), and 21 days as a cycle. Forty-seven patients of the traditional Chinese medicine group and 46 patients of the chemotherapy group completed their treatment, respectively. The clinical benefit rate (CBR) in the traditional Chinese medicine group was 83.0%, significantly higher than that in the chemotherapy group (69.6%) (P < 0.01). The Karnofsky performance status and weight improvement in the traditional Chinese medicine group was superior to that in the chemotherapy group (P < 0.05). Except the skin irritation in one patient in the traditional Chinese medicine group, there were no other clinical adverse effects related with the large dose compound Sophora flavescens Ait injection. Large dose compound Sophora flavescens Ait injection in the treatment of advanced malignant tumors is safe and effective. The recommended dose is 20 ml/d.

Intrathecal Spread of Injectate Following an Ultrasound-Guided Selective C5 Nerve Root Injection in a Human Cadaver Model.

PubMed

Falyar, Christian R; Abercrombie, Caroline; Becker, Robert; Biddle, Chuck

2016-04-01

Ultrasound-guided selective C5 nerve root blocks have been described in several case reports as a safe and effective means to anesthetize the distal clavicle while maintaining innervation of the upper extremity and preserving diaphragmatic function. In this study, cadavers were injected with 5 mL of 0.5% methylene blue dye under ultrasound guidance to investigate possible proximal and distal spread of injectate along the brachial plexus, if any. Following the injections, the specimens were dissected and examined to determine the distribution of dye and the structures affected. One injection revealed dye extended proximally into the epidural space, which penetrated the dura mater and was present on the spinal cord and brainstem. Dye was noted distally to the divisions in 3 injections. The anterior scalene muscle and phrenic nerve were stained in all 4 injections. It appears unlikely that local anesthetic spread is limited to the nerve root following an ultrasound-guided selective C5 nerve root injection. Under certain conditions, intrathecal spread also appears possible, which has major patient safety implications. Additional safety measures, such as injection pressure monitoring, should be incorporated into this block, or approaches that are more distal should be considered for the acute pain management of distal clavicle fractures.

Long-term efficacy and safety of self-intracavernous injection of prostaglandin E1 for treatment of erectile dysfunction in China.

PubMed

He, L; Wen, J; Jiang, X; Chen, H; Tang, Y

2011-06-01

The study evaluated the long-term efficacy and safety profiles of self-intracavernous injection of prostaglandin E1 (PGE1) for erectile dysfunction (ED). Four hundred and sixteen ED patients were treated with self-intracavernous injection of PGE1 from January 1998 to December 2007 in our outpatient service. Follow-up was made to investigate the efficacy and side effects of this treatment. It was found that 261 patients (62.7%) felt satisfied and kept using this treatment due to its advantages of satisfactory efficacy and reasonable expense. Twenty-seven of them (6.5%) got rid of PGE1 treatment after five times injections and did not need any other drugs to maintain satisfactory sexual lives. Two hundred and fourteen (51.4%) patients kept using this treatment for over 1 year, 26 (6.2%) over 5 years, 12 (2.9%) over 8 years and 7 (1.7%) over 10 years. The major complications of self-intracavernous injection of PGE1 include fibrosis of corpus cavernosum (three cases), ecchymosis associated with vascular injury due to injection (23 cases) and pain associated with injection (295 cases). There were no patients displaying priapism. It is concluded that self-intracavernous injection of PGE1 is a safe and effective treatment for ED with various aetiologies and a broad range of severity, and no serious complications were observed after long-term application. © 2011 Blackwell Verlag GmbH.

Inferior or double joint spaces injection versus superior joint space injection for temporomandibular disorders: a systematic review and meta-analysis.

PubMed

Li, Chunjie; Zhang, Yifan; Lv, Jun; Shi, Zongdao

2012-01-01

To compare the effect and safety of inferior or double temporomandibular joint spaces drug injection versus superior temporomandibular joint space injection in the treatment of temporomandibular disorders. MEDLINE (via Ovid, 1948 to March 2011), CENTRAL (Issue 1, 2011), Embase (1984 to March 2011), CBM (1978 to March 2011), and World Health Organization International Clinical Trials Registry Platform were searched electronically; relevant journals as well as references of included studies were hand-searched for randomized controlled trials comparing effect or safety of inferior or double joint spaces drug injection technique with those of superior space injection technique. Risk of bias assessment with the tool recommended by Cochrane Collaboration, reporting quality assessment with CONSORT and data extraction, were carried out independently by 2 reviewers. Meta-analysis was delivered with RevMan 5.0.23. Four trials with 349 participants were included. All the included studies had moderate risk of bias. Meta-analysis showed that inferior or double spaces injection technique could significantly increase 2.88 mm more maximal mouth opening (P = .0001) and alleviate pain intensity in the temporomandibular area on average by 9.01 mm visual analog scale scores (P = .0001) compared with superior space injection technique, but could not markedly change synthesized clinical index (P = .05) in the short term; nevertheless, they showed more beneficial maximal mouth opening (P = .002), pain relief (P < .0001), and synthesized clinical variable (P < .0001) in the long term than superior space injection. No serious adverse events were reported. Inferior or double temporomandibular joint spaces drug injection technique shows better effect than superior space injection technique, and their safety is affirmative. However, more high-quality studies are still needed to test and verify the evidence. Crown Copyright © 2012. Published by Elsevier Inc. All rights reserved.

Fexapotide triflutate: results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement.

PubMed

Shore, Neal; Tutrone, Ronald; Efros, Mitchell; Bidair, Mohamed; Wachs, Barton; Kalota, Susan; Freedman, Sheldon; Bailen, James; Levin, Richard; Richardson, Stephen; Kaminetsky, Jed; Snyder, Jeffrey; Shepard, Barry; Goldberg, Kenneth; Hay, Alan; Gange, Steven; Grunberger, Ivan

2018-05-01

These studies were undertaken to determine if fexapotide triflutate 2.5 mg transrectal injectable (FT) has significant long-term (LT) safety and efficacy for the treatment of benign prostatic hyperplasia (BPH). Two placebo controlled double-blind randomized parallel group trials with 995 BPH patients at 72 sites treated 3:2 FT:placebo, with open-label FT crossover (CO) re-injection in 2 trials n = 344 and long-term follow-up (LF) 2-6.75 years (mean 3.58 years, median 3.67 years; FT re-injection CO mean 4.27 years, median 4.42 years) were evaluated. 12 months post-treatment patients elected no further treatment, approved oral medications, FT, or interventional treatment. Primary endpoint variable was change in Symptom Score (IPSS) at 12 months and at LF. CO primary co-endpoints were 3-year incidence of (1) surgery for BPH in FT treated CO patients versus patients crossed over to oral BPH medications and (2) surgery or acute urinary retention in FT-treated CO placebo patients versus placebo patients crossed over to oral BPH medications. 28 CO secondary endpoints assessed surgical and symptomatic outcomes in FT reinjected patients versus conventional BPH medication CO and control subgroups at 2 and 3 years. FT injection had no significant safety differences from placebo. LF IPSS change from baseline was higher in FT treated patients compared to placebo (median FT group improvement - 5.2 versus placebo - 3.0, p < 0.0001). LF incidence of AUR (1.08% p = 0.0058) and prostate cancer (PCa) (1.1% p = 0.0116) were both reduced in FT treated patients. LF incidence of intervention for BPH was reduced in the FT group versus oral BPH medications (8.08% versus 27.85% at 3 years, p < 0.0001). LF incidence of intervention or AUR in placebo CO group with FT versus placebo CO group with oral medications was reduced (6.07% versus 33.3% at 3 years, p < 0.0001). 28/28 secondary efficacy endpoints were reached in LF CO re-injection studies. FT 2.5 mg is a safe

Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren contracture: report of 40 cases.

PubMed

Alberton, F; Corain, M; Garofano, A; Pangallo, L; Valore, A; Zanella, V; Adani, R

2014-12-01

Dupuytren's disease (DD) is a fibroproliferative pathology that affects the palmar aponeurosis causing the development of nodules and collagen cords and the progressive flexion of the fingers. The standard procedure is surgical fasciectomy, followed by high recurrence rates. Collagenase Clostridium histolyticum (CCH) injection represents an innovative noninvasive approach to the treatment of DD. This prospective study was designed to examine the efficacy and safety of CCH injection performed in the outpatient, using local anesthesia. Forty patients [32 metacarpophalangeal (MP), 8 proximal interphalangeal (PIP)] with Dupuytren's contracture of at least 20° for MP joint and any degree for PIP joint were included. The mean age was 66. All joints were treated with a single vial of collagenase injection and manual breaking of the cord 24 h after. All adverse effects (AEs) were monitored. Patients were checked 7, 30, 90, and 180 days after the injection. Primary endpoint was a reduction in digit contracture within 0°-5° of normal extension. Secondary endpoints were the improvement of range of motion, the evaluation of AEs incidence, and cost-effectiveness of collagenase treatment. About 67.5 % of patients obtained a clinical success. At 6 months, a further 7.5% attained the same result. The mean contracture of treated joints was 5.3º for MP and 6.8° for PIP joints. Twenty-three patients had one or more mild-to-moderate side effects. The use of collagenase appears to be an effective and safe method for the treatment of Dupuytren's contracture. Therapeutic success was achieved in a significant percentage of patients. The incidence of side effects was higher, but they were local reactions of short duration. The use of a single collagenase vial in patients treated in day surgery appears more cost-effective than surgery.

Early Botulinum Toxin Injections in Infants With Musculoskeletal Disorders: A Systematic Review of Safety and Effectiveness.

PubMed

Bourseul, Jean-Sébastien; Molina, Anais; Lintanf, Mael; Houx, Laetitia; Chaléat-Valayer, Emmanuelle; Pons, Christelle; Brochard, Sylvain

2018-06-01

To report current evidence regarding the safety of intramuscular botulinum toxin injection (BTI) in children with orthopedic- and neurologic-related musculoskeletal disorders >2 years of age. PubMed, Cochrane Library, and ScienceDirect, Google Scholar, and Web of Science. Two reviewers independently selected studies based on predetermined inclusion criteria. Data relating to the aim were extracted. Methodologic quality was graded independently by 2 reviewers using the Physiotherapy Evidence Database scale for randomized controlled trials (RCTs) and the Downs and Black evaluation tool for non-RCTs. Level of evidence was determined using the modified Sackett scale. Data of 473 infants were analyzed. Fifty-five infants had cerebral palsy, 112 had obstetric brachial plexus palsy, 257 had clubfoot, and 44 had congenital torticollis. No studies reported any severe adverse event that could be attributed to the BTI. The rate of mild to moderate adverse events reported varied from 5% to 25%. Results regarding efficacy were preliminary, dependent on the pathology, and limited by the small number of studies and their low levels of evidence. BTI is already widely used as an early treatment for this age group. The safety profile of BTI in infants appears similar to that of older children and risks appear more related to the severity of the pathology and the location of the injections than to the toxin itself. Regarding effectiveness, other studies with higher levels of evidence should be carried out for each specific pathology. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Subcutaneous injections: preventing needlestick injuries in the community.

PubMed

Aziz, Ann-Marie

2012-06-01

Community nurses provide care to patients in a variety of settings, for example health centres, community hospitals, patients' homes, residential and nursing homes. Administering subcutaneous injections to patients in the community is an everyday activity for many nurses in clinical practice. Many problems related to being 'sharps safe' are common to both community nurses and hospital staff. The majority of subcutaneous injections administered in the community are for patients with diabetes. Reducing needlestick injuries after the administration of subcutaneous injections in the community remains paramount to all NHS staff. This article provides information on what national standards to employ when administrating subcutaneous injections and what safety practices should be undertaken for good sharps management. Staff administering subcutaneous injections in the community need to ensure that they are updated on the latest developments in safety needle devices in order to prevent needlestick injuries and provide safe, effective and individualised care for their patients.

Evaluation of safety in clinical use of generic paclitaxel [NK] for injection.

PubMed

Tsukiyama, Ikuto; Hotta, Kazuo; Takeuchi, Masayuki; Onishi, Masahumi; Toyama, Yukio; Saito, Hiroko; Sai, Yoshimichi; Miyamoto, Ken-Ichi; Hasegawa, Takaaki

2012-04-01

The introduction of generic drugs is a favored strategy in reducing medical costs, but some clinicians are often reluctant to use them because of lack of information with regard to their side effects. Generic paclitaxel [NK] differs from the proprietary version, Taxol®, in containing added citric acid and a more pure form of castor oil. However, little information exists regarding the effects of these additives on adverse events such as vascular pain, phlebitis, hypersensitivity and hepatic dysfunction. To compensate for this lack of information and to validate the safety of using generic paclitaxel, we investigated adverse events in response to generic paclitaxel [NK]. Our investigation focused on patients treated with both the proprietary formulation (Taxol® for injection) and the generic version(paclitaxel [NK] for injection)sequentially from April 2008 to March 2009. Adverse events were investigated retrospectively. Incidence of vascular pain, phlebitis and hypersensitivity was similar to that with the original product. Although the expression of some liver enzymes was slightly increased and some gastrointestinal events were reduced following generic paclitaxel [NK] treatment there was no statistically significant difference. The profiles of other adverse events were not significantly different. Increased vascular pain and phlebitis, predicted due to low pH conditions caused by citric acid, were not observed. Similarly, the pure castor oil included in generic paclitaxel [NK] did not influence hypersensitivity and hepatic function. We found no significant differences in our study of proprietary and generic paclitaxel [NK]. Thus, clinicians have no reason for prejudice against using generic paclitaxel [NK] on the basis of increased risk of side effects.

Profiling safety of intravitreal injections for retinoblastoma using an anti-reflux procedure and sterilisation of the needle track.

PubMed

Munier, Francis L; Soliman, Sameh; Moulin, Alexandre P; Gaillard, Marie-Claire; Balmer, Aubin; Beck-Popovic, Maja

2012-08-01

The preservation of globe integrity has always been a major concern during the treatment of retinoblastoma for fear of extraocular or metastatic spread. Intravitreal chemotherapy has been attempted as a desperate salvage therapy only for eyes with refractory retinoblastoma. Published data on the safety and efficacy of this route are, however, limited. A modified technique of intravitreal injection in eyes with retinoblastoma is described. All children with retinoblastoma who received one or more intravitreal injections using this technique were retrospectively reviewed concerning ocular complications of the injection procedure as well as clinical or histopathological evidence of tumour spread. 30 eyes of 30 children with retinoblastoma received a total of 135 intravitreal injections, with a median follw-up duration of 13.5 months. No extraocular spread was seen on clinical follow-up in any patients and there was no tumour contamination of the retrieved entry sites histopathologically analysed among the five enucleated eyes. No significant ocular side effects were observed except transient localised vitreous haemorrhage (3/135). This technique is potentially safe and effective at a low cost and may play a promising role, especially in the treatment of recurrent and/or resistant vitreous disease in retinoblastoma, as an alternative to enucleation and/or external beam radiotherapy. However, this treatment should not replace the primary standard of care of retinoblastoma and should not be considered in group E eyes. Its application should be approved by an ophthalmological-oncological team and it should be performed by an experienced eye surgeon in a tertiary referral centre after careful selection of a tumour-free injection site.

Industrial-grade silicone injections causing intermittent bilateral malar swelling: review of safety and efficacy of techniques and products available.

PubMed

Seward, Austin C; Meara, Daniel J

2013-07-01

Silicone and other fillers have become a popular aid to increase soft tissue density, decrease static skin rhytids, and treat muscle wasting, particularly in the face. As a result, injectable silicone has become popular in patients with the human immunodeficiency virus (HIV). It has been postulated that highly active antiretroviral therapy detrimentally induces the physiologic process of fat atrophy of the temporal and buccal fat pads of the face and regional fat wasting of the arms, legs, and buttocks and that HIV protease inhibitors may induce fat atrophy by binding and inhibiting homologous human proteins that are involved in fat metabolism. The classic hollowed-out facial appearance linked to HIV positivity can have detrimental social implications in infected patients who are otherwise very functional. In consequence, facial implantation, fat transplantation, and dermal and subcutaneous fillers have been used to aid in the restoration of facial appearance. This report describes the case of a patient who underwent multiple rounds of silicone injections and complained of intermittent facial swelling and pain long after the injections. The authors report on the safety of specific medical-grade injectable fillers and techniques found to be safely effective, especially in the HIV-positive population. Copyright © 2013 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

[Developing traditional Chinese medicine injection is the need for curing sickness to save patients].

PubMed

He, Ping; Li, Feng-Jie; Li, Lian-da; Li, Yi-Kui

2017-03-01

Safety issues of traditional Chinese medicine injections has been heated debate. There are two diametrically opposed views: it should be used reasonable and developed healthily or be forbidden to use. Some people have many misunderstandings and prejudices about the safety of traditional Chinese medicine injections. Compared with western medicine,traditional Chinese medicine has its own particularity. Traditional Chinese medicine has complex components. Its research and clinical application is different from western medicine. Adverse reactions of traditional Chinese medicine injections are related to many factors,such as a large number of irrational use,blind use of traditional Chinese medicine injections and western medicine injections,counterfeit and substandard drugs,incorrect methods of intravenous infusion,toxicity of supplementary materials,drug ingredients. Developing traditional Chinese medicine injection is the need for curing sickness to save patients. The purposeful, targeted, organized and planned systematic research of traditional Chinese medicine injections should be strengthened,especially the safety of traditional Chinese medicine. Strengthen supervision and control of rational drug use.Strengthen the examination and approval,supervision and management of all aspects to ensure the safety of patients. Copyright© by the Chinese Pharmaceutical Association.

77 FR 16036 - Determination That CITANEST (Prilocaine Hydrochloride) Injection, 1%, 2%, and 3%, and CITANEST...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

... marketing for reasons other than safety or effectiveness. ANDAs that refer to CITANEST (prilocaine HCl... Hydrochloride) Injection, 4%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food... (prilocaine HCl) Injection, 4%, were not withdrawn from sale for reasons of safety or effectiveness. This...

Efficacy and safety of collagenase clostridium histolyticum injection for Dupuytren contracture: short-term results from 2 open-label studies.

PubMed

Witthaut, Jörg; Jones, Graeme; Skrepnik, Nebojsa; Kushner, Harvey; Houston, Anthony; Lindau, Tommy R

2013-01-01

The JOINT I (United States) and JOINT II (Australia and Europe) studies evaluated the efficacy and safety of collagenase clostridium histolyticum (CCH) injection for the treatment of Dupuytren contracture. Both studies used identical open-label protocols. Patients with fixed-flexion contractures of metacarpophalangeal (MCP) (20° to 100°) or proximal interphalangeal (PIP) joints (20° to 80°) could receive up to three 0.58-mg CCH injections per cord (up to 5 total injections per patient). We performed standardized finger extension procedures to disrupt injected cords the next day, with follow-up 1, 2, 6, and 9 months thereafter. The primary end point (clinical success) was reduction in contracture to within 0° to 5° of full extension 30 days after the last injection. Clinical improvement was defined as 50% or more reduction from baseline contracture. Dupuytren cords affecting 879 joints (531 MCP and 348 PIP) in 587 patients were administered CCH injections at 14 U.S. and 20 Australian/European sites, with similar outcomes in both studies. Clinical success was achieved in 497 (57%) of treated joints using 1.2 ± 0.5 (mean ± SD) CCH injections per cord. More MCP than PIP joints achieved clinical success (70% and 37%, respectively) or clinical improvement (89% and 58%, respectively). Less severely contracted joints responded better than those more severely contracted. Mean change in contracture was 55° for MCP joints and 25° for PIP joints. With average contracture reductions of 73% and improvements in range of motion by 30°, most patients (92%) were "very satisfied" (71%) or "quite satisfied" (21%) with treatment. Physicians rated change from baseline as "very much improved" (47%) or "much improved" (35%). The CCH injections were well tolerated, causing no tendon ruptures or systemic reactions. Collagenase clostridium histolyticum was an effective, minimally invasive option for the treatment of Dupuytren contracture of a broad range of severities. Most

Rapid assessment of injection practices in Cambodia, 2002

PubMed Central

Vong, Sirenda; Perz, Joseph F; Sok, Srun; Som, Seiharath; Goldstein, Susan; Hutin, Yvan; Tulloch, James

2005-01-01

Background Injection overuse and unsafe injection practices facilitate transmission of bloodborne pathogens such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Anecdotal reports of unsafe and unnecessary therapeutic injections and the high prevalence of HBV (8.0%), HCV (6.5%), and HIV (2.6%) infection in Cambodia have raised concern over injection safety. To estimate the magnitude and patterns of such practices, a rapid assessment of injection practices was conducted. Methods We surveyed a random sample of the general population in Takeo Province and convenience samples of prescribers and injection providers in Takeo Province and Phnom Penh city regarding injection-related knowledge, attitudes, and practices. Injection providers were observed administering injections. Data were collected using standardized methods adapted from the World Health Organization safe injection assessment guidelines. Results Among the general population sample (n = 500), the overall injection rate was 5.9 injections per person-year, with 40% of participants reporting receipt of ≥ 1 injection during the previous 6 months. Therapeutic injections, intravenous infusions, and immunizations accounted for 74%, 16% and 10% of injections, respectively. The majority (>85%) of injections were received in the private sector. All participants who recalled their last injection reported the injection was administered with a newly opened disposable syringe and needle. Prescribers (n = 60) reported that 47% of the total prescriptions they wrote included a therapeutic injection or infusion. Among injection providers (n = 60), 58% recapped the syringe after use and 13% did not dispose of the used needle and syringe appropriately. Over half (53%) of the providers reported a needlestick injury during the previous 12 months. Ninety percent of prescribers and injection providers were aware HBV, HCV, and HIV were transmitted through unsafe injection practices

Are nursing students safe when choosing gluteal intramuscular injection locations?

PubMed

Cornwall, J

2011-01-01

Nurses are required to perform gluteal intramuscular (IM) injections in practice. There are dangers associated with erroneous performance of this task, particularly with dorsogluteal injections. Knowledge regarding safe injection practice is therefore vital for nursing students. Fifty-eight second year students at a New Zealand Nursing School were given schematic drawings of the posterior and lateral aspects of the gluteal region. They were asked to mark and justify the safest location for gluteal IM injections. Fifty-seven students marked the dorsal schematic and one the lateral, with 38 (66.7%) marking in the upper outer quadrant (UOQ). Twenty indicating the UOQ (52.6%) wrote 'sciatic' or 'nerve' in justifying their location. Nineteen (33.3%) marked a location outside the UOQ; nine (47.4%) of these mentioned 'sciatic' or 'nerve' as reasons for injection safety. Overall, 50% of students mentioned 'sciatic' or 'nerve' in justifying the safety of their chosen injection location. Results suggest some second year nursing students do not understand safe gluteal IM injection locations and rationale. Current teaching practices and IM injection techniques could be revisited to prepare students more effectively; this may help prevent pathologies arising from this procedure.

Efficacy and Safety of Levosulpiride Versus Haloperidol Injection in Patients With Acute Psychosis: A Randomized Double-Blind Study.

PubMed

Lavania, Sagar; Praharaj, Samir Kumar; Bains, Hariender Singh; Sinha, Vishal; Kumar, Abhinav

2016-01-01

Injectable antipsychotics are frequently required for controlling agitation and aggression in acute psychosis. No study has examined the use of injectable levosulpiride for this indication. To compare the efficacy and safety of injectable levosulpiride and haloperidol in patients with acute psychosis. This was a randomized, double-blind, parallel-group study in which 60 drug-naive patients having acute psychosis were randomly assigned to receive either intramuscular haloperidol (10-20 mg/d) or levosulpiride (25-50 mg/d) for 5 days. All patients were rated on Brief Psychiatric Rating Scale (BPRS), Overt Agitation Severity Scale (OASS), Overt Aggression Scale-Modified (OAS-M) scores, Simpson Angus Scale (SAS), and Barnes Akathisia Rating Scale (BARS). Repeated-measures ANOVA for BPRS scores showed significant effect of time (P < 0.001) and a trend toward greater reduction in scores in haloperidol group as shown by group × time interaction (P = 0.076). Repeated-measures ANOVA for OASS showed significant effect of time (P < 0.001) but no group × time interaction. Repeated-measures ANOVA for OAS-M scores showed significant effect of time (P < 0.001) and greater reduction in scores in haloperidol group as shown by group × time interaction (P = 0.032). Lorazepam requirement was much lower in haloperidol group as compared with those receiving levosulpiride (P = 0.022). Higher rates of akathisia and extrapyramidal symptoms were noted in the haloperidol group. Haloperidol was more effective than levosulpiride injection for psychotic symptoms, aggression, and severity of agitation in acute psychosis, but extrapyramidal adverse effects were less frequent with levosulpiride as compared with those receiving haloperidol.

Safety and efficacy of intravitreal injection of recombinant erythropoietin for protection of photoreceptor cells in a rat model of retinal detachment

PubMed Central

Xie, Z; Chen, F; Wu, X; Zhuang, C; Zhu, J; Wang, J; Ji, H; Wang, Y; Hua, X

2012-01-01

Purpose To elucidate the safety and efficacy of exogenous erythropoietin (EPO) for the protection of photoreceptor cells in a rat model of retinal detachment (RD). Methods Recombinant rat EPO (400 ng) was injected into the vitreous cavity of normal rats to observe the eye manifestations. Retinal function was assessed by flash electroretinograms. Histopathological examination of retinal tissue was performed at 14 days and 2 months after injection, respectively. To investigate the inhibitory effect of EPO on photoreceptor cell apoptosis in RD rats, 100, 200, or 400 ng EPO was injected into the vitreous cavity immediately after RD model establishment. Apoptosis of photoreceptor cells was determined at 3 days after injection. Caspase-3 activation was measured by western blot analysis and immunofluorescence, respectively, and the level of Bcl-XL expression was analyzed by western blot. Results Intravitreal injection of EPO 400 ng into normal rats had no significant impact on retinal function, morphology, or structure. Apoptosis of retinal photoreceptor cells apparently increased after RD and was significantly reduced following EPO treatment. The thickness of the outer nuclear layer in the RD+400 ng group was significantly thicker than that in other experimental RD groups both at 14 days and at 2 months after RD (P<0.05). Western blot and immunofluorescence analyses showed decreased caspase-3 activation and increased Bcl-XL expression following EPO treatment. Conclusion Intravitreal injection of EPO 400 ng is safe, and EPO may suppress caspase-3 activation and enhance Bcl-XL expression, resulting in inhibition of apoptosis and protection of photoreceptor cells. PMID:22020175

A protocol for the retina surgeon's safe initial intravitreal injections.

PubMed

Frenkel, Ronald E P; Haji, Shamim A; La, Melvin; Frenkel, Max P C; Reyes, Angela

2010-11-10

To determine the safety of a surgeon's initial consecutive intravitreal injections using a specific protocol and to review the complications that may be attributed to the injection procedure. A retrospective chart review. Fifty-nine patients (30 females, 29 males) received intravitreal injections of pegaptanib, bevacizumab, or ranibizumab as part of their treatment for neovascular age-related macular degeneration. The average patient age was 80 years. Twenty-two patients were diagnosed with or suspected of having glaucoma. Each patient received an average of 5.8 injections. The charts of 59 patients who received a total of 345 intravitreal injections (104 pegaptanib, 74 bevacizumab, 167 ranibizumab) were reviewed. All injections were performed in an office-based setting. Povidone-iodine, topical antibiotics, and eye speculum were used as part of the pre injection procedure. Vision and intraocular pressure were evaluated immediately following each injection. Incidence of post injection complications, including but not limited to endophthalmitis, retinal detachment, traumatic cataract, and vitreous hemorrhage. There were no cases of endophthalmitis, toxic reactions, traumatic cataracts, retinal detachment, or vitreous hemorrhage. There was one case each of lid swelling, transient floaters, retinal pigment epithelial tear, corneal edema, and corneal abrasion. There were five cases of transient no light perception following pegaptanib injections. The incidence of serious complications was very low for the intravitreal injections given. A surgeon's initial intravitreal injections may be performed with a very high degree of safety using this protocol.

Assessment of the efficacy and safety of single platelet-rich plasma injection on different types and grades of facial wrinkles.

PubMed

Elnehrawy, Naema Y; Ibrahim, Zeinab A; Eltoukhy, Azza M; Nagy, Hala M

2017-03-01

Platelet-rich plasma (PRP) is considered as a growing modality for tissue regeneration and a developing research area for clinicians and researchers. PRP injection treatment provides supraphysiological concentrations of growth factors that may help in accelerated tissue remodeling and regeneration. To evaluate the efficacy and safety of single autologous PRP intradermal injection for treatment of facial wrinkles and for facial rejuvenation. A total of 20 subjects with different types of facial wrinkles were included in this study. All subjects received single PRP intradermal injection and were clinically assessed before and after treatment for a period of 8 weeks using Wrinkle Severity Rating Scale (WSRS), Skin Homogeneity and Texture (SHnT) Scale, Physician Assessment Scale, and Subject Satisfaction Scale. The mean value of WSRS reduced from 2.90 ± 0.91 before treatment to 2.10 ± 0.79 after 8 weeks of treatment. The most significant results were with younger subjects that have mild and moderate wrinkles of the nasolabial folds (NLFs). Fourteen of seventeen subjects with NLFs showed more than 25% improvement in their appearance. Side effects of PRP treatment were minimal to mild and with excellent tolerability. Single PRP intradermal injection is well tolerated and capable of rejuvenating the face and producing a significant correction of wrinkles especially the NLFs. © 2016 Wiley Periodicals, Inc.

Uncovering high rates of unsafe injection equipment reuse in rural Cameroon: validation of a survey instrument that probes for specific misconceptions

PubMed Central

2011-01-01

Background Unsafe reuse of injection equipment in hospitals is an on-going threat to patient safety in many parts of Africa. The extent of this problem is difficult to measure. Standard WHO injection safety assessment protocols used in the 2003 national injection safety assessment in Cameroon are problematic because health workers often behave differently under the observation of visitors. The main objective of this study is to assess the extent of unsafe injection equipment reuse and potential for blood-borne virus transmission in Cameroon. This can be done by probing for misconceptions about injection safety that explain reuse without sterilization. These misconceptions concern useless precautions against cross-contamination, i.e. "indirect reuse" of injection equipment. To investigate whether a shortage of supply explains unsafe reuse, we compared our survey data against records of purchases. Methods All health workers at public hospitals in two health districts in the Northwest Province of Cameroon were interviewed about their own injection practices. Injection equipment supply purchase records documented for January to December 2009 were compared with self-reported rates of syringe reuse. The number of HIV, HBV and HCV infections that result from unsafe medical injections in these health districts is estimated from the frequency of unsafe reuse, the number of injections performed, the probability that reused injection equipment had just been used on an infected patient, the size of the susceptible population, and the transmission efficiency of each virus in an injection. Results Injection equipment reuse occurs commonly in the Northwest Province of Cameroon, practiced by 44% of health workers at public hospitals. Self-reported rates of syringe reuse only partly explained by records on injection equipment supplied to these hospitals, showing a shortage of syringes where syringes are reused. Injection safety interventions could prevent an estimated 14-336 HIV

Injection practices in a metropolis of North India: perceptions, determinants and issues of safety.

PubMed

Kotwal, A; Priya, R; Thakur, R; Gupta, V; Kotwal, J; Seth, T

2004-08-01

At least 50 percent of the injections administered each year are unsafe, more particularly in developing countries, posing serious health risks. An initial assessment to describe injection practices; their determinants and adverse effects can prevent injection-associated transmission of blood borne pathogens by reducing injection frequency and adoption of safe injection practices. To assess the injection practices in a large metropolitan city encompassing varied socio-cultural scenarios. STUDY SETTING AND DESIGN: Field based cross sectional survey covering urban non-slum, slum and peri-urban areas of a large metropolitan city. Injection prescribers, providers and community members selected by random sampling from the study areas. Pre tested questionnaires assessed knowledge and perceptions of study subjects towards injections and their possible complications. Observation of the process of injection and prescription audit also carried out. MS Access for database and SPSS ver 11 for analysis. Point estimates, 95% confidence intervals, Chi Square, t test, one-way ANOVA. The per capita injection rate was 5.1 per year and ratio of therapeutic to immunization injections was 4.4:1. Only 22.5%of injections were administered with a sterile syringe and needle. The level of knowledge about HIV and HBV transmission by unsafe injections was satisfactory amongst prescribers and community, but inadequate amongst providers. HCV was known to a very few in all the groups. The annual incidence of needle stick injuries among providers was quite high. A locally relevant safe injection policy based on multi disciplinary approach is required to reduce number of injections, unsafe injections and their attendant complications.

The efficacy and safety of intramuscular injections of methylcobalamin in patients with chronic nonspecific low back pain: a randomised controlled trial.

PubMed

Chiu, C K; Low, T H; Tey, Y S; Singh, V A; Shong, H K

2011-12-01

Chronic, nonspecific low back pain is a difficult ailment to treat and poses an economic burden in terms of medical expenses and productivity loss. The aim of this study was to determine the efficacy and safety of intramuscular metylcobalamin in the treatment of chronic nonspecific low back pain. This was a double-blinded, randomised, controlled experimental study. 60 patients were assigned to either the methylcobalamin group or the placebo group. The former received intramuscular injections of 500 mcg parenteral methylcobalamin in 1 ml solution three times a week for two weeks, and the placebo group received 1 ml normal saline. Patients were assessed with Oswestry Disability Index questionnaire Version 2.0 and Visual Analogue Scale pain score. They were scored before commencement of the injections and at two months interval. Of the 60 patients, 27 received the placebo injections and 33 were given methylcobalamin injections. A total of 58 patients were available for review at two months (placebo: n is 26; methylcobalamin: n is 32). There was a significant improvement in the Oswestry Disability Index and Visual Analogue Scale pain scores in the methylcobalamin group as compared with the placebo group (p-value less than 0.05). Only minor adverse reactions such as pain and haematoma at the injection sites were reported by some patients. Intramuscular methylcobalamin is both an effective and safe method of treatment for patients with nonspecific low back pain, both singly or in combination with other forms of treatment.

Injection practices in Nepal: health policymakers’ perceptions

PubMed Central

2014-01-01

Background The unnecessary and unsafe use of injections is common in developing countries like Nepal. Policymakers have an important role in promoting rational and safe injection use. Hence, the present study was carried out to explore the perception of health policymakers regarding safe injection practice in Nepal. Methods An exploratory qualitative study design was used in this study. Key policymakers from both the central and regional level were selected using purposive sampling. A semi-structured questionnaire advocated by the World Health Organization (WHO) was used after modifying the context. Interviews were conducted to clarify doubts and obtain additional information. The data was analyzed manually using deductive content analysis technique. Results In total, eleven policymakers participated. All unanimously agreed that injection safety is a problem and seven participants reported that injections are overused. They shared the opinion that injections are administered by various providers, including formal and informal health providers, and also quacks. Almost half the respondents reported that the National Drug Policy discourages injection overuse, while others reported that the policy contains no provisions regarding injection overuse. Most policymakers stated that only single-use disposable injection equipment is used to provide injection, while others thought that sterilizable glass syringe is also used. More than half of the participants believed that the quality of injection equipment available in the Nepalese market is not regulated by any government institution. Almost two-third of the policymakers stated that syringes and needles are not reused, while the rest thought syringes might be reused without sterilization in some parts of the country. Almost half of the respondents stated that illegal commercialization of used syringes exists in Nepal. Almost all respondents thought that health care institutions have a waste management plan, while more than

Injection practices in Nepal: health policymakers' perceptions.

PubMed

Gyawali, Sudesh; Rathore, Devendra Singh; Shankar, Pathiyil Ravi; Maskey, Manisha; Vikash, Kumar K C

2014-06-24

The unnecessary and unsafe use of injections is common in developing countries like Nepal. Policymakers have an important role in promoting rational and safe injection use. Hence, the present study was carried out to explore the perception of health policymakers regarding safe injection practice in Nepal. An exploratory qualitative study design was used in this study. Key policymakers from both the central and regional level were selected using purposive sampling. A semi-structured questionnaire advocated by the World Health Organization (WHO) was used after modifying the context. Interviews were conducted to clarify doubts and obtain additional information. The data was analyzed manually using deductive content analysis technique. In total, eleven policymakers participated. All unanimously agreed that injection safety is a problem and seven participants reported that injections are overused. They shared the opinion that injections are administered by various providers, including formal and informal health providers, and also quacks. Almost half the respondents reported that the National Drug Policy discourages injection overuse, while others reported that the policy contains no provisions regarding injection overuse. Most policymakers stated that only single-use disposable injection equipment is used to provide injection, while others thought that sterilizable glass syringe is also used. More than half of the participants believed that the quality of injection equipment available in the Nepalese market is not regulated by any government institution. Almost two-third of the policymakers stated that syringes and needles are not reused, while the rest thought syringes might be reused without sterilization in some parts of the country. Almost half of the respondents stated that illegal commercialization of used syringes exists in Nepal. Almost all respondents thought that health care institutions have a waste management plan, while more than half of them opined that

Efficacy and safety of newly developed cross-linked dextran gel injection for glans penis augmentation with a novel technique

PubMed Central

Yang, Dae Yul; Ko, Kyungtae; Lee, Seong Ho; Moon, Du Geon; Kim, Jong Wook; Lee, Won Ki

2018-01-01

There is no safe and effective standard method for glans penis augmentation. Furthermore, there has been scant research on glans penis augmentation due to a poor understanding of glans anatomy, technical difficulty, and a lack of suitable substances for augmentation. Cross-linked dextran gel is a newly developed filler for soft-tissue augmentation. We evaluated the efficacy and safety of using a novel technique to inject cross-linked dextran gel for glans penis augmentation during a 24-week follow-up study. This prospective, single-arm, multicenter study enrolled twenty healthy adult men who underwent glans penis augmentation between June and August 2013. Cross-linked dextran gel was injected into the glans penis using a simple and easy technique. The sizes of the glans penis and individual satisfaction were assessed. Any adverse event was also reported. A total of 18 individuals were analyzed; two of them were lost to follow-up. The mean procedure time and injected volume were about 30 min and 6.6 ± 0.9 ml, respectively. The mean surface areas of the glans at baseline and 24 weeks were 20.0 ± 3.5 cm2 and 33.6 ± 5.4 cm2, respectively, representing a mean increase of 68.7% ± 14.0% (P < 0.001). Sixteen individuals (88.9%) were satisfied with the outcomes, and none were dissatisfied. There were no serious adverse events during the study. Cross-linked dextran gel injection for glans penis augmentation was easy and showed a significant augmentative effect on the glans penis, good durability, and was well tolerated without serious adverse events. Therefore, cross-linked dextran gel injection may be an effective, new technique for glans penis augmentation. PMID:28303807

Does intrauterine injection of low-molecular-weight heparin improve the clinical pregnancy rate in intracytoplasmic sperm injection?

PubMed Central

El-Faissal, Yahia; Aboulghar, Mona; Mansour, Ragaa; Serour, Gamal I; Aboulghar, Mohamed

2016-01-01

Objective Heparin can modulate proteins, and influence processes involved in implantation and trophoblastic development. This study aimed to assess the improvement of clinical pregnancy and implantation rates after local intrauterine injection of low-molecular-weight heparin (LMWH) in patients undergoing intracytoplasmic sperm injection (ICSI). Methods A randomised case/control design was followed in women scheduled for ICSI. The study arm was injected with intrauterine LMWH during mock embryo transfer immediately following the ovum pickup procedure, while the control arm was given an intrauterine injection with a similar volume of tissue culture media. Side effects, the clinical pregnancy rate, and the implantation rate were recorded. Results The pregnancy rate was acceptable (33.9%) in the LMWH arm with no significant reported side effects, confirming the safety of the intervention. No statistically significant differences were found in the clinical pregnancy and implantation rates between both groups (p=0.182 and p=0.096, respectively). The odds ratio of being pregnant after intrauterine injection with LMWH compared to the control group was 0.572 (95% confidence interval [CI], 0.27−1.22), while the risk ratio was 0.717 (95% CI, 0.46−1.13; p=0.146). No statistical significance was found between the two groups in other factors affecting implantation, such as day of transfer (p=0.726), number of embryos transferred (p=0.362), or embryo quality. Conclusion Intrauterine injection of LMWH is a safe intervention, but the dose used in this study failed to improve the outcome of ICSI. Based on its safety, further research involving modification of the dosage and/or the timing of administration could result in improved ICSI success rates. PMID:28090465

A comprehensive situation assessment of injection practices in primary health care hospitals in Bangladesh

PubMed Central

2011-01-01

Background Understanding injection practices is crucial for evidence-based development of intervention initiatives. This study explored the extent of injection use and injection safety practices in primary care hospitals in Bangladesh. Methods The study employed both quantitative and qualitative research methods. The methods used were - a retrospective audit of prescriptions (n = 4320), focus group discussions (six with 43 participants), in-depth interviews (n = 38) with a range service providers, and systematic observation of the activities of injection providers (n = 120), waste handlers (n = 48) and hospital facilities (n = 24). Quantitative and qualitative data were assessed with statistical and thematic analysis, respectively, and then combined. Results As many as 78% of our study sample (n = 4230) received an injection. The most commonly prescribed injections (n = 3354) including antibiotics (78.3%), IV fluids (38.6%), analgesics/pain killers (29.4%), vitamins (26.7%), and anti-histamines (18.5%). Further, 43.7% (n = 1145) of the prescribed antibiotics (n = 2626) were given to treat diarrhea and 42.3% (n = 600) of IV fluids (n = 1295) were used to manage general weakness conditions. Nearly one-third (29.8%; n = 36/120) of injection providers reported needle-stick injuries in the last 6 months with highest incidences in Rajshahi division followed by Dhaka division. Disposal of injection needles, syringes and other materials was not done properly in 83.5% (n = 20/24) of the facilities. Health providers' safety concerns were not addressed properly; only 23% (n = 28/120) of the health providers and 4.2% (n = 2/48) of the waste handlers were fully immunized against Hepatitis B virus. Moreover, 73% (n = 87/120) of the injection providers and 90% (n = 43/48) of the waste handlers were not trained in injection safety practices and infection prevention. Qualitative data further confirmed that both providers and patients preferred injections, believing that they

Experimental study on the instability of Pressure Balance Injection System (PBIS)

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

Okamoto, Koji; Teshima, Hideyuki; Madarame, Haruki

1996-06-01

The Passive Safety Reactor has been developed to reduce the construction cost and to improve the safety. Japan Atomic Energy Research institute (JAERI) proposed the System-Integrated Pressurized Water Reactor (SPWR) as a Passive Safety Reactor. In the SPWR design, the Pressure Balanced Injection System (PBIS) was introduced for the passive safety concept. The water with boron in a containment vessel were passively injected into the core by the pressure difference between the containment vessel and reactor vessel at a severe accidental condition. However there are few studies on the thermo-hydraulic characteristics of the PBIS. In this study, the thermal hydraulicsmore » of the PBIS are experimentally investigated using the small scale model. The instability of the injected flow was observed in the adiabatic experiment. The instability was caused by the pressure balance between the two vessels. The mechanism of the instability are discussed, resulting in the good agreement with the experimental results. In the steam experiment, another instability was observed, which was caused by the heat balance in the main tank.« less

Quality Control of Injection Molded Eyewear by Non-Contact Deflectometry

NASA Astrophysics Data System (ADS)

Speck, A.; Zelzer, B.; Langenbucher, A.; Eppig, T.

2014-07-01

Occupational eye wear such as safety spectacles are manufactured by injection molding techniques. Testing of the assembled safety spectacle lenses in transmission is state of the art, but there is a lack of surface measurement systems for occupational safety lenses. The purpose of this work was to validate a deflectometric setup for topography measurement, detection of defects and visualization of the polishing quality, e.g. casting indentations or impressions, for the production process of safety spectacles. The setup is based on a customized stereo phase measuring deflectometer (PMD), equipped with 3 cameras with f'1,2 = 16 mm and f'3 = 8.5 mm and a specified measurement uncertainty of ± 3 μm. Sixteen plastic lenses and 8 corresponding injection molds from 4 parallel cavities were used for validation of the deflectometer. For comparison an interferometric method and a reference standard (< λ/10 super polished) was used. The accuracy and bias with a spherical safety spectacle sample was below 1 μm, according to DIN ISO 5725-2.2002-12. The repeatability was 2.1 μm and 35.7 μm for a blind radius fit. In conclusion, the PMD technique is an appropriate tool for characterizing occupational safety spectacle and injections mold surfaces. With the presented setup we were able to quantify the surface quality. This can be useful and may optimize the quality of the end product, in addition to standardized measuring systems in transmission.

Assessment of injection practice in primary health care facilities of Shiraz, Iran.

PubMed

Mclaws, Mary-Louise; Ghahramani, Sulmaz; Palenik, Charles John; Keshtkar, Vahid; Askarian, Mehrdad

2014-03-01

Occupational risk for several bloodborne viruses is attributable to unsafe injection practices. To understand injection frequency and safety, we surveyed injection rates and factors influencing injection prescription in primary health care facilities and associated health clinics in Shiraz, Iran. We used both quantitative and qualitative approaches to study the frequency and safety of injections delivered in 27 primary health care facilities. We used observations and 3 data collecting tools. Patterns of 600 general practice physicians' (GPs) prescriptions were also reviewed. In-depth interviews to elicit the factors contributing to injection prescriptions were conducted. The annual per capita injection rate was 3.12. Corticosteroids were prescribed more frequently than antibiotics (P < .001). Knowledge of participants concerning transmission risks for 3 of the most common bloodborne infections (BBIs) was less than 75%. Factors affecting use of injections by GPs included strong patient preference for injections over oral medications and financial benefit for GPs, especially those in private practice settings. Frequency of therapeutic injections in the participating facilities in Shiraz was high. Sociocultural factors in the patient community and their beliefs in the effectiveness of injections exerted influence on GP prescribing practices. Programs for appropriate and safe injection practices should target GP and injection providers, as well as patients, informing them about alternative treatments and possible complications of unnecessary and unsafe injections. Copyright © 2014 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

Reduced injection pressures using a compressed air injection technique (CAIT): an in vitro study.

PubMed

Tsui, Ban C H; Knezevich, Mark P; Pillay, Jennifer J

2008-01-01

High injection pressures have been associated with intraneural injection and persistent neurological injury in animals. Our objective was to test whether a reported simple compressed air injection technique (CAIT) would limit the generation of injection pressures to below a suggested 1,034 mm Hg limit in an in vitro model. After ethics board approval, 30 consenting anesthesiologists injected saline into a semiclosed system. Injection pressures using 30 mL syringes connected to a 22 gauge needle and containing 20 mL of saline were measured for 60 seconds using: (1) a typical "syringe feel" method, and (2) CAIT, thereby drawing 10 mL of air above the saline and compressing this to 5 mL prior to and during injections. All anesthesiologists performed the syringe feel method before introduction and demonstration of CAIT. Using CAIT, no anesthesiologist generated pressures above 1,034 mm Hg, while 29 of 30 produced pressures above this limit at some time using the syringe feel method. The mean pressure using CAIT was lower (636 +/- 71 vs. 1378 +/- 194 mm Hg, P = .025), and the syringe feel method resulted in higher peak pressures (1,875 +/- 206 vs. 715 +/- 104 mm Hg, P = .000). This study demonstrated that CAIT can effectively keep injection pressures under 1,034 mm Hg in this in vitro model. Animal and clinical studies will be needed to determine whether CAIT will allow objective, real-time pressure monitoring. If high pressure injections are proven to contribute to nerve injury in humans, this technique may have the potential to improve the safety of peripheral nerve blocks.

Vibration Anesthesia for Pain Reduction During Intralesional Steroid Injection for Keloid Treatment.

PubMed

Park, Kui Young; Lee, Yohan; Hong, Ji Yeon; Chung, Won Soon; Kim, Myeung Nam; Kim, Beom Joon

2017-05-01

Patients suffer significant pain during intralesional steroid injection treatment for keloids and hypertrophic scars. Vibration anesthesia has been shown to effectively and safely alleviate pain sensations, likely by reducing pain transmission from peripheral receptors to the brain. The objective was to evaluate the efficacy, safety, and patient satisfaction associated with vibration anesthesia for reducing pain during intralesional corticosteroid injection. The authors recruited 40 patients with 58 keloids who were scheduled to undergo intralesional triamcinolone acetonide (TA) injections. Half of each keloid was injected with concomitant vibration anesthesia, whereas the other half was injected without vibration anesthesia. Pain experienced by patients during both procedures was assessed according to visual analog scale (VAS) score. The authors also assessed procedure safety. The mean VAS score during intralesional TA injection therapy without vibration was 5.88 ± 2.34. By contrast, the same patients yielded a mean VAS score during intralesional TA injection therapy with vibration of 3.28 ± 1.85; the difference between the mean scores was significant (p < .05). Thirty-nine (97.5%) patients tolerated this therapy well. Vibration anesthesia is a promising option for reducing pain during keloid treatment with intralesional steroid injection.

Repeated onabotulinumtoxin-a injections provide better results than single injection in treatment of painful bladder syndrome.

PubMed

Kuo, Hann-Chorng

2013-01-01

Onabotulinumtoxin-A (BoNT-A) is effective for the treatment of interstitial cystitis/painful bladder syndrome (IC/PBS). However, long-term follow-up does not show successful outcome after a single injection. To evaluate the efficacy and safety of repeated intravesical BoNT-A injections for treatment of IC/PBS and compare the success rates among patient groups receiving different injection numbers. Prospective interventional study. Tertiary medical center. Intravesical injection of 100 U of BoNT-A was performed in 81 patients every 6 months for up to 4 times or until patients' symptoms significantly improved. Patients who received a single injection served as active controls. Measured parameters included O'Leary-Sant symptom indexes (ICSI) and problem indexes (ICPI), visual analogue score (VAS) for pain, voiding diary variables, urodynamic parameters, maximal bladder capacity under anesthesia, glomerulation grade, and global response assessment. Multiple measurements and Kaplan-Meier analysis were used for comparison of consecutive data and success rates among groups. Among 81 patients, 20 received single injections, 19 received 2 injections, 12 received 3 injections, and 30 received 4 injections. The mean (± standard deviation) of ICSI, ICPI, total scores, VAS, functional bladder capacity, and daytime frequency all showed significant improvement after repeated BoNT-A treatment with different injections. Significantly better success rates were noted in patients who received 4 repeated injections (P = 0.0242) and 3 injections (P = 0.050), compared to those who received a single injection. However, there was no significant difference of long-term success rates among patients who received 2, 3, and 4 injections. Lack of placebo control group is the main limitation. Repeated intravesical BoNT-A injections were safe and effective for pain relief and they increased bladder capacity and provided a better long-term success rate than a single injection did for treatment of

[Onyx embolization for treatment of dural arteriovenous fistula: comparison of long- distance versus routine injection method].

PubMed

He, Xiao-Yan; Zhang, Guo-Zhong; Li, Ming-Zhou; Wang, Gang; Liu, Dan; Qi, Song-Tao; Li, Wei-Guang; Feng, Wen-Feng

2016-03-01

To compare the efficacy, clinical characteristics, safety, injection time and radiation exposure of Onyx embolization using a long-distance injection method and routine injection method for management of dural arteriovenous fistula (DAVF). The clinical data were retrospectively analyzed in 59 patients with DAVF treated with Onyx embolization using long-distance injection method (28 patients) and routine injection method (31 patients). The efficacy, safety, injection time and radiation exposure during Onyx embolization were compared between the two injections methods. The average radiation dose exposure to the surgeon per procedure was significantly lower in the long-distance injection group than in the routine group. The injection time (P=0.53), injection volume (P=0.78), number of supply arteries (P=0.80), Cognard types (P=0.67), and effect of embolization (P=0.88) were all similar between the two groups. Endovaseular treatment of intracranial DAVF with Onyx embolization using the long-distance injection method is feasible, safe and effective and can reduce the radiation exposure to the surgeon.

Patient Safety Threat - Syringe Reuse

MedlinePlus

... Fingerstick Devices Clinical Reminder: Insulin Pens Publications Infection Control Assessment of Ambulatory Surgical Centers Meetings Insurance Stakeholders Meeting – December 2011 Ambulatory Surgical Centers – October 2010 Safety by Design – May 2010 Sticking with Safety – May 2010 Injection ...

Methodology for the Randomised Injecting Opioid Treatment Trial (RIOTT): evaluating injectable methadone and injectable heroin treatment versus optimised oral methadone treatment in the UK

PubMed Central

Lintzeris, Nicholas; Strang, John; Metrebian, Nicola; Byford, Sarah; Hallam, Christopher; Lee, Sally; Zador, Deborah

2006-01-01

Whilst unsupervised injectable methadone and diamorphine treatment has been part of the British treatment system for decades, the numbers receiving injectable opioid treatment (IOT) has been steadily diminishing in recent years. In contrast, there has been a recent expansion of supervised injectable diamorphine programs under trial conditions in a number of European and North American cities, although the evidence regarding the safety, efficacy and cost effectiveness of this treatment approach remains equivocal. Recent British clinical guidance indicates that IOT should be a second-line treatment for those patients in high-quality oral methadone treatment who continue to regularly inject heroin, and that treatment be initiated in newly-developed supervised injecting clinics. The Randomised Injectable Opioid Treatment Trial (RIOTT) is a multisite, prospective open-label randomised controlled trial (RCT) examining the role of treatment with injected opioids (methadone and heroin) for the management of heroin dependence in patients not responding to conventional substitution treatment. Specifically, the study examines whether efforts should be made to optimise methadone treatment for such patients (e.g. regular attendance, supervised dosing, high oral doses, access to psychosocial services), or whether such patients should be treated with injected methadone or heroin. Eligible patients (in oral substitution treatment and injecting illicit heroin on a regular basis) are randomised to one of three conditions: (1) optimized oral methadone treatment (Control group); (2) injected methadone treatment; or (3) injected heroin treatment (with access to oral methadone doses). Subjects are followed up for 6-months, with between-group comparisons on an intention-to-treat basis across a range of outcome measures. The primary outcome is the proportion of patients who discontinue regular illicit heroin use (operationalised as providing >50% urine drug screens negative for markers of

Novel electric power-driven hydrodynamic injection system for gene delivery: safety and efficacy of human factor IX delivery in rats.

PubMed

Yokoo, T; Kamimura, K; Suda, T; Kanefuji, T; Oda, M; Zhang, G; Liu, D; Aoyagi, Y

2013-08-01

The development of a safe and reproducible gene delivery system is an essential step toward the clinical application of the hydrodynamic gene delivery (HGD) method. For this purpose, we have developed a novel electric power-driven injection system called the HydroJector-EM, which can replicate various time-pressure curves preloaded into the computer program before injection. The assessment of the reproducibility and safety of gene delivery system in vitro and in vivo demonstrated the precise replication of intravascular time-pressure curves and the reproducibility of gene delivery efficiency. The highest level of luciferase expression (272 pg luciferase per mg of proteins) was achieved safely using the time-pressure curve, which reaches 30 mm Hg in 10 s among various curves tested. Using this curve, the sustained expression of a therapeutic level of human factor IX protein (>500 ng ml(-1)) was maintained for 2 months after the HGD of the pBS-HCRHP-FIXIA plasmid. Other than a transient increase in liver enzymes that recovered in a few days, no adverse events were seen in rats. These results confirm the effectiveness of the HydroJector-EM for reproducible gene delivery and demonstrate that long-term therapeutic gene expression can be achieved by automatic computer-controlled hydrodynamic injection that can be performed by anyone.

Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials.

PubMed

Coombes, Brooke K; Bisset, Leanne; Vicenzino, Bill

2010-11-20

Few evidence-based treatment guidelines for tendinopathy exist. We undertook a systematic review of randomised trials to establish clinical efficacy and risk of adverse events for treatment by injection. We searched eight databases without language, publication, or date restrictions. We included randomised trials assessing efficacy of one or more peritendinous injections with placebo or non-surgical interventions for tendinopathy, scoring more than 50% on the modified physiotherapy evidence database scale. We undertook meta-analyses with a random-effects model, and estimated relative risk and standardised mean differences (SMDs). The primary outcome of clinical efficacy was protocol-defined pain score in the short term (4 weeks, range 0-12), intermediate term (26 weeks, 13-26), or long term (52 weeks, ≥52). Adverse events were also reported. 3824 trials were identified and 41 met inclusion criteria, providing data for 2672 participants. We showed consistent findings between many high-quality randomised controlled trials that corticosteroid injections reduced pain in the short term compared with other interventions, but this effect was reversed at intermediate and long terms. For example, in pooled analysis of treatment for lateral epicondylalgia, corticosteroid injection had a large effect (defined as SMD>0·8) on reduction of pain compared with no intervention in the short term (SMD 1·44, 95% CI 1·17-1·71, p<0·0001), but no intervention was favoured at intermediate term (-0·40, -0·67 to -0·14, p<0·003) and long term (-0·31, -0·61 to -0·01, p=0·05). Short-term efficacy of corticosteroid injections for rotator-cuff tendinopathy is not clear. Of 991 participants who received corticosteroid injections in studies that reported adverse events, only one (0·1%) had a serious adverse event (tendon rupture). By comparison with placebo, reductions in pain were reported after injections of sodium hyaluronate (short [3·91, 3·54-4·28, p<0·0001], intermediate

Intravitreal, Subretinal, and Suprachoroidal Injections: Evolution of Microneedles for Drug Delivery.

PubMed

Hartman, Rachel R; Kompella, Uday B

Even though the very thought of an injection into the eye may be frightening, an estimated 6 million intravitreal (IVT) injections were made in the USA during 2016. With the introduction of new therapeutic agents, this number is expected to increase. In addition, drug products that are injectable in ocular compartments other than the vitreous humor are expected to enter the back of the eye market in the not so distant future. Besides the IVT route, some of the most actively investigated routes of invasive administration to the eye include periocular, subretinal, and suprachoroidal (SC) routes. While clinical efficacy is the driving force behind new injectable drug product development for the eye, safety is also being improved with time. In the case of IVT injections, the procedural guidelines have evolved over the years to improve patient comfort and reduce injection-related injury and infection. Similar advances are anticipated for other routes of administration of injectable products to the eye. In addition to procedural improvements, the design of needles, particularly those with smaller diameters, length, and controlled bevel angles are expected to improve overall safety and acceptance of injected ophthalmic drug products. A key development in this area is the introduction of microneedles of a length less than a millimeter that can target the SC space. In the future, needles with smaller diameters and lengths, potentially approaching nanodimensions, are expected to revolutionize ophthalmic disease management.

75 FR 1274 - Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

... safety warning for use of hyaluronate sodium injectable solution in horses. DATES: This rule is effective... human food safety warning on product labeling. The supplemental NADA is approved as of December 11, 2009...

Efficacy and Safety of Injectable Robenacoxib for the Treatment of Pain Associated With Soft Tissue Surgery in Dogs.

PubMed

Friton, G; Thompson, C; Karadzovska, D; King, S; King, J N

2017-05-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) are used routinely to control pain and inflammation after surgery in dogs. Robenacoxib is a cyclooxygenase-2 selective NSAID. Assess the clinical efficacy and safety of an injectable formulation of robenacoxib in dogs undergoing surgery. Three hundred and seventeen client-owned dogs (N = 159 robenacoxib or N = 158 placebo). In this prospective, multicenter, randomized, masked, placebo-controlled, parallel-group study, dogs received a SC injection of either robenacoxib, at a target dose of 2.0 mg/kg, or placebo once prior to surgery and for 2 additional days postoperatively. Pain assessments were performed using the short form of the Glasgow Composite Measure Pain Scale (CMPS-SF). The primary efficacy variable was treatment success/failure, with failure defined as the need for rescue therapy to control pain or withdrawal of the dog from the study due to an adverse event. Significantly (P = .006) more dogs administered robenacoxib were considered treatment successes (108 of 151, 73.7%) compared to dogs given placebo (85 of 152, 58.1%). Total pain scores (P < .01), pain at the surgery sites (response to touch, P < .01), and posture/activity (P < .05) were significantly improved at 3, 5, and 8 hours postextubation in dogs receiving robenacoxib versus placebo. Robenacoxib administered by SC injection prior to surgery and for 2 additional days postoperatively was effective and well tolerated in the control of postoperative pain and inflammation associated with soft tissue surgery in dogs. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Safety, pharmacokinetics, and pharmacodynamics of S-(-)-pantoprazole sodium injections after single and multiple intravenous doses in healthy Chinese subjects.

PubMed

Jiao, Hui-Wen; Sun, Lu-Ning; Li, Yue-Qi; Yu, Lei; Zhang, Hong-Wen; Wang, Mei-Feng; Yu, Li-Yuan; Yuan, Zi-Qing-Yun; Xie, Li-Jun; Chen, Juan; Meng, Ling; Zhang, Xue-Hui; Wang, Yong-Qing

2018-03-01

The objective of this study was to evaluate the safety, pharmacokinetics, and pharmacodynamics of S-(-)-pantoprazole (PPZ) sodium injections following single and multiple intravenous doses in healthy Chinese subjects. The dosage groups were set as followed: 20 mg of single and multiple intravenous administration of S-(-)-PPZ, 40 mg of single and multiple intravenous administration of S-(-)-PPZ or pantoprazole, and 80 mg of single dosage group of S-(-)-PPZ. Subjects were sampled for pharmacokinetic analysis and were monitored for 24-h intragastric pH prior to and 48-h intragastric pH after administration for the pharmacodynamic study. The pharmacokinetic and pharmacodynamic parameters were compared between S-(-)-PPZ and PPZ. Safety was evaluated on the basis of adverse events, vital signs, laboratory tests, and physical examination. All adverse events were mild and of limited duration. Maximum plasma concentration and area under the concentration-time curve for S-(-)-PPZ were dose proportional over the range of 20-80 mg following a single intravenous administration. Elimination rate constant and half-life observed statistical difference from a single dose to multiple doses in 40 mg of S-(-)-PPZ groups. After administration of a single dose, the mean 24-h intragastric pH value was observed higher in 80-mg group than in 40- and 20-mg groups. Slightly increase of intragastric pH was found after a single dose of 40 mg S-(-)-PPZ than 40 mg PPZ; however, the differences were not statistically significant. Twice daily of 40 mg S-(-)-PPZ sodium injections is effective in achieving satisfying acid inhibition. Compared with plasma R-(+)-PPZ levels, most subjects presented more potent and prolonged suppression of gastric acid of S-(-)-PPZ, while a few subjects showed faster metabolic rate of S-(-)-PPZ in vivo.

Comparative Study of Efficacy and Safety of Botulinum Toxin a Injections and Subcutaneous Curettage in the Treatment of Axillary Hyperhidrosis

PubMed Central

Budamakuntla, Leelavathy; Loganathan, Eswari; George, Anju; Revanth, BN; Sankeerth, V; Sarvjnamurthy, Sacchidananda Aradhya

2017-01-01

Background: Primary focal axillary hyperhidrosis is a chronic distressing disorder affecting both the sexes. When the condition is refractory to conservative management, we should go for more promising therapies like intradermal botulinum toxin A (BtxA) injections in the axilla, and surgical therapies like subcutaneous curettage of sweat glands. Aims and Objectives: The aim of this study is to compare the efficacy, safety and duration of action of intradermal BtxA injections in one axilla and subcutaneous curettage of sweat glands in the other axilla of the same patient with axillary hyperhidrosis. Materials and Methods: Twenty patients (40 axillae) received intradermal BtxA injections on the right side (20 axillae) and underwent tumescent subcutaneous curettage of sweat glands on the left side (20 axillae). Sweat production rate was measured using gravimetry analyses at baseline and at 3 months after the procedure. Subjective analyses were done using hyperhidrosis disease severity scale (HDSS) score at baseline, at 3rd and 6th month after the procedure. Results: At 3 months post-treatment, the resting sweat rate in the toxin group improved by 80.32% versus 79.79% in the subcutaneous curettage method (P = 0.21). Exercise-induced sweat rate in the toxin group improved by 88.76% versus 88.8% in the subcutaneous curettage group (P = 0.9). There was a significant difference in the HDSS score after treatment with both the modalities. There were no adverse events with BtxA treatment compared to very minor adverse events with the surgical method. Conclusion: Both intradermal BtxA injections and tumescent subcutaneous curettage of sweat glands had a significant decrease in the sweat rates with no significant difference between the two modalities. Hence, in resource poor settings where affordability of BtxA injection is a constraint, subcutaneous curettage of sweat glands can be preferred which has been found equally effective with no or minimal adverse events. PMID

[On relationship of acupoint-injection with injury of peripheral nerves].

PubMed

Guo, Chang-Qing; Chen, You-Nan

2007-04-01

To provide basis for strengthening safety of acupoint-injection and increasing clinical therapeutic effect. Analyze and study on the relative articles from the databank of whole articles of Chinese periodicals of CNKI by information retrieval with computer, with acupoint-injection, nerve injury as key words. Most of clinical reports focus on acupoint-injection for treatment of nervous injury induced by trauma and birth injury. The studies indicate that the injuries of the peripheral nerves induced by acupoint-injection can be divided into 3 grades and the injury mechanisms can be divided into 3 classifications. The injuring causes include improper posture of the patients, improper angle and depth of injection and improper medicine selection. Acupoint-injection can be applied more widely as soon as the accomplishment of the standardization of operation.

Intraseptal anesthesia: a review of a relevant injection technique.

PubMed

Woodmansey, Karl

2005-01-01

Although overshadowed by intraosseous anesthesia and the periodontal ligament injection, intraseptal anesthesia remains a useful local anesthesia technique for general dentists. Intraseptal anesthesia can be employed with safety and efficacy as an alternative to conventional local infiltration or regional nerve block injections. It also can serve as an adjunctive technique when conventional techniques fail to achieve adequate local anesthesia. This article reviews the intraseptal anesthesia technique, including its indications and limitations.

Safety of Ultrasound-Guided Botulinum Toxin Injections for Sialorrhea as Performed by Pediatric Otolaryngologists.

PubMed

Shariat-Madar, Bahbak; Chun, Robert H; Sulman, Cecille G; Conley, Stephen F

2016-05-01

To evaluate incidence of complications and hospital readmission as a result of ultrasound-guided botulinum toxin injections to manage sialorrhea. Case series with chart review. Children's Hospital of Wisconsin. A case series with chart review was performed of all cases of ultrasound-guided injection of botulinum toxin by pediatric otolaryngologists from March 5, 2010, to September 26, 2014,. Primary outcomes included complications such as dysphagia, aspiration pneumonia, and motor paralysis. Secondary outcomes included hospitalization, intubation, and nasogastric tube placement. There were 48 patients, 111 interventions, and 306 intraglandular injections identified. Botulinum toxin type A and type B were utilized in 4 and 107 operative interventions, respectively. Type A was injected into 4 parotid and 4 submandibular glands, utilizing doses of 20 U per parotid and 30 U per submandibular gland. Type B was injected into 98 parotid and 200 submandibular glands, with average dosing of 923 U per parotid and 1170 U per submandibular gland, respectively. There were 2 instances of subjectively worsening of baseline dysphagia that self-resolved. No cases were complicated by aspiration pneumonia or motor paralysis. No patients required hospital readmission, intubation, or nasogastric tube placement. Prior published data indicated 16% complication incidence with ultrasound-guided injection of botulinum toxin. Our study found a low complication rate (0.6%) with ultrasound-guided injections of botulinum toxin to manage sialorrhea, without cases of aspiration pneumonia or motor paralysis. Of 306 intraglandular injections, there were 2 cases of worsening baseline subjective dysphagia that self-resolved. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

Safe use of epidural corticosteroid injections: recommendations of the WIP Benelux workgroup.

PubMed

Van Boxem, Koen; Rijsdijk, Mienke; Hans, Guy; de Jong, Jasper; Kallewaard, Jan Willem; Vissers, Kris; van Kleef, Maarten; Rathmell, James P; Van Zundert, Jan

2018-05-14

Epidural corticosteroid injections are used frequently worldwide in the treatment of radicular pain. Concerns have risen involving rare major neurologic injuries after this treatment. Recommendations to prevent these complications have been published, but local implementation is not always feasible due to local circumstances and necessitating local recommendations based on literature review. A workgroup of 4 stakeholder pain societies in Belgium, The Netherlands and Luxembourg (Benelux) has reviewed the literature involving neurological complications after epidural corticosteroid injections and possible safety measures to prevent these major neurologic injuries. Twenty-six considerations and recommendations were selected by the workgroup. These involve the use of imaging, injection equipment particulate and non-particulate corticosteroids, epidural approach and maximal volume to be injected. Raising awareness about possible neurological complications and adoption of safety measures recommended by the work group aim at reducing the risks of these devastating events. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Automatic and remote controlled ictal SPECT injection for seizure focus localization by use of a commercial contrast agent application pump.

PubMed

Feichtinger, Michael; Eder, Hans; Holl, Alexander; Körner, Eva; Zmugg, Gerda; Aigner, Reingard; Fazekas, Franz; Ott, Erwin

2007-07-01

In the presurgical evaluation of patients with partial epilepsy, the ictal single photon emission computed tomography (SPECT) is a useful noninvasive diagnostic tool for seizure focus localization. To achieve optimal SPECT scan quality, ictal tracer injection should be carried out as quickly as possible after the seizure onset and under highest safety conditions possible. Compared to the commonly used manual injection, an automatic administration of the radioactive tracer may provide higher quality standards for this procedure. In this study, therefore, we retrospectively analyzed efficiency and safety of an automatic injection system for ictal SPECT tracer application. Over a 31-month period, 26 patients underwent ictal SPECT by use of an automatic remote-controlled injection pump originally designed for CT-contrast agent application. Various factors were reviewed, including latency of ictal injection, radiation safety parameters, and ictal seizure onset localizing value. Times between seizure onset and tracer injection ranged between 3 and 48 s. In 21 of 26 patients ictal SPECT supported the localization of the epileptogenic focus in the course of the presurgical evaluation. In all cases ictal SPECT tracer injection was performed with a high degree of safety to patients and staff. Ictal SPECT by use of a remote-controlled CT-contrast agent injection system provides a high scan quality and is a safe and confirmatory presurgical evaluation technique in the epilepsy-monitoring unit.

Treatment of Lipoma by Injection Lipolysis

PubMed Central

Nanda, Soni

2011-01-01

Injection lipolysis or lipodissolve is the practice of injecting phosphatidyl choline/ sodium deoxycholate (PDC/DC) compounds in the subcutaneous fat. Though this practice is being used extensively for nonsurgical contouring of body and dissolving localized collections of excess fat, it's use as a treatment modality for lipomas needs further evaluation. We present a case where this technique was used for treating a lipoma, with no recurrence after 9 months of follow up. Injection lipolysis as a treatment modality for lipomas needs to be evaluated for safety and efficacy in trials on larger population. This could prove to be a very valuable adjunct to the current practice of excision, if done by a trained person in a properly selected patient. Also the side effects and the controversies regarding this procedure have been discussed in detail in the present paper. PMID:21976907

Safety and effectiveness of a single and repeat intramuscular injection of a GnRH vaccine (GonaCon™) in adult female domestic cats.

PubMed

Vansandt, L M; Kutzler, M A; Fischer, A E; Morris, K N; Swanson, W F

2017-04-01

Sterilization is a key strategy to reduce the number of domestic cats entering and killed in shelters each year. However, surgical sterilization is expensive and labour-intensive and cannot fully address the 70 million free-roaming cats estimated to exist in the United States. GonaCon™ is a gonadotropin-releasing hormone vaccine originally developed for use as a wildlife immunocontraceptive. An earlier formulation was tested in domestic cats and found to be safe and effective for long-term contraception. However, the current Environmental Protection Agency (EPA)-registered formulation consists of a different antigen-carrier protein and increased antigen concentration and has never been tested in cats. A pilot study was undertaken to evaluate the short-term safety of a single GonaCon immunization, assess the consequences of vaccinated cats receiving an accidental second GonaCon injection and determine the humoral immune response to immunization. During Phase 1, cats in Group A (n = 3) received a single intramuscular injection of GonaCon and Group B (n = 3) received a single intramuscular injection of saline. During Phase 2, Group A received a second GonaCon injection and Group B received their initial GonaCon injection. All cats developed GnRH antibodies within 30 days of vaccine administration. The endpoint titre (1:1,024,000) was similar among all cats, and levels remained high throughout the duration of the study. Four cats developed a sterile, painless, self-limiting mass at the site of injection. The mean number of days to mass development was 110.3 (range, 18-249 days). In conclusion, this preliminary study suggests that the EPA-registered GonaCon formulation is safe for continued testing in domestic cats, an accidental revaccination should not increase the risk of a vaccine reaction and the EPA-registered formulation effectively elicits a strong humoral immune response. © 2016 Blackwell Verlag GmbH.

Engine performance with a hydrogenated safety fuel

NASA Technical Reports Server (NTRS)

Schey, Oscar W; Young, Alfred W

1933-01-01

This report presents the results of an investigation to determine the engine performance obtained with a hydrogenated safety fuel developed to eliminate fire hazard. The tests were made on a single-cylinder universal test engine at compression ratios of 5.0, 5.5, and 6.0. Most of the tests were made with a fuel-injection system, although one set of runs was made with a carburetor when using gasoline to establish comparative performance. The tests show that the b.m.e.p. obtained with safety fuel when using a fuel-injection system is slightly higher than that obtained with gasoline when using a carburetor, although the fuel consumption with safety fuel is higher. When the fuel-injection system is used with each fuel and with normal engine temperatures the b.m.e.p. with safety fuel is from 2 to 4 percent lower than with gasoline and the fuel consumption about 25 to 30 percent higher. However, a few tests at an engine coolant temperature of 250 F have shown a specific fuel consumption approximating that obtained with gasoline with only a slight reduction in power. The idling of the test engine was satisfactory with the safety fuel. Starting was difficult with a cold engine but could be readily accomplished when the jacket water was hot. It is believed that the use of the safety fuel would practically eliminate crash fires.

Safety syringes and anti-needlestick devices in orthopaedic surgery.

PubMed

Sibbitt, Wilmer L; Band, Philip A; Kettwich, Lawrence G; Sibbitt, Cristina R; Sibbitt, Lori J; Bankhurst, Arthur D

2011-09-07

The American Academy of Orthopaedic Surgery (AAOS), The Joint Commission, the Occupational Safety and Health Administration (OSHA), and the Needlestick Safety and Prevention Act encourage the integration of safety-engineered devices to prevent needlestick injuries to health-care workers and patients. We hypothesized that safety syringes and needles could be used in outpatient orthopaedic injection and aspiration procedures. The study investigated the orthopaedic uses and procedural idiosyncrasies of safety-engineered devices, including (1) four safety needles (Eclipse, SafetyGlide, SurGuard, and Magellan), (2) a mechanical safety syringe (RPD), (3) two automatic retractable syringes (Integra, VanishPoint), (4) three manual retractable syringes (Procedur-SF, Baksnap, Invirosnap), and (5) three shielded syringes (Safety-Lok, Monoject, and Digitally Activated Shielded [DAS] Syringe). The devices were first tested ex vivo, and then 1300 devices were used for 425 subjects undergoing outpatient arthrocentesis, intra-articular injections, local anesthesia, aspiration biopsy, and ultrasound-guided procedures. During the clinical observation, there were no accidental needlesticks (0 needlesticks per 1300 devices). Safety needles could be successfully used on a Luer syringe but were limited to ≤1.5 in (≤3.81 cm) in length and the shield could interfere with sonography. The mechanical safety syringes functioned well in all orthopaedic procedures. Automatic retractable syringes were too small for arthrocentesis of the knee, and the plunger blew out and prematurely collapsed with high-pressure injections. The manual retractable syringes and shielded syringes could be used with conventional needles for most orthopaedic procedures. The most effective and reliable safety devices for orthopaedic syringe procedures are shielded safety needles, mechanical syringes, manual retractable syringes, and shielded syringes, but not automatic retractable syringes. Even when adopting

9 CFR 113.44 - Swine safety test.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Swine safety test. 113.44 Section 113... Procedures § 113.44 Swine safety test. The swine safety test provided in this section shall be conducted when.... (1) Inject each of two swine of the minimum age for which the product is recommended with the...

9 CFR 113.44 - Swine safety test.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Swine safety test. 113.44 Section 113... Procedures § 113.44 Swine safety test. The swine safety test provided in this section shall be conducted when.... (1) Inject each of two swine of the minimum age for which the product is recommended with the...

9 CFR 113.44 - Swine safety test.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Swine safety test. 113.44 Section 113... Procedures § 113.44 Swine safety test. The swine safety test provided in this section shall be conducted when.... (1) Inject each of two swine of the minimum age for which the product is recommended with the...

9 CFR 113.44 - Swine safety test.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Swine safety test. 113.44 Section 113... Procedures § 113.44 Swine safety test. The swine safety test provided in this section shall be conducted when.... (1) Inject each of two swine of the minimum age for which the product is recommended with the...

9 CFR 113.44 - Swine safety test.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Swine safety test. 113.44 Section 113... Procedures § 113.44 Swine safety test. The swine safety test provided in this section shall be conducted when.... (1) Inject each of two swine of the minimum age for which the product is recommended with the...

Efficacy and safety of penile girth enhancement by autologous fat injection for patients with thin penises.

PubMed

Kang, Dong Hyuk; Chung, Jae Hoon; Kim, Yong Jin; Lee, Haeng Nam; Cho, Seung Hoon; Chang, Taek Hee; Lee, Seung Wook

2012-08-01

This study aimed to investigate the efficacy and safety of autologous fat injection (AFI) for penile girth enhancement (PGE) in patients with thin penises. This study investigated 52 patients with a small penile circumference who underwent AFI for PGE and were followed up for more than 6 months. The patients whose proximal one third (G1) and distal one third of their penis (G2) had a mean thickness of 7.4 cm or less were selected as subjects. After fat suction using a liposuction device, fat was evenly injected into the superficial, middle, and deep layers of the Colles' fascia. Patient age and operative time were analyzed. The G1, G2, flaccid (L1), stretched length (L2), and five-item version of the International Index of Erectile Function-5 (IIEF-5) before and 6 months after the surgery were compared. Postoperative complications were surveyed. The patient mean age was 42.15 years (range, 22-56) years, and the operative time was 44.44 min (range, 37-49 min). The injected fat volume was 38.54 ml (range, 25-49 ml). Preoperatively, G1 was 7.01±0.39 cm, and G2 was 7.06±0.37 cm. Postoperatively, G1 was 9.29±0.82 cm (P<0.001), and G2 was 9.34±0.86 (P<0.001) cm 6 months after the surgery. The difference between L1 and L2 before and after the surgery was not significant. The IIEF-5 was 19.10±3.22 before the surgery and 19.90±3.05 after the surgery (P=0.001). The only complication was nodular fat observed in one case (1.92%). The use of AFI for PGE in men with thin penises was effective and safe without major complications. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors at www.springer.com/00266.

Intra-articular glucocorticoid injections in patients with juvenile idiopathic arthritis in a Singapore hospital.

PubMed

Leow, Olivia Min Yi; Lim, Lee Kean; Ooi, Pei Ling; Shek, Lynette Pei Chi; Ang, Elizabeth You Ning; Son, Mary Beth

2014-05-01

This study aimed to evaluate the efficacy and safety of intra-articular glucocorticoid (IAG) injections in our institution in children with juvenile idiopathic arthritis (JIA). This is a retrospective assessment of IAG injections performed by the Department of Paediatrics, National University Hospital, Singapore, from October 2009 to October 2011. A total of 26 procedures were evaluated for efficacy, considering parameters such as clinical response, changes in systemic medication, length of time between repeat injections, safety, consent-taking, pre- and post-procedural advice, compliance with aseptic technique, and post-procedural complications. A total of 26 IAG injections of triamcinolone hexacetonide were administered over 17 occasions (i.e. patient encounters) to ten patients with JIA during the study period. After the injections, clinical scoring by a paediatric rheumatologist showed overall improvement by an average of 2.62 points out of 15. Besides six patient encounters that had an increase in systemic medication on the day of the injection, five required an increase within six months post injection, two required no adjustments, and one resulted in a decrease in medications. In all, 21 injections did not require subsequent injections. The mean interval between repeat injections was 7.8 months. Cutaneous side effects were noted in three anatomically difficult joints. Medical documentation with regard to patient progress was found to be lacking. As per the recommendations of the American College of Rheumatology, we safely used IAG injections as the first-line therapy in our group of patients with oligoarticular JIA, and/or as an adjunct to systemic therapy in our patients with JIA.

Salvianolate injection in the treatment of unstable angina pectoris

PubMed Central

Zhang, Dan; Wu, Jiarui; Liu, Shi; Zhang, Xiaomeng; Zhang, Bing

2016-01-01

Abstract Background: To systematically evaluate the clinical efficacy and safety of Salvianolate injection in the treatment of unstable angina pectoris (UAP). Methods: Using literature databases, we conducted a thorough and systematic retrieval of randomized controlled trials (RCTs) that using Salvianolate injection for treating UAP. The Cochrane Risk of Bias Assessment Tool was used to evaluate the methodological quality of the RCTs, and then the data were extracted and meta-analyzed by RevMan5.2 software. Results: A total of 22 RCTs with 2050 participants were included. The meta-analysis indicated that the combined use of Salvianolate injection and western medicine (WM) in the treatment of UAP can achieve a superior effect in angina pectoris total effective rate (risk ratio [RR] = 1.22, 95% confidence interval [CI] (1.17, 1.27), Z = 10.15, P < 0.00001], and the total effectiveness rate of electrocardiogram [RR = 1.26, 95% CI (1.19,1.34), Z = 7.77, P < 0.00001]. In addition, Salvianolate injection can improve the nitroglycerin withdrawal rate and the serum level of NO, decrease high-sensitivity C-reactive protein. Adverse drug reactions (ADRs) or adverse drug events (ADEs) were reported in 6 RCTs involving 15 cases; however, there were no serious ADRs/ADEs. Conclusion: Based on the systematic review, the combined use of Salvianolate injection and WM in the treatment of UAP can achieve a better effect; however, there was no definitive conclusion about its safety. More the large-sample and multicenter RCTs are needed to support its clinical usage. PMID:28002341

Efficacy and Safety of Postoperative Pain Relief by Parecoxib Injection after Laparoscopic Surgeries: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

PubMed

Huang, Jun-Ming; Lv, Zheng-Tao; Zhang, Ya-Nan; Jiang, Wen-Xiu; Li, Han-Ning; Nie, Ming-Bo

2017-10-17

This study aims to evaluate the efficacy and safety of parecoxib injection in pain relief after laparoscopic surgeries. A comprehensive literature search based on 4 online databases (PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science) was applied to retrieve all related randomized controlled trials (RCTs). Two independent reviewers screened each article for eligibility according to the predetermined inclusion criteria. The Cochrane Collaboration's tool was applied to evaluate the methodological quality of included studies. A standardized data collection sheet was designed to extract data from included studies. RevMan version 5.3 (The Cochrane Collaboration, Copenhagen, Denmark) was selected to perform meta-analysis. A total of 1,060 participants who were scheduled for gynecological laparoscopic surgery or laparoscopic cholecystectomy (LC) were enrolled in 12 selected RCTs. The methodological qualities of the studies were evaluated as moderate to high. The combined data showed that perioperative parecoxib injection could significantly reduce the proportion of patients who required adjuvant pain relieve after laparoscopic surgeries. Significantly lower pain scores in the parecoxib groups were observed, which proved that preoperative or intraoperative injection of 40 mg parecoxib was more effective than placebo for immediate pain relief after LC. But preoperative injection of 40 mg parecoxib showed no improvement compared with placebo in the management of immediate pain following gynecological laparoscopic surgery. The occurrence of adverse events showed no differences between perioperative parecoxib administration and placebo control. Perioperative parecoxib administration was effective in reducing the proportion of patients who required adjuvant pain relief after laparoscopic surgeries without significant adverse events compared with placebo. The effect of parecoxib injection on immediate pain relief remains in question. Future RCTs

Intraarticular cortisone injection for osteoarthritis of the hip. Is it effective? Is it safe?

PubMed

Kruse, David W

2008-12-01

Osteoarthritis of the hip is a significant source of morbidity in the elderly. Treatment guidelines are available for the management of hip osteoarthritis, but these do not address the application of intraarticular corticosteroid injection. The intraarticular injection of corticosteroid is used in the management of other large joint osteoarthritic diseases and is well studied in the knee, however, this data cannot be used to make sound clinical decisions regarding its use for hip osteoarthritis. There are also concerns regarding the safety of this modality. Review of the published literature reveals that there are eight trials examining the efficacy of intraarticular corticosteroid injection for hip osteoarthritis and of these only four are randomized controlled trials. In general, the available literature demonstrates a short-term reduction of pain with corticosteroid injection and is indicated for patients refractory to non-pharmacologic or analgesic and NSAID therapy. The use of radiologic-guidance is recommended and, with proper sterile technique, the risk of adverse outcomes is very low. Future randomized controlled trials are needed to further examine the efficacy and safety of intraarticular corticosteroid injection for hip osteoarthritis.

9 CFR 113.38 - Guinea pig safety test.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

9 CFR 113.38 - Guinea pig safety test.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

9 CFR 113.38 - Guinea pig safety test.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

9 CFR 113.38 - Guinea pig safety test.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

9 CFR 113.38 - Guinea pig safety test.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

Using cold air for reducing needle-injection pain.

PubMed

Al-Qarqaz, Firas; Al-Aboosi, Mustafa; Al-shiyab, Diala; Al Dabbagh, Ziad

2012-07-01

Pain is associated with skin injections. Reducing injection-associated pain is important especially when multiple injections are needed in difficult areas, such as the palms. We present a new safe application for cold air used in laser therapy. The main objectives of this study are to see whether cold air can reduce needle-injection pain and to evaluate the safety of this new application. Patients undergoing skin injection (n=40) were included. Assessment of pain level using visual analog scale (VAS) was done using cold air and again without cold air in the same patient. Comparison of pain scores was performed. Thirty-three patients had lower VAS scores using cold air. Five patients had worse VAS scores, and two patients did not have any change in their pain score. In the group of patients where injections were made to the palms (n=5), there was even more reduction in VAS scores. There were no significant immediate or delayed side effects. Cold air seems to be useful in reducing needle-injection pain in the majority of patients, especially in the palms. This procedure is safe, apart from immediate tolerable discomfort when used around the nose. © 2012 The International Society of Dermatology.

Endoscopic Cyanoacrylate Injection with Post-injection Audible Doppler Assessment of Gastric Varices: A Single-Institution Experience.

PubMed

Catron, Tom D; Smallfield, George B; Kang, Le; Sterling, Richard K; Siddiqui, Mohammad S

2017-11-01

Gastric varices (GV) have higher rates of morbidity and mortality from hemorrhage than esophageal varices. Several studies have shown the safety and efficacy of cyanoacrylate (CA) injection for acute gastric variceal hemorrhage. We report data from our experience with CA injection for GV before and after routine use of post-injection audible Doppler assessment (ADA) for GV obturation and describe long-term outcomes after this therapy. We retrospectively identified patients who had documented GV, underwent CA injection, and had at least 2 weeks of follow-up. We recorded and analyzed the survival and rebleeding rates with patient demographics, clinical data, and endoscopy findings between two groups of patients who were categorized by CA injection prior to and after inception of the ADA technique. Seventy-one patients were identified with 16 patients analyzed in a group where ADA was not used (Pre-ADA) and 55 analyzed where ADA was used (Post-ADA). No rebleeding events were observed within 1 week of initial CA injection. No embolic events were reported after any initial CA injection within 4 weeks. The rate of bleed-free survival at 1 year was 69.6% in the Pre-ADA group and 85.8% in the Post-ADA without statistical significance. The all-cause 1-year mortality was 13.8% in the Pre-ADA group and 10.7% in the Post-ADA group without statistical significance. ADA of CA-injected GV does not appear to significantly affect adverse events or clinical outcomes; however, our findings are limited by small sample size and cohort proportions allowing for significant type II statistical error. Further prospective investigation is required to determine the impact of ADA on clinical outcomes after GV obturation.

[Development of injection containers for patient and medical staff].

PubMed

Kawasaki, Yoichi; Sendo, Toshiaki

2015-01-01

Recently, there has been a transition from glass to plastic injection containers in Japan. In our previous study, we suggested that plastic containers had less impurity contamination than glass containers. However, the use of some plasticizers has been limited because of their endocrine disrupting effects. Therefore, contamination has been a concern due to chemicals in injection solution packed with plastic containers. Indeed, in our recent study, photoinitiators were detected in an injection solution coming from plastic containers. Photoinitiators mainly exist in ink. We therefore speculated that ink originating from a photoinitiator directly printing on plastic containers had migrated into the injection solutions. In a clinical setting, plastic containers are very tractable because they are lightweight and less breakable. On the other hand, from a safety view point, these containers may be hazardous because of permeation by steam, ambient air or photoinitiators. In the present symposium, we will discuss the risk of photoinitiators leaking into injection solution packed with plastic containers, and countermeasures to avoid this risk.

Safety becomes danger: dilemmas of drug-use in public space.

PubMed

Dovey, K; Fitzgerald, J; Choi, Y

2001-12-01

This paper provides a socio-spatial analysis of injecting drug-use in public space. It focuses on one urban district in Melbourne, Australia, which has become strongly identified with heroin sale and use in public space. Selling activities are camouflaged within a diverse street life while injecting sites are dispersed through a broad diversity of laneways, car parks and toilets. These injecting zones occupy liminal places which slide between categories of private and public, and which mediate complex and paradoxical relations between safety and danger. Those who inject in public space are caught in a dilemma--needing both privacy and exposure in the event of an overdose, safety from police becomes danger from an overdose. This empirical work, based on interview and spatial analysis, is presented as a basis for theorizing the socio-spatial construction of heroin use and for assessing the prospects for safe injecting.

[On the history of injection].

PubMed

Norn, Svend; Kruse, Poul R; Kruse, Edith

2006-01-01

Although the effect of snake bites and poisoned arrows was known from ancient time, the development of the syringe and the needle lasted several centuries. Forms of intravenous injection and infusion are clearly documented in the 1650s. Sir Christopher Wren used a syringe made of animal bladder fixed to a goose quill to inject wine and opium into the veins of dogs. J.D. Major from Kiel and J.S. Elsholtz from Berlin probably were the first to deliberately administer intravenous injections to people in the 1660s. However, these early injections were not successful and injections did not come into fashion again until the latter part of the 1800s. Forerunners of subcutaneous administration were either the introduction of the drug under the epidermis by means of a vaccination-lancet or the application of a vesicant to remove the epidermis, after which the drug was applied to the denuded cutis. Lafargue, Lembert and Lesieur described these methods in the first half of the 1800s, and the methods continued to be of use in the second part of the century until the advent of subcutaneous injection. Alexander Wood of Edinburgh and Charles-Gabriel Pravaz from Lyon are known commonly as the inventors of the syringe for subcutaneous injection, but other pioneers such as Taylor, Washington and Rynd had already begun this form of administration. Increased use, safety and accuracy were accomplished by the progressive steps introduced by Wood, Pravaz and Luer. Thus, the syringe of Luer was fitted for aseptic heating, and a sharp needle readily perforated the skin. Sterilization by heating in an autoclave was developed by Pasteur, Chamberland and Koch, after managing aseptic conditions by the addition of preservatives such as carbolic acid. A safe method for the storage of sterile injectates was provided by Limousin's ampoule from 1886, and later by the introduction of multi-dose containers. The evolution of the syringe and its needle continues with the introduction of transdermal

Efficacy and safety of botulinum toxin injection for interstitial cystitis/bladder pain syndrome: a systematic review and meta-analysis.

PubMed

Shim, Sung Ryul; Cho, Young Joo; Shin, In-Soo; Kim, Jae Heon

2016-08-01

To investigate the overall treatment efficacy and safety of botulinum toxin type A (BoNTA) injections compared with placebo in interstitial cystitis/bladder pain syndrome (IC/BPS). We conducted a systematic review and meta-analysis of the published literature in PubMed, Cochrane Library, and EMBASE on BoNTA use in IC/BPS. Outcome measures included changes of OLS, ICSI, ICPI, VAS, frequency, nocturia, FBC, Qmax, and PVR from baseline and also included adverse events. A total of five studies were included, with a total sample size of 252 subjects (133 subjects in the experimental group and 119 subjects in the control group). The duration of follow-up ranged from 8 to 12 weeks. The BoNTA dosage was from 50 to 200 U. The pooled overall SMD in the mean change of VAS for the BoNTA group versus the placebo group was -0.49 (95 % CI -0.74, -0.23). There were also significant improvements in ICPI and frequency. The other outcomes (ICSI, nocturia, Qmax, and FBC) were not statistically different between the two groups. Although BoNTA is not regulatory approved indication, this first evidence-based systematic review and meta-analysis of BoNTA injection for IC/BPS showed significant differences in efficacy of treatment compared with placebo, especially for pain control, and also showed no differences in the rate of procedure-related adverse events.

Intraoperative Injection vs Sponge-applied Mitomycin C during Trabeculectomy: One-year Study.

PubMed

S Khouri, Albert; Huang, Grace; Y Huang, Linda

2017-01-01

To determine the safety and efficacy of intraoperative injection of mitomycin C (MMC) against conventional sponge-applied MMC during trabeculectomy. This study was a retrospective, comparative case series. Thirty eyes with primary open-angle glaucoma underwent consecutive trabeculectomies with MMC injection (injection group), and thirty eyes with sponge-applied MMC were as controls (sponge group). Data were collected preoperatively and postoperatively at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year after surgery. Demographic data, applanation intraocular pressure (IOP), best-corrected visual acuity (VA), number of glaucoma medications, postoperative interventions, postoperative complications, and number of visits within 3 months were recorded. In order to stratify data, proportion of eyes achieving >30% IOP reduction from baseline with or without glaucoma medications was calculated and defined as surgical success. Mean IOP reduction at 1 year was significant in both the injection and sponge groups from baseline (46.8 and 37.8% respectively). The injection group had overall lower postoperative IOP and comparable complete treatment success, defined as achieving >30% IOP reduction without glaucoma medications (p = 0.941). The number of postoperative visits within 3 months and the proportion of eyes needing 5-fluorouracil (5-FU) intervention were significantly lower in the injection group (p = 0.03, p = 0.04 respectively). Injection of MMC was as safe and effective as sponge application with comparable estimated complete treatment success, less need for visits within 3 months, and 5-FU intervention. Surgeons may consider intraopera-tive injection of MMC in appropriate patient cohorts given comparable safety and efficacy and several advantages over traditional sponge application. Further study in a prospective, larger, long-term manner is necessary to assess this modality. How to cite this article: Khouri AS, Huang G, Huang LY. Intraoperative Injection vs

Intra-articular glucocorticoid injections in patients with juvenile idiopathic arthritis in a Singapore hospital

PubMed Central

Leow, Olivia Min Yi; Lim, Lee Kean; Ooi, Pei Ling; Shek, Lynette Pei Chi; Ang, Elizabeth You Ning; Son, Mary Beth

2014-01-01

INTRODUCTION This study aimed to evaluate the efficacy and safety of intra-articular glucocorticoid (IAG) injections in our institution in children with juvenile idiopathic arthritis (JIA). METHODS This is a retrospective assessment of IAG injections performed by the Department of Paediatrics, National University Hospital, Singapore, from October 2009 to October 2011. A total of 26 procedures were evaluated for efficacy, considering parameters such as clinical response, changes in systemic medication, length of time between repeat injections, safety, consent-taking, pre- and post-procedural advice, compliance with aseptic technique, and post-procedural complications. RESULTS A total of 26 IAG injections of triamcinolone hexacetonide were administered over 17 occasions (i.e. patient encounters) to ten patients with JIA during the study period. After the injections, clinical scoring by a paediatric rheumatologist showed overall improvement by an average of 2.62 points out of 15. Besides six patient encounters that had an increase in systemic medication on the day of the injection, five required an increase within six months post injection, two required no adjustments, and one resulted in a decrease in medications. In all, 21 injections did not require subsequent injections. The mean interval between repeat injections was 7.8 months. Cutaneous side effects were noted in three anatomically difficult joints. Medical documentation with regard to patient progress was found to be lacking. CONCLUSION As per the recommendations of the American College of Rheumatology, we safely used IAG injections as the first-line therapy in our group of patients with oligoarticular JIA, and/or as an adjunct to systemic therapy in our patients with JIA. PMID:24862747

Safety and efficacy of botulinum toxin injection therapy for esophageal achalasia in Japan

PubMed Central

Yamaguchi, Daisuke; Tsuruoka, Nanae; Sakata, Yasuhisa; Shimoda, Ryo; Fujimoto, Kazuma; Iwakiri, Ryuichi

2015-01-01

Botulinum toxin injection is an accepted treatment modality for esophageal achalasia in western countries. This pilot study aimed to clarify the effectiveness of botulinum toxin injection for esophageal achalasia in Japanese patients. We enrolled 10 patients diagnosed with esophageal achalasia between 2008 and 2014. A total of 100 U botulinum toxin A was divided into eight aliquots and injected around the esophagogastric junction. We compared the lower esophageal sphincter pressure before and 1 week after treatment. Scores of subjective symptoms for esophageal achalasia were assessed using a visual analog scale (VAS) before and after 1 week of follow-up of treatment. Barium passage was improved in barium esophagography and passage of contrast agent was also improved. Mean Eckardt score was reduced from 5.5 to 1.6 after treatment (p<0.001). By esophageal manometric study, mean lower esophageal sphincter pressure was reduced from 46.9 to 29.1 mmHg after treatment (p = 0.002). One week after treatment, mean VAS score was reduced from 10 to 3.9 (p<0.001). There were no side effects in any cases. Botulinum toxin injection for esophageal achalasia was safe and effective with few complications. Therefore, botulinum toxin could be used as minimally invasive therapy for esophageal achalasia in Japan. PMID:26566311

Safety and efficacy of botulinum toxin injection therapy for esophageal achalasia in Japan.

PubMed

Yamaguchi, Daisuke; Tsuruoka, Nanae; Sakata, Yasuhisa; Shimoda, Ryo; Fujimoto, Kazuma; Iwakiri, Ryuichi

2015-11-01

Botulinum toxin injection is an accepted treatment modality for esophageal achalasia in western countries. This pilot study aimed to clarify the effectiveness of botulinum toxin injection for esophageal achalasia in Japanese patients. We enrolled 10 patients diagnosed with esophageal achalasia between 2008 and 2014. A total of 100 U botulinum toxin A was divided into eight aliquots and injected around the esophagogastric junction. We compared the lower esophageal sphincter pressure before and 1 week after treatment. Scores of subjective symptoms for esophageal achalasia were assessed using a visual analog scale (VAS) before and after 1 week of follow-up of treatment. Barium passage was improved in barium esophagography and passage of contrast agent was also improved. Mean Eckardt score was reduced from 5.5 to 1.6 after treatment (p<0.001). By esophageal manometric study, mean lower esophageal sphincter pressure was reduced from 46.9 to 29.1 mmHg after treatment (p = 0.002). One week after treatment, mean VAS score was reduced from 10 to 3.9 (p<0.001). There were no side effects in any cases. Botulinum toxin injection for esophageal achalasia was safe and effective with few complications. Therefore, botulinum toxin could be used as minimally invasive therapy for esophageal achalasia in Japan.

Preventing contamination between injections with multiple-use nozzle needle-free injectors: a safety trial.

PubMed

Kelly, Kimberly; Loskutov, Anatoly; Zehrung, Darin; Puaa, Kapaakea; LaBarre, Paul; Muller, Nancy; Guiqiang, Wang; Ding, Hui-Guo; Hu, Darong; Blackwelder, William C

2008-03-04

Multiple-use nozzle jet injectors (MUNJIs), a type of needle-free injector, use a high-pressure stream to penetrate skin and deliver medicament. Concerns for their potential to transmit blood borne pathogens led to development of a hybrid MUNJI for use in mass immunizations. The HSI-500, referred to here as a protector cap needle-free injector (PCNFI), utilizes a disposable cap as a shield between the reusable injector nozzle and the skin to reduce the risk of contamination. This study aimed to determine the presence of hepatitis B virus (HBV) contamination in post-injection ("next person") samples immediately following injection in HBV-carrier adults. Tolerability and pain were also assessed. The study ended early because the PCNFI failed to prevent contamination in the first batch tested (8.2% failure rate). The injections were very well tolerated, with most followed by no bleeding (81.2%) or mild bleeding (7.8%). 55.2% of participants experienced no pain while 42.3% experienced mild pain following injection.

Technical tips for collagenase injection treatment for Dupuytren contracture.

PubMed

Meals, Roy A; Hentz, Vincent R

2014-06-01

We describe technical tips for injecting collagenase into Dupuytren cords based on experience acquired during the prerelease Food and Drug Administration clinical trials and with subsequent clinical practice. These tips include techniques for extracting the reconstituted enzyme efficiently from the vial, injecting the cord(s) with increased safety to the tendons, and anesthetizing the hand before manipulation. The tips are intended to supplement but by no means replace the manufacturer's prescribing information and training video. Copyright © 2014 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Multiple collagenase injections are safe for treatment of Dupuytren's contractures.

PubMed

Gajendran, Varun K; Hentz, Vincent; Kenney, Deborah; Curtin, Catherine M

2014-07-01

The authors report the case of a 65-year-old, right-hand-dominant man who had severe Dupuytren's disease with multiple cords and flexion contractures of the metacarpophalangeal and proximal interphalangeal joints of both hands and underwent repeated collagenase injections for treatment. Collagenase has been shown to be safe and effective in the treatment of Dupuytren's contractures when administered as a single dose, but the results of multiple injections over a prolonged period are unknown. Antibodies to collagenase develop in all patients after several treatments, raising concerns about safety and efficacy as a result of sensitization from repeated exposures. The antibodies generated as a result of repeated exposure to collagenase could theoretically render it less effective with time and could also lead to immune reactions as severe as anaphylaxis. The authors present the case of a single patient who experienced continued correction of his contractures with only minor and self-limited adverse reactions after administration of 12 collagenase doses through 15 injections during a 4-year period. Over time, the injections continued to be effective at correcting metacarpophalangeal joint contractures, but less effective at correcting proximal interphalangeal joint contractures. The patient did eventually require a fasciectomy, but the safety and modest success of the repeated collagenase injections shows promise for a less invasive treatment with a better risk profile than open fasciectomy. Although further studies are needed, repeated administration of collagenase appears to be safe and modestly effective for severe Dupuytren's contractures, although a fasciectomy may ultimately be required in the most severe cases. Copyright 2014, SLACK Incorporated.

Alopecia with foreign body granulomas induced by Radiesse injection: A case report.

PubMed

Liu, Ren-Feng; Kuo, Tseng-Tong; Chao, Yen-Yu; Huang, Yu-Huei

2018-02-26

Radiesse is a soft tissue filler which has been widely used for cosmetic enhancement. The safety of Radiesse has been thoroughly investigated via numerous studies. A late-onset complication of Radiesse injection consists of foreign body granulomas, with only three case reports in over 10 years of clinical use. Herein, we describe the case of a patient who experienced alopecia with foreign body granulomas at the injection region one month after receiving a Radiesse injection. To our knowledge, this is the first report in the English literature of alopecia as an adverse event associated with Radiesse injection. The present case reminded physicians to evaluate more cautiously the necessity of injecting filler into hair-bearing area for lifting purpose. This procedure may cause foreign body granulomatous reaction, which may result in hair loss at the injection region.

Autologous Platelet-Poor Plasma Gel for Injection Laryngoplasty

PubMed Central

Woo, Seung Hoon; Kim, Jin Pyeong; Park, Jung Je; Chung, Phil-Sang

2013-01-01

Purpose To overcome the potential disadvantages of the use of foreign materials and autologous fat or collagen, we introduce here an autologous plasma gel for injection laryngoplasty. The purpose of this study was to present a new injection material, a plasma gel, and to discuss its clinical effectiveness. Materials and Methods From 2 mL of blood, the platelet poor serum layer was collected and heated at 100℃ for 12 min to form a plasma gel. The plasma gel was then injected into a targeted site; the safety and efficacy thereof were evaluated in 30 rats. We also conducted a phase I/II clinical study of plasma gel injection laryngoplasty in 11 unilateral vocal fold paralysis patients. Results The plasma gel was semi-solid and an easily injectable material. Of note, plasma gel maintains the same consistency for up to 1 year in a sealed bottle. However, exposure to room air causes the plasma gel to disappear within 1 month. In our animal study, the autologous plasma gel remained in situ for 6 months in animals with minimal inflammation. Clinical study showed that vocal cord palsy was well compensated for with the plasma gel in all patients at two months after injection with no significant complications. Jitter, shimmer, maximum, maximum phonation time (MPT) and mean voice handicap index (VHI) also improved significantly after plasma gel injection. However, because the injected plasma gel was gradually absorbed, 6 patients needed another injection, while the gel remained in place in 2 patients. Conclusion Injection laryngoplasty with autologous plasma gel may be a useful and safe treatment option for temporary vocal cord palsy. PMID:24142660

Post-marketing safety monitoring of shenqifuzheng injection: a solution made of dangshen (Radix Codonopsis) and huangqi (Radix Astragali Mongolici).

PubMed

Ai, Qinghua; Zhang, Wen; Xie, Yanming; Huang, Wenhua; Liang, Hong; Cao, Hui

2014-08-01

To identify the potential risk factors associated with Shenqifuzheng injection (SFI), a solution made of Dangshen (Radix Codonopsis) and Huangqi (Radix Astragali Mongolici), for the timely provision of information to regulatory authorities. A comprehensive analysis of the production process, quality standards, pharmacology, post-marketing clinical studies, and safety evaluation using the primary literature of adverse reactions (ADR), case analyses, and systematic reviews, intensive hospital safety monitoring of post-marketing drugs, and data provided by the hospital information system (HIS). Sub-acute toxicity tests suggesting that a dose of 15 mL/kg (concentrated solution) had specific biological effects, whereas a smaller dose engendered no observable effects. Long-term toxicity testing in domestic rabbits showed that after SFI was administered for 90 days, the animals in each dosing group showed no chronic toxic reactions. Among 20 100 cases observed, the incidence of an ADR was 1.85 per thousand. From March to November 2013, of the leading institutions and 22 sub-centers involved in the post-marketing clinical safety intensive hospital monitoring, 21 units completed 8484 cases of monitoring, and reported 23 cases of adverse reactions. No damage to renal function was found using SFI at a dosage and a treatment course larger and longer than that recommended for the adjuvant treatment of tumors. This could reduce the mortality rate of admitted patients based on the analysis of the data provided by the HIS. A total of 16 clinical case reports of adverse reactions related to SFI in 1999-2012 were obtained through literature retrieval. These reports contained information concerning 17 cases, with adverse reaction symptoms including thrombocytopenia, rash, chills, feeling cold, palpitation, dyspnea, edema of a lower extremity, palpebral edema, and superficial vein inflammation, among others. This study introduces "get full access" to the flow of information on

Nursing benefits of using an automated injection system for ictal brain single photon emission computed tomography.

PubMed

Vonhofen, Geraldine; Evangelista, Tonya; Lordeon, Patricia

2012-04-01

The traditional method of administering radioactive isotopes to pediatric patients undergoing ictal brain single photon emission computed tomography testing has been by manual injections. This method presents certain challenges for nursing, including time requirements and safety risks. This quality improvement project discusses the implementation of an automated injection system for isotope administration and its impact on staffing, safety, and nursing satisfaction. It was conducted in an epilepsy monitoring unit at a large urban pediatric facility. Results of this project showed a decrease in the number of nurses exposed to radiation and improved nursing satisfaction with the use of the automated injection system. In addition, there was a decrease in the number of nursing hours required during ictal brain single photon emission computed tomography testing.

[Needle-free injection--science fiction or comeback of an almost forgotten drug delivery system?].

PubMed

Ziegler, Andreas

2007-08-01

The first to create a "needle-free injector" was the American anesthetist Robert A. Hingson, 65 year ago. Since that time those devices underwent a changeful history. In 1986 an outbreak of hepatitis B among patients receiving injections from a needle-free multiple-use-nozzle injector was documented and related to the use of the injector device. Due to such risk of transmission of infection with these reusable devices, their application has been restricted. In 1998 the WHO recommended that only conventional needles and syringes should be used for immunization until safe needle-free injectors are identified through independent safety testing. Since needle-free injection has shown numerous advantages in comparison to conventional injection, new systems were developed that combine the advantages of needle-free injection with sufficient safety in mass vaccination programs. As an alternative to this early injector type, the disposable-cartridge injectors were developed. The newest research field in the area of the needle-free injection systems opened with the development of powder injectors, in which the drug preparation is no longer a suspension or solution, but a powdered solid. This injector type using powder formulations shows a number of advantages in comparison with the conventional needle/syringe injection technique as well as towards the liquid jet injectors. Due to this new kind of injectors the comeback of the needle-free injection technique in large-scale vaccination programs of the WHO seems reasonable and within reach.

21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Inactivated influenza vaccine, general safety test... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety test... subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each guinea...

21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Inactivated influenza vaccine, general safety test... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety test... subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each guinea...

21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Inactivated influenza vaccine, general safety test... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety test... subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each guinea...

21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Inactivated influenza vaccine, general safety test... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety test... subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each guinea...

Micro-fragmented adipose tissue injection for the treatment of complex anal fistula: a pilot study accessing safety and feasibility.

PubMed

Naldini, G; Sturiale, A; Fabiani, B; Giani, I; Menconi, C

2018-02-01

The aim of the present study was to evaluate the safety and efficacy of autologous, micro-fragmented and minimally manipulated adipose tissue injection associated closure of the internal opening in promoting healing of complex anal fistula. A pilot study was conducted on patients referred to our center with anal fistula, from April 2015-December 2016. Inclusion criteria were age over 16 years old and a diagnosis of complex anal fistula according to the American Gastroenterological Association classification The patients were divided into 2 groups; the "first time group" (Group I) in which micro-fragmented adipose tissue injection with closure of the internal opening was the first sphincter-saving procedure, and the "recurrent group" (Group II) consisting of patients who had failed prior sphincter-saving procedures. The procedure was carried out 4-6 weeks after seton placement. Follow-up visits were scheduled at 7 days, and 1, 3, 6 and 12 months after surgery. Fistula healing was defined as the closure of the internal and external openings without any discharge. Out of 47 patients with complex transsphincteric anal fistula, 19 met the inclusion criteria and were selected to undergo the procedure. Twelve of these patients (Group I) had micro-fragmented adipose tissue injection as first-line treatment, and 7 (Group II) had failed previous sphincter-saving procedures. The mean operative time was 55 ± 6 min (range 50-70 min). The mean postoperative pain score measured with the visual analog pain scale was 2 ± 1.4 (range 0-4). No intraoperative difficulties related to the use of the kit were recorded. There were no cases of postoperative fever or abdominal sepsis related to the procedure and no post-treatment perianal bleeding or impaired anal continence. Only 3 cases of minor abdominal wall hematoma that did not require any treatment and 1 case of perianal abscess were observed. Patients were evaluated for a mean follow-up time of 9 ± 3.1 months (range 3

Comparison of Single Intra-Articular Injection of Novel Hyaluronan (HYA-JOINT Plus) with Synvisc-One for Knee Osteoarthritis: A Randomized, Controlled, Double-Blind Trial of Efficacy and Safety.

PubMed

Sun, Shu-Fen; Hsu, Chien-Wei; Lin, Huey-Shyan; Liou, I-Hsiu; Chen, Yin-Han; Hung, Chia-Ling

2017-03-15

Viscosupplementation has been widely used for the treatment of knee osteoarthritis. Because we found no well-controlled trial comparing single-injection regimens of hyaluronan for knee osteoarthritis, we compared the efficacy and safety of a single intra-articular injection of a novel cross-linked hyaluronan (HYA-JOINT Plus) with a single injection of Synvisc-One in patients with knee osteoarthritis. In a prospective, randomized, controlled, double-blind trial with a 6-month follow-up, 132 patients with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) were randomized to receive 1 intra-articular injection of 3 mL of HYA-JOINT Plus (20 mg/mL) (n = 66) or 6 mL of Synvisc-One (8 mg/mL) (n = 66). The primary outcome was the change from baseline in the visual analog scale (VAS) (0 to 100 mm) pain score at 6 months. Secondary outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert scale), Lequesne index, timed "Up & Go" (TUG) test, single-limb stance (SLS) test, use of rescue analgesics, and patient satisfaction. A total of 121 patients were available for the intention-to-treat analysis at 6 months. Both groups had a significant improvement in the VAS, WOMAC, and Lequesne index scores at each follow-up visit (p < 0.001). Patients who received HYA-JOINT Plus experienced a significantly greater improvement in the VAS pain score at 1, 3, and 6 months compared with those treated with Synvisc-One (adjusted mean difference: -12.0, -8.5, and -6.6; p = 0.001, 0.033, and 0.045, respectively). There were no significant between-group differences in any of the secondary outcomes except the WOMAC stiffness scores at 6 months, which favored HYA-JOINT Plus treatment (p = 0.043). The TUG time did not change significantly in either group during the study (p > 0.05), but the SLS time improved significantly in both the HYA-JOINT Plus and the Synvisc-One group (p = 0.004 and p = 0.022, respectively). No significant between

Pilot cohort study of endoscopic botulinum neurotoxin injection in Parkinson's disease.

PubMed

Triadafilopoulos, George; Gandhy, Rita; Barlow, Carrolee

2017-11-01

Gastrointestinal symptoms, such as dysphagia, postprandial bloating, and defecatory straining are common in Parkinson's Disease (PD) and they impact quality of life. Endoscopic botulinum neurotoxin (BoNT) injection has been used in the treatment of dysphagia, gastroparesis and chronic anismus. To examine the feasibility, safety and efficacy of endoscopically delivered BoNT injection to distal esophagus, pylorus or anal canal aiming at relieving regional gastrointestinal symptoms in patients with PD. This is a retrospective open cohort pilot study to assess the clinical response to endoscopic BoNT injection on selected PD patients with symptoms and identifiable abnormalities on high-resolution manometry and wireless motility capsule, to generate early uncontrolled data on feasibility, tolerability, safety and efficacy. Baseline symptoms and response to therapy were assessed by questionnaires. Fourteen PD patients (10 M:4 F), mean age 73 (range: 62-93) were treated. Three patients had esophageal Botox for ineffective esophageal motility (IEM) (n = 1), esophago-gastric junction outlet obstruction (EGJOO) & IEM (n = 1), and diffuse esophageal spasm (DES) (n = 1). Nine patients were treated with pyloric BoNT injection for gastroparesis with mean gastric transit time of 21.2 h; range 5.2-44.2 h. Two patients received anal Botox for defecatory dyssynergia ((Type I) (n = 1) and overlap (slow-transit and dyssynergic) constipation (n = 1). Endoscopic BoNT injection (100-200 units) was well tolerated and there were no significant adverse events. Endoscopic BoNT injection to esophagus, pylorus or anal canal is safe, well-tolerated and leads to symptomatic improvement that lasts up to several months. The procedure can be repeated as needed and combined with other therapies. Copyright © 2017 Elsevier Ltd. All rights reserved.

Design optimisation of a nanofluid injection system for LOCA events in a nuclear power plant

NASA Astrophysics Data System (ADS)

Călimănescu, I.; Stan, L. C.; Velcea, D. D.

2016-08-01

The safety issues inside a Nuclear Power Plant (NPP) are encompassing their capacity to ensure the heat sink, meaning the capacity of the systems to release the heat from the rector to the environment. The nanofluids having good heat transfer properties, are recommended to be used in such applications. The paper is solving the following scenario: considering the Safety Injection tank and the Nanofluid injection Tank, and considering the Nanofluid injection Tank filled with a 10% alumina-water nanofluid, how can we select the best design of the connecting point between the pipes of the SIT and the Nanofluid Tank and the pressures inside of any of these tanks in order to have the biggest density of nanoparticles leaving the tanks toward the cold leg. In conclusion the biggest influence over the rate of disposal of the nanofluid inside ECCS is that of the pressure inside the SIT followed in order by the injection pipe diameter and the pressure inside the nanofluid tank. The optimum balance of these three design parameters may be reached following the procedure shown in this paper.

Bladder base/trigone injection is safe and as effective as bladder body injection of onabotulinumtoxinA for idiopathic detrusor overactivity refractory to antimuscarinics.

PubMed

Kuo, Hann-Chorng

2011-09-01

The purpose of this study was to evaluate the efficacy and safety of onabotulinumtoxinA injections at bladder base/trigone and compare with injections at bladder body or bladder body/trigone for the treatment of idiopathic detrusor overactivity (IDO) refractory to antimuscarinics. A single blind, randomized, paralleled, actively controlled trial was performed in patients with urodynamically proven IDO who failed antimuscarinic therapy. Patients were randomly assigned to receive intravesical injections of 100 U of onabotulinumtoxinA into three different bladder sites. All treatments were evaluated by voiding diary variables, urgency severity score, urodynamic studies, and patient perception of bladder condition. Long-term success rates over 12 months were also determined. Among the patients, 37 were randomized to injections in the bladder body, 35 into the bladder body/trigone, and 33 into the bladder base/trigone. Successful results were reported in 76 (72%) patients at 3 months: 26 (70%) in the bladder body group, 26 (74%) in the bladder body/trigone group, and 24 (73%) in the bladder base/trigone group. There were no significant differences in success rates, changes in urgency and urgency incontinence episodes, urodynamic variables, or long-term success rates among the three subgroups. The incidence of adverse events was similar among three groups. No vesicoureteral reflux was noted in all patients with or without involving trigone injection. Intravesical onabotulinumtoxinA injection is an effective treatment for IDO regardless of the bladder injection site. Bladder base/trigone injection is as safe and effective as bladder body injections with or without trigone involvement. Copyright © 2011 Wiley-Liss, Inc.

Safer injections following a new national medicine policy in the public sector, Burkina Faso 1995 – 2000

PubMed Central

Logez, Sophie; Hutin, Yvan; Somda, Paul; Thuault, Jérôme; Holloway, Kathleen

2005-01-01

Background The common failure of health systems to ensure adequate and sufficient supplies of injection devices may have a negative impact on injection safety. We conducted an assessment in April 2001 to determine to which extent an increase in safe injection practices between 1995 and 2000 was related to the increased access to injection devices because of a new essential medicine policy in Burkina Faso. Methods We reviewed outcomes of the new medicine policy implemented in1995. In April 2001, a retrospective programme review assessed the situation between 1995 and 2000. We visited 52 health care facilities where injections had been observed during a 2000 injection safety assessment and their adjacent operational public pharmaceutical depots. Data collection included structured observations of available injection devices and an estimation of the proportion of prescriptions including at least one injection. We interviewed wholesaler managers at national and regional levels on supply of injection devices to public health facilities. Results Fifty of 52 (96%) health care facilities were equipped with a pharmaceutical depot selling syringes and needles, 37 (74%) of which had been established between 1995 and 2000. Of 50 pharmaceutical depots, 96% had single-use 5 ml syringes available. At all facilities, patients were buying syringes and needles out of the depot for their injections prescribed at the dispensary. While injection devices were available in greater quantities, the proportion of prescriptions including at least one injection remained stable between 1995 (26.5 %) and 2000 (23.8 %). Conclusion The implementation of pharmaceutical depots next to public health care facilities increased geographical access to essential medicines and basic supplies, among which syringes and needles, contributing substantially to safer injection practices in the absence of increased use of therapeutic injections. PMID:16364178

A comparison of the oral application and injection routes using the onderstepoort biological products fowl typhoid vaccine, its safety, efficacy and duration of protection in commercial laying hens.

PubMed

Purchase, C; Picard, J; McDonald, R; Bisschop, S P R

2008-03-01

This study was undertaken to establish whether the Onderstepoort Biological Products Fowl Typhoid (OBPft) vaccine registered as an injectable vaccine was effective and safe when administered orally to commercial layers. Its efficacy and duration of protection were compared with application by intramuscular injection. Commercial brown layer hens were used as they were found to be highly susceptible to Salmonella gallinarum infections. In the vaccine safety trial birds were euthanased at timed intervals spanning 4 weeks postvaccination. Necropsies were performed and samples were taken and tested. No clinical signs or mortalities could be attributed to the OBPft vaccine nor could active shedding of the vaccine strain be detected. Slight pathological changes were noted with both routes of vaccination; however, these changes were transient, returning to normal within the observation period. The injected groups showed a better serological response with the rapid serum plate agglutination (RSPA) test than the orally vaccinated groups. In the duration of protection trial, birds were challenged at 3-8-week intervals post-vaccination. All unvaccinated birds died. Protection 8 and 16 weeks after vaccination was above 60 %,by 24 weeks after challenge, the vaccine protection was below 30 %. It was found that there was no significant difference (P < 0.05) in the protection offered by either the oral or injected route of vaccination with the OBPft vaccine.

Vibration anesthesia for the reduction of pain with facial dermal filler injections.

PubMed

Mally, Pooja; Czyz, Craig N; Chan, Norman J; Wulc, Allan E

2014-04-01

Vibration anesthesia is an effective pain-reduction technique for facial cosmetic injections. The analgesic effect of this method was tested in this study during facial dermal filler injections. The study aimed to evaluate the safety and efficacy of vibration anesthesia for these facial injections. This prospective study analyzed 41 patients who received dermal filler injections to the nasolabial folds, tear troughs, cheeks, and other facial sites. The injections were administered in a randomly assigned split-face design. One side of the patient's face received vibration together with dermal filler injections, whereas the other side received dermal filler injections alone. The patients completed a posttreatment questionnaire pertaining to injection pain, adverse effects, and preference for vibration with future dermal filler injections. The patients experienced both clinically and statistically significant pain reduction when a vibration stimulus was co-administered with the dermal filler injections. No adverse events were reported. The majority of the patients (95 %) reported a preference for vibration anesthesia with subsequent dermal filler injections. Vibration is a safe and effective method of achieving anesthesia during facial dermal filler injections. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Long-term follow-up of ultrasound-guided botulinum toxin-A injections for sialorrhea in neurological dysphagia.

PubMed

Barbero, Pierangelo; Busso, Marco; Tinivella, Marco; Artusi, Carlo Alberto; De Mercanti, Stefania; Cucci, Angele; Veltri, Andrea; Avagnina, Paolo; Calvo, Andrea; Chio', Adriano; Durelli, Luca; Clerico, Marinella

2015-12-01

Literature provides reports only of a limited follow-up single injection of botulinum toxin-A (BoNT-A) in patients with sialorrhea. The aim of our study is to evaluate the long-lasting efficacy and safety of ultrasound-guided BoNT-A injections for severe sialorrhea secondary to neurological dysphagia. We enrolled 38 severe adult sialorrhea patients referred consecutively to the neurology unit and performed bilateral parotid and submandibular gland BoNT-A injections under ultrasound guidance. The outcomes of the study were reduction of sialorrhea, duration of therapeutic effect, and subjective patient- and caregiver-reported satisfaction. A total of 113 BoNT-A administrations were given during the study period with a mean duration of follow-up of 20.2 ± 4.4 months. We observed a significant decrease from baseline in mean number of daily aspirations and a significant improvement in patient- and caregiver-reported outcomes following ultrasound-guided BoNT-A injections (p < 0.001 vs baseline for all comparisons) and the mean duration of the efficacy was 5.6 ± 1 months. No major treatment-related adverse events occurred and a low incidence of minor adverse events was reported. This study confirms the long-lasting efficacy and safety of ultrasound-guided BoNT-A injections for sialorrhea, regardless of the causative neurological disorder. These results should encourage the use of BoNT-A in the treatment of severe sialorrhea and highlight the role of ultrasound guidance to obtain optimal results in terms of safety and reproducible outcomes.

Huangqi injection (a traditional Chinese patent medicine) for chronic heart failure: a systematic review.

PubMed

Fu, Shufei; Zhang, Junhua; Menniti-Ippolito, Francesca; Gao, Xiumei; Galeotti, Francesca; Massari, Marco; Hu, Limin; Zhang, Boli; Ferrelli, Rita; Fauci, Alice; Firenzuoli, Fabio; Shang, Hongcai; Guerra, Ranieri; Raschetti, Roberto

2011-05-06

Chronic heart failure (CHF) is a global public health problem. Therefore, novel and effective drugs that show few side-effects are needed. Early literature studies indicated that Huangqi injection is one of the most commonly used traditional Chinese patent medicines for CHF in China. As a large number of clinical studies has been carried out and published, it is essential to evaluate the effectiveness and safety of Huangqi injection. Therefore, we carried out this systematic review under the support of the framework of the Joint Sino-Italian Laboratory (JoSIL). To evaluate the efficacy and safety of Huangqi injection for CHF according to the available scientific knowledge. An extensive search including PubMed, EMBASE, CBM, the Cochrane Library and Chinese literature databases was performed up to July 2008. Clinical trials regarding Huangqi injection for the treatment of CHF were searched for, irrespective of languages. The quality of each trial was assessed according to the Cochrane Reviewers' Handbook 5.0, and RevMan 5.0 provided by the Cochrane Collaboration and STATA 9.2 were used for data analysis. After selection of 1,205 articles, 62 RCTs and quasi-RCTs conducted in China and published in Chinese journals were included in the review. The methodological quality of the trials was low. In most trials inclusion and exclusion criteria were not specified. Furthermore, only one study evaluated the outcomes for drug efficacy after an adequate period of time. For these reasons and because of the different baseline characteristics we did not conduct a meta-analysis. Although available studies are not adequate to draw a conclusion on the efficacy and safety of Huangqi injection (a traditional Chinese patent medicine), we hope that our work could provide useful experience on further studies on Huangqi injections. The overall level of TCM clinical research needs to be improved so that the efficacy of TCM can be evaluated by the international community and possibly some

Large-particle calcium hydroxylapatite injection for correction of facial wrinkles and depressions.

PubMed

Alam, Murad; Havey, Jillian; Pace, Natalie; Pongprutthipan, Marisa; Yoo, Simon

2011-07-01

Small-particle calcium hydroxylapatite (Radiesse, Merz, Frankfurt, Germany) is safe and effective for facial wrinkle reduction, and has medium-term persistence for this indication. There is patient demand for similar fillers that may be longer lasting. We sought to assess the safety and persistence of effect in vivo associated with use of large-particle calcium hydroxylapatite (Coaptite, Merz) for facial augmentation and wrinkle reduction. This was a case series of 3 patients injected with large-particle calcium hydroxylapatite. Large-particle calcium hydroxylapatite appears to be effective and well tolerated for correction of facial depressions, including upper mid-cheek atrophy, nasolabial creases, and HIV-associated lipoatrophy. Adverse events included erythema and edema, and transient visibility of the injection sites. Treated patients, all of whom had received small-particle calcium hydroxylapatite correction before, noted improved persistence at 6 and 15 months with the large-particle injections as compared with prior small-particle injections. This is a small case series, and there was no direct control to compare the persistence of small-particle versus large-particle correction. For facial wrinkle correction, large-particle calcium hydroxylapatite has a safety profile comparable with that of small-particle calcium hydroxylapatite. The large-particle variant may have longer persistence that may be useful in selected clinical circumstances. Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Evolution of the global use of unsafe medical injections, 2000-2010.

PubMed

Pépin, Jacques; Abou Chakra, Claire Nour; Pépin, Eric; Nault, Vincent

2013-01-01

Since 1999, substantial efforts have been made by the international community to reduce the risks associated with unsafe injections, through ministries of health, international donors, the World Health Organization and the Safe Injection Global Network. The present study attempted to measure the progress, or lack thereof, made over the 2000-2010 decade in reducing unsafe injections in ten regions of the world corresponding to developing and transitional economies. Data about the number of injections per person per year and the proportion of re-use of syringes and needles were obtained for 2010, mainly from population surveys, and compared with previous estimates for 2000 which had used various sources of information including injection safety assessments, population surveys and published studies on injection practices. From 2000 to 2010, in developing countries and transitional economies, the average number of injections per person per year decreased from 3.40 to 2.88, while the proportion of re-use of injection devices dropped from 39.8% to 5.5%. Combining both factors the number of unsafe injections per person per year decreased from 1.35 to 0.16. Even if substantial progress has been made, the Eastern Mediterranean region remains problematic, with 0.57 unsafe injections per person per year. In sub-Saharan Africa and Latin America, people now receive on average only 0.04-0.05 unsafe injections per year. Substantial progress has been made in reducing the number of unsafe injections in developing countries and transitional economies, essentially through a reduction in the re-use of injection devices. In some regions, elimination of unsafe injections might become a reasonable goal.

Critical appraisal of 3-monthly paliperidone depot injections in the treatment of schizophrenia.

PubMed

Carpiniello, Bernardo; Pinna, Federica

2016-01-01

Three-monthly injections of paliperidone palmitate (PP-3M) represent a new and recently introduced long-acting antipsychotic therapeutic option. This review focuses on available data relating to the efficacy and safety of PP-3M and its position in the current therapeutic scenario. An analysis of PubMed, Scopus, and ISI Web of Knowledge databases was conducted, and all available papers on PP-3M, including poster presentations, were selected and considered for the purpose of the present review. to date, three full papers have been published, the first, a Phase 1 randomized, open label study investigating the pharmacokinetics, safety, and tolerability of the drug; the second, a Phase 3 double blind study vs placebo focusing on efficacy and tolerability; and the last relating to the practical use of PP-3M. The five posters identified describe data reported in the above-cited papers. Overall, the pharmacokinetic findings obtained in these studies highlight the feasibility of administering PP-3M on a 3-monthly basis, subsequent to the administration of four 1-monthly injections of PP at doses 3.5 times higher than the stabilized dose of 1-monthly injections of PP (ie, 175, 300, 450, and 525 mgs). The published studies highlight a significantly longer time to relapse compared to placebo, and significantly better results compared to placebo for all secondary end-points (Positive and Negative Syndrome Scale, Clinical Global Impression-Severity Scale, Personal and Social Performance Scale scores), in addition to reasonably good safety and tolerability profiles. PP-3M emerges as a potential candidate for use as a first-line long-acting agent in the maintenance treatment of patients with schizophrenia. Further studies should however be conducted to confirm this expectation. In view of its efficacy, tolerability, and safety, together with the longer timespan between injections, PP-3M currently represents one of the best available options, and may contribute towards addressing

30 CFR 250.124 - Will BSEE approve gas injection into the cap rock containing a sulphur deposit?

Code of Federal Regulations, 2012 CFR

2012-07-01

... rock containing a sulphur deposit? 250.124 Section 250.124 Mineral Resources BUREAU OF SAFETY AND... CONTINENTAL SHELF General Performance Standards § 250.124 Will BSEE approve gas injection into the cap rock containing a sulphur deposit? To receive the Regional Supervisor's approval to inject gas into the cap rock...

30 CFR 250.124 - Will BSEE approve gas injection into the cap rock containing a sulphur deposit?

Code of Federal Regulations, 2013 CFR

2013-07-01

... rock containing a sulphur deposit? 250.124 Section 250.124 Mineral Resources BUREAU OF SAFETY AND... CONTINENTAL SHELF General Performance Standards § 250.124 Will BSEE approve gas injection into the cap rock containing a sulphur deposit? To receive the Regional Supervisor's approval to inject gas into the cap rock...

30 CFR 250.124 - Will BSEE approve gas injection into the cap rock containing a sulphur deposit?

Code of Federal Regulations, 2014 CFR

2014-07-01

... rock containing a sulphur deposit? 250.124 Section 250.124 Mineral Resources BUREAU OF SAFETY AND... CONTINENTAL SHELF General Performance Standards § 250.124 Will BSEE approve gas injection into the cap rock containing a sulphur deposit? To receive the Regional Supervisor's approval to inject gas into the cap rock...

Ice Reduces Needle-Stick Pain Associated With Local Anesthetic Injection

PubMed Central

Mahshidfar, Babak; Cheraghi Shevi, Salimeh; Abbasi, Mohsen; Kasnavieh, Mohammad Hosseini; Rezai, Mahdi; Zavereh, Mina; Mosaddegh, Reza

2016-01-01

Background Local anesthetic injections are widely used in the emergency department for different purposes. Pain management for such injections is of great importance to both patients and the healthcare system. Objectives Our study aimed to determine the effectiveness and safety of cryotherapy in patients receiving local anesthetic injections. Methods Subjects who presented with superficial lacerations were randomly assigned to 2 groups, the first group received ice packing prior to injection and the second did not. The pain severity, length and depth of the laceration, and the other necessary information before and after the pain-reducing intervention were measured, documented, and compared at the end of the study. Pain scores were measured using a numerical rating scale before and after the procedure, and the differences were compared using a t-test. Results Ninety subjects were enrolled in the study, 45 in each group. There were no statistical differences between the 2 groups in terms of baseline preoperative and operative characteristics (P > 0.05). The pain scores in the cryotherapy group were significantly lower before and after the procedure (P < 0.001). There was no statistically significant difference between the 2 groups for wound infection (P = 0.783). Conclusions Cooling the injection site prior to local anesthetic injection is an effective and inexpensive method to reduce the pain and discomfort caused by the injection. PMID:27847696

Top-Off Injection and Higher Currents at the Stanford Synchrotron Radiation Lightsource

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

Bauer, Johannes M.; Liu, James C.; Prinz, Alyssa A.

2011-04-05

The Stanford Synchrotron Radiation Lightsource (SSRL) at the SLAC National Accelerator Laboratory is a 234 m circumference storage ring for 3 GeV electrons with its synchrotron radiation serving currently 13 beamlines with about 27 experimental stations. It operated for long time with 100 mA peak current provided by usually three injections per day. In July 2009, the maximum beam current was raised to 200 mA. Over the period from June 2009 to March 2010, Top-Off operation started at every beamline. Top-Off, i.e., the injection of electrons into the storage ring with injection stoppers open, is necessary for SSRL to reachmore » its design current of 500 mA. In the future, the maximal power of the injection current will also soon be raised from currently 1.5 W to 5 W. The Radiation Protection Department at SLAC worked with SSRL on the specifications for the safety systems for operation with Top-Off injection and higher beam currents.« less

Survey of intravitreal injection techniques among retina specialists in Israel

PubMed Central

Segal, Ori; Segal-Trivitz, Yael; Nemet, Arie Y; Geffen, Noa; Nesher, Ronit; Mimouni, Michael

2016-01-01

Purpose The purpose of this study was to describe antivascular endothelial growth factor intravitreal injection techniques of retinal specialists in order to establish a cornerstone for future practice guidelines. Methods All members of the Israeli Retina Society were contacted by email to complete an anonymous, 19-question, Internet-based survey regarding their intravitreal injection techniques. Results Overall, 66% (52/79) completed the survey. Most (98%) do not instruct patients to discontinue anticoagulant therapy and 92% prescribe treatment for patients in the waiting room. Three quarters wear sterile gloves and prepare the patient in the supine position. A majority (71%) use sterile surgical draping. All respondents apply topical analgesics and a majority (69%) measure the distance from the limbus to the injection site. A minority (21%) displace the conjunctiva prior to injection. A majority of the survey participants use a 30-gauge needle and the most common quadrant for injection is superotemporal (33%). Less than half routinely assess postinjection optic nerve perfusion (44%). A majority (92%) apply prophylactic antibiotics immediately after the injection. Conclusion The majority of retina specialists perform intravitreal injections similarly. However, a relatively large minority performs this procedure differently. Due to the extremely low percentage of complications, it seems as though such differences do not increase the risk. However, more evidence-based medicine, a cornerstone for practice guidelines, is required in order to identify the intravitreal injection techniques that combine safety and efficacy while causing as little discomfort to the patients as possible. PMID:27366050

Women's injection drug practices in their own words: a qualitative study.

PubMed

Tuchman, Ellen

2015-03-07

There are significant gender differences in injection drug practices and relative risks involved for women who inject drug compared with men. This qualitative study aims to explore the social, contextual, and behavioral dimensions of injecting practices among women who inject drugs. Participants were selected by purposive venue-based sampling from a syringe exchange program in 2012-2013. In-depth interviews were conducted with 26 women to elicit detailed perspectives regarding injection drug use practices and women-focused decision-making. All interviews were transcribed verbatim and analyzed with Atlas.ti. Participant's mean age was 43.2 years, 48% Caucasian, 36% African American, and 16% Latina, poorly educated, mostly single, and heroin self-injectors. Three themes emerged; a) transitioning from non-injection to injection drug use; b) patterns and variations of initiation to injecting; and c) shifting toward autonomy or reliance on others. Women were predominantly influenced to transition to injection drug use by other women with their claims that injecting was a way to curtail their daily drug expenditure. More than half the women received their first injection from another woman in their social network rather than a male sexual partner. Self-injecting women exhibited agency around the circumstances of injection safety and potential risks. Other women revealed that their inability to inject themselves could and did make them dependent on others for unsafe injection practices. The finding that many women were influenced to transition to injection drug use and receive the first injection from a woman is contrary to literature claims that male sexual partners introduce and initiate women to injection drug use. Self-injecting women possessed capacity to act in a way that produced the results they wanted, not sharing prepared drugs or injecting equipment. In stark contrast, women assisted with injections could and did make them vulnerable to unsafe injecting

Intracameral air injection for acute hydrops in keratoconus.

PubMed

Miyata, Kazunori; Tsuji, Hideki; Tanabe, Tatsuro; Mimura, Yoshiko; Amano, Shiro; Oshika, Tetsuro

2002-06-01

To evaluate the efficacy and safety of intracameral air injection in treating acute hydrops in keratoconus. Retrospective, nonrandomized, comparative trial. Thirty eyes (30 patients) with acute hydrops secondary to keratoconus. Nine eyes (nine patients) with acute hydrops in keratoconus were treated with intracameral injection of 0.1 ml filtered air. Additional 0.1 ml filtered air was injected if corneal edema persisted when air disappeared from the anterior chamber. Twenty-one eyes (21 patients) with acute hydrops that received no therapy or conventional therapy not likely to shorten the duration of hydrops served as controls. The period of persistence of corneal edema, the interval between the onset of acute hydrops, and the time when the eye could begin to wear a hard-contact lens, and best spectacle-corrected and hard-contact lens-corrected visual acuity after corneal edema subsided were used as criteria to evaluate any differences between the two groups. The average period of persistence of corneal edema was 20.1 +/- 9.0 days (+/- SD) in the intracameral air injection group and 64.7 +/- 34.6 days in the control (P =.0008). The average interval between the onset of acute hydrops and the time when the eye could begin to wear a hard-contact lens, was 33.4 +/- 5.6 days in the air injection group and 128.9 +/- 85.8 days in the control group (P =.0058). The best-corrected visual acuity after corneal edema subsided was similar between the two groups. Intracameral air injection induced no complications. The results suggest that the intracameral air injection is a safe and useful therapy to shorten the period of corneal edema in acute hydrops secondary to keratoconus.

Centrifugal Compressor Surge Margin Improved With Diffuser Hub Surface Air Injection

NASA Technical Reports Server (NTRS)

Skoch, Gary J.

2002-01-01

Aerodynamic stability is an important parameter in the design of compressors for aircraft gas turbine engines. Compression system instabilities can cause compressor surge, which may lead to the loss of an aircraft. As a result, engine designers include a margin of safety between the operating line of the engine and the stability limit line of the compressor. The margin of safety is typically referred to as "surge margin." Achieving the highest possible level of surge margin while meeting design point performance objectives is the goal of the compressor designer. However, performance goals often must be compromised in order to achieve adequate levels of surge margin. Techniques to improve surge margin will permit more aggressive compressor designs. Centrifugal compressor surge margin improvement was demonstrated at the NASA Glenn Research Center by injecting air into the vaned diffuser of a 4:1-pressure-ratio centrifugal compressor. Tests were performed using injector nozzles located on the diffuser hub surface of a vane-island diffuser in the vaneless region between the impeller trailing edge and the diffuser-vane leading edge. The nozzle flow path and discharge shape were designed to produce an air stream that remained tangent to the hub surface as it traveled into the diffuser passage. Injector nozzles were located near the leading edge of 23 of the 24 diffuser vanes. One passage did not contain an injector so that instrumentation located in that passage would be preserved. Several orientations of the injected stream relative to the diffuser vane leading edge were tested over a range of injected flow rates. Only steady flow (nonpulsed) air injection was tested. At 100 percent of the design speed, a 15-percent improvement in the baseline surge margin was achieved with a nozzle orientation that produced a jet that was bisected by the diffuser vane leading edge. Other orientations also improved the baseline surge margin. Tests were conducted at speeds below the

Comparative study of the novel and conventional injection approach for inferior alveolar nerve block.

PubMed

Boonsiriseth, K; Sirintawat, N; Arunakul, K; Wongsirichat, N

2013-07-01

This study aimed to evaluate the efficacy of anesthesia obtained with a novel injection approach for inferior alveolar nerve block compared with the conventional injection approach. 40 patients in good health, randomly received each of two injection approaches of local anesthetic on each side of the mandible at two separate appointments. A sharp probe and an electric pulp tester were used to test anesthesia before injection, after injection when the patients' sensation changed, and 5 min after injection. This study comprised positive aspiration and intravascular injection 5% and neurovascular bundle injection 7.5% in the conventional inferior alveolar nerve block, but without occurrence in the novel injection approach. A visual analog scale (VAS) pain assessment was used during injection and surgery. The significance level used in the statistical analysis was p<0.05. For the novel injection approach compared with the conventional injection approach, no significant difference was found on the subjective onset, objective onset, operation time, duration of anesthesia and VAS pain score during operation, but the VAS pain score during injection was significantly different. The efficacy of inferior alveolar nerve block by the novel injection approach provided adequate anesthesia and caused less pain and greater safety during injection. Copyright © 2012 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Efficacy and Safety of Single Botulinum Toxin Type A (Botox®) Injection for Relief of Upper Trapezius Myofascial Trigger Point: A Randomized, Double-Blind, Placebo-Controlled Study.

PubMed

Kwanchuay, Photsawee; Petchnumsin, Thavatchai; Yiemsiri, Pichet; Pasuk, Nakkamol; Srikanok, Wannarat; Hathaiareerug, Chanasak

2015-12-01

Botulinum toxin injection has been applied for pain relief in various chronic pain syndromes. Recently, systematic review studies reported inconclusive effects of Botulinum toxin in myofascial pain management. The present study aimed to demonstrate the efficacy and safety of Botulinum toxin type A (BTxA) (Botox®) injection for pain reduction in myofascial trigger point (MTrP) of the upper trapezius muscle. Thirty-three patients with 48 MTrP on the upper trapezius muscles over three months with moderate to severe pain intensity diagnosed at physical medicine and rehabilitation outpatient department were recruited between December 2011 and March 2012. Eligible patients were blinded and randomly injected with single 0.2 ml (20 IU) of BTxA for 24 MTrP and 0.2 ml of 0.9% NaCl solution for 24 MTrP at the most tender trigger point on the upper trapezius muscle. All patients were advised for stretching exercise and ergonomic adaptation throughout the study. At 3- and 6-week after injections, visual analogue scale (VAS), the pressure pain threshold (PPT), and reported adverse effects were measured. Both BTxA and control groups demonstrated statistically significant differences in VAS reduction and increased PPT after 3 weeks and 6 weeks compared with before treatment. There were no statistically significant differences in VAS reduction from baseline between the two groups at 3- and 6-week after treatment. A statistically significant difference in improvement of PPT from baseline and 6-week after BTxA injection compared with 0.9% NaCl group was shown (1.0 ± 0.9 and 0.5 ± 0.7, p = 0.036). There was mild degree side-effects that spontaneous resolved within one week in both groups without significant difference in percentage. No severe adverse effects were reported during the study. The efficacy in VAS reduction of a single 20 IU of Botulinum toxin type A (Botox®) injection was not different from 0.9% NaCl for myofascial trigger point at the upper trapezius muscle. However

Evidence based knee injections for the management of arthritis

PubMed Central

Cheng, Olivia T.; Souzdalnitski, Dmitri; Vrooman, Bruce; Cheng, Jianguo

2012-01-01

Objective Arthritis of the knee affects 46 million Americans. We aimed to determine the level of evidence of intraarticular knee injections in the management of arthritic knee pain. Methods We systematically searched PUBMED/MEDLINE and the Cochrane databases for articles published on knee injections and evaluated their level of evidence and recommendations according to established criteria. Results The evidence supports the use of intraarticular corticosteroid injections for rheumatoid arthritis (1A+ level), osteoarthritis (1A+ level), and juvenile idiopathic arthritis (2C+ level). Pain relief and functional improvement are significant for months up to one year after the injection. Triamcinolone hexacetonide offers an advantage over triamcinolone acetonide and should be the intraarticular steroid of choice (2B+ level). Intraarticular injection of hyaluronate may provide longer pain relief than steroid injection in osteoarthritis (2B+ level). It can also be effective for rheumatoid arthritis knee pain (1A+ level). However, it is only recommended for patients with significant surgical risk factors and for patients with mild radiographic disease in whom conservative treatment has failed (2B± level). Botulinum toxin Type A injection is effective in reducing arthritic knee pain (2B+ level) and so is tropisetron (2B+ level) and tanezumab (2B+ level). The new agents, such as rAAV2-TNFR:Fc, SB-210396/CE 9.1, and various radioisotopes have provided various degrees of success, but their long-term safety and efficacy remains to be determined. Conclusions We conclude that strong evidence supports the use of intraarticular knee injection as a valuable intervention in the continuum of management of arthritis between conservative treatment and knee surgeries. PMID:22621287

[Rapid screening and quality evaluation for the harmful substance 5-hydroxymethyl furfural in commercially available traditional Chinese medicine injection using LC-MS/MS method].

PubMed

Zang, Qing-ce; He, Jing-jing; Bai, Jin-fa; Zheng, Ya-jie; Zhang, Rui-ping; Li, Tie-gang; Wang, Zhong-hua; He, Jiu-ming; Abliz, Zeper

2013-11-01

To screen the harmful substance 5-hydroxymethyl furfural content in commercially available traditional Chinese medicine injection which are commonly used, and to preliminarily evaluate the quality of these injections, 5-hydroxymethyl furfural was taken as an index. The contents of 5-hydroxymethyl furfural in 56 samples which consist of 23 kinds of traditional Chinese medicine injections and glucose injection were determined using LC-MS/MS, and 5-hydroxymethyl furfural was detected in 52 of these samples. The minimal content was 0.0038 microg x L(-1) and the maximum content was 1420 microg x mL(-1). The contents of 5-hydroxymethyl furfural were significantly different in traditional Chinese medicine injection which came from different kinds, manufacturers or batches. The results showed the quality difference of commercially available traditional Chinese medicine injection is significant taking 5-hydroxymethyl furfural content as assessment index. More attention should be paid to the safety of 5-hydroxymethyl furfural in traditional Chinese medicine injection, and unified limitation standard should be set to improve medication safety of traditional Chinese medicine injection.

Predictors of injecting cessation among a cohort of people who inject drugs in Tijuana, Mexico.

PubMed

Horyniak, Danielle; Strathdee, Steffanie A; West, Brooke S; Meacham, Meredith; Rangel, Gudelia; Gaines, Tommi L

2018-04-01

Little is known about the cessation of injecting drug use (IDU) among people who inject drugs (PWID) in low and middle-income settings, where access to effective interventions for reducing drug use (e.g., opioid substitution treatment; OST), may be limited. We measured the incidence and identified predictors of IDU cessation among a cohort of PWID in Tijuana, Mexico. Data were drawn from 621 participants in Proyecto El Cuete IV, a prospective cohort of PWID recruited in 2011 and interviewed biannually to 2016. A multivariable Extended Cox model was constructed to identify socio-demographic, drug use, risk environment and health-related predictors of IDU cessation (no IDU for ≥six months). 141 participants (23%) reported at least one IDU cessation event during follow-up. The crude IDU cessation rate was 7.3 per 100 person-years (95% Confidence Interval [CI]: 6.2-8.7). IDU cessation was negatively associated with injecting at least daily on average and heroin/methamphetamine co-injection in the past six months, and positively associated with testing HIV positive at baseline, being on methadone maintenance therapy in the past six months, and recent arrest. Concern for personal safety was also independently associated with IDU cessation. The rate of IDU cessation among PWID in Tijuana was low. These findings underscore the importance of expansion of services including OST to help reduce drug use and facilitate IDU cessation for those who wish to do so. In this setting, interventions addressing individual-level economic barriers as well as broader social and structural barriers to harm reduction services are integral. Copyright © 2018 Elsevier B.V. All rights reserved.

Clinicopathologic findings following intra-articular injection of autologous and allogeneic placentally derived equine mesenchymal stem cells in horses.

PubMed

Carrade, Danielle D; Owens, Sean D; Galuppo, Larry D; Vidal, Martin A; Ferraro, Gregory L; Librach, Fred; Buerchler, Sabine; Friedman, Michael S; Walker, Naomi J; Borjesson, Dori L

2011-04-01

The development of an allogeneic mesenchymal stem cell (MSC) product to treat equine disorders would be useful; however, there are limited in vivo safety data for horses. We hypothesized that the injection of self (autologous) and non-self (related allogeneic or allogeneic) MSC would not elicit significant alterations in physical examination, gait or synovial fluid parameters when injected into the joints of healthy horses. Sixteen healthy horses were used in this study. Group 1 consisted of foals (n = 6), group 2 consisted of their dams (n = 5) and group 3 consisted of half-siblings (n = 5) to group 1 foals. Prior to injection, MSC were phenotyped. Placentally derived MSC were injected into contralateral joints and MSC diluent was injected into a separate joint (control). An examination, including lameness evaluation and synovial fluid analysis, was performed at 0, 24, 48 and 72 h post-injection. MSC were major histocompatibility complex (MHC) I positive, MHC II negative and CD86 negative. Injection of allogeneic MSC did not elicit a systemic response. Local responses such as joint swelling or lameness were minimal and variable. Intra-articular MSC injection elicited marked inflammation within the synovial fluid (as measured by nucleated cell count, neutrophil number and total protein concentration). However, there were no significant differences between the degree and type of inflammation elicited by self and non-self-MSC. The healthy equine joint responds similarly to a single intra-articular injection of autologous and allogeneic MSC. This pre-clinical safety study is an important first step in the development of equine allogeneic stem cell therapies.

Corticosteroid injection for adhesive capsulitis in primary care: a systematic review of randomised clinical trials

PubMed Central

Koh, Kim Hwee

2016-01-01

Adhesive capsulitis is a common cause of shoulder pain and limited movement. The objectives of this review were to assess the efficacy and safety of corticosteroid injections for adhesive capsulitis and to evaluate the optimum dose and anatomical site of injections. PubMed and CENTRAL databases were searched for randomised trials and a total of ten trials were included. Results revealed that corticosteroid injection is superior to placebo and physiotherapy in the short-term (up to 12 weeks). There was no difference in outcomes between corticosteroid injection and oral nonsteroidal anti-inflammatory drugs at 24 weeks. Dosages of intra-articular triamcinolone 20 mg and 40 mg showed identical outcomes, while subacromial and glenohumeral corticosteroid injections had similar efficacy. The use of corticosteroid injections is also generally safe, with infrequent and minor side effects. Physicians may consider corticosteroid injection to treat adhesive capsulitis, especially in the early stages when pain is the predominant presentation. PMID:27570870

Corticosteroid injection for adhesive capsulitis in primary care: a systematic review of randomised clinical trials.

PubMed

Koh, Kim Hwee

2016-12-01

Adhesive capsulitis is a common cause of shoulder pain and limited movement. The objectives of this review were to assess the efficacy and safety of corticosteroid injections for adhesive capsulitis and to evaluate the optimum dose and anatomical site of injections. PubMed and CENTRAL databases were searched for randomised trials and a total of ten trials were included. Results revealed that corticosteroid injection is superior to placebo and physiotherapy in the short-term (up to 12 weeks). There was no difference in outcomes between corticosteroid injection and oral nonsteroidal anti-inflammatory drugs at 24 weeks. Dosages of intra-articular triamcinolone 20 mg and 40 mg showed identical outcomes, while subacromial and glenohumeral corticosteroid injections had similar efficacy. The use of corticosteroid injections is also generally safe, with infrequent and minor side effects. Physicians may consider corticosteroid injection to treat adhesive capsulitis, especially in the early stages when pain is the predominant presentation. Copyright: © Singapore Medical Association.

Evolution of the Global Use of Unsafe Medical Injections, 2000–2010

PubMed Central

Pépin, Jacques; Abou Chakra, Claire Nour; Pépin, Eric; Nault, Vincent

2013-01-01

Objective Since 1999, substantial efforts have been made by the international community to reduce the risks associated with unsafe injections, through ministries of health, international donors, the World Health Organization and the Safe Injection Global Network. The present study attempted to measure the progress, or lack thereof, made over the 2000–2010 decade in reducing unsafe injections in ten regions of the world corresponding to developing and transitional economies. Methods Data about the number of injections per person per year and the proportion of re-use of syringes and needles were obtained for 2010, mainly from population surveys, and compared with previous estimates for 2000 which had used various sources of information including injection safety assessments, population surveys and published studies on injection practices. Results From 2000 to 2010, in developing countries and transitional economies, the average number of injections per person per year decreased from 3.40 to 2.88, while the proportion of re-use of injection devices dropped from 39.8% to 5.5%. Combining both factors the number of unsafe injections per person per year decreased from 1.35 to 0.16. Even if substantial progress has been made, the Eastern Mediterranean region remains problematic, with 0.57 unsafe injections per person per year. In sub-Saharan Africa and Latin America, people now receive on average only 0.04–0.05 unsafe injections per year. Conclusion Substantial progress has been made in reducing the number of unsafe injections in developing countries and transitional economies, essentially through a reduction in the re-use of injection devices. In some regions, elimination of unsafe injections might become a reasonable goal. PMID:24324650

Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial.

PubMed

Granel, Brigitte; Daumas, Aurélie; Jouve, Elisabeth; Harlé, Jean-Robert; Nguyen, Pierre-Sébastien; Chabannon, Christian; Colavolpe, Nathalie; Reynier, Jean-Charles; Truillet, Romain; Mallet, Stéphanie; Baiada, Antoine; Casanova, Dominique; Giraudo, Laurent; Arnaud, Laurent; Veran, Julie; Sabatier, Florence; Magalon, Guy

2015-12-01

In patients with systemic sclerosis (scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relieved by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune diseases. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with SSc with hand disability. We did an open-label, single arm, at one study site with 6-month follow-up among 12 female SSc patients with Cochin Hand Function Scale score >20/90. Autologous SVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles. Primary outcome was the number and the severity of adverse events related to SVF-based therapy. Secondary endpoints were changes in hand disability and fibrosis, vascular manifestations, pain and quality of life from baseline to 2 and 6 months after cell therapy. All enrolled patients had surgery, and there were no dropouts or patients lost to follow-up. No severe adverse events occurred during the procedure and follow-up. Four minor adverse events were reported and resolved spontaneously. A significant improvement in hand disability and pain, Raynaud's phenomenon, finger oedema and quality of life was observed. This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population. GFRS (Groupe Francophone de Recherche sur la Sclérodermie). NCT01813279. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

Effective gene expression in the rat dorsal root ganglia with a non-viral vector delivered via spinal nerve injection

PubMed Central

Chang, Ming-Fong; Hsieh, Jung-Hsien; Chiang, Hao; Kan, Hung-Wei; Huang, Cho-Min; Chellis, Luke; Lin, Bo-Shiou; Miaw, Shi-Chuen; Pan, Chun-Liang; Chao, Chi-Chao; Hsieh, Sung-Tsang

2016-01-01

Delivering gene constructs into the dorsal root ganglia (DRG) is a powerful but challenging therapeutic strategy for sensory disorders affecting the DRG and their peripheral processes. The current delivery methods of direct intra-DRG injection and intrathecal injection have several disadvantages, including potential injury to DRG neurons and low transfection efficiency, respectively. This study aimed to develop a spinal nerve injection strategy to deliver polyethylenimine mixed with plasmid (PEI/DNA polyplexes) containing green fluorescent protein (GFP). Using this spinal nerve injection approach, PEI/DNA polyplexes were delivered to DRG neurons without nerve injury. Within one week of the delivery, GFP expression was detected in 82.8% ± 1.70% of DRG neurons, comparable to the levels obtained by intra-DRG injection (81.3% ± 5.1%, p = 0.82) but much higher than those obtained by intrathecal injection. The degree of GFP expression by neurofilament(+) and peripherin(+) DRG neurons was similar. The safety of this approach was documented by the absence of injury marker expression, including activation transcription factor 3 and ionized calcium binding adaptor molecule 1 for neurons and glia, respectively, as well as the absence of behavioral changes. These results demonstrated the efficacy and safety of delivering PEI/DNA polyplexes to DRG neurons via spinal nerve injection. PMID:27748450

Ultrasound-Guided Single-Injection Infraclavicular Block Versus Ultrasound-Guided Double-Injection Axillary Block: A Noninferiority Randomized Controlled Trial.

PubMed

Boivin, Ariane; Nadeau, Marie-Josée; Dion, Nicolas; Lévesque, Simon; Nicole, Pierre C; Turgeon, Alexis F

2016-01-01

Single-injection ultrasound-guided infraclavicular block is a simple, reliable, and effective technique. A simplified double-injection ultrasound-guided axillary block technique with a high success rate recently has been described. It has the advantage of being performed in a superficial and compressible location, with a potentially improved safety profile. However, its effectiveness in comparison with single-injection infraclavicular block has not been established. We hypothesized that the double-injection ultrasound-guided axillary block would show rates of complete sensory block at 30 minutes noninferior to the single-injection ultrasound-guided infraclavicular block. After approval by our research ethics committee and written informed consent, adults undergoing distal upper arm surgery were randomized to either group I, ultrasound-guided single-injection infraclavicular block, or group A, ultrasound-guided double-injection axillary block. In group I, 30 mL of 1.5% mepivacaine was injected posterior to the axillary artery. In group A, 25 mL of 1.5% mepivacaine was injected posteromedial to the axillary artery, after which 5 mL was injected around the musculocutaneous nerve. Primary outcome was the rate of complete sensory block at 30 minutes. Secondary outcomes were the onset of sensory and motor blocks, surgical success rates, performance times, and incidence of complications. All outcomes were assessed by a blinded investigator. The noninferiority of the double-injection ultrasound-guided axillary block was considered if the limits of the 90% confidence intervals (CIs) were within a 10% margin of the rate of complete sensory block of the infraclavicular block. At 30 minutes, the rate of complete sensory block was 79% in group A (90% CI, 71%-85%) compared with 91% in group I (90% CI, 85%-95%); the upper limit of CI of group A is thus included in the established noninferiority margin of 10%. The rate of complete sensory block was lower in group A (proportion

Injection System for Multi-Well Injection Using a Single Pump

PubMed Central

Wovkulich, Karen; Stute, Martin; Protus, Thomas J.; Mailloux, Brian J.; Chillrud, Steven N.

2015-01-01

Many hydrological and geochemical studies rely on data resulting from injection of tracers and chemicals into groundwater wells. The even distribution of liquids to multiple injection points can be challenging or expensive, especially when using multiple pumps. An injection system was designed using one chemical metering pump to evenly distribute the desired influent simultaneously to 15 individual injection points through an injection manifold. The system was constructed with only one metal part contacting the fluid due to the low pH of the injection solutions. The injection manifold system was used during a three-month pilot scale injection experiment at the Vineland Chemical Company Superfund site. During the two injection phases of the experiment (Phase I = 0.27 L/min total flow, Phase II = 0.56 L/min total flow), flow measurements were made 20 times over three months; an even distribution of flow to each injection well was maintained (RSD <4%). This durable system is expandable to at least 16 injection points and should be adaptable to other injection experiments that require distribution of air-stable liquids to multiple injection points with a single pump. PMID:26140014

Effectiveness and safety of CEUS-guided haemostatic injection for blunt splenic trauma: an animal experiment.

PubMed

Li, W; Tang, J; Lv, F; Zhang, H; Zhang, S; An, L

2010-10-01

The aim of this study was to investigate whether complications occur after haemostatic agents are injected into blunt splenic injuries. After undergoing ultrasound (US), contrast-enhanced US (CEUS) and contrast-enhanced computed tomography (CECT) examinations, dogs with grade III-IV injury received the minimally invasive therapy. After treatment, CEUS was performed to observe changes in the regions treated. In the immediate group, dogs underwent laparotomy 30 min after treatment to observe the haemostatic effect. In the survival group, animals underwent CEUS and CECT examinations to observe the short-term healing outcome and complications at 3, 7, 14, and 21 days after the injection. After undergoing CEUS and CECT examinations, 12 dogs with grade III-IV injury received the minimally invasive therapy. Before injection, CEUS examinations showed anechoic and/or hypoechoic perfusion defects and active bleeding at the injury sites, and CECT showed traumatic lesions as low-density regions without enhancement. After treatment, CEUS demonstrated the disappearance of active bleeding, and hyperechoic spots emerged at the injury sites. Uneven density regions were displayed on CECT. Treated areas were covered by blood clots and glue membrane in the immediate-group animals. Three weeks later, CEUS showed a decrease of hyperechoic spots in the survival group, and the splenic parenchyma enhanced uniformly on CECT. Laparotomy showed that the greater omentum had moved upwards and partly covered the wound in four animals, and the injury sites had completely healed. Histopathological examination showed that fibrous connective tissue covered the splenic capsule and that the haemostatic glue had degraded. No complication occurred, such as delayed splenic haemorrhage, splenic abscesses, splenic pseudoaneurysms, intestinal obstruction or intestinal adhesions. CEUS-guided haemostatic injection is not only effective in stopping active bleeding immediately, but it is also safe in that no

Performance of a Fuel-Injection Spark-Ignition Engine Using a Hydrogenated Safety Fuel

NASA Technical Reports Server (NTRS)

Schey, Oscar W; Young, Alfred W

1934-01-01

This report presents the performance of a single-cylinder test engine using a hydrogenated safety fuel. The safety fuel has a flash point of 125 degrees f. (Cleveland open-dup method), which is high enough to remove most of the fire hazard, and an octane number of 95, which permits higher compression ratios to be used than are permissible with most undoped gasolines.

Targeted endomyocardial injections of therapeutic cells using x-ray fused with MRI guidance

NASA Astrophysics Data System (ADS)

Gutiérrez, Luis F.; de Silva, Ranil; McVeigh, Elliot R.; Ozturk, Cengizhan; Lederman, Robert J.

2006-03-01

The utility of X-ray fused with MRI (XFM) using external fiducial markers to perform targeted endomyocardial injections in infarcted hearts of swine was tested. Endomyocardial injections of feridex-labeled mesenchymal stromal cells (Fe-MSC) were performed in the previously infarcted hearts of 12 Yucatan miniswine (33-67 kg). Animals had pre-injection cardiac MRI, XFM-guided endomyocardial injection of Fe-MSC suspension spiked with tissue dye, and post-injection MRI. 24 hours later, after euthanasia, the hearts were excised, sliced and stained with TTC. During the injection procedure, operators were provided with 3D surfaces of endocardium, epicardium, myocardial wall thickness and infarct registered with live XF images to facilitate device navigation and choice of injection location. 130 injections were performed in hearts where diastolic wall thickness ranged from 2.6 to 17.7 mm. Visual inspection of the pattern of dye staining on TTC stained heart slices correlated (r=0.98) with XFM-derived injection locations mapped onto delayed hyperenhancement MRI and the susceptibility artifacts seen on the post-injection T2*-weighted gradient echo MRI. The in vivo target registration error was 3.17+/-2.61 mm (n=64) and 75% of injections were within 4 mm of the predicted location. 3D to 2D registration of XF and MR images using external fiducial markers enables accurate targeted endomyocardial injection in a swine model of myocardial infarction. The present data suggest that the safety and efficacy of this approach for performing targeted endomyocardial delivery should be evaluated further clinically.

Carbon microgranule injection into NSTX-U discharges for edge diagnostic research

NASA Astrophysics Data System (ADS)

Lunsford, Robert; Roquemore, A. Lane; Scotti, Filippo; Mansfield, Dennis; Bortolon, Alessandro; Kaita, Robert; Maingi, Rajesh

2016-10-01

Microgranule injection is a versatile means for investigating edge plasmas in fusion devices. Employing a dual bladed rotary turbine, carbon microgranules ranging in diameter from 300 - 700 microns are radially injected into NSTX-U discharges at approximately 50 m/sec. Utilizing multiple high speed camera views, a 3D reconstruction of the injection geometry is created which characterizes the ablation rate and granule trajectory. By coupling this with a neutral gas shielding (NGS) ablation model, the granule mass deposition profile can be determined. Simulation projects a depositional barycenter near the pedestal shoulder for H-mode discharges, and 20 cm inboard of the LCFS for L-mode discharges. Spectroscopic measurements of this localized particle source can be used to characterize impurity transport within the discharge, and potentially allows for direct measurement of the safety factor profile (q). In addition, the transient pressure peaking resultant from injection into H-mode plasmas can also result in the prompt triggering of an edge localized mode (ELM). Work supported by DOE Contract No. DE-AC02-09CH11466.

Comparison of two ultrasound-guided injection techniques targeting the sacroiliac joint region in equine cadavers.

PubMed

Stack, John David; Bergamino, Chiara; Sanders, Ruth; Fogarty, Ursula; Puggioni, Antonella; Kearney, Clodagh; David, Florent

2016-09-20

To compare the accuracy and distribution of injectate for cranial (CR) and caudomedial (CM) ultrasound-guided injections of equine sacroiliac joints. Both sacroiliac joints from 10 lumbosacropelvic specimens were injected using cranial parasagittal (CR; curved 18 gauge, 25 cm spinal needles) and caudomedial (CM; straight 18 gauge, 15 cm spinal needles) ultrasound-guided approaches. Injectate consisted of 4 ml iodinated contrast and 2 ml methylene blue. Computed tomographical (CT) scans were performed before and after injections. Time for needle guidance and repositioning attempts were recorded. The CT sequences were analysed for accuracy and distribution of contrast. Intra-articular contrast was detected in sacroiliac joints following 15/40 injections. The CR and CM approaches deposited injectate ≤2 cm from sacroiliac joint margins following 17/20 and 20/20 injections, respectively. Median distance of closest contrast to the sacroiliac joint was 0.4 cm (interquartile range [IQR]: 1.5 cm) for CR approaches and 0.6 cm (IQR: 0.95 cm) for CM approaches. Cranial injections resulted in injectate contacting lumbosacral intertransverse joints 15/20 times. Caudomedial injections were perivascular 16/20 times. Safety and efficacy could not be established. Cranial and CM ultrasound-guided injections targeting sacroiliac joints were very accurate for periarticular injection, but accuracy was poor for intra-articular injection. Injectate was frequently found in contact with interosseous sacroiliac ligaments, as well as neurovascular and synovial structures in close vicinity of sacroiliac joints.

Short-term clinical evaluation of intralesional triamcinolone acetonide injection for ulcerative oral lichen planus.

PubMed

Xia, Juan; Li, Chunyang; Hong, Yun; Yang, Linglan; Huang, Yulei; Cheng, Bin

2006-07-01

Efforts are made in a continued searching for novel therapies for symptomatic oral lichen planus (OLP). This study aimed to evaluate the efficacy and safety of intralesional triamcinolone acetonide (TA) injection for ulcerative OLP. Forty-five patients with clinical and histologically confirmed ulcerative OLP on bilateral buccal mucosa, one for treatment and the other for control, were studied. All participants received 0.5 ml TA (40 mg/ml) on experimental sites. Visual analogue scale score and lesion areas were recorded at the time of injection and 1-week interval. After 2 weeks, if the treated ulceration reduced < 81% in size, a second injection was given. The treated group gave rapid relief of signs and symptoms, while the control group showed minimal decrease. 38 (84.4%) patients demonstrated complete response in ulceration size. No complications were noted with TA injections. Intralesional TA injection in ulcerative OLP is effective and safe in achieving lesion and pain regression.

Short-term outcome after intravitreal ranibizumab injections for the treatment of retinopathy of prematurity.

PubMed

Castellanos, María Ana Martínez; Schwartz, Shulamit; García-Aguirre, Gerardo; Quiroz-Mercado, Hugo

2013-07-01

To evaluate ocular outcome in premature infants treated with intravitreal ranibizumab injections for retinopathy of prematurity (ROP) over a period of 3 years. An interventional case series. Premature infants with high-risk prethreshold or threshold ROP with plus disease received an off label monotherapy with intravitreal injections of ranibizumab. The primary outcome was treatment success defined as regression of neovascularisation (NV) and absence of recurrence. The secondary outcomes were ocular and systemic adverse events and visual acuity. Six eyes were included in the study and treated with intravitreal injections of ranibizumab. All showed complete resolution of NV after a single injection. The anti-angiogenic intravitreal injections allowed for continued normal vessel growth into the peripheral retina, without any signs of disease recurrence or progression during the follow up period. No ocular or systemic adverse effects were observed. Three years of follow up in a small series suggest that intravitreal ranibizumab injections for ROP result in apparently preserved ocular outcome. Further large scale studies are needed to address the long-term safety and efficacy.

Effect of the helicity injection rate and the Lundquist number on spheromak sustainment

NASA Astrophysics Data System (ADS)

García-Martínez, Pablo Luis; Lampugnani, Leandro Gabriel; Farengo, Ricardo

2014-12-01

The dynamics of the magnetic relaxation process during the sustainment of spheromak configurations at different helicity injection rates is studied. The three-dimensional activity is recovered using time-dependent resistive magnetohydrodynamic simulations. A cylindrical flux conserver with concentric electrodes is used to model configurations driven by a magnetized coaxial gun. Magnetic helicity is injected by tangential boundary flows. Different regimes of sustainment are identified and characterized in terms of the safety factor profile. The spatial and temporal behavior of fluctuations is described. The dynamo action is shown to be in close agreement with existing experimental data. These results are relevant to the design and operation of helicity injected devices, as well as to basic understanding of the plasma relaxation mechanism in quasi-steady state.

Non-injection Drug Use and Injection Initiation Assistance among People Who Inject Drugs in Tijuana, Mexico.

PubMed

Ben Hamida, Amen; Rafful, Claudia; Jain, Sonia; Sun, Shelly; Gonzalez-Zuniga, Patricia; Rangel, Gudelia; Strathdee, Steffanie A; Werb, Dan

2018-02-01

Although most people who inject drugs (PWID) report receiving assistance during injection initiation events, little research has focused on risk factors among PWID for providing injection initiation assistance. We therefore sought to determine the influence of non-injection drug use among PWID on their risk to initiate others. We used generalized estimating equation (GEE) models on longitudinal data among a prospective cohort of PWID in Tijuana, Mexico (Proyecto El Cuete IV), while controlling for potential confounders. At baseline, 534 participants provided data on injection initiation assistance. Overall, 14% reported ever initiating others, with 4% reporting this behavior recently (i.e., in the past 6 months). In a multivariable GEE model, recent non-injection drug use was independently associated with providing injection initiation assistance (adjusted odds ratio [AOR] = 2.42, 95% confidence interval [CI] = 1.39-4.20). Further, in subanalyses examining specific drug types, recent non-injection use of cocaine (AOR = 9.31, 95% CI = 3.98-21.78), heroin (AOR = 4.00, 95% CI = 1.88-8.54), and methamphetamine (AOR = 2.03, 95% CI = 1.16-3.55) were all significantly associated with reporting providing injection initiation assistance. Our findings may have important implications for the development of interventional approaches to reduce injection initiation and related harms. Further research is needed to validate findings and inform future approaches to preventing entry into drug injecting.

Granisetron Injection

MedlinePlus

... and vomiting that may occur after surgery. Granisetron extended-release (long-acting) injection is used with other ... be injected intravenously (into a vein) and granisetron extended-release injection comes as a liquid to be ...

Outcomes of intradetrusor onabotulinum toxin A injection in patients with Parkinson's disease.

PubMed

Vurture, Gregory; Peyronnet, Benoit; Feigin, Andrew; Biagioni, Milton C; Gilbert, Rebecca; Rosenblum, Nirit; Frucht, Steven; Di Rocco, Alessandro; Nitti, Victor W; Brucker, Benjamin M

2018-05-16

To assess the safety and efficacy of intradetrusor onabotulinum toxin A injections for the treatment of overactive bladder (OAB) in patients with Parkinson's disease (PD). All PD patients who underwent intradetrusor injections of onabotulinum toxin A (BoNT-A) for storage symptoms between 2010 and 2017 were included in a retrospective study. A 100 U dose of BoNT-A (Botox®, Allergan Irvine, CA) was used for the first injection in all patients. The primary endpoint was clinical success defined as any subjective improvement in OAB symptoms self-assessed by the patients 4 weeks after the injections. Out of 24 patients analyzed, 19 reported improvement of their OAB symptoms 4 weeks after the first injection (79.2%) with complete resolution of urgency urinary incontinence in seven patients (29.1%; P < 0.001). The average post-void residual (PVR) increased significantly after the first injection from 17.6 to 125.3 mL (P < 0.001). Three of the patients had to start clean intermittent catheterization (CIC) after the first injection (12.5%). Out of 49 injections in total, only five caused incomplete bladder emptying requiring the use of CIC (10.2%). Higher pre-injection PVR was significantly associated with both a lower chance of symptomatic improvement (P = 0.04) and a higher risk of incomplete bladder emptying with institution of CIC (P = 0.047). Intradetrusor injections of BoNT-A 100 U appeared as a safe and effective option in PD patients with OAB symptoms and a low PVR before the injection. Higher preoperative PVR was the strongest predictor of both treatment failure and postoperative urinary retention requiring CIC. © 2018 Wiley Periodicals, Inc.

Safety and Immunogenicity of a Candidate Parvovirus B19 Vaccine

PubMed Central

Bernstein, David I; El Sahly, Hana M; Keitel, Wendy A; Wolff, Mark; Simone, Gina; Segawa, Claire; Wong, Susan; Shelly, Daniel; Young, Neal S; Dempsey, Walla

2011-01-01

Parvovirus B19 is an important human pathogen causing erythema infectiosum, transient aplastic crisis in individuals with underlying hemolytic disorders and hydrops fetalis. We therefore evaluated a parvovirus B19 virus like particle (VLP) vaccine. The safety and immunogenicity of a 25 μg dose of parvovirus B19 recombinant capsid; 2.5 and 25 μg doses of the recombinant capsid given with MF59; and saline placebo were assessed in healthy adults. Because of 3 unexplained cutaneous events the study was halted after enrollment of 43 subjects and before any subject received their third scheduled dose. The rashes developed 5-9 days after the first or second injection and were seen in one placebo recipient (without an injection site lesion) and two vaccine recipients (with injection site reactions). No clear cause was established. Other safety evaluations revealed mostly injection site reactions that were mild to moderate with an increase in pain in subjects receiving vaccine and MF59. After dose 2 the majority of vaccine recipients developed ELISA and neutralizing antibody to parvovirus B19. Given the possible severe consequences of parvovirus B19 infection, further development of a safe and effective vaccine continues to be important. PMID:21807052

Safety and immunogenicity of a candidate parvovirus B19 vaccine.

PubMed

Bernstein, David I; El Sahly, Hana M; Keitel, Wendy A; Wolff, Mark; Simone, Gina; Segawa, Claire; Wong, Susan; Shelly, Daniel; Young, Neal S; Dempsey, Walla

2011-10-06

Parvovirus B19 is an important human pathogen causing erythema infectiosum, transient aplastic crisis in individuals with underlying hemolytic disorders and hydropsfetalis. We therefore evaluated a parvovirus B19 virus like particle (VLP) vaccine. The safety and immunogenicity of a 25 μg dose of parvovirus B19 recombinant capsid; 2.5 and 25 μg doses of the recombinant capsid given with MF59; and saline placebo were assessed in healthy adults. Because of 3 unexplained cutaneous events the study was halted after enrollment of 43 subjects and before any subject received their third scheduled dose. The rashes developed 5-9 days after the first or second injection and were seen in one placebo recipient (without an injection site lesion) and two vaccine recipients (with injection site reactions). No clear cause was established. Other safety evaluations revealed mostly injection site reactions that were mild to moderate with an increase in pain in subjects receiving vaccine and MF59. After dose 2 the majority of vaccine recipients developed ELISA and neutralizing antibody to parvovirus B19. Given the possible severe consequences of parvovirus B19 infection, further development of a safe and effective vaccine continues to be important. Copyright © 2011 Elsevier Ltd. All rights reserved.

Nusinersen Injection

MedlinePlus

Nusinersen injection comes as a solution (liquid) to inject intrathecally (into the fluid-filled space of the spinal canal). Nusinersen injection is given by a doctor in a medical office or clinic. It is usually given as ...

A randomized, double-blind, placebo-controlled study to determine the safety and efficacy of cultured and expanded autologous fibroblast injections for the treatment of interdental papillary insufficiency associated with the papilla priming procedure.

PubMed

McGuire, Michael K; Scheyer, E Todd

2007-01-01

The aim of this study was to assess the efficacy and safety of using autologous fibroblast injections following a minimally invasive papilla priming procedure to augment open interproximal spaces. Twenty-one patients with open interproximal spaces were enrolled in this study, with 20 patients retained to study completion. Two primary sites were selected and randomized to receive autologous fibroblast injections or placebo injections beginning 1 week following the papilla priming procedure; two additional injections were performed 7 to 14 days following the initial injections. Up to seven additional sites could be treated per patient, and the analyses were conducted for the primary and secondary sites. The primary efficacy parameter was the percentage change in papillary height of the primary treatment areas from baseline to the 4-month visit, as measured by a periodontal probe from the base of the contact area to the tip of the interproximal papilla. Digital image analysis and diagnostic models were used to confirm clinical measurements. A visual analog scale (VAS) was used by the examiner and subject to assess the defect change from baseline to 2, 3, and 4 months. Tissue texture also was assessed by the examiner. The primary efficacy analysis failed to show a significant treatment effect at 4 months, but the treatment areas showed a statistically significant mean percentage increase from baseline in papillary height (P = 0.0067; signed-rank test) at 2 months. The difference between test and placebo sites in papillary height at 2 months approached statistical significance (P = 0.0730), suggesting that the test treatment was superior to the placebo treatment. The examiner and subject VASs were statistically significantly different from baseline for both treatment groups, and the VAS was superior for the test sites over the placebo. Based on safety data, the test treatment was deemed safe. This early-phase study using cell transplantation of autologous cultured and

Fear of repeated injections in children younger than 4 years receiving subcutaneous allergy immunotherapy.

PubMed

de Vos, Gabriele; Shankar, Viswanathan; Nazari, Ramin; Kooragayalu, Shravan; Smith, Mitchell; Wiznia, Andrew; Rosenstreich, David

2012-12-01

Allergy immunotherapy during early childhood may have potential benefits for the prevention of asthma and allergy morbidity. However, subcutaneous immunotherapy has not yet been prospectively researched in children younger than 4 years, primarily because of safety concerns, including the fear and psychological distress young children may experience with repeated needle injections. To quantify fear in atopic children younger than 4 years with a history of wheezing who are receiving subcutaneous immunotherapy. Fear of injection was graded during a total of 788 immunotherapy injection visits in 18 children (age, 37 months; SD, 9 months) receiving subcutaneous allergy immunotherapy. The parent and the injection nurse assigned fear scores on a scale of 0 to 10 after each injection visit. At the time of analysis, children had a median of 49 injection visits (range, 12-88) during a median study period of 81.5 weeks (range, 15-165 weeks). Fifteen children (83%) lost their fear of injections during the study. A fear score of 0 was achieved after a mean of 8.4 visits (SD, 7.4). The more injection visits were missed, the more likely children were to retain fear of injections (hazard ratio, 0.13; 95% confidence interval, 0.02-1.02; P=.05). Age, adverse events, number of injections at each visit, and change of injection personnel were not associated with increased fear. Our analysis suggests that most children receiving weekly subcutaneous immunotherapy lose their fear of injections during the treatment course. Children with increased intervals between visits may be at higher risk of experiencing fear of injections. clinicaltrial.gov identifier NCT01028560. Copyright © 2012 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Human adipose-derived mesenchymal stem cells for osteoarthritis: a pilot study with long-term follow-up and repeated injections.

PubMed

Song, Yang; Du, Hui; Dai, Chengxiang; Zhang, Li; Li, Suke; Hunter, David J; Lu, Liangjing; Bao, Chunde

2018-04-01

This study aimed to evaluate the safety and therapeutic potential of autologous human adipose-derived mesenchymal stem cells (haMSCs) in patients with osteoarthritis. Safety and efficacy of haMSCs were preclinically assessed in vitro and in BALB/c-nu nude mice. 18 patients were enrolled and divided into three dose groups: the low-dose, mid-dose and high-dose group (1 × 10 7 , 2 × 10 7 and 5 × 10 7 cells, respectively), provided three injections and followed up for 96 weeks. The preclinical study established the safety and efficacy of haMSCs. Intra-articular injections of haMSCs were safe and improved pain, function and cartilage volume of the knee joint, rendering them a promising novel treatment for knee osteoarthritis. The dosage of 5 × 10 7 haMSCs exhibited the highest improvement (ClinicalTrials.gov Identifier: NCT01809769).

An injection and mixing element for delivery and monitoring of inhaled nitric oxide.

PubMed

Martin, Andrew R; Jackson, Chris; Fromont, Samuel; Pont, Chloe; Katz, Ira M; Caillobotte, Georges

2016-08-30

Inhaled nitric oxide (NO) is a selective pulmonary vasodilator used primarily in the critical care setting for patients concurrently supported by invasive or noninvasive positive pressure ventilation. NO delivery devices interface with ventilator breathing circuits to inject NO in proportion with the flow of air/oxygen through the circuit, in order to maintain a constant, target concentration of inhaled NO. In the present article, a NO injection and mixing element is presented. The device borrows from the design of static elements to promote rapid mixing of injected NO-containing gas with breathing circuit gases. Bench experiments are reported to demonstrate the improved mixing afforded by the injection and mixing element, as compared with conventional breathing circuit adapters, for NO injection into breathing circuits. Computational fluid dynamics simulations are also presented to illustrate mixing patterns and nitrogen dioxide production within the element. Over the range of air flow rates and target NO concentrations investigated, mixing length, defined as the downstream distance required for NO concentration to reach within ±5 % of the target concentration, was as high as 47 cm for the conventional breathing circuit adapters, but did not exceed 7.8 cm for the injection and mixing element. The injection and mixing element has potential to improve ease of use, compatibility and safety of inhaled NO administration with mechanical ventilators and gas delivery devices.

Identification of protein components and quantitative immunoassay for SEC2 in staphylococcin injection.

PubMed

Ding, Ding; Huang, Peng; Sun, Hongying; Xue, Qiao; Pan, Yingqiu; Chen, Shuqing

2009-08-15

In China, staphylococcin injection has been commonly used in combined cancer therapy to enhance the systemic immune response and reduce the toxicities associated with chemotherapy or radiation therapy in the last decade. It is claimed that the main effective component is staphylococcal enterotoxin C2 (SEC2). However, no standard method based on the concentration of SEC2 has been established for quality control of the injection products. In this study, a sensitive and reliable biotin-streptavidin-ELISA (BS-ELISA) method was established for detection and quantification of SEC2. In addition, 1-D SDS-PAGE coupled with nano-LC-MS/MS was performed to identify the protein components in the injection products from one manufacturing company. The results of the BS-ELISA showed that SEC2 only accounted for less than 0.1% of the total protein in the injection products, and the nano-LC-MS/MS results showed that fifty-five proteins of Staphylococcus aureus were confidently identified in the injection solution. Seventeen out of these proteins, including SEC2, were well-known virulence factors. In addition, eighteen proteins of other Gram-positive bacteria were also confidently identified. Thus, the results indicated that SEC2 is of very low concentration in the injection products and the process of the injection preparation should be improved for health and safety consideration.

Hemifacial spasm: results of treatment with low dose botulinum toxin injection.

PubMed

Suputtitada, Areerat; Phanthumchinda, Kammant; Locharernkul, Chaichon; Suwanwela, Nijasri C

2004-10-01

Hemifacial Sapsm (HFS) is a common movement disorder in Thailand. Botulinum toxin type A (BTA) is an effective and safe treatment for this condition. The success of BTA treatment depends on the experience of the clinician. To study the demographic data, efficacy and safety of low dose BTA injection in HFS patients. The Spastic and Dystonia Clinic, Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital. Open-label, prospective case-series study. All patients with HFS referred for BTA injection from December 1st, 1995 to November 30th, 2003. Sex, age, side of spasm, onset of symptoms before BTA injection, underlying diseases, sites of BTA injection, dose of each BTA treatment, duration of response, efficacy, and side-effects were analyzed. 3-5 units of BOTOX were intramuscularly injected per site to all muscles that had spasm. After injection, a 20-minute cold compression on the first day was followed by 20-minute warm compression with massage at each injection site per day for 14 days. A total of 112 patients with HFS were treated with 874 BTA treatments. There were 71 females (63.4%) and 41 males (36.6%). The mean age was 45 years. 75 patients (67%) were affected on the left side. Mean duration of symptoms was 3.4 years. The sites of injection were orbicularis occuli and orbicularis oris muscles in all 874 treatments (100%). The mean dose of all treatments was 25 units. The mean initial dose was 30.5 units. The mean dose for subsequent injection was 23 units. The mean duration between treatments was 4.7 months. The mean initial duration was 3.5 months. The mean duration for subsequent injection was 4.8 months. The outcomes of treatment assessed at 4 weeks after injection classified as excellent (>80% improvement) were found in 845 treatments (96.7%). Most treatments had no complication (91.9%). Ptosis, facial paresis and double vision were mild and transient, lasting 1-4 weeks. There were no long-term complications of BTA treatment in the

Development of Lingzhi or Reishi medicinal mushroom, Ganoderma lucidum (Higher Basidiomycetes) polysaccharides injection formulation.

PubMed

Jiang, Yuji; He, Anle; Liu, Yanhong; Xie, Baogui; Li, Ye; Deng, Youjin; Liu, Xinrui; Liu, Qichao

2014-01-01

Biochemical and pharmacological research has demonstrated that Lingzhi or Reishi medicinal mushroom Ganoderma lucidum polysaccharides (GLPS) have significant anticancer, antitumor, and antioxidant activities. To investigate the effect of injecting GLPS into hosts for clinical studies, aqueous polysaccharide extracts from G. lucidum fruit bodies were purified by deproteinization using the Sevage method, anion-exchange chromatography elution (cellulose DEAE-52 chromatography), dialysis, ethanol precipitation, and active carbon and millipore membrane filtration techniques. The purified GLPS were used for injection in mice. Polysaccharide indexes, protein, tannin, heavy metal, arsenic salt, oxalate, potassium ion, resin, pH, ignition residue measurements, evaluation criterion for allergic reactions, and total solids content of the GLPS injection were all performed using the reference methods in the Chinese Pharmacopoeia. Our results showed that polysaccharide was the key component of injection mixtures. The ignition residue and total solids content in the injection mixture were 1.4% and 2.4%, respectively. The other indices were all within the expected safety ranges. Furthermore, studies from mice functional assays showed that the injection mixture improved the antifatigue capacity of mice without any effect on weight loss/gain. In addition, the injection mixture was safe, which was confirmed by allergy testing in guinea pigs. The development of a GLPS injection offers a novel approach for future medicinal mushroom utilization and holds great commercial promise.

Measuring tissue back-pressure--in vivo injection forces during subcutaneous injection.

PubMed

Allmendinger, Andrea; Mueller, Robert; Schwarb, Edward; Chipperfield, Mark; Huwyler, Joerg; Mahler, Hanns-Christian; Fischer, Stefan

2015-07-01

Limited information is available on injection forces of parenterals representing the in vivo situation. Scope of the present study was to investigate the contribution of the subcutaneous (sc) tissue layer to injection forces during in vivo injection. Göttingen minipigs received injections of isotonic dextran solutions (1-100 mPas) into the plica inguinalis using different injection rates and volumes (0.025-0.2 mL/s and 2.5 vs. 4.5 mL). The contribution of the sc back-pressure to injection forces was found to increase linearly with viscosity and injection rate ranging from 0.6 ± 0.5 N to 1.0 ± 0.4 N (1 mPas), 0.7 ± 0.2 N to 2.4 ± 1.9 N (10 mPas), and 1.8 ± 0.6 N to 4.7 ± 3.3 N (20 mPas) for injection rates of 0.025 to 0.2 mL/s, respectively. Variability increased with viscosity and injection rate. Values are average values from 10 randomized injections. A maximum of 12.9 N was reached for 20 mPas at 0.2 mL/s; 6.9 ± 0.3 N was determined for 100 mPas at 0.025 mL/s. No difference was found between injection volumes of 2.5 and 4.5 mL. The contribution of the tissue was differentiated from the contribution of the injection device and a local temperature effect. This effect was leading to warming of the (equilibrated) sample in the needle, therefore smaller injection forces than expected compensating tissue resistance to some parts. When estimating injection forces representative for the in vivo situation, the contribution of the tissue has to be considered as well as local warming of the sample in the needle during injection.

[Determination of aconitine, hypaconitine and mesaconitine in Shenfu injection].

PubMed

Zhang, Pan-Pan; Zhang, Jun-Zhen; Wang, Zhao-Hong; Lu, Yong-Jiang; Jiang, Ye

2013-05-01

To establish a method for the content determination of indexes for measuring aconitic compounds contained in Shenfu injection, in order to provide basis for the evaluation of the curative effect of monkshood in Shenfu injection. The sample were purified and enriched with HF-LPME. ACQUITY UPLC BEH C18 column (2.1 mm x 50 mm, 1.7 microm) was adopted and eluted with a gradient program, with acetonitrile-10 mmol x L(-1) NH4HCO3 (pH 10) as the mobile phases. The flow rate was 0.45 mL x min(-1). The content was determined with ESI and MRM. The results showed that aconitine, hypaconitine and mesaconitine showed a good linear relationship, with r > 0.999, within the range of 0.1-100 ng x L(-1). The recoveries were detected to be 100.1%, 97.4%, 97.5%, with RSD being 1.2%, 1.1%, 1.5%, respectively. This method was used to prove the safety of Shenfu injection, and provide scientific basis for correct evaluation of curative effect of monkshood, as well as a reliable, simple and practical means for quality control of monkshood-containing Chinese materia medica preparations.

[Impurity removal technology of Tongan injection in liquid preparation process].

PubMed

Yang, Xu-fang; Wang, Xiu-hai; Bai, Wei-rong; Kang, Xiao-dong; Liu, Jun-chao; Wu, Yun; Xiao, Wei

2015-08-01

In order to effectively remove the invalid impurities in Tongan injection, optimize the optimal parameters of the impurity removal technology of liquid mixing process, in this paper, taking Tongan injection as the research object, with the contents of celandine alkali, and sinomenine, solids reduction efficiency, and related substances inspection as the evaluation indexes, the removal of impurities and related substances by the combined process of refrigeration, coction and activated carbon adsorption were investigated, the feasibility of the impurity removal method was definited and the process parameters were optimized. The optimized process parameters were as follows: refrigerated for 36 h, boiled for 15 min, activated carbon dosage of 0.3%, temperature 100 degrees C, adsorption time 10 min. It can effectively remove the tannin, and other impurities, thus ensure the quality and safety of products.

Nanodrugs: pharmacokinetics and safety

PubMed Central

Onoue, Satomi; Yamada, Shizuo; Chan, Hak-Kim

2014-01-01

To date, various nanodrug systems have been developed for different routes of administration, which include dendrimers, nanocrystals, emulsions, liposomes, solid lipid nanoparticles, micelles, and polymeric nanoparticles. Nanodrug systems have been employed to improve the efficacy, safety, physicochemical properties, and pharmacokinetic/pharmacodynamic profile of pharmaceutical substances. In particular, functionalized nanodrug systems can offer enhanced bioavailability of orally taken drugs, prolonged half-life of injected drugs (by reducing immunogenicity), and targeted delivery to specific tissues. Thus, nanodrug systems might lower the frequency of administration while providing maximized pharmacological effects and minimized systemic side effects, possibly leading to better therapeutic compliance and clinical outcomes. In spite of these attractive pharmacokinetic advantages, recent attention has been drawn to the toxic potential of nanodrugs since they often exhibit in vitro and in vivo cytotoxicity, oxidative stress, inflammation, and genotoxicity. A better understanding of the pharmacokinetic and safety characteristics of nanodrugs and the limitations of each delivery option is necessary for the further development of efficacious nanodrugs with high therapeutic potential and a wide safety margin. This review highlights the recent progress in nanodrug system development, with a focus on the pharmacokinetic advantages and safety challenges. PMID:24591825

Design process of the nanofluid injection mechanism in nuclear power plants

NASA Astrophysics Data System (ADS)

Kang, Myoung-Suk; Jee, Changhyun; Park, Sangjun; Bang, In Choel; Heo, Gyunyoung

2011-04-01

Nanofluids, which are engineered suspensions of nanoparticles in a solvent such as water, have been found to show enhanced coolant properties such as higher critical heat flux and surface wettability at modest concentrations, which is a useful characteristic in nuclear power plants (NPPs). This study attempted to provide an example of engineering applications in NPPs using nanofluid technology. From these motivations, the conceptual designs of the emergency core cooling systems (ECCSs) assisted by nanofluid injection mechanism were proposed after following a design framework to develop complex engineering systems. We focused on the analysis of functional requirements for integrating the conventional ECCSs and nanofluid injection mechanism without loss of performance and reliability. Three candidates of nanofluid-engineered ECCS proposed in previous researches were investigated by applying axiomatic design (AD) in the manner of reverse engineering and it enabled to identify the compatibility of functional requirements and potential design vulnerabilities. The methods to enhance such vulnerabilities were referred from TRIZ and concretized for the ECCS of the Korean nuclear power plant. The results show a method to decouple the ECCS designs with the installation of a separate nanofluids injection tank adjacent to the safety injection tanks such that a low pH environment for nanofluids can be maintained at atmospheric pressure which is favorable for their injection in passive manner.

Design process of the nanofluid injection mechanism in nuclear power plants

PubMed Central

2011-01-01

Nanofluids, which are engineered suspensions of nanoparticles in a solvent such as water, have been found to show enhanced coolant properties such as higher critical heat flux and surface wettability at modest concentrations, which is a useful characteristic in nuclear power plants (NPPs). This study attempted to provide an example of engineering applications in NPPs using nanofluid technology. From these motivations, the conceptual designs of the emergency core cooling systems (ECCSs) assisted by nanofluid injection mechanism were proposed after following a design framework to develop complex engineering systems. We focused on the analysis of functional requirements for integrating the conventional ECCSs and nanofluid injection mechanism without loss of performance and reliability. Three candidates of nanofluid-engineered ECCS proposed in previous researches were investigated by applying axiomatic design (AD) in the manner of reverse engineering and it enabled to identify the compatibility of functional requirements and potential design vulnerabilities. The methods to enhance such vulnerabilities were referred from TRIZ and concretized for the ECCS of the Korean nuclear power plant. The results show a method to decouple the ECCS designs with the installation of a separate nanofluids injection tank adjacent to the safety injection tanks such that a low pH environment for nanofluids can be maintained at atmospheric pressure which is favorable for their injection in passive manner. PMID:21711896

Design process of the nanofluid injection mechanism in nuclear power plants.

PubMed

Kang, Myoung-Suk; Jee, Changhyun; Park, Sangjun; Bang, In Choel; Heo, Gyunyoung

2011-04-27

Nanofluids, which are engineered suspensions of nanoparticles in a solvent such as water, have been found to show enhanced coolant properties such as higher critical heat flux and surface wettability at modest concentrations, which is a useful characteristic in nuclear power plants (NPPs). This study attempted to provide an example of engineering applications in NPPs using nanofluid technology. From these motivations, the conceptual designs of the emergency core cooling systems (ECCSs) assisted by nanofluid injection mechanism were proposed after following a design framework to develop complex engineering systems. We focused on the analysis of functional requirements for integrating the conventional ECCSs and nanofluid injection mechanism without loss of performance and reliability. Three candidates of nanofluid-engineered ECCS proposed in previous researches were investigated by applying axiomatic design (AD) in the manner of reverse engineering and it enabled to identify the compatibility of functional requirements and potential design vulnerabilities. The methods to enhance such vulnerabilities were referred from TRIZ and concretized for the ECCS of the Korean nuclear power plant. The results show a method to decouple the ECCS designs with the installation of a separate nanofluids injection tank adjacent to the safety injection tanks such that a low pH environment for nanofluids can be maintained at atmospheric pressure which is favorable for their injection in passive manner.

Aripiprazole once-monthly long-acting injectable for the treatment of schizophrenia.

PubMed

Potkin, Steven G; Preda, Adrian

2016-01-01

Patient non-adherence increases the risk for relapse and the long-term care of schizophrenia. Long-acting injectable (LAI) antipsychotics can decrease this risk by ensuring adherence. An extended formulation, aripiprazole 400 mg once-monthly (AOM 400) LAI (AOM LAI), received regulatory approval in the year 2013 for the treatment of schizophrenia. AOM LAI is the first dopamine D2 partial agonist available in a long-acting formulation for the treatment of schizophrenia. This review covers data on the efficacy and tolerability/safety of AOM LAI. AOM LAI is a lyophilized powder of aripiprazole, with an elimination half-life of 29.9 - 46.5 days, allowing for a 4-week injection interval. Antipsychotic efficacy was documented in a 12-week double-blind trial (n = 340) and in two maintenance-of-effect trials: a 38-week trial (n = 662) and a 52-week trial (n = 403). The side effect profile is similar to that of oral aripiprazole. Adverse events (≥5% and at least twice that for placebo) were typically mild or moderate and did not lead to discontinuation: increased weight, akathisia, injection site pain and sedation. The 400 mg dose is tolerated by >90% of patients. Injection does not require additional training of health personnel or post-injection observation. AOM LAI is an efficacious and well-tolerated antipsychotic treatment for schizophrenia.

Rapid and non-destructive identification of water-injected beef samples using multispectral imaging analysis.

PubMed

Liu, Jinxia; Cao, Yue; Wang, Qiu; Pan, Wenjuan; Ma, Fei; Liu, Changhong; Chen, Wei; Yang, Jianbo; Zheng, Lei

2016-01-01

Water-injected beef has aroused public concern as a major food-safety issue in meat products. In the study, the potential of multispectral imaging analysis in the visible and near-infrared (405-970 nm) regions was evaluated for identifying water-injected beef. A multispectral vision system was used to acquire images of beef injected with up to 21% content of water, and partial least squares regression (PLSR) algorithm was employed to establish prediction model, leading to quantitative estimations of actual water increase with a correlation coefficient (r) of 0.923. Subsequently, an optimized model was achieved by integrating spectral data with feature information extracted from ordinary RGB data, yielding better predictions (r = 0.946). Moreover, the prediction equation was transferred to each pixel within the images for visualizing the distribution of actual water increase. These results demonstrate the capability of multispectral imaging technology as a rapid and non-destructive tool for the identification of water-injected beef. Copyright © 2015 Elsevier Ltd. All rights reserved.

Office-based Electromyography-guided Botulinum Toxin Injection to the Cricopharyngeus Muscle: Optimal Patient Selection and Technique.

PubMed

Kim, Min-Su; Kim, Go-Woon; Rho, Young-Soo; Kwon, Kee-Hwan; Chung, Eun-Jae

2017-05-01

This retrospective study was carried out to investigate the effectiveness and safety of office-based electromyography-guided injection of botulinum toxin in the cricopharyngeus muscle of patients who did not show upper esophageal sphincter passage in a swallowing study in spite of maximal swallowing rehabilitation. Thirty-six patients who showed no or limited ability to oral feed after maximum swallowing rehabilitation were enrolled. Video fluoroscopic swallowing study, flexible endoscopic evaluation of swallowing, disability rating scale, penetration aspiration score, and National Institutes of Health swallowing safety scale were used in the evaluation of dysphagia. Success was defined as nondependence on gastrostomy for patients who previously were dependent on gastrostomy and improvement in disability rating scale score after botulinum toxin injections. The total success rate was 63.9%. The complication rate was very low, with only 1 patient showing temporary unilateral vocal fold paralysis. Botulinum toxin injection was more effective in patients with cranial nerve IX or X palsy than in those without it ( P = .006). This procedure can be a simple, safe, and effective tool in patients with cricopharyngeal dysfunction after swallowing rehabilitation, especially for cranial nerve IX or X palsy.

Towards safe injection practices for prevention of hepatitis C transmission in South Asia: Challenges and progress.

PubMed

Janjua, Naveed Zafar; Butt, Zahid Ahmad; Mahmood, Bushra; Altaf, Arshad

2016-07-07

To summarize the available information about injection use and its determinants in the South Asian region. We searched published and unpublished literature on injection safety in South Asia published during 1995-2016 using the keywords "injection" "unsafe injection" and "immunization injection" and combined these with each of the countries and/or their respective states or provinces in South Asia. We used a standardized questionnaire to abstract the following data from the articles: the annual number of injections per capita, the proportion of injections administered with a reused syringe or needle, the distribution of injections with respect to prescribers and providers and determinants of injection use. Although information is very limited for certain countries (i.e., Bhutan, Maldives and Sri Lanka), healthcare injection use is very common across South Asia, with cross-country rates ranging from 2.4 to 13.6 injections/person/year. Furthermore, recent studies show that 5% to 50% of these injections are provided with reused syringes, thus creating potential to transmission of blood-borne pathogens. Qualified and unqualified practitioners, especially in the private sector, are the major drivers behind injection use, but patients also prefer injections, especially among the rural, poor or uneducated in certain countries. According to available data, Pakistan and India have recently taken steps towards achieving safe injection. Potential interventions include the introduction of reuse prevention devices, and patient-, community- and patient/community and provider-centered interventions to change population and practitioner behavior. Injection use is common in South Asian countries. Multilevel interventions aiming at patients, providers and the healthcare system are needed to reduce injection use and reuse.

Safety, tolerability, clinical, and joint structural outcomes of a single intra-articular injection of allogeneic mesenchymal precursor cells in patients following anterior cruciate ligament reconstruction: a controlled double-blind randomised trial.

PubMed

Wang, Yuanyuan; Shimmin, Andrew; Ghosh, Peter; Marks, Paul; Linklater, James; Connell, David; Hall, Stephen; Skerrett, Donna; Itescu, Silviu; Cicuttini, Flavia M

2017-08-02

Few clinical trials have investigated the safety and efficacy of mesenchymal stem cells for the management of post-traumatic osteoarthritis. The objectives of this pilot study were to determine the safety and tolerability and to explore the efficacy of a single intra-articular injection of allogeneic human mesenchymal precursor cells (MPCs) to improve clinical symptoms and retard joint structural deterioration over 24 months in patients following anterior cruciate ligament (ACL) reconstruction. In this phase Ib/IIa, double-blind, active comparator clinical study, 17 patients aged 18-40 years with unilateral ACL reconstruction were randomized (2:1) to receive either a single intra-articular injection of 75 million allogeneic MPCs suspended in hyaluronan (HA) (MPC + HA group) (n = 11) or HA alone (n = 6). Patients were monitored for adverse events. Immunogenicity was evaluated by anti-HLA panel reactive antibodies (PRA) against class I and II HLAs determined by flow cytometry. Pain, function, and quality of life were assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and SF-36v2 scores. Joint space width was measured from radiographs, and tibial cartilage volume and bone area assessed from magnetic resonance imaging (MRI). Moderate arthralgia and swelling within 24 h following injection that subsided were observed in 4 out of 11 in the MPC + HA group and 0 out of 6 HA controls. No cell-related serious adverse effects were observed. Increases in class I PRA >10% were observed at week 4 in the MPC + HA group that decreased to baseline levels by week 104. Compared with the HA group, MPC + HA-treated patients showed greater improvements in KOOS pain, symptom, activities of daily living, and SF-36 bodily pain scores (p < 0.05). The MPC + HA group had reduced medial and lateral tibiofemoral joint space narrowing (p < 0.05), less tibial bone expansion (0.5% vs 4.0% over 26 weeks, p = 0.02), and a trend towards reduced tibial cartilage volume loss (0

Compressed air injection technique to standardize block injection pressures.

PubMed

Tsui, Ban C H; Li, Lisa X Y; Pillay, Jennifer J

2006-11-01

Presently, no standardized technique exists to monitor injection pressures during peripheral nerve blocks. Our objective was to determine if a compressed air injection technique, using an in vitro model based on Boyle's law and typical regional anesthesia equipment, could consistently maintain injection pressures below a 1293 mmHg level associated with clinically significant nerve injury. Injection pressures for 20 and 30 mL syringes with various needle sizes (18G, 20G, 21G, 22G, and 24G) were measured in a closed system. A set volume of air was aspirated into a saline-filled syringe and then compressed and maintained at various percentages while pressure was measured. The needle was inserted into the injection port of a pressure sensor, which had attached extension tubing with an injection plug clamped "off". Using linear regression with all data points, the pressure value and 99% confidence interval (CI) at 50% air compression was estimated. The linearity of Boyle's law was demonstrated with a high correlation, r = 0.99, and a slope of 0.984 (99% CI: 0.967-1.001). The net pressure generated at 50% compression was estimated as 744.8 mmHg, with the 99% CI between 729.6 and 760.0 mmHg. The various syringe/needle combinations had similar results. By creating and maintaining syringe air compression at 50% or less, injection pressures will be substantially below the 1293 mmHg threshold considered to be an associated risk factor for clinically significant nerve injury. This technique may allow simple, real-time and objective monitoring during local anesthetic injections while inherently reducing injection speed.

A New Partial Reconfiguration-Based Fault-Injection System to Evaluate SEU Effects in SRAM-Based FPGAs

NASA Astrophysics Data System (ADS)

Sterpone, L.; Violante, M.

2007-08-01

Modern SRAM-based field programmable gate array (FPGA) devices offer high capability in implementing complex system. Unfortunately, SRAM-based FPGAs are extremely sensitive to single event upsets (SEUs) induced by radiation particles. In order to successfully deploy safety- or mission-critical applications, designer need to validate the correctness of the obtained designs. In this paper we describe a system based on partial-reconfiguration for running fault-injection experiments within the configuration memory of SRAM-based FPGAs. The proposed fault-injection system uses the internal configuration capabilities that modern FPGAs offer in order to inject SEU within the configuration memory. Detailed experimental results show that the technique is orders of magnitude faster than previously proposed ones.

"Injection first": a unique group of injection drug users in Tijuana, Mexico.

PubMed

Morris, Meghan D; Brouwer, Kimberly C; Lozada, Remedios M; Gallardo, Manuel; Vera, Alicia; Strathdee, Steffanie A

2012-01-01

Using baseline data from a study of injection drug users (IDUs) in Tijuana, Mexico (N = 1,052), we identified social and behavioral factors associated with injecting at the same age or earlier than other administration routes of illicit drug use (eg, "injection first") and examined whether this IDU subgroup had riskier drug using and sexual behaviors than other IDUs. Twelve-percent "injected first." Characteristics independently associated with a higher odds of "injection first" included being younger at first injection, injecting heroin as their first drug, being alone at the first injection episode, and having a sexual debut at the same age or earlier as when they initiated drug use; family members' illicit drug use was associated with lower odds of injecting first. When adjusting for age at first injection and number of years injecting, "injection first" IDUs had lower odds of ever overdosing, and ever trading sex. On the other hand, they were less likely to have ever been enrolled in drug treatment, and more commonly obtained their syringes from potentially unsafe sources. In conclusion, a sizable proportion of IDUs in Tijuana injected as their first drug using experience, although evidence that this was a riskier subgroup of IDUs was inconclusive.  Copyright © American Academy of Addiction Psychiatry.

Prevalence and characteristics of femoral injection among Seattle-area injection drug users.

PubMed

Coffin, Phillip O; Coffin, Lara S; Murphy, Shilo; Jenkins, Lindsay M; Golden, Matthew R

2012-04-01

Injection drug use (IDU) into central veins, most common among long-term IDUs with no other options, can lead to severe infectious, vascular, and traumatic medical consequences. To follow-up on anecdotal reports of femoral vein injection and related medical problems in Seattle, we analyzed data from the annual survey of a community-based syringe exchange program. A total of 276 (81%) of 343 program attendees completed the survey in August 2010. Among 248 IDUs, 66% were male, 78% white, and 86% primarily injected opiates. One hundred respondents (40%) had injected into the femoral vein, 55% of whom were actively doing so, and 58% of whom reported medical complications that they attributed to the practice. Most (66%) used the femoral vein due to difficulty accessing other veins, although 61% reported other veins they could access and 67% reporting using other sites since initiating femoral injection. While injecting into muscle was more frequent among older IDUs with longer injection careers, the prevalence of femoral injection was highest among respondents in their late twenties with 2.5-6 years of injecting drugs. Multivariate analysis demonstrated an increased risk of initiating femoral injection each calendar year after 2007. Injecting into the femoral vein was also associated with white versus other race (odds ratio [OR] 2.7, 95% CI 1.3-5.4) and injection of primarily opiates versus other drugs (OR 6.3, 95% CI 1.2-32.9) and not associated with age, length of IDU career, or a history of injecting into muscle. These findings suggest a secular trend of increasing femoral injection among Seattle-area IDUs with a high rate of related medical problems. Interventions, such as education regarding the hazards of central venous injection and guidance on safe injection into peripheral veins, are needed to minimize the health consequences of femoral injection.

Aripiprazole Long-Acting Injectable for Maintenance Treatment of Bipolar I Disorder in Adults.

PubMed

Aggarwal, Arpit; Schrimpf, Lindsey; Lauriello, John

2018-01-01

Bipolar I disorder is a serious and disabling psychiatric illness. It is associated with a significant reduction in quality of life and an increased risk for suicide. Pharmacotherapy is essential for both the acute and maintenance treatment of bi-polar I disorder. While multiple oral medications are recommended for the maintenance treatment, there are not many long-acting injectable medications approved for this indication. New treatments that would improve patient adherence have the potential for decreasing relapses and improving patients' ability to remain functional members of society. In this paper we discuss the available data for safety and efficacy of aripiprazole long-acting injectable in bipolar disorder.

SHORT-TERM SAFETY PROFILE OF INTRAVITREAL ZIV-AFLIBERCEPT.

PubMed

Chhablani, Jay; Narayanan, Raja; Mathai, Annie; Yogi, Rohit; Stewart, Michael

2016-06-01

To evaluate the safety of intravitreal ziv-aflibercept (Zaltrap) in the treatment choroidal neovascularization secondary to age-related macular degeneration. Eligible eyes with choroidal neovascularization secondary to age-related macular degeneration each received a single intravitreal injection of ziv-aflibercept. Comprehensive ophthalmic examinations and detailed systemic evaluations were performed at baseline and Days 1, 7, and 30 after injection, and International Society for Clinical Electrophysiology of Vision standard electroretinography was performed at baseline and Day 30. Primary outcome measures were safety parameters that included signs of clinical and electroretinographic toxicity. Secondary outcome measures included changes in best-corrected visual acuity and central subfield thickness. Twelve eyes of 12 patients were treated. None of the patients complained of blurred vision, ocular pain, or bulbar injection at any of the follow-up visits, nor was intraocular inflammation noted. There were no significant differences in implicit times, "a" and "b" wave amplitudes, or b/a ratios at 1 month when compared with baseline (P = 0.4). None of the patients experienced serious ocular or systemic adverse events. Mean best-corrected visual acuity improved only slightly at 30 days (LogMAR 0.45 ± 0.31 [Snellen equivalent: 20/60]) compared with baseline (LogMAR 0.37 ± 0.24 [Snellen equivalent: 20/50]; P = 0.51). Single intravitreal injections of ziv-aflibercept into eyes with neovascular age-related macular degeneration appear to be safe through 1 month. Ziv-aflibercept could become a safe, low-cost therapy for macular diseases in developing countries and in those where intravitreal aflibercept (Eylea) is not available.

Biocompatibility of intravitreal injection of human mesenchymal stem cells in immunocompetent rabbits.

PubMed

Labrador Velandia, Sonia; Di Lauro, Salvatore; Alonso-Alonso, Maria Luz; Tabera Bartolomé, Soraya; Srivastava, Girish Kumar; Pastor, José Carlos; Fernandez-Bueno, Ivan

2018-01-01

To evaluate the feasibility, safety, and biocompatibility of intravitreal injection of human mesenchymal stem cells (MSCs) in immunocompetent pigmented rabbits. Thirty-two pigmented rabbits (24 females, 8 males; Chinchilla-New Zealand White) were divided into 8 groups of 4 animals. Commercially prepared human MSCs were injected (0.05 ml) into the post-lens vitreous of the right eyes. Groups 1 and 4 received isotonic medium (Ringer lactate-based), groups 2, 5, 7, and 8 received a low dose of 15 × 10 6 cells/ml. Groups 3 and 6 received a high dose of 30 × 10 6 cells/ml. Clinical signs were evaluated and scored before MSCs injection and weekly for 2 or 6 weeks. Animals were sacrificed at 2 or 6 weeks after injection. Eyes, liver, spleen, and gonads were assessed by histology and by fluorescent in situ hybridization to evaluate survival and extraocular migration of MSCs. There were no relevant clinical findings between control and MSC-injected rabbit eyes at any time point. There were also no relevant histological findings between control and MSC-injected rabbits related to ocular, liver, spleen, or gonad tissues modifications. MSCs survived intravitreally for at least 2 weeks after injection. Extraocular migration of MSCs was not detected. MSCs are safe and well-tolerated when administered intravitreally at a dose of 15 × 10 6 cells/ml in pigmented rabbits. These findings enable future research to explore the intravitreal use of commercially prepared allogenic human MSCs in clinical trials of retinal diseases.

Compressor Stall Recovery Through Tip Injection Assessed

NASA Technical Reports Server (NTRS)

Suder, Ken L.

2001-01-01

Aerodynamic stability is a fundamental limit in the compressor design process. The development of robust techniques for increasing stability has several benefits: enabling higher loading and fewer blades, increasing safety throughout a mission, increasing tolerance to stage mismatch during part-speed operation and speed transients, and providing an opportunity to match stages at the compressor maximum efficiency point, thus reducing fuel burn. Mass injection upstream of the tip of a high-speed axial compressor rotor is a stability enhancement approach known to be effective in suppressing stall in tip-critical rotors if the injection is activated before stall occurs. This approach to stall suppression requires that a reliable stall warning system be available. Tests have recently been performed to assess whether steady injection can also be used to recover from fully developed stall. If mass injection is effective in recovering from stall quickly enough to avoid structural damage or loss of engine power, then a stall warning system may not be required. The stall recovery tests were performed on a transonic compressor rotor at its design tip speed of 1475 ft/sec using four injectors evenly spaced around the compressor case upstream of the rotor. The injectors were connected to an external air source. In an actual engine application, the injected air would be supplied with compressor bleed air. The injectors were isolated from the air source by a fast-acting butterfly valve. With the injectors turned off, the compressor was throttled into stall. Air injection was then activated with no change in throttle setting by opening the butterfly valve. The compressor recovered from stall at a fixed throttle setting with the aid of tip injection. The unsteady operating characteristic of the rotor was measured during these tests using high-response pressure sensors located upstream and downstream of the rotor. The figure shows the results, where the unsteady pressure and mass

Sericin/Dextran Injectable Hydrogel as an Optically Trackable Drug Delivery System for Malignant Melanoma Treatment.

PubMed

Liu, Jia; Qi, Chao; Tao, Kaixiong; Zhang, Jinxiang; Zhang, Jian; Xu, Luming; Jiang, Xulin; Zhang, Yunti; Huang, Lei; Li, Qilin; Xie, Hongjian; Gao, Jinbo; Shuai, Xiaoming; Wang, Guobin; Wang, Zheng; Wang, Lin

2016-03-01

Severe side effects of cancer chemotherapy prompt developing better drug delivery systems. Injectable hydrogels are an effective site-target system. For most of injectable hydrogels, once delivered in vivo, some properties including drug release and degradation, which are critical to chemotherapeutic effects and safety, are challenging to monitor. Developing a drug delivery system for effective cancer therapy with in vivo real-time noninvasive trackability is highly desired. Although fluorescence dyes are used for imaging hydrogels, the cytotoxicity limits their applications. By using sericin, a natural photoluminescent protein from silk, we successfully synthesized a hydrazone cross-linked sericin/dextran injectable hydrogel. This hydrogel is biodegradable and biocompatible. It achieves efficient drug loading and controlled release of both macromolecular and small molecular drugs. Notably, sericin's photoluminescence from this hydrogel is directly and stably correlated with its degradation, enabling long-term in vivo imaging and real-time monitoring of the remaining drug. The hydrogel loaded with Doxorubicin significantly suppresses tumor growth. Together, the work demonstrates the efficacy of this drug delivery system, and the in vivo effectiveness of this sericin-based optical monitoring strategy, providing a potential approach for improving hydrogel design toward optimal efficiency and safety of chemotherapies, which may be widely applicable to other drug delivery systems.

Induced seismicity closed-form traffic light system for actuarial decision-making during deep fluid injections.

PubMed

Mignan, A; Broccardo, M; Wiemer, S; Giardini, D

2017-10-19

The rise in the frequency of anthropogenic earthquakes due to deep fluid injections is posing serious economic, societal, and legal challenges to many geo-energy and waste-disposal projects. Existing tools to assess such problems are still inherently heuristic and mostly based on expert elicitation (so-called clinical judgment). We propose, as a complementary approach, an adaptive traffic light system (ATLS) that is function of a statistical model of induced seismicity. It offers an actuarial judgement of the risk, which is based on a mapping between earthquake magnitude and risk. Using data from six underground reservoir stimulation experiments, mostly from Enhanced Geothermal Systems, we illustrate how such a data-driven adaptive forecasting system could guarantee a risk-based safety target. The proposed model, which includes a linear relationship between seismicity rate and flow rate, as well as a normal diffusion process for post-injection, is first confirmed to be representative of the data. Being integrable, the model yields a closed-form ATLS solution that is both transparent and robust. Although simulations verify that the safety target is consistently ensured when the ATLS is applied, the model from which simulations are generated is validated on a limited dataset, hence still requiring further tests in additional fluid injection environments.

[Strategy of constructing post-market integral evaluation system of traditional Chinese medicine injection].

PubMed

Zhang, Xiao-Yu; Wang, Yan-Ping; Lin, Li-Kai; Shang, Hong-Cai; Wang, Yong-Yan

2017-08-01

As an important representative of modern Chinese medicine, traditional Chinese medicine (TCM) injzection has become an indispensable part of the Chinese medicine industry. However, its development is now restricted by the bottleneck of insufficient core competitiveness, low-level research and production, even injection quality and the safe use are not guaranteed. Thus, it is urgent to reevaluate post-marketing TCM injection generally and to make secondary development. Under current circumstances, taking major brands which have good clinical and market foundation, as well as research value, as the main subject of cultivation and evaluation is an important approach to innovative development of TCM injection industry. Unlike oral proprietary Chinese medicine, the cultivatation of major brands of TCM injection needs higher technical support, quality standards and more timely feedback. Therefore, a post-market integral evaluation system adaptive to TCM injection is required. This article discussed some key points on the construction of a post-market integral evaluation system of TCM injection in three levels： optimizing evaluation methods, building synergistic innovation platforms which combine the medical research institutions and pharmaceutical enterprises, and finally constructing the integral evaluation system. A "five to one" structure has been proposed to enhance TCM injection effectiveness, safety and adaptability on the whole, which are from the following aspects： mechanism research, clinical evidence validation, literature information mining, sustainable development of resources and industrialization operation. Copyright© by the Chinese Pharmaceutical Association.

Risperidone long-acting injection: a review of its long term safety and efficacy

PubMed Central

Rainer, Michael K

2008-01-01

A long-acting form of the second-generation antipsychotic drug risperidone is now broadly available for the treatment of schizophrenia and closely related psychiatric conditions. It combines the advantage of previously available depot formulations for first-generation drugs with the favorable characteristics of the modern “atypical” antipsychotics, namely higher efficacy in the treatment of the negative symptoms of schizophrenia and reduced motor disturbances. Published clinical studies show an objective clinical efficacy (as per psychiatric symptom scores and relapse data) that exceeds that of oral atypical antipsychotics when patients are switched to the long-acting injectable form, a low incidence of treatment-emergent extrapyramidal side effects, and very good acceptance by patients. Available data for maintenance treatment of bipolar disorder show equivalence with the oral form instead of superiority, but are still limited. As it seems likely that efficacy benefits are mostly due to the fact that the injectable form reduces the demand for patient compliance to one physician visit every 2 weeks instead of self-administration on a daily or twice-daily basis, additional potential could exist in other psychiatric disorders where atypical antipsychotic drugs are of benefit but where patient adherence to treatment schedules is typically low. PMID:19183782

Validation of a Preclinical Spinal Safety Model: Effects of Intrathecal Morphine in the Neonatal Rat

PubMed Central

Westin, B. David; Walker, Suellen M.; Deumens, Ronald; Grafe, Marjorie; Yaksh, Tony L.

2010-01-01

Background Preclinical studies demonstrate increased neuroapoptosis after general anesthesia in early life. Neuraxial techniques may minimize potential risks, but there has been no systematic evaluation of spinal analgesic safety in developmental models. We aimed to validate a preclinical model for evaluating dose-dependent efficacy, spinal cord toxicity, and long term function following intrathecal morphine in the neonatal rat. Methods Lumbar intrathecal injections were performed in anesthetized rats aged postnatal day (P)3, 10 and 21. The relationship between injectate volume and segmental spread was assessed post mortem and by in-vivo imaging. To determine the antinociceptive dose, mechanical withdrawal thresholds were measured at baseline and 30 minutes following intrathecal morphine. To evaluate toxicity, doses up to the maximum tolerated were administered, and spinal cord histopathology, apoptosis and glial response were evaluated 1 and 7 days following P3 or P21 injection. Sensory thresholds and gait analysis were evaluated at P35. Results Intrathecal injection can be reliably performed at all postnatal ages and injectate volume influences segmental spread. Intrathecal morphine produced spinally-mediated analgesia at all ages with lower dose requirements in younger pups. High dose intrathecal morphine did not produce signs of spinal cord toxicity or alter long-term function. Conclusions The therapeutic ratio for intrathecal morphine (toxic dose / antinociceptive dose) was at least 300 at P3, and at least 20 at P21 (latter doses limited by side effects). This data provides relative efficacy and safety data for comparison with other analgesic preparations and contributes supporting evidence for the validity of this preclinical neonatal safety model. PMID:20526189

Validation of a preclinical spinal safety model: effects of intrathecal morphine in the neonatal rat.

PubMed

Westin, B David; Walker, Suellen M; Deumens, Ronald; Grafe, Marjorie; Yaksh, Tony L

2010-07-01

Preclinical studies demonstrate increased neuroapoptosis after general anesthesia in early life. Neuraxial techniques may minimize potential risks, but there has been no systematic evaluation of spinal analgesic safety in developmental models. We aimed to validate a preclinical model for evaluating dose-dependent efficacy, spinal cord toxicity, and long-term function after intrathecal morphine in the neonatal rat. Lumbar intrathecal injections were performed in anesthetized rats aged postnatal day (P) 3, 10, and 21. The relationship between injectate volume and segmental spread was assessed postmortem and by in vivo imaging. To determine the antinociceptive dose, mechanical withdrawal thresholds were measured at baseline and 30 min after intrathecal morphine. To evaluate toxicity, doses up to the maximum tolerated were administered, and spinal cord histopathology, apoptosis, and glial response were evaluated 1 and 7 days after P3 or P21 injection. Sensory thresholds and gait analysis were evaluated at P35. Intrathecal injection can be reliably performed at all postnatal ages and injectate volume influences segmental spread. Intrathecal morphine produced spinally mediated analgesia at all ages with lower dose requirements in younger pups. High-dose intrathecal morphine did not produce signs of spinal cord toxicity or alter long-term function. The therapeutic ratio for intrathecal morphine (toxic dose/antinociceptive dose) was at least 300 at P3 and at least 20 at P21 (latter doses limited by side effects). These data provide relative efficacy and safety for comparison with other analgesic preparations and contribute supporting evidence for the validity of this preclinical neonatal safety model.

Botulinum toxin A in the treatment of glabellar lines: scheduling the next injection.

PubMed

Ascher, Benjamin; Zakine, Benjamin; Kestemont, Philippe; Baspeyras, Martine; Bougara, Ali; Niforos, François; Malet, Thierry; Santini, José

2005-01-01

A single intramuscular treatment with botulinum toxin A (BoNT-A) into the facial muscles underlying glabellar rhytids has been shown to effectively attenuate or totally erase these lines for at least 3 months. We sought to evaluate the optimal time for a second injection of BoNT-A (Dysport, Ipsen). One hundred patients with moderate to severe glabellar rhytids at rest were randomized to a first, double-blind injection of 50 U of BoNT-A (n = 50) divided into 5 intramuscular sites, or placebo (n = 50). At monthly intervals between Month 3 and Month 6, the patient and the investigator consensually decided to repeat the injection with open-label BoNT-A in both groups. The main outcome was the time between the first and second injections. Responder ratings (mild or no glabellar lines) after the first and second injections, patient satisfaction, and safety were also assessed. At Months 3 and 4 after the first injection, the cumulative percentage of patients having a second injection was lower in the BoNT-A group compared to the placebo group, with a significant difference at Month 4. Following the first double-blind injection, responder rates were significantly higher in BoNT-A group (up to 75%) compared to placebo up to Month 4, and a large majority of patients were significantly satisfied with the BoNT-A treatment at Month 4 (75% satisfied and completely satisfied versus 9.1% with placebo) and Month 5 (86.7% versus 0%, respectively). Headache was the most frequent adverse event in the BoNT-A group (10% versus 6% in the placebo group). No blepharoptosis was reported. The effectiveness of 50 U of BoNT-A was confirmed for the treatment of glabellar lines. A second injection was sought within 3 to 4 months by most patients and investigators. Both injections were safe.

[Post-marketing re-evaluation of Kudiezi injection study on early treatment in patients with ischemic stroke].

PubMed

Ye, Xiaoqin; Wei, Xu; Xie, Yanming; Zou, Yihuai; Zhao, Xingquan; Han, Jianhua; Wang, Xinzhi; Ma, Yunzhi; Bi, Qi; Xie, Qingfan; Zhao, Jianjun; Cao, Xiaolan; Chen, Hongxia; Wang, Shizhong; Yan, Rongmei; Han, Zucheng; Yi, Danhui; Wang, Yongyan

2011-10-01

To study the effect and safety of Kudiezi injection on patients with acute ischemic stroke. Seven hundreds patients were divided into two groups by central randomization system. The study group, 346 cases, was treated with kudiezi injection plus traditional Chinese medicine (TCM) synthesis rehabilitation project, and the control group, 354 cases, was treated with synthetic rehabilitation project. The patients were treated for 10 to 21 days. Before treatment and at the 7th, 14th and 21th day of treatment, the indexes include NIHSS used for evaluating the neurological deficit degree and the motor function score (Fugl-Meyer) for evaluating motor function were observed. The safety index is defined by adverse observation event and laboratory test. The incidence of adverse events and laboratory tests results were observed before and after treatment at the same time. Application of generalized estimating equation model, we found that as the treatment time, NIHSS score and FMI score of the two groups showed a trend of improvement. And at the 14th days and 21th days of treatment, compared to the control group the treatment group showed significant statistical difference on the impact of NIHSS and FMI (P<0.05). No serious adverse events were observed. Kudiezi injection plus TCM rehabilitation project of ischemic stroke showed some superiority to western medicine rehabilitation program on improving the neurological deficit and motor function. Kudiezi injection is safe and effective in the treatment of acute ischemic stroke.

Locoregional mitomycin C injection for esophageal stricture after endoscopic submucosal dissection.

PubMed

Machida, H; Tominaga, K; Minamino, H; Sugimori, S; Okazaki, H; Yamagami, H; Tanigawa, T; Watanabe, K; Watanabe, T; Fujiwara, Y; Arakawa, T

2012-06-01

This prospective study aimed to evaluate the feasibility and safety of locoregional mitomycin C (MMC) injection to treat refractory esophageal strictures after endoscopic submucosal dissection (ESD) for superficial esophageal carcinoma. Patients with dysphagia and strictures that were refractory to repeated endoscopic balloon dilation (EBD) were eligible. After EBD, MMC was injected into the dilated site. Between June 2009 and August 2010, five patients were recruited. The treatment was performed once in two patients and twice in three patients with recurrent dysphagia or restenosis. In all patients, passing a standard endoscope through the site was easy and the dysphagia grade improved (grade 3→1 in 3 patients, grade 4→2 in 2 patients). No serious complications were noted. During the observation period of 4.8 months, neither recurrent dysphagia nor re-stricture appeared in any of the patients. The combination of locoregional MMC injections and EBD is feasible and safe for the treatment of esophageal strictures after ESD.Recently, endoscopic submucosal dissection (ESD) has been developed and accepted as a new endoscopic treatment for gastrointestinal tumors. ESD is a promising treatment for superficial esophageal carcinoma (SEC), and it has a reliable en bloc resection rate. However, the application of ESD for widespread lesions is challenging because of the high risk of the development of severe strictures, which lead to a low quality of life after ESD. Although endoscopic balloon dilation (EBD) is effective for benign strictures, it needs to be performed frequently until the dysphagia disappears 1. Mitomycin C (MMC), which is a chemotherapeutic agent derived from some Streptomyces species 2, reduces scar formation when topically applied to a surgical lesion. MMC has been applied to treat strictures in a variety of anatomical locations, including a variety of organs 3. The aim of this study was to prospectively evaluate both the feasibility and the safety of

Towards safe injection practices for prevention of hepatitis C transmission in South Asia: Challenges and progress

PubMed Central

Janjua, Naveed Zafar; Butt, Zahid Ahmad; Mahmood, Bushra; Altaf, Arshad

2016-01-01

AIM: To summarize the available information about injection use and its determinants in the South Asian region. METHODS: We searched published and unpublished literature on injection safety in South Asia published during 1995-2016 using the keywords “injection” “unsafe injection” and “immunization injection” and combined these with each of the countries and/or their respective states or provinces in South Asia. We used a standardized questionnaire to abstract the following data from the articles: the annual number of injections per capita, the proportion of injections administered with a reused syringe or needle, the distribution of injections with respect to prescribers and providers and determinants of injection use. RESULTS: Although information is very limited for certain countries (i.e., Bhutan, Maldives and Sri Lanka), healthcare injection use is very common across South Asia, with cross-country rates ranging from 2.4 to 13.6 injections/person/year. Furthermore, recent studies show that 5% to 50% of these injections are provided with reused syringes, thus creating potential to transmission of blood-borne pathogens. Qualified and unqualified practitioners, especially in the private sector, are the major drivers behind injection use, but patients also prefer injections, especially among the rural, poor or uneducated in certain countries. According to available data, Pakistan and India have recently taken steps towards achieving safe injection. Potential interventions include the introduction of reuse prevention devices, and patient-, community- and patient/community and provider-centered interventions to change population and practitioner behavior. CONCLUSION: Injection use is common in South Asian countries. Multilevel interventions aiming at patients, providers and the healthcare system are needed to reduce injection use and reuse. PMID:27433097

Immunogenicity and safety of different injection routes and schedules of IC41, a Hepatitis C virus (HCV) peptide vaccine.

PubMed

Firbas, Christa; Boehm, Thomas; Buerger, Vera; Schuller, Elisabeth; Sabarth, Nicolas; Jilma, Bernd; Klade, Christoph S

2010-03-11

An effective vaccine would be a significant progress in the management of chronic HCV infections. This study was designed to examine whether different application schedules and injection routes may enhance the immunogenicity of the HCV peptide vaccine IC41. In this randomized trial 54 healthy subjects received either subcutaneous (s.c.) or intradermal (i.d.) vaccinations weekly (16 injections) or every other week (8 injections). One group additionally received imiquimod, an activator of the toll-like receptor (TLR) 7. The T cell epitope-specific immune response to IC41 was assessed using [(3)H]-thymidine CD4+ T cell proliferation, interferon-gamma (IFN-gamma) CD8+ and CD4+ ELIspot and HLA-A*0201 fluorescence-activated cell sorting (FACS) tetramer-binding assays. More than 60% of vaccinees responded in the CD4+ T cell proliferation assay in all groups. An HLA-A*0201 FACS tetramer-binding assay and IFN-gamma CD8+ ELIspot class I response of more than 70% was induced in four and three groups, respectively. IC41 induced significant immunological responses in all groups with responder rates of up to 100%. Interestingly, topical imiquimod was not able to enhance immunogenicity but was associated with a lower immune response. Local injection site reactions were mostly transient. Intradermal injections caused more pronounced reactions compared to s.c., especially erythema and edema. Compared to a previous study intensified dosing and/or i.d. injections enhanced the response rates to the vaccine IC41 in three assays measuring T cell function. Immunization with IC41 was generally safe in this study. These results justify testing IC41 in further clinical trials with HCV-infected individuals.

Correcting Nasojugal Groove with Autologous Cultured Fibroblast Injection: A Pilot Study.

PubMed

Moon, Kyung-Chul; Lee, Hyun-Su; Han, Seung-Kyu; Chung, Ho-Yun

2018-06-01

A new commercial drug that contains autologous cultured fibroblasts has been developed and approved by the United States Food and Drug Administration for improving the appearance of nasolabial folds. However, the treatment requires three sessions every 3-6 weeks. It is known that the skin overlying the nasojugal groove is thinner, and the wrinkle is generally shallower than nasolabial folds. Therefore, we hypothesized that the nasojugal groove could be improved by just one treatment session. Therefore, the purpose of this study was to evaluate the efficacy and safety of autologous cultured fibroblast injection to correct nasojugal grooves. Forty-six subjects with nasojugal grooves were enrolled in this study. They were injected with autologous cultured fibroblasts or placebo in one session. Blinded evaluators and subjects assessed the efficacy using a validated wrinkle assessment scale at 4, 12, and 24 weeks after the injection. Information of adverse events was collected at each visit. Based on the evaluators' assessment at 24 weeks after the injection, 76% of subjects treated with autologous cultured fibroblasts showed improvement whereas 0% of subjects treated with placebo showed improvement (P < 0.0001). Based on self-assessment at 24 weeks after the injection, 72% of subjects treated with autologous cultured fibroblasts and 45% of subjects treated with placebo showed improvement (P = 0.0662). There were no serious adverse events related to autologous cultured fibroblast injection. Autologous cultured fibroblast injection might be effective and safe to correct nasojugal grooves. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Agreement between a physiotherapist and an orthopaedic surgeon regarding management and prescription of corticosteroid injection for patients with shoulder pain.

PubMed

Marks, Darryn; Comans, Tracy; Thomas, Michael; Ng, Shu Kay; O'Leary, Shaun; Conaghan, Philip G; Scuffham, Paul A; Bisset, Leanne

2016-12-01

Physiotherapists increasingly manage shoulder referrals in place of orthopaedic doctors. Better understanding the agreement between these professionals will help inform the safety, quality and potential costs of these care models. To establish the level of agreement between a physiotherapist and an orthopaedic surgeon regarding diagnosis, management and corticosteroid injection, in a representative sample of orthopaedic shoulder referrals. Blinded inter-rater agreement study. 274 public orthopaedic shoulder patients were independently assessed by a physiotherapist and an orthopaedic surgeon. Management, subacromial corticosteroid injection, diagnosis and investigation decisions were compared using inter-rater reliability statistics. Agreement between the physiotherapist and the orthopaedic surgeon was near perfect for surgical versus nonsurgical management (Gwets agreement coefficient AC1 = 0.93, 95%CI: 0.90-0.93), safety of injection (AC1 = 0.85, CI: 0.79-0.91) and investigations requested (AC1 = 0.87, CI: 0.83-0.91); substantial for the presence of subacromial pain (AC1 = 0.74, CI: 0.66-0.81) and diagnosis (AC1 = 0.72, CI: 0.66-0.78); and moderate regarding delivery of subacromial corticosteroid injection as an immediate treatment (AC1 = 0.48, CI 0.33-0.53), with the physiotherapist less inclined to select corticosteroid injection as the first intervention. In this study a physiotherapist with prescribing and injection training made decisions analogous to those of an orthopaedic surgeon at initial consultation for orthopaedic shoulder pain, including the safe identification of patients for subacromial injection, without prior screening of referrals by orthopaedic doctors. Australia and New Zealand Clinical Trials Registry, number 12612000532808. Copyright © 2016 Elsevier Ltd. All rights reserved.

Delayed manipulation after collagenase clostridium histolyticum injection for Dupuytren contracture.

PubMed

Kaplan, F Thomas D; Badalamente, Marie A; Hurst, Lawrence C; Merrell, Gregory A; Pahk, Raymond

2015-09-01

Collagenase clostridium histolyticum (CCH) injection for Dupuytren contracture was approved in the USA in 2010. Current FDA guidelines stipulate that finger manipulation occurs the day following injection. To investigate the safety and efficacy of delaying manipulation to 2 or 4 days following CCH injection, we conducted a prospective, randomized trial at two sites. Patients with Dupuytren contracture involving the metacarpophalangeal (MCP) joint ≥20° caused by a palpable cord participated. All patients received one dose of CCH (0.58 mg/0.25 ml) and were followed for 90 days. The primary end point was the percent of patients maintaining clinical success (reduction of contracture to 0°-5°) at 90 days post-injection. Adverse events and change in Michigan Hand Questionnaire (MHQ) score were recorded as secondary end points. Thirty-seven patients enrolled; 13 were manipulated on day 1, 11 on day 2, and 13 on day 4. At 30 days after injection, the percentage of patients obtaining reduction of contracture to <0°-5° extension was 92, 82, and 85 % in groups 1, 2, and 3, respectively, with no significant difference. At 90 days follow-up, the percentage of patients maintaining 0°-5° extension was 91, 82, and 83 % in groups 1, 2, and 3, respectively, with no significant difference. Adverse events were comparable to rates in prior studies. There were no serious adverse events. There was no statistical difference in MHQ scores between groups at any time point. Delaying manipulation to day 2 or 4 following CCH injection for MCP joint contractures does not increase adverse events or result in loss of efficacy. Therapeutic, Level II.

Central venous catheter integrity during mechanical power injection of iodinated contrast medium.

PubMed

Macha, Douglas B; Nelson, Rendon C; Howle, Laurens E; Hollingsworth, John W; Schindera, Sebastian T

2009-12-01

To evaluate a widely used nontunneled triple-lumen central venous catheter in order to determine whether the largest of the three lumina (16 gauge) can tolerate high flow rates, such as those required for computed tomographic angiography. Forty-two catheters were tested in vitro, including 10 new and 32 used catheters (median indwelling time, 5 days). Injection pressures were continuously monitored at the site of the 16-gauge central venous catheter hub. Catheters were injected with 300 and 370 mg of iodine per milliliter of iopamidol by using a mechanical injector at increasing flow rates until the catheter failed. The infusion rate, hub pressure, and location were documented for each failure event. The catheter pressures generated during hand injection by five operators were also analyzed. Mean flow rates and pressures at failure were compared by means of two-tailed Student t test, with differences considered significant at P < .05. Injections of iopamidol with 370 mg of iodine per milliliter generate more pressure than injections of iopamidol with 300 mg of iodine per milliliter at the same injection rate. All catheters failed in the tubing external to the patient. The lowest flow rate at which catheter failure occurred was 9 mL/sec. The lowest hub pressure at failure was 262 pounds per square inch gauge (psig) for new and 213 psig for used catheters. Hand injection of iopamidol with 300 mg of iodine per milliliter generated peak hub pressures ranging from 35 to 72 psig, corresponding to flow rates ranging from 2.5 to 5.0 mL/sec. Indwelling use has an effect on catheter material property, but even for used catheters there is a substantial safety margin for power injection with the particular triple-lumen central venous catheter tested in this study, as the manufacturer's recommendation for maximum pressure is 15 psig.

Multiple intravenous injections of allogeneic equine mesenchymal stem cells do not induce a systemic inflammatory response but do alter lymphocyte subsets in healthy horses.

PubMed

Kol, Amir; Wood, Joshua A; Carrade Holt, Danielle D; Gillette, Jessica A; Bohannon-Worsley, Laurie K; Puchalski, Sarah M; Walker, Naomi J; Clark, Kaitlin C; Watson, Johanna L; Borjesson, Dori L

2015-04-15

Intravenous (IV) injection of mesenchymal stem cells (MSCs) is used to treat systemic human diseases and disorders but is not routinely used in equine therapy. In horses, MSCs are isolated primarily from adipose tissue (AT) or bone marrow (BM) and used for treatment of orthopedic injuries through one or more local injections. The objective of this study was to determine the safety and lymphocyte response to multiple allogeneic IV injections of either AT-derived MSCs (AT-MSCs) or BM-derived MSCs (BM-MSCs) to healthy horses. We injected three doses of 25 × 10(6) allogeneic MSCs from either AT or BM (a total of 75 × 10(6) MSCs per horse) into five and five, respectively, healthy horses. Horses were followed up for 35 days after the first MSC infusion. We evaluated host inflammatory and immune response, including total leukocyte numbers, serum cytokine concentration, and splenic lymphocyte subsets. Repeated injection of allogeneic AT-MSCs or BM-MSCs did not elicit any clinical adverse effects. Repeated BM-MSC injection resulted in increased blood CD8(+) T-cell numbers. Multiple BM-MSC injections also increased splenic regulatory T cell numbers compared with AT-MSC-injected horses but not controls. These data demonstrate that multiple IV injections of allogeneic MSCs are well tolerated by healthy horses. No clinical signs or clinico-pathologic measurements of organ toxicity or systemic inflammatory response were recorded. Increased numbers of circulating CD8(+) T cells after multiple IV injections of allogeneic BM-MSCs may indicate a mild allo-antigen-directed cytotoxic response. Safety and efficacy of allogeneic MSC IV infusions in sick horses remain to be determined.

Prevalence and correlates of neck injection among people who inject drugs in Tijuana, Mexico.

PubMed

Rafful, Claudia; Wagner, Karla D; Werb, Dan; González-Zúñiga, Patricia E; Verdugo, Silvia; Rangel, Gudelia; Strathdee, Steffanie A

2015-11-01

Injecting drugs in the neck has been related to adverse health conditions such as jugular vein thrombosis, deep neck infections, aneurysm, haematomas, airway obstruction, vocal cord paralysis and wound botulism, among others. We identified prevalence and correlates of neck injection among people who inject drugs (PWID) in Tijuana, Mexico. Beginning in 2011, PWID aged ≥18 years who injected drugs within the last month were recruited into a prospective cohort. At baseline and semi-annually, PWID completed interviewer-administered surveys soliciting data on drug-injecting practices. Logistic regression was used to identify predictors of injecting in the neck as the most frequent injection site at a single visit. Of 380 PWID, 35.3% injected in the neck at least once in the past 6 months, among whom 71.6% reported it as their most common injection site, the most common injecting site after the arms (47%). Controlling for age, years injecting and injecting frequency, injecting heroin and methamphetamine two or more times per day and having sought injection assistance were associated with injecting in the neck [adjusted odds ratios (AOR): 2.12; 95% confidence intervals (CI): 1.27-3.53 and AOR: 2.65; 95% CI: 1.52-4.53 respectively]. Injecting in the neck was very common among PWID in Tijuana and was associated with polydrug use and seeking injection assistance. Tailoring harm reduction education interventions for individuals who provide injection assistance ('hit doctors') may allow for the dissemination of safe injecting knowledge to reduce injection-related morbidity and mortality. © 2015 Australasian Professional Society on Alcohol and other Drugs.

Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013.

PubMed

Miller, Elaine R; Moro, Pedro L; Cano, Maria; Lewis, Paige; Bryant-Genevier, Marthe; Shimabukuro, Tom T

2016-05-27

23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax(®)23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), injection site erythema (28%) and injection site pain (25%) were the most commonly reported non-serious AEs in children. Injection site erythema (32%), injection site pain (27%) and injection site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies. Published by Elsevier Ltd.

Small-Volume Injections: Evaluation of Volume Administration Deviation From Intended Injection Volumes.

PubMed

Muffly, Matthew K; Chen, Michael I; Claure, Rebecca E; Drover, David R; Efron, Bradley; Fitch, William L; Hammer, Gregory B

2017-10-01

In the perioperative period, anesthesiologists and postanesthesia care unit (PACU) nurses routinely prepare and administer small-volume IV injections, yet the accuracy of delivered medication volumes in this setting has not been described. In this ex vivo study, we sought to characterize the degree to which small-volume injections (≤0.5 mL) deviated from the intended injection volumes among a group of pediatric anesthesiologists and pediatric postanesthesia care unit (PACU) nurses. We hypothesized that as the intended injection volumes decreased, the deviation from those intended injection volumes would increase. Ten attending pediatric anesthesiologists and 10 pediatric PACU nurses each performed a series of 10 injections into a simulated patient IV setup. Practitioners used separate 1-mL tuberculin syringes with removable 18-gauge needles (Becton-Dickinson & Company, Franklin Lakes, NJ) to aspirate 5 different volumes (0.025, 0.05, 0.1, 0.25, and 0.5 mL) of 0.25 mM Lucifer Yellow (LY) fluorescent dye constituted in saline (Sigma Aldrich, St. Louis, MO) from a rubber-stoppered vial. Each participant then injected the specified volume of LY fluorescent dye via a 3-way stopcock into IV tubing with free-flowing 0.9% sodium chloride (10 mL/min). The injected volume of LY fluorescent dye and 0.9% sodium chloride then drained into a collection vial for laboratory analysis. Microplate fluorescence wavelength detection (Infinite M1000; Tecan, Mannedorf, Switzerland) was used to measure the fluorescence of the collected fluid. Administered injection volumes were calculated based on the fluorescence of the collected fluid using a calibration curve of known LY volumes and associated fluorescence.To determine whether deviation of the administered volumes from the intended injection volumes increased at lower injection volumes, we compared the proportional injection volume error (loge [administered volume/intended volume]) for each of the 5 injection volumes using a linear

Rich catalytic injection

DOEpatents

Veninger, Albert [Coventry, CT

2008-12-30

A gas turbine engine includes a compressor, a rich catalytic injector, a combustor, and a turbine. The rich catalytic injector includes a rich catalytic device, a mixing zone, and an injection assembly. The injection assembly provides an interface between the mixing zone and the combustor. The injection assembly can inject diffusion fuel into the combustor, provides flame aerodynamic stabilization in the combustor, and may include an ignition device.

Anesthetic efficacy of a repeated intraosseous injection following a primary intraosseous injection.

PubMed

Jensen, Joanne; Nusstein, John; Drum, Melissa; Reader, Al; Beck, Mike

2008-02-01

The purpose of this prospective, randomized, single-blinded study was to determine the anesthetic efficacy of a repeated intraosseous injection given 30 minutes after a primary intraosseous injection. Using a crossover design, 55 subjects randomly received a primary X-tip intraosseous injection (Dentsply Inc, York, PA) of 1.4 mL of 2% lidocaine with epinephrine (using the Wand; Milestone Scientific, Deerfield, IL) and a repeated intraosseous or mock injection at 30 minutes in two appointments. The first molar and adjacent teeth were pulp tested every 2 minutes for a total of 120 minutes. Success was defined as obtaining two consecutive 80 readings with the electric pulp tester. Success of the initial intraosseous injection was 100% for the first molar. The repeated intraosseous injection mimicked the initial intraosseous injection in terms of pulpal anesthesia and statistically provided another 15 minutes of pulpal anesthesia. In conclusion, using the methodology presented, repeating the intraosseous injection 30 minutes after an initial intraosseous injection will provide an additional 15 minutes of pulpal anesthesia.

Prevalence and correlates of neck injection among people who inject drugs in Tijuana, Mexico

PubMed Central

RAFFUL, CLAUDIA; WAGNER, KARLA D.; WERB, DAN; GONZÁLEZ-ZÚÑIGA, PATRICIA E.; VERDUGO, SILVIA; RANGEL, GUDELIA; STRATHDEE, STEFFANIE A.

2016-01-01

Introduction and Aims Injecting drugs in the neck has been related to adverse health conditions such as jugular vein thrombosis, deep neck infections, aneurysm, haematomas, airway obstruction, vocal cord paralysis and wound botulism, among others. We identified prevalence and correlates of neck injection among people who inject drugs (PWID) in Tijuana, Mexico. Design and Methods Beginning in 2011, PWID aged ≥18 years who injected drugs within the last month were recruited into a prospective cohort. At baseline and semi-annually, PWID completed interviewer-administered surveys soliciting data on drug-injecting practices. Logistic regression was used to identify predictors of injecting in the neck as the most frequent injection site at a single visit. Results Of 380 PWID, 35.3% injected in the neck at least once in the past 6 months, among whom 71.6% reported it as their most common injection site, the most common injecting site after the arms (47%). Controlling for age, years injecting and injecting frequency, injecting heroin and methamphetamine two or more times per day and having sought injection assistance were associated with injecting in the neck [adjusted odds ratios (AOR): 2.12; 95% confidence intervals (CI): 1.27–3.53 and AOR: 2.65; 95% CI: 1.52–4.53 respectively]. Discussion and Conclusions Injecting in the neck was very common among PWID in Tijuana and was associated with polydrug use and seeking injection assistance. Tailoring harm reduction education interventions for individuals who provide injection assistance (‘hit doctors’) may allow for the dissemination of safe injecting knowledge to reduce injection-related morbidity and mortality. PMID:25867795

Ultrasound-guided corticosteroid injection therapy for juvenile idiopathic arthritis: 12-year care experience.

PubMed

Young, Cody M; Shiels, William E; Coley, Brian D; Hogan, Mark J; Murakami, James W; Jones, Karla; Higgins, Gloria C; Rennebohm, Robert M

2012-12-01

Intra-articular corticosteroid injections are a safe and effective treatment for patients with juvenile idiopathic arthritis. The potential scope of care in ultrasound-guided corticosteroid therapy in children and a joint-based corticosteroid dose protocol designed to optimize interdisciplinary care are not found in the current literature. The purpose of this study was to report the spectrum of care, technique and safety of ultrasound-guided corticosteroid injection therapy in patients with juvenile idiopathic arthritis and to propose an age-weight-joint-based corticosteroid dose protocol. A retrospective analysis was performed of 198 patients (ages 21 months to 28 years) referred for treatment of juvenile idiopathic arthritis with corticosteroid therapy. Symptomatic joints and tendon sheaths were treated as prescribed by the referring rheumatologist. An age-weight-joint-based dose protocol was developed and utilized for corticosteroid dose prescription. A total of 1,444 corticosteroid injections (1,340 joints, 104 tendon sheaths) were performed under US guidance. Injection sites included small, medium and large appendicular skeletal joints (upper extremity 497, lower extremity 837) and six temporomandibular joints. For patients with recurrent symptoms, 414 repeat injections were performed, with an average time interval of 17.7 months (range, 0.5-101.5 months) between injections. Complications occurred in 2.6% of injections and included subcutaneous tissue atrophy, skin hypopigmentation, erythema and pruritis. US-guided corticosteroid injection therapy provides dynamic, precise and safe treatment of a broad spectrum of joints and tendon sheaths throughout the entire pediatric musculoskeletal system. An age-weight-joint-based corticosteroid dose protocol is effective and integral to interdisciplinary care of patients with juvenile idiopathic arthritis.

Influence of pre-injection control parameters on main-injection fuel quantity for an electronically controlled double-valve fuel injection system of diesel engine

NASA Astrophysics Data System (ADS)

Song, Enzhe; Fan, Liyun; Chen, Chao; Dong, Quan; Ma, Xiuzhen; Bai, Yun

2013-09-01

A simulation model of an electronically controlled two solenoid valve fuel injection system for a diesel engine is established in the AMESim environment. The accuracy of the model is validated through comparison with experimental data. The influence of pre-injection control parameters on main-injection quantity under different control modes is analyzed. In the spill control valve mode, main-injection fuel quantity decreases gradually and then reaches a stable level because of the increase in multi-injection dwell time. In the needle control valve mode, main-injection fuel quantity increases with rising multi-injection dwell time; this effect becomes more obvious at high-speed revolutions and large main-injection pulse widths. Pre-injection pulse width has no obvious influence on main-injection quantity under the two control modes; the variation in main-injection quantity is in the range of 1 mm3.

A New Technique for Femoral Venous Access in Infants Using Arterial Injection Venous Return Guidance

PubMed Central

Ebishima, Hironori; Kitano, Masataka; Kurosaki, Kenichi; Shiraishi, Isao

2017-01-01

Objectives: Although venography guidance is helpful for central venous catheter placement, it is sometimes difficult to place a peripheral intravenous cannula for enhancement. We designed a new technique for establishing femoral venous access using venography guidance in the return phase of peripheral arteriography. This new technique was named arterial injection venous return guidance. Here we assessed the efficacy and safety of arterial injection venous return guidance. Methods: We reviewed data of 29 infants less than 6 months old undergoing catheter intervention at our institute in 2014. Of the 29 patients, femoral venous cannulation was performed using arterial injection venous return guidance in 5 patients, venography in 20 patients, and the landmark method in 4 patients. The technical success rates and incidence of complications were compared. Results: The overall success rates were 100% in the arterial injection venous return-guided and venography-guided groups. The mean procedure duration and mean contrast material injection time were similar between the groups. The contrast effect on the femoral vein in the arterial injection venous return-guided group was lower than that in the venography-guided group, but adequate for surgery. The overall complication rate was 17%, and obstruction of previously placed intravenous catheters was the most common complication. Conclusions: Therefore, the arterial injection venous return guidance technique was as safe and efficient as venography for establishing venous access. PMID:29034015

RimabotulinumtoxinB Injection

MedlinePlus

... tightening of the neck muscles that may cause neck pain and abnormal head positions). RimabotulinumtoxinB injection is in ... cannot be substituted for another.RimabotulinumtoxinB injection controls ... longer before you feel the full benefit of rimabotulinumtoxinB injection.

Lacosamide Injection

MedlinePlus

Lacosamide injection is used in combination with other medications to control certain types of seizures in people who cannot take oral medications. Lacosamide injection is in a class of medications called ...

Urinary retention in female OAB after intravesical Botox injection: who is really at risk?

PubMed

Miotla, Pawel; Cartwright, Rufus; Skorupska, Katarzyna; Bogusiewicz, Michal; Markut-Miotla, Ewa; Futyma, Konrad; Rechberger, Tomasz

2017-06-01

Intravesical onabotulinumtoxinA (Botox) injections are effective for the treatment of idiopathic overactive bladder (OAB) symptoms. The aim of our study was to assess the predisposing factors for urinary retention in women with OAB after intravesical Botox injection. All participants were women of European descent with idiopathic OAB. OnabotulinumtoxinA (100 U) was administered in 20 intra-detrusor injections. Analysis was performed based on the results of safety assessments made during follow-up (FU) visits on weeks 2, 4 and 12, in 208 women who were treated with Botox injections for refractory OAB and who completed all FU visits. Women who required clean intermittent self-catheterisation (CISC) and those with post-void residual (PVR) greater than 200 ml were older in comparison with patients with PVR between 50 and 200 ml. Patients who required CISC were also characterised by higher parity and particularly by a higher number of vaginal deliveries. Other factors such as body mass index or comorbidities did not significantly influence PVR and the risk of CISC. Elderly and/or multiparous women are at increased risk of urinary retention after intravesical 100-U Botox injections. The risk of new onset urine retention in our study has completely disappeared 2 weeks after Botox injections. Based on our results of the way in which the PVRs have changed over time, we can conclude that OAB patients should be optimally assessed during the first 2 weeks after Botox injections.

Ultrasound-guided corticosteroid injection of the subtalar joint for treatment of juvenile idiopathic arthritis.

PubMed

Young, Cody M; Horst, Deanna M; Murakami, James W; Shiels, William E

2015-07-01

The subtalar joint is commonly affected in children with juvenile idiopathic arthritis and is challenging to treat percutaneously. To describe the technique for treating the subtalar joint with US-guided corticosteroid injections in children and young adults with juvenile idiopathic arthritis and to evaluate the safety of the treatment. We retrospectively analyzed 122 patients (age 15 months-29 years) with juvenile idiopathic arthritis who were referred by a pediatric rheumatologist for corticosteroid injection therapy for symptoms related to the hindfoot or ankle. In these patients the diseased subtalar joint was targeted for therapy, often in conjunction with adjacent affected joints or tendon sheaths of the ankle. We used a protocol based on age, weight and joint for triamcinolone hexacetonide or triamcinolone acetonide dose prescription. We describe the technique for successful treatment of the subtalar joint. A total of 241 subtalar joint corticosteroid injections were performed under US guidance, including 68 repeat injections for recurrent symptoms in 26 of the 122 children and young adults. The average time interval between repeat injections was 24.8 months (range 2.2-130.7 months, median 14.2 months). Subcutaneous tissue atrophy and skin hypopigmentation were the primary complications observed. These complications occurred in 3.9% of the injections. With appropriate training and practice, the subtalar joint can be reliably and safely targeted with US-guided corticosteroid injection to treat symptoms related to juvenile idiopathic arthritis.

Injection Laryngoplasty Using Micronized Acellular Dermis for Vocal Fold Paralysis: Long-term Voice Outcomes.

PubMed

Hernandez, Stephen C; Sibley, Haley; Fink, Daniel S; Kunduk, Melda; Schexnaildre, Mell; Kakade, Anagha; McWhorter, Andrew J

2016-05-01

Micronized acellular dermis has been used for nearly 15 years to correct glottic insufficiency. With previous demonstration of safety and efficacy, this study aims to evaluate intermediate and long-term voice outcomes in those who underwent injection laryngoplasty for unilateral vocal fold paralysis. Technique and timing of injection were also reviewed to assess their impact on outcomes. Case series with chart review. Tertiary care center. Patients undergoing injection laryngoplasty from May 2007 to September 2012 were reviewed for possible inclusion. Pre- and postoperative Voice Handicap Index (VHI) scores, as well as senior speech-language pathologists' blinded assessment of voice, were collected for analysis. The final sample included patients who underwent injection laryngoplasty for unilateral vocal fold paralysis, 33 of whom had VHI results and 37 of whom had voice recordings. Additional data were obtained, including technique and timing of injection. Analysis was performed on those patients above with VHI and perceptual voice grades before and at least 6 months following injection. Mean VHI improved by 28.7 points at 6 to 12 months and 22.8 points at >12 months (P = .001). Mean perceptual voice grades improved by 17.6 points at 6 to 12 months and 16.3 points at >12 months (P < .001). No statistically significant difference was found with technique or time to injection. Micronized acellular dermis is a safe injectable that improved both patient-completed voice ratings and blinded reviewer voice gradings at intermediate and long-term follow-up. Further investigation may be warranted regarding technique and timing of injection. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

Colistimethate Injection

MedlinePlus

... is used to treat certain infections caused by bacteria. Colistimethate injection is in a class of medications called antibiotics. It works by killing bacteria.Antibiotics such as colistimethate injection will not work ...

Curative efficacy and safety of traditional Chinese medicine xuebijing injections combined with ulinastatin for treating sepsis in the Chinese population: A meta-analysis.

PubMed

Xiao, Shi-Hui; Luo, Liang; Liu, Xiang-Hong; Zhou, Yu-Ming; Liu, Hong-Ming; Huang, Zhen-Fei

2018-06-01

Sepsis is a clinically critical disease. However, it is still controversial whether the combined use of traditional Chinese medicine Xuebijing injections (XBJI) and western medicine can enhance curative efficacy and ensure safety compared with western medicine alone. Thus, this research consisted of a systematic review of the curative efficacy and safety of traditional Chinese medicine XBJI combined with ulinastatin for treating sepsis in the Chinese population. A total of 8 databases were retrieved: 4 foreign databases, namely, PubMed, The Cochrane Library, Embase, and Web of Science; and 4 Chinese databases, namely, Sino Med, China National Knowledge Infrastructure (CNKI), VIP, and Wangfang Data. The time span of retrieval began from the establishment of each database and ended on August 1, 2017. Published randomized controlled trials about the combined use of traditional Chinese medicine XBJI and western medicine were included, regardless of language. Stata12.0 software was used for statistical analysis. Finally, 16 papers involving 1335 cases were included. The result of meta-analysis showed that compared with the single use of ulinastatin, traditional Chinese medicine XBJI combined with ulinastatin could reduce the time of mechanical ventilation, shorten the length of intensive care unit (ICU) stay, improve the 28-day survival rate, and decrease the occurrence rate of multiple organ dysfunction syndrome, case fatality rate, procalcitonin (PCT) content, APACKEII score, tumor necrosis factor (TNF)-α level, and interleukin (IL)-6 level. On the basis of the common basic therapeutic regimen, the combined use of traditional Chinese medicine XBJI and ulinastatin was compared with the use of ulinastatin alone for treating sepsis in the Chinese population. It was found that the number of adverse events of combination therapy is not significantly increased, and its clinical safety is well within the permitted range. However, considering the limitations of this

The effects of cross-linked thermo-responsive PNIPAAm-based hydrogel injection on retinal function.

PubMed

Turturro, Sanja B; Guthrie, Micah J; Appel, Alyssa A; Drapala, Pawel W; Brey, Eric M; Pérez-Luna, Victor H; Mieler, William F; Kang-Mieler, Jennifer J

2011-05-01

There is significant interest in biomaterials that provide sustained release of therapeutic molecules to the retina. Poly(N-isopropylacrylamide) (PNIPAAm)-based materials have received significant attention as injectable drug delivery platforms due to PNIPAAm's thermo-responsive properties at approximately 32 °C. While the drug delivery properties of PNIPAAm materials have been studied extensively, there is a need to evaluate the safety effects of hydrogel injection on retinal function. The purpose of this study was to examine the effect of poly(ethylene glycol) diacrylate (PEG-DA) crosslinked PNIPAAm hydrogel injection on retinal function. Utilizing scanning laser ophthalmoscopy (SLO), optical coherent tomography (OCT), and electroretinography (ERG), retinal function was assessed following hydrogel injection. In region near the hydrogel, there was a significant decrease in arterial and venous diameters (∼4%) and an increase in venous blood velocity (∼8%) 1 week post-injection. Retinal thickness decreased (∼6%) at 1 week and the maximum a- and b-wave amplitudes of ERG decreased (∼15%). All data returned to baseline values after week 1. These data suggest that the injection of PEG-DA crosslinked PNIPAAm hydrogel results in a small transient effect on retinal function without any long-term effects. These results further support the potential of PNIPAAm-based materials as an ocular drug delivery platform. Copyright © 2011 Elsevier Ltd. All rights reserved.

Hydrocortisone Injection

MedlinePlus

Hydrocortisone injection is used to treat symptoms of low corticosteroid levels (lack of certain substances that are ... is also used to treat severe allergic reactions. Hydrocortisone injection is used in the management of multiple ...

Teduglutide Injection

MedlinePlus

... the medication should read the manufacturer's directions for mixing and injecting the medication before you use it ... Teduglutide must be used within 3 hours after mixing teduglutide powder with the diluent.You can inject ...

Doxycycline Injection

MedlinePlus

Doxycycline injection is used to treat or prevent bacterial infections, including pneumonia and other respiratory tract infections. ... certain skin, genital, intestine, and urinary system infections. Doxycycline injection may be used to treat or prevent ...

Dupilumab Injection

MedlinePlus

... injection is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the ... use other medications for their condition or whose eczema has not responded to other medications. Dupilumab injection ...

Naltrexone Injection

MedlinePlus

Naltrexone injection is used along with counseling and social support to help people who have stopped drinking ... injection is also used along with counseling and social support to help people who have stopped abusing ...

Doripenem Injection

MedlinePlus

... tract, kidney, and abdomen that are caused by bacteria. Doripenem injection is not approved by the Food ... medications called carbapenem antibiotics. It works by killing bacteria.Antibiotics such as doripenem injection will not work ...

Chloramphenicol Injection

MedlinePlus

... treat certain types of serious infections caused by bacteria when other antibiotics cannot be used. Chloramphenicol injection ... antibiotics. It works by stopping the growth of bacteria..Antibiotics such as chloramphenicol injection will not work ...

Cefoxitin Injection

MedlinePlus

... injection is used to treat infections caused by bacteria including pneumonia and other lower respiratory tract (lung) ... medications called cephamycin antibiotics. It works by killing bacteria.Antibiotics such as cefoxitin injection will not work ...

Tocilizumab Injection

MedlinePlus

... of age or older after receiving certain immunotherapy infusions. Tocilizumab injection is in a class of medications ... you miss an appointment to receive a tocilizumab infusion, call your doctor.If you forget to inject ...

Aripiprazole Injection

MedlinePlus

... a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or ... aripiprazole injection and aripiprazole extended-release injection developed gambling problems or other intense urges or behaviors that ...

Mipomersen Injection

MedlinePlus

Mipomersen injection is used to decrease levels of cholesterol and other fatty substances in the blood in ... procedure that removes LDL from the blood), but mipomersen injection should not be used along with this ...

Paclitaxel Injection

MedlinePlus

... other medications. Paclitaxel injection manufactured with polyoxyethylated castor oil is used to treat ovarian cancer (cancer that ... and lung cancer. Paclitaxel injection with polyoxyethylated castor oil is also used to treat Kaposi's sarcoma (a ...

Pramlintide Injection

MedlinePlus

... eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your ... inject pramlintide into your arm. Choose a different spot to inject pramlintide every day. Be sure that ...

Medroxyprogesterone Injection

MedlinePlus

... Medroxyprogesterone injection is a very effective method of birth control but does not prevent the spread of human ... you have been using a different method of birth control and are switching to medroxyprogesterone injection, your doctor ...

Triptorelin Injection

MedlinePlus

... used to treat the symptoms associated with advanced prostate cancer. Triptorelin injection (Triptodur) is used to treat central ... a medical office or clinic. When used for prostate cancer, an injection of 3.75 mg of triptorelin ( ...

Adalimumab Injection

MedlinePlus

... causes pain, swelling, and damage) including the following: rheumatoid arthritis (a condition in which the body attacks its ... If you are using adalimumab injection to treat rheumatoid arthritis, your doctor may tell you to inject the ...

Buprenorphine Injection

MedlinePlus

Buprenorphine extended-release injection is used to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers) ... sublingual buprenorphine for at least 7 days. Buprenorphine extended-release injection is in a class of medications ...

Golimumab Injection

MedlinePlus

... body and causes pain, swelling, and damage) including: rheumatoid arthritis (condition in which the body attacks its own ... doctor.If golimumab injection is used to treat rheumatoid arthritis, it may also be injected intravenously (into a ...

Evolocumab Injection

MedlinePlus

... coronary artery bypass (CABG) surgery in people with cardiovascular disease. Evolocumab injection is also used along with diet ... evolocumab injection is used to treat HeFH or cardiovascular disease or to reduce the risk of a stroke, ...

A discrete-choice experiment to determine patient preferences for injectable multiple sclerosis treatments in Germany.

PubMed

Poulos, Christine; Kinter, Elizabeth; Yang, Jui-Chen; Bridges, John F P; Posner, Joshua; Gleißner, Erika; Mühlbacher, Axel; Kieseier, Bernd

2016-03-01

The aim of this study was to assess the relative importance of features of a hypothetical injectable disease-modifying treatment for patients with multiple sclerosis using a discrete-choice experiment. German residents at least 18 years of age with a self-reported physician diagnosis of multiple sclerosis completed a 25-30 minute online discrete-choice experiment. Patients were asked to choose one of two hypothetical injectable treatments for multiple sclerosis, defined by different levels of six attributes (disability progression, the number of relapses in the next 4 years, injection time, frequency of injections, presence of flu-like symptoms, and presence of injection-site reactions). The data were analyzed using a random-parameters logit model. Of 202 adults who completed the survey, results from 189 were used in the analysis. Approximately 50% of all patients reported a diagnosis of relapsing-remitting multiple sclerosis, and 31% reported secondary progressive multiple sclerosis. Approximately 71% of patients had current or prior experience with injectable multiple sclerosis medication. Approximately 53% had experienced flu-like symptoms caused by their medication, and 47% had experienced mild injection-site reactions. At least one significant difference was seen between levels in all attributes, except injection time. The greatest change in relative importance between levels of an attribute was years until symptoms get worse from 1 to 4 years. The magnitude of this difference was about twice that of relapses in the next 4 years, frequency of injections, and flu-like symptoms. Most attributes examined in this experiment had an influence on patient preference. Patients placed a significant value on improvements in the frequency of dosing and disability progression. Results suggest that changes in injection frequency can be as important as changes in efficacy and safety attributes. Understanding which attributes of injectable therapies influence patient

The acceptability of an injectable, once-a-month male contraceptive in China.

PubMed

Zhang, Liying; Shah, Iqbal H; Liu, Yunrong; Vogelsong, Kirsten M; Zhang, Lihong

2006-05-01

An acceptability study of an injectable preparation of the synthetic steroid testosterone undecanoate as a once-a-month male contraceptive method was carried out concurrently with, but independently from, a clinical safety and efficacy trial of this preparation in China, from 1997 to 1999. Three hundred eight men, the entire group of volunteers enrolled in the clinical trial, were interviewed using a structured questionnaire. In addition, 24 sessions of focus group discussions and 54 in-depth interviews were conducted with a broad range of stakeholders, including men enrolled in the trial and their wives, potential users, service providers, principal investigators of the six participating clinical trial centers, provincial and national policy makers, and experts engaged in research and development of male methods of contraception. Overall, men found the regimen to be acceptable, and most reported no change or an improvement in their well-being as a result of participating in the clinical study. The frequency of the injections, monthly semen analyses and the need to use another contraceptive method during the period of sperm suppression were reported inconveniences of the trial. Further research is needed to assess the long-term safety, continuation rates, satisfaction among users and issues related to service delivery.

Adverse Event Rates Associated with Transforaminal and Interlaminar Epidural Steroid Injections: A Multi-Institutional Study.

PubMed

El-Yahchouchi, Christine A; Plastaras, Christopher T; Maus, Timothy P; Carr, Carrie M; McCormick, Zachary L; Geske, Jennifer R; Smuck, Matthew; Pingree, Matthew J; Kennedy, David J

2016-02-01

Transforaminal epidural steroid injections (TFESI) have demonstrated efficacy and effectiveness in treatment of radicular pain. Despite little evidence of efficacy/effectiveness, interlaminar epidural steroid injections (ILESI) are advocated by some as primary therapy for radicular pain due to purported greater safety. To assess immediate and delayed adverse event rates of TFESI and ILESI injections at three academic medical centers utilizing International Spine Intervention Society practice guidelines. Quality assurance databases from a Radiology and two physical medicine and rehabilitation (PM&R) practices were interrogated. Medical records were reviewed, verifying immediate and delayed adverse events. There were no immediate major adverse events of neurologic injury or hemorrhage in 16,638 consecutive procedures in all spine segments (14,956 TFESI; 1,682 ILESI). Vasovagal reactions occurred in 1.2% of procedures, more frequently (P = 0.004) in TFESI (1.3%) than ILESI (0.5%). Dural punctures occurred in 0.06% of procedures, more commonly after ILESI (0.2% vs 0.04%, P = 0.006). Delayed follow up on PM&R patients (92.5% and 78.5, next business day) and radiology patients (63.1%, 2 weeks) identified no major adverse events of neurologic injury, hemorrhage, or infection. There were no significant differences in delayed minor adverse event rates. Central steroid response (sleeplessness, flushing, nonpositional headache) was seen in 2.6% of both TFESI and ILESI patients. 2.1% of TFESI and 1.8% of ILESI patients reported increased pain. No long-term sequelae were seen from any immediate or delayed minor adverse event. Both transforaminal and ILESI are safely performed with low immediate and delayed adverse event rates when informed by evidence-based procedural guidelines. By demonstrating comparable safety, this study suggests that the choice between ILESI and TFESIs can be based on documented efficacy and effectiveness and not driven by safety concerns.

Levoleucovorin Injection

MedlinePlus

... injection is used to prevent harmful effects of methotrexate (Rheumatrex, Trexall) when methotrexate is used to to treat certain types of ... people who have accidentally received an overdose of methotrexate or similar medications. Levoleucovorin injection is in a ...

An Innovative Needle-free Injection System: Comparison to 1 ml Standard Subcutaneous Injection.

PubMed

Kojic, Nikola; Goyal, Pragun; Lou, Cheryl Hamer; Corwin, Michael J

2017-11-01

A needle-free delivery system may lead to improved satisfaction and compliance, as well as reduced anxiety among patients requiring frequent or ongoing injections. This report describes a first-in-man assessment comparing Portal Instruments' innovative needle-free injection system with subcutaneous injections using a 27G needle. Forty healthy volunteer participants each received a total of four injections of 1.0 mL sterile saline solution, two with a standard subcutaneous injection using a 27G needle, and two using the Portal injection system. Perception of pain was measured using a 100-mm visual analog scale (VAS). Injection site reactions were assessed at 2 min and at 20-30 min after each injection. Follow-up contact was made 24-48 h after the injections. Subject preference regarding injection type was also assessed. VAS pain scores at Portal injection sites met the criteria to be considered non-inferior to the pain reported at 27G needle injection sites (i.e., upper 95% confidence bound less than +5 mm). Based on a mixed effects model, at time 0, accounting for potential confounding variables, the adjusted difference in VAS scores indicated that Portal injections were 6.5 mm lower than the 27G needle injections (95% CI -10.5, -2.5). No clinically important adverse events were noted. Portal injections were preferred by 24 (60%) of the subjects (P = 0.0015). As an early step in the development of this new needle-free delivery system, the current study has shown that a 1.0-mL saline injection can be given with less pain reported than a standard subcutaneous injection using a 27G needle.

Injection-controlled laser resonator

DOEpatents

Chang, J.J.

1995-07-18

A new injection-controlled laser resonator incorporates self-filtering and self-imaging characteristics with an efficient injection scheme. A low-divergence laser signal is injected into the resonator, which enables the injection signal to be converted to the desired resonator modes before the main laser pulse starts. This injection technique and resonator design enable the laser cavity to improve the quality of the injection signal through self-filtering before the main laser pulse starts. The self-imaging property of the present resonator reduces the cavity induced diffraction effects and, in turn, improves the laser beam quality. 5 figs.

Injection-controlled laser resonator

DOEpatents

Chang, Jim J.

1995-07-18

A new injection-controlled laser resonator incorporates self-filtering and self-imaging characteristics with an efficient injection scheme. A low-divergence laser signal is injected into the resonator, which enables the injection signal to be converted to the desired resonator modes before the main laser pulse starts. This injection technique and resonator design enable the laser cavity to improve the quality of the injection signal through self-filtering before the main laser pulse starts. The self-imaging property of the present resonator reduces the cavity induced diffraction effects and, in turn, improves the laser beam quality.

Degarelix Injection

MedlinePlus

... injection is used to treat advanced prostate cancer (cancer that begins in the prostate [a male reproductive gland]). Degarelix injection is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of ...

Excipients and their role in approved injectable products: current usage and future directions.

PubMed

Nema, Sandeep; Brendel, Ronald J

2011-01-01

This review article is a current survey of excipients used in approved injectable products. Information provided includes concentration ranges, function, frequency of use, and role in dosage form. This article is an update of a paper published more than a decade ago (reference 11). Since then many new products have been approved. Safety concerning excipients has evolved as the scientific community continues to learn about their usage. New excipients are being used in early phases of clinical trials to support novel therapeutic entities like RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving specific needs that traditional excipients are unable to provide and for which safety studies are necessary to support a novel excipient for marketing applications. Excipients are added to parenteral dosage forms to serve a variety of functions including stabilization and as vehicles. This review article is a survey of excipients used in approved injectable products. Information provided includes excipient concentrations, functional roles, and frequency of use. This article is an update of an article originally published over a decade ago. Since then new products have been approved and safety concerns have evolved as the scientific community has learned about the usage of excipients. In addition, new excipients are being used in early phases of clinical trials to support novel therapeutic entities such as RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds. Because these excipients are not inert, various pharmacopoeias are responding with monographs or informational chapters addressing excipient functionality. The final sections of this article discuss new excipients, serving

Administering Multiple Injectable Vaccines During a Single Visit-Summary of Findings From the Accelerated Introduction of Inactivated Polio Vaccine Globally.

PubMed

Dolan, Samantha B; Patel, Manish; Hampton, Lee M; Burnett, Eleanor; Ehlman, Daniel C; Garon, Julie; Cloessner, Emily; Chmielewski, Elizabeth; Hyde, Terri B; Mantel, Carsten; Wallace, Aaron S

2017-07-01

In 2013, the World Health Organization's (WHO's) Strategic Advisory Group of Experts (SAGE) recommended that all 126 countries using only oral polio vaccine (OPV) introduce at least 1 dose of inactivated polio vaccine (IPV) into their routine immunization schedules by the end of 2015. In many countries, the addition of IPV would necessitate delivery of multiple injectable vaccines (hereafter, "multiple injections") during a single visit, with infants receiving IPV alongside pentavalent vaccine (which covers diphtheria, tetanus, and whole-cell pertussis; hepatitis B; and Haemophilus influenzae type b) and pneumococcal vaccine. Unanticipated concerns emerged from countries over acceptability of multiple injections, sites of administration, and safety. We contextualized the issues surrounding multiple injections by documenting concerns associated with administration of ≥3 injections, existing evidence in the published literature, and findings of a systematic review on administration practices and techniques. Concerns associated with multiple-injection visits were documented from meetings and personal communications with immunization program managers. Published literature on the acceptability of multiple injections by providers and caregivers was summarized, and a systematic review of the literature on administration practices was completed on the following topics: spacing between injection sites (ie, vaccine spacing), site of injection, route of injection, and procedural preparedness. WHO and United Nations Children's Fund data from 2013-2015 were used to assess multiple-injection visits included in national immunization schedules. Healthcare provider and caregiver attitudes and practices indicated concerns about infant pain, potential adverse effects, and uncertainty about vaccine effectiveness with multiple-injection visits. Published literature reinforced the record of safety and acceptance of the recommended schedule of IPV by the SAGE, but the evidence was

[Prevention and management of locoregional complications of botulinum A toxin injections in cosmetic treatment].

PubMed

Gassia, V

2009-05-01

Botulinum toxin serotype A injections used in treating dynamic wrinkles is one of the least invasive cosmetic procedures. High patient satisfaction and low onset of always moderate side effects contribute to the growing popularity of botulinum toxin injections in cosmetic treatment over the past few years. Years of experience and use, in therapeutics [1,2] and esthetics (20 years) have proven the efficacy and the safety of this wrinkle treatment. Today, no severe or long-term side effects have been reported in esthetics. This article discusses only the most frequent locoregional effects. They are rare, moderate, transitory, and totally reversible. Properly informing and selecting patients will contribute to successfully preventing and managing these effects.

Non-injection routes for allergen immunotherapy: focus on sublingual immunotherapy.

PubMed

Passalacqua, Giovanni; Guerra, Laura; Pasquali, Mercedes; Canonica, Giorgio Walter

2006-01-01

Allergen specific immunotherapy, together with drugs and allergen avoidance, is a cornerstone in the management of respiratory allergy. The non-injection or local routes were developed with the main goal of improving the safety and minimizing the risk of those side effects, which can accompany the injection route. The pure oral route and the bronchial route showed, in the clinical trials, only a marginal efficacy with not negligible side effects. Therefore, these routes are no longer recommended for clinical use. The nasal route proved effective and safe, but its efficacy is strictly limited to the nose. Moreover, the practical problems with administration have made the use of nasal immunotherapy progressively declining. The efficacy of the sublingual route is confirmed by numerous controlled trials, and a meta analysis (in allergic rhinitis). The safety profile, as derived from clinical trials and post marketing surveillance studies, is satisfactory, with mild gastrointestinal complaints being the more frequent side effect reported. Recent studies have also demonstrated that SLIT has a long-lasting effect and a preventive effect on the onset of new skin sensitizations, and interesting data on adherence and mechanisms of action have become recently available. Based on these experimental data, SLIT is now officially accepted as a viable alternative to the subcutaneous route in adults and children. Several points still need to be elucidated, including: mechanisms of action, optimal dosages, and indications in pediatric patients.

Driving reaction times in patients with foot and ankle pathology before and after image-guided injection: pain relief without improved function.

PubMed

Talusan, Paul G; Miller, Christopher P; Save, Ameya V; Reach, John S

2015-04-01

Foot and ankle pathology is common in the driving population. Local anesthetic steroid injections are frequent ambulatory treatments. Brake reaction time (BRT) has validated importance in motor vehicle safety. There are no prior studies examining the effect of foot and ankle pathology and injection treatment on the safe operation of motor vehicles. We studied BRT in patients with foot and ankle musculoskeletal disease before and after image-guided injection treatment. A total of 37 participants were enrolled. Image-guided injections of local anesthetic and steroid were placed into the pathological anatomical location of the right or left foot and ankles. A driving reaction timer was used to measure BRTs before and after injection. Patients suffering right "driving" and left "nondriving" pathology as well as a healthy control group were studied. All patients reported >90% pain relief postinjection. All injections were confirmed to be accurate by imaging. Post hoc Bonferonni analysis demonstrated significant difference between the healthy group and the right-sided injection group (P = .008). Mean BRT for healthy controls was 0.57 ± 0.11 s. Patients suffering right foot and ankle disease displayed surprisingly high BRTs (0.80 ± 0.23 s preinjection and 0.78 ± 0.16 s postinjection, P > .99). Left nondriving foot and ankle pathology presented a driving hazard as well (BRT of 0.75 ± 0.12 s preinjection and 0.77 ± 0.12 s postinjection, P > .99). Injections relieved pain but did not significantly alter BRT (P > .99 for all). Patients suffering chronic foot and ankle pathology involving either the driving or nondriving side have impaired BRTs. This preexisting driving impairment has not previously been reported and exceeds recommended cutoff safety values in the United States. Despite symptom improvement, there was no statistically significant change in BRT following image-guided injection in either foot and ankle. Therapeutic, Level II: Prospective Comparative Study. �

Polidocanol injection decreases the bleeding rate after colon polypectomy: a propensity score analysis.

PubMed

Facciorusso, Antonio; Di Maso, Marianna; Antonino, Matteo; Del Prete, Valentina; Panella, Carmine; Barone, Michele; Muscatiello, Nicola

2015-08-01

EMR is the standard of care for the resection of large polyps. To compare the efficacy and safety profile of submucosal polidocanol injection with epinephrine-saline solution injection for colon polypectomy with a diathermic snare. After 1-to-1 propensity score caliper matching, comparison of submucosal epinephrine injection was performed with polidocanol injection. Endoscopic suite at the University of Foggia between 2005 and 2014. Of 711 patients who underwent endoscopic resection of colon sessile polyps 20 mm or larger, 612 were analyzed after matching. Submucosal epinephrine injection in 306 patients and polidocanol injection in 306 patients. Univariate and multivariate logistic regression models aimed at identifying independent predictors of postpolypectomy bleeding (PPB). The 2 groups presented similar baseline clinical parameters and lesion characteristics. All patients had a single polyp 20 mm or larger; the median size was 32 mm (interquartile range [IQR], 25-38) in the polidocanol group and 32 (IQR, 24-38) in the epinephrine group (P=.7). Polidocanol was more effective in preventing both immediate and delayed PPB (P<.001 and P=.003, respectively), and its efficacy was confirmed in almost all of the subgroups, regardless of polyp size and histology. Postprocedure perforation was observed in 2 patients (0.3%), both in the epinephrine group (P=.49). The 2 groups did not differ in the number of snare resections of lesions or the procedure duration (P=.24 and .6, respectively). Absence of randomization. The submucosal injection of polidocanol for colon EMR is effective and significantly lowers the PPB rate. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Indian Injection Technique Study: Injecting Complications, Education, and the Health Care Professional.

PubMed

Kalra, Sanjay; Mithal, Ambrish; Sahay, Rakesh; John, Mathew; Unnikrishnan, A G; Saboo, Banshi; Ghosh, Sujoy; Sanyal, Debmalya; Hirsch, Laurence J; Gupta, Vandita; Strauss, Kenneth W

2017-06-01

Using the Indian and rest of world (ROW) injection technique questionnaire (ITQ) data, we address key insulin injection complications. In 2015 we conducted an ITQ survey throughout India involving 1011 patients. Indian values were compared with those from 41 other countries participating in the ITQ, known here as ROW. More than a quarter of Indian insulin users described lesions consistent with lipohypertrophy (LH) at their injection sites and approximately 1 in 5 were found to have LH by the examining nurse (using visual inspection and palpation). Just over half of Indian injectors report having pain on injection. Of these, 4 out of 5 report having painful injections only several times a month or year (i.e., not with every injection). Doctors and diabetes educators in India (as opposed to nurses) have a larger role in teaching patients how to inject than they do in ROW. Despite this specialized approach, a very high percentage of patients report that they have not been trained (at least cannot remember being trained) in a wide range of essential injection topics. Only about 30% of Indian injectors get their sites checked at least annually, with nearly a third only having sites checked when they specifically complained and nearly 4 out of 10 never having had their sites checked. Indian HCPs can clearly do a better job covering all the vital topics essential to proper injection habits.

Ixekizumab Injection

MedlinePlus

... or runny nose redness or pain at the injection site abdominal pain diarrhea (with or without blood) weight loss Some side effects can be serious. If you experience any of these symptoms ... ixekizumab injection and call your doctor immediately or get emergency ...

Zidovudine Injection

MedlinePlus

... immunodeficiency virus (HIV) infection. Zidovudine is given to HIV-positive pregnant women to reduce the chance of passing the infection to the baby. Zidovudine injection is in a class of medications ... the amount of HIV in the blood. Although zidovudine injection does not ...

Intravitreal injection therapy in the treatment of noninfectious uveitis.

PubMed

Modorati, Giulio; Miserocchi, Elisabetta

2012-01-01

Uveitis is responsible for 5-20% of legal blindness in the United States and in Europe. In noninfectious uveitis, the most frequent uveitic complication that endangers sight is cystoid macular edema. Clinical characteristics, inflammation grading and visual acuity determine the choice of the correct therapy for each patient. We can utilize drugs either alone or in combination using different dosages and routes of administration. Intravitreal injection directly into the vitreous cavity leads to rapid therapeutic drug concentration in the retinal tissue and reduces systemic side effects. Intravitreally injected triamcinolone acetonide is the most powerful drug for the treatment of cystoid macular edema related to intraocular inflammation, but it also causes the most frequent and serious side effects. Due to the numerous side effects associated with the use of corticosteroids, there is a need to identify other anti-inflammatory agents with a better safety profile. Recent studies have demonstrated that intravitreal immunosuppressant injections of methotrexate or anti-VEGF agents may lead to fewer intraocular side effects, but also have a lower therapeutic activity for the reduction of macular edema. At present, intraocular anti-TNF-α drugs do not show promising results. As regards nonsteroidal anti-inflammatory drugs, further data are necessary to fully understand their efficacy and potential side effects. Copyright © 2012 S. Karger AG, Basel.

Usefulness of intra-articular botulinum toxin injections. A systematic review.

PubMed

Khenioui, Hichem; Houvenagel, Eric; Catanzariti, Jean François; Guyot, Marc Alexandre; Agnani, Olivier; Donze, Cécile

2016-03-01

Botulinum toxin is a proven and widely used treatment for numerous conditions characterized by excessive muscular contractions. Recent studies have assessed the analgesic effect of botulinum toxin in joint pain and started to unravel its mechanisms. We searched the international literature via the Medline database using the term "intraarticular botulinum toxin injection" combined with any of the following terms: "knee", "ankle", "shoulder", "osteoarthritis", "adhesive capsulitis of the shoulder". Of 16 selected articles about intraarticular botulinum toxin injections, 7 were randomized controlled trials done in patients with osteoarthritis, adhesive capsulitis of the shoulder, or chronic pain after joint replacement surgery. Proof of anti-nociceptive effects was obtained in some of these indications and the safety and tolerance profile was satisfactory. The studies are heterogeneous. The comparator was usually a glucocorticoid or a placebo; a single study used hyaluronic acid. Pain intensity was the primary outcome measure. The number of randomized trials and sample sizes are too small to provide a satisfactory level of scientific evidence or statistical power. Unanswered issues include the effective dosage and the optimal dilution and injection modalities of botulinum toxin. Copyright © 2015 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

Multiple injections of electroporated autologous T cells expressing a chimeric antigen receptor mediate regression of human disseminated tumor.

PubMed

Zhao, Yangbing; Moon, Edmund; Carpenito, Carmine; Paulos, Chrystal M; Liu, Xiaojun; Brennan, Andrea L; Chew, Anne; Carroll, Richard G; Scholler, John; Levine, Bruce L; Albelda, Steven M; June, Carl H

2010-11-15

Redirecting T lymphocyte antigen specificity by gene transfer can provide large numbers of tumor-reactive T lymphocytes for adoptive immunotherapy. However, safety concerns associated with viral vector production have limited clinical application of T cells expressing chimeric antigen receptors (CAR). T lymphocytes can be gene modified by RNA electroporation without integration-associated safety concerns. To establish a safe platform for adoptive immunotherapy, we first optimized the vector backbone for RNA in vitro transcription to achieve high-level transgene expression. CAR expression and function of RNA-electroporated T cells could be detected up to a week after electroporation. Multiple injections of RNA CAR-electroporated T cells mediated regression of large vascularized flank mesothelioma tumors in NOD/scid/γc(-/-) mice. Dramatic tumor reduction also occurred when the preexisting intraperitoneal human-derived tumors, which had been growing in vivo for >50 days, were treated by multiple injections of autologous human T cells electroporated with anti-mesothelin CAR mRNA. This is the first report using matched patient tumor and lymphocytes showing that autologous T cells from cancer patients can be engineered to provide an effective therapy for a disseminated tumor in a robust preclinical model. Multiple injections of RNA-engineered T cells are a novel approach for adoptive cell transfer, providing flexible platform for the treatment of cancer that may complement the use of retroviral and lentiviral engineered T cells. This approach may increase the therapeutic index of T cells engineered to express powerful activation domains without the associated safety concerns of integrating viral vectors. Copyright © 2010 AACR.

Multiple injections of electroporated autologous T cells expressing a chimeric antigen receptor mediate regression of human disseminated tumor

PubMed Central

Zhao, Yangbing; Moon, Edmund; Carpenito, Carmine; Paulos, Chrystal M.; Liu, Xiaojun; Brennan, Andrea L; Chew, Anne; Carroll, Richard G.; Scholler, John; Levine, Bruce L.; Albelda, Steven M.; June, Carl H.

2010-01-01

Redirecting T lymphocyte antigen specificity by gene transfer can provide large numbers of tumor reactive T lymphocytes for adoptive immunotherapy. However, safety concerns associated with viral vector production have limited clinical application of T cells expressing chimeric antigen receptors (CARs). T lymphocytes can be gene modified by RNA electroporation without integration-associated safety concerns. To establish a safe platform for adoptive immunotherapy, we first optimized the vector backbone for RNA in vitro transcription to achieve high level transgene expression. CAR expression and function of RNA-electroporated T cells could be detected up to a week post electroporation. Multiple injections of RNA CAR electroporated T cells mediated regression of large vascularized flank mesothelioma tumors in NOD/scid/γc(−/−) mice. Dramatic tumor reduction also occurred when the pre-existing intraperitoneal human-derived tumors, that had been growing in vivo for over 50 days, were treated by multiple injections of autologous human T cells electroporated with anti-mesothelin CAR mRNA. This is the first report using matched patient tumor and lymphocytes demonstrating that autologous T cells from cancer patients can be engineered to provide an effective therapy for a disseminated tumor in a robust preclinical model. Multiple injections of RNA engineered T cells are a novel approach for adoptive cell transfer, providing flexible platform for the treatment of cancer that may complement the use of retroviral and lentiviral engineered T cells. This approach may increase the therapeutic index of T cells engineered to express powerful activation domains without the associated safety concerns of integrating viral vectors. PMID:20926399

A System for Integrated Reliability and Safety Analyses

NASA Technical Reports Server (NTRS)

Kostiuk, Peter; Shapiro, Gerald; Hanson, Dave; Kolitz, Stephan; Leong, Frank; Rosch, Gene; Coumeri, Marc; Scheidler, Peter, Jr.; Bonesteel, Charles

1999-01-01

We present an integrated reliability and aviation safety analysis tool. The reliability models for selected infrastructure components of the air traffic control system are described. The results of this model are used to evaluate the likelihood of seeing outcomes predicted by simulations with failures injected. We discuss the design of the simulation model, and the user interface to the integrated toolset.

Sonographically guided deep plantar fascia injections: where does the injectate go?

PubMed

Maida, Eugene; Presley, James C; Murthy, Naveen; Pawlina, Wojciech; Smith, Jay

2013-08-01

To determine the distribution of sonographically guided deep plantar fascia injections in an unembalmed cadaveric model. A single experienced operator completed 10 sonographically guided deep plantar fascia injections in 10 unembalmed cadaveric specimens (5 right and 5 left) obtained from 6 donors (2 male and 4 female) aged 49 to 95 years (mean, 77.5 years) with a mean body mass index of 23.2 kg/m(2) (range, 18.4-26.3 kg/m(2)). A 12-3-MHz linear array transducer was used to direct a 22-gauge, 38-mm stainless steel needle deep to the plantar fascia at the anterior aspect of the calcaneus using an in-plane, medial-to-lateral approach. In each case, 1.5 mL of 50% diluted colored latex was injected deep to the plantar fascia. After a minimum of 72 hours, study coinvestigators dissected each specimen to assess injectate placement. All 10 injections accurately placed latex adjacent to the deep side of the plantar fascia at the anterior calcaneus. However, the flexor digitorum brevis (FDB) origin from the plantar fascia variably limited direct latex contact with the plantar fascia, and small amounts of latex interdigitated with the FDB origin in 90% (9 of 10). In all 10 specimens, latex also covered the traversing first branch of the lateral plantar nerve (FBLPN, ie, Baxter nerve) between the FDB and quadratus plantae muscles. No latex was found in the plantar fat pad or plantar fascia in any specimen. Sonographically guided deep plantar fascia injections reliably deliver latex deep to the plantar fascia while avoiding intrafascial injection. However, the extent of direct plantar fascia contact is variable due to the intervening FDB. On the contrary, the traversing FBLPN is reliably covered by the injection. Deep plantar fascia injections may have a role in the management of refractory plantar fasciitis, particularly following failed superficial perifascial or intrafascial injections, in cases of preferential deep plantar fascia involvement, or when entrapment

Treatment of Stress Velopharyngeal Incompetence With Injection of Hyaluronic Acid.

PubMed

Koprowski, Steven; VanLue, Michael J; McCormick, Michael E

2018-04-01

Stress velopharyngeal incompetence (VPI) is a challenging clinical entity that can be managed by a variety of surgical and nonsurgical approaches. We describe the case of a clarinetist who presented with nasal air escape while playing. She had successful improvement in her symptoms after targeted injection of a hyaluronic acid compound to her posterior pharyngeal wall. Our objective is to describe the safety and efficacy of this technique, to emphasize the multidisciplinary management of patients with stress VPI, and to review the importance of both nasopharyngoscopy and videofluoroscopy in their evaluation.

Safety and immunogenicity of pneumococcal protein vaccine candidates: monovalent choline-binding protein A (PcpA) vaccine and bivalent PcpA-pneumococcal histidine triad protein D vaccine.

PubMed

Bologa, Monica; Kamtchoua, Thierry; Hopfer, Robert; Sheng, Xiaohua; Hicks, Bryony; Bixler, Garvin; Hou, Victor; Pehlic, Vildana; Yuan, Tao; Gurunathan, Sanjay

2012-12-14

Pneumococcal vaccines based on protein antigens may provide expanded protection against Streptococcus pneumoniae. To evaluate safety and immunogenicity in adults of pneumococcal vaccine candidates comprising S. pneumoniae pneumococcal histidine triad protein D (PhtD) and pneumococcal choline-binding protein A (PcpA) in monovalent and bivalent formulations. This was a phase I, randomized, observer-blinded, placebo-controlled, step-wise dose-escalation study. Following a pilot safety study in which participants received one intramuscular injection of either aluminum hydroxide (AH)-adjuvanted PcpA (25 μg) or PhtD-PcpA (10 μg each), participants in the main study received AH-adjuvanted PcpA (25 μg), AH-adjuvanted PhtD-PcpA (10, 25, or 50 μg each), unadjuvanted PhtD-PcpA (25 μg each), or placebo as 2 injections 30 days apart. Assignment of successive dose cohorts was made after blinded safety reviews after each dose level. Safety endpoints included rates of solicited injection site and systemic reactions, unsolicited adverse events (AEs), serious AEs (SAEs), and safety laboratory tests. Immunogenicity endpoints included levels of anti-PhtD and anti-PcpA antibodies (ELISA). Six adults 18-50 years of age were included in the pilot study and 125 in the main study. No obvious increases in solicited reactions or unsolicited AEs were reported with escalating doses (adjuvanted vaccine) after either injection, or with repeated administration. Adjuvanted vaccine candidates were associated with a higher incidence of solicited reactions (particularly injection site reactions) than unadjuvanted vaccine candidates. However, no SAE or discontinuation due to an AE occurred. Geometric mean concentrations of anti-PhtD IgG and anti-PcpA IgG increased significantly after injection 2 compared with injection 1 at each dose level. No enhancement of immune responses was shown with adjuvanted vaccine candidates compared with the unadjuvanted vaccine candidate. In the dose

Efficacy and safety of botulinum toxin in treatment of anismus: A systematic review.

PubMed

Emile, Sameh Hany; Elfeki, Hossam Ayman; Elbanna, Hosam Ghazy; Youssef, Mohamed; Thabet, Waleed; Abd El-Hamed, Tito M; Said, Basem; Lotfy, Ahmed

2016-08-06

To evaluate the efficacy and safety of botulinum toxin type A (BTX-A) in the management of patients with anismus. An organized search of published literature was conducted using electronic databases including: PubMed/MEDLINE, and Cochrane Central Register of Controlled Trials, also an internet-based search using "Google Scholar" service was conducted. Both comparative and observational studies were included. We excluded irrelevant articles, editorials, case reports, reviews, and meta-analyses. The studies that followed the patients less than 6 mo were excluded. Variables collected were demographic data of the patients, technique of BTX-A injection and number of sessions, short-term and long-term clinical improvement, post-injection changes in electromyography (EMG), defecography, manometry, and balloon expulsion test, and complications recorded after BTX-A injection. Seven studies comprising 189 patients were included in the review. The median age of the patients was 41.2 years and female-to-male ratio was 1.3:1. The median dose of BTX-A injected per procedure was 100 IU (range, 20-100 IU). Lateral injection was done in five trails and combined lateral and posterior injections in two trials. Three studies used endorectal ultrasonography-guided technique, one study used EMG-guided technique, whereas the remaining three studies used manual palpation with the index finger. The median percentage of patients who reported initial improvement of symptoms was 77.4% (range 37.5%-86.7%), this percentage declined to a median of 46% (range 25%-100%) at 4 mo after injection of BTX-A. Rates of improvement evaluated by balloon expulsion test, EMG, and defecography ranged between (37.5%-80%), (54%-86.7%), and (25%-86.6%), respectively. Fourteen (7.4%) patients developed complications after injection of BTX-A. Complication rates across the studies ranged from 0% to 22.6%. Initial satisfactory improvement of symptoms after BTX-A injection remarkably deteriorated after 3 mo of the

Efficacy and safety of botulinum toxin in treatment of anismus: A systematic review

PubMed Central

Emile, Sameh Hany; Elfeki, Hossam Ayman; Elbanna, Hosam Ghazy; Youssef, Mohamed; Thabet, Waleed; Abd El-Hamed, Tito M; Said, Basem; Lotfy, Ahmed

2016-01-01

AIM: To evaluate the efficacy and safety of botulinum toxin type A (BTX-A) in the management of patients with anismus. METHODS: An organized search of published literature was conducted using electronic databases including: PubMed/MEDLINE, and Cochrane Central Register of Controlled Trials, also an internet-based search using “Google Scholar” service was conducted. Both comparative and observational studies were included. We excluded irrelevant articles, editorials, case reports, reviews, and meta-analyses. The studies that followed the patients less than 6 mo were excluded. Variables collected were demographic data of the patients, technique of BTX-A injection and number of sessions, short-term and long-term clinical improvement, post-injection changes in electromyography (EMG), defecography, manometry, and balloon expulsion test, and complications recorded after BTX-A injection. RESULTS: Seven studies comprising 189 patients were included in the review. The median age of the patients was 41.2 years and female-to-male ratio was 1.3:1. The median dose of BTX-A injected per procedure was 100 IU (range, 20-100 IU). Lateral injection was done in five trails and combined lateral and posterior injections in two trials. Three studies used endorectal ultrasonography-guided technique, one study used EMG-guided technique, whereas the remaining three studies used manual palpation with the index finger. The median percentage of patients who reported initial improvement of symptoms was 77.4% (range 37.5%-86.7%), this percentage declined to a median of 46% (range 25%-100%) at 4 mo after injection of BTX-A. Rates of improvement evaluated by balloon expulsion test, EMG, and defecography ranged between (37.5%-80%), (54%-86.7%), and (25%-86.6%), respectively. Fourteen (7.4%) patients developed complications after injection of BTX-A. Complication rates across the studies ranged from 0% to 22.6%. CONCLUSION: Initial satisfactory improvement of symptoms after BTX-A injection

Administering Multiple Injectable Vaccines During a Single Visit—Summary of Findings From the Accelerated Introduction of Inactivated Polio Vaccine Globally

PubMed Central

Patel, Manish; Hampton, Lee M.; Burnett, Eleanor; Ehlman, Daniel C.; Garon, Julie; Cloessner, Emily; Chmielewski, Elizabeth; Hyde, Terri B.; Mantel, Carsten; Wallace, Aaron S.

2017-01-01

Abstract Background. In 2013, the World Health Organization’s (WHO’s) Strategic Advisory Group of Experts (SAGE) recommended that all 126 countries using only oral polio vaccine (OPV) introduce at least 1 dose of inactivated polio vaccine (IPV) into their routine immunization schedules by the end of 2015. In many countries, the addition of IPV would necessitate delivery of multiple injectable vaccines (hereafter, “multiple injections”) during a single visit, with infants receiving IPV alongside pentavalent vaccine (which covers diphtheria, tetanus, and whole-cell pertussis; hepatitis B; and Haemophilus influenzae type b) and pneumococcal vaccine. Unanticipated concerns emerged from countries over acceptability of multiple injections, sites of administration, and safety. We contextualized the issues surrounding multiple injections by documenting concerns associated with administration of ≥3 injections, existing evidence in the published literature, and findings of a systematic review on administration practices and techniques. Methods. Concerns associated with multiple-injection visits were documented from meetings and personal communications with immunization program managers. Published literature on the acceptability of multiple injections by providers and caregivers was summarized, and a systematic review of the literature on administration practices was completed on the following topics: spacing between injection sites (ie, vaccine spacing), site of injection, route of injection, and procedural preparedness. WHO and United Nations Children’s Fund data from 2013–2015 were used to assess multiple-injection visits included in national immunization schedules. Results. Healthcare provider and caregiver attitudes and practices indicated concerns about infant pain, potential adverse effects, and uncertainty about vaccine effectiveness with multiple-injection visits. Published literature reinforced the record of safety and acceptance of the recommended

Effect of injection routes on the biodistribution, clearance, and tumor uptake of carbon dots.

PubMed

Huang, Xinglu; Zhang, Fan; Zhu, Lei; Choi, Ki Young; Guo, Ning; Guo, Jinxia; Tackett, Kenneth; Anilkumar, Parambath; Liu, Gang; Quan, Qimeng; Choi, Hak Soo; Niu, Gang; Sun, Ya-Ping; Lee, Seulki; Chen, Xiaoyuan

2013-07-23

The emergence of photoluminescent carbon-based nanomaterials has shown exciting potential in the development of benign nanoprobes. However, the in vivo kinetic behaviors of these particles that are necessary for clinical translation are poorly understood to date. In this study, fluorescent carbon dots (C-dots) were synthesized and the effect of three injection routes on their fate in vivo was explored by using both near-infrared fluorescence and positron emission tomography imaging techniques. We found that C-dots are efficiently and rapidly excreted from the body after all three injection routes. The clearance rate of C-dots is ranked as intravenous > intramuscular > subcutaneous. The particles had relatively low retention in the reticuloendothelial system and showed high tumor-to-background contrast. Furthermore, different injection routes also resulted in different blood clearance patterns and tumor uptakes of C-dots. These results satisfy the need for clinical translation and should promote efforts to further investigate the possibility of using carbon-based nanoprobes in a clinical setting. More broadly, we provide a testing blueprint for in vivo behavior of nanoplatforms under various injection routes, an important step forward toward safety and efficacy analysis of nanoparticles.

Efficacy of a Subacromial Corticosteroid Injection for Persistent Pain After Arthroscopic Rotator Cuff Repair.

PubMed

Shin, Sang-Jin; Do, Nam-Hoon; Lee, Juyeob; Ko, Young-Won

2016-09-01

Corticosteroid injections have been widely used for reducing shoulder pain. However, catastrophic complications induced by corticosteroid such as infections and tendon degeneration have made surgeons hesitant to use a corticosteroid injection as a pain control modality, especially during the postoperative recovery phase. To determine the effectiveness and safety of a subacromial corticosteroid injection for persistent pain control during the recovery period and to analyze the factors causing persistent pain after arthroscopic rotator cuff repair. Cohort study; Level of evidence, 3. A total of 458 patients who underwent arthroscopic rotator cuff repair were included in this study. Patient-specific parameters, tear size and pattern, and pain intensity were reviewed. Seventy-two patients were administered a postoperative subacromial corticosteroid injection under ultrasound guidance. The corticosteroid injection was administered to patients who awakened overnight because of constant severe shoulder pain or whose pain was exacerbated at the time of rehabilitation exercises within 8 weeks after surgery. Pain intensity, patient satisfaction, and functional outcomes using the American Shoulder and Elbow Surgeons (ASES) and Constant scores were compared between the patients with and without a subacromial corticosteroid injection. The retear rate was evaluated with magnetic resonance imaging at 6 months postoperatively. In patients with an injection, the mean (±SD) visual analog scale for pain (pVAS) score was 7.7 ± 1.2 at the time of the injection. This significantly decreased to 2.3 ± 1.4 at the end of the first month after the injection, demonstrating a 70.2% reduction in pain (P < .01). At 3 months after the injection, the mean pVAS score was 1.2 ± 1.8. Functional outcomes at final follow-up showed no significant differences between patients with and without an injection (ASES score: 90.1 ± 14.6 with injection, 91.9 ± 8.2 without injection [P = .91]; Constant

Procedure-Oriented Torsional Anatomy of the Hand for Spasticity Injection.

PubMed

John, Joslyn; Cianca, John; Chiou-Tan, Faye; Pandit, Sindhu; Furr-Stimming, Erin; Taber, Katherine H

locations if the sonographer is competent in recognizing the appearance of normal anatomy and is skilled in resolving the visual changes that occur in spastic hemiparesis. The authors hope this series of images will increase the accuracy, safety, and efficacy of spasticity injections in the hand.

21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

Code of Federal Regulations, 2010 CFR

2010-04-01

... guinea pigs, the test shall be satisfied if the product provides satisfactory results using either the subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each guinea pig. The requirements for general safety for inactivated influenza vaccine shall not be considered to...

Reducing Risk in CO2 Sequestration: A Framework for Integrated Monitoring of Basin Scale Injection

NASA Astrophysics Data System (ADS)

Seto, C. J.; Haidari, A. S.; McRae, G. J.

2009-12-01

Geological sequestration of CO2 is an option for stabilization of atmospheric CO2 concentrations. Technical ability to safely store CO2 in the subsurface has been demonstrated through pilot projects and a long history of enhanced oil recovery and acid gas disposal operations. To address climate change, current injection operations must be scaled up by a factor of 100, raising issues of safety and security. Monitoring and verification is an essential component in ensuring safe operations and managing risk. Monitoring provides assurance that CO2 is securely stored in the subsurface, and the mechanisms governing transport and storage are well understood. It also provides an early warning mechanism for identification of anomalies in performance, and a means for intervention and remediation through the ability to locate the CO2. Through theoretical studies, bench scale experiments and pilot tests, a number of technologies have demonstrated their ability to monitor CO2 in the surface and subsurface. Because the focus of these studies has been to demonstrate feasibility, individual techniques have not been integrated to provide a more robust method for monitoring. Considering the large volumes required for injection, size of the potential footprint, length of time a project must be monitored and uncertainty, operational considerations of cost and risk must balance safety and security. Integration of multiple monitoring techniques will reduce uncertainty in monitoring injected CO2, thereby reducing risk. We present a framework for risk management of large scale injection through model based monitoring network design. This framework is applied to monitoring CO2 in a synthetic reservoir where there is uncertainty in the underlying permeability field controlling fluid migration. Deformation and seismic data are used to track plume migration. A modified Ensemble Kalman filter approach is used to estimate flow properties by jointly assimilating flow and geomechanical

Intralesional Injection of Collagenase Clostridium histolyticum May Increase the Risk of Late-Onset Penile Fracture.

PubMed

Beilan, Jonathan A; Wallen, Jared J; Baumgarten, Adam S; Morgan, Kevin N; Parker, Justin L; Carrion, Rafael E

2018-04-01

The use of intralesional injection of collagenase Clostridium histolyticum (CCH) has become a valid treatment option in the management of Peyronie's disease (PD). Multiple studies have shown the drug's safety and efficacy. However, sparse literature exists on the utility of the injection protocol's 14-day "observation period," in which patients are instructed to abstain from all sexual activity. To summarize the contemporary literature and report on our series of patients treated with CCH in an effort to explore the effectiveness of the postinjection observation period. We retrospectively reviewed the clinical course of men treated with at least one CCH injection at our institution from April 2014 through February 2017. The main outcome measure for our cohort was complication rate (hematoma, fracture). Secondary outcomes included progression to corrective surgery. Of the 102 patients treated, 5 (4.9%) developed a corporal fracture. Four of these occurred outside the 14-day observation period. One fracture was managed conservatively and the rest underwent surgical exploration and repair. Twelve penile hematomas were reported; one of these patients was surgically explored because of suspicious magnetic resonance imaging findings. Seven patients (6.9%) progressed to corrective surgery. Penile hematoma and corporal fracture are serious complications that must be discussed with patients before initiation of intralesional CCH treatment. Little evidence exists to direct physicians on the proper management of post-CCH penile fractures; many caregivers and patients elect to treat these injuries conservatively and avoid surgical exploration. Further studies are warranted to generate discussion and reassessment regarding the safety and effectiveness of this 14-day observation period. Beilan JA, Wallen JJ, Baumgarten AS, Morgan KN, Parker JL, Carrion RE. Intralesional Injection of Collagenase Clostridium histolyticum May Increase the Risk of Late-Onset Penile Fracture. Sex

Injectable Drug Eluting Elastomeric Polymer: A Novel Submucosal Injection Material

PubMed Central

Tran, Richard T.; Palmer, Michael; Tang, Shou-Jiang; Abell, Thomas L.; Yang, Jian

2011-01-01

Background Biodegradable hydrogels can deliver therapeutic payloads with great potentials in endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) to yield improvements in efficacy and foster mucosal regeneration. Objective To assess the efficacy of an injectable drug eluting elastomeric polymer (iDEEP) as a submucosal injection material. Design Comparative study among 3 different solutions using material characterization tests, ex vivo and in vivo porcine models. Setting Academic hospital. Interventions 30 gastric submucosal cushions were achieved with saline (0.9%), sodium hyaluronate (0.4%), and iDEEP (n = 10) in ex vivo porcine stomachs. Four porcine gastric submucosal cushions were then performed in vivo using iDEEP. Main outcome measurements Maximum injection pressure, Rebamipide release rate, submucosal elevation duration, and assessment of in vivo efficacy by en bloc resection. Results No significant difference in injection pressures between iDEEP (28.9 ± 0.3 PSI) and sodium hyaluronate (29.5 ± 0.4 PSI, P > .05) was observed. iDEEP gels displayed a controlled release of Rebamipide up to 2 weeks in vitro. The elevation height of iDEEP (5.7 ± 0.5 mm) was higher than saline (2.8 ± 0.2 mm, P < .01) and SH (4.2 ± 0.2 mm, P < .05). All EMR procedures were successfully performed after injection of iDEEP, and a large gel cushion was noted after the resection procedure. Limitations Benchtop, ex vivo, and non-survival pig study. Conclusions A novel injection solution was evaluated for endoscopic resection. These results suggest that iDEEP may provide a significant step towards the realization of an ideal EMR and ESD injection material. PMID:22301346

Institutional Ethical Review and Ethnographic Research Involving Injection Drug Users: A Case Study

PubMed Central

Small, Will; Maher, Lisa; Kerr, Thomas

2014-01-01

Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators’ responses to the committee’s concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. PMID:24581074

Injections during labor and intrapartum-related hypoxic injury and mortality in rural southern Nepal

PubMed Central

Mullany, Luke C.; Khatry, Subarna K.; Katz, Joanne; Stanton, Cynthia K.; Lee, Anne C.C.; Darmstadt, Gary L.; LeClerq, Steven C.; Tielsch, James M.

2013-01-01

Objective To estimate the association between unmonitored use of injections during labor and intrapartum-related neonatal mortality and morbidity among home births. Methods Recently delivered women in Sarlahi, Nepal, reported whether they had received injections during labor. Data on breathing and crying status at birth, time to first breath, respiratory rate, sucking ability, and lethargy were gathered. Neonatal respiratory depression (NRD) and encephalopathy (NE) were compared by injection receipt status using multivariate regression models. Results Injections during labor were frequently reported (7108 of 22 352 [31.8%]) and were predominantly given by unqualified village “doctors.” Multivariate analysis (excluding facility births and complicated deliveries) revealed associations with intrapartum-related NRD (relative risk [RR] 2.52; 95% CI, 2.29–2.78) and NE (RR 3.48; 95% CI, 2.46–4.93). The risks of neonatal death associated with intrapartum-related NRD (RR 3.78; 95% CI, 2.53–5.66) or NE (RR 4.47; 95% CI, 2.78–7.19) were also elevated. Conclusion Injection during labor was widespread at the community level. This practice was associated with poor outcomes and possibly related to the inappropriate use of uterotonics by unqualified providers. Interventions are required to increase the safety of childbirth in the community and in peripheral health facilities. Parent trial registered at clinicaltrials.gov (NCT00 109616). PMID:23523332

The longitudinal association between homelessness, injection drug use, and injection-related risk behavior among persons with a history of injection drug use in Baltimore, MD.

PubMed

Linton, Sabriya L; Celentano, David D; Kirk, Gregory D; Mehta, Shruti H

2013-10-01

Few studies have assessed the temporal association between homelessness and injection drug use, and injection-related risk behavior. Among a cohort of 1405 current and former injection drug users in follow-up from 2005 to 2009, we used random intercept models to assess the temporal association between homelessness and subsequent injection drug use, and to determine whether the association between homelessness and sustained injection drug use among active injectors differed from the association between homelessness and relapse among those who stopped injecting. We also assessed the association between homelessness and subsequent injection-related risk behavior among participants who injected drugs consecutively across two visits. Homelessness was categorized by duration: none, <1 month, and ≥1 month. Homelessness was reported on at least one occasion by 532 (38%) participants. The relationship between homelessness and subsequent injection drug use was different for active injectors and those who stopped injecting. Among those who stopped injecting, homelessness was associated with relapse [<1 month: AOR=1.67, 95% CI (1.01, 2.74); ≥1 month: AOR=1.34 95% CI (0.77, 2.33)]. Among active injectors, homelessness was not associated with sustained injection drug use [<1 month: AOR=1.03, 95% CI (0.71, 1.49); ≥1 month: AOR=0.81 95% CI (0.56, 1.17)]. Among those injecting drugs across two consecutive visits, homelessness ≥1 month was associated with subsequent injection-related risk behavior [AOR=1.61, 95% CI (1.06, 2.45)]. Homelessness appears to be associated with relapse and injection-related risk behavior. Strengthening policies and interventions that prevent homelessness may reduce injection drug use and injection-related risk behaviors. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Urethral injection therapy for urinary incontinence in women.

PubMed

Kirchin, Vivienne; Page, Tobias; Keegan, Phil E; Atiemo, Kofi Om; Cody, June D; McClinton, Samuel; Aluko, Patricia

2017-07-25

Urinary incontinence imposes a significant health and economic burden to society. Periurethral or transurethral injection of bulking agents is a minimally invasive surgical procedure used as one the surgical treatments of stress urinary incontinence (SUI) in adult women. To assess the effects of periurethral or transurethral injection therapy on the cure or improvement of urinary incontinence in women. We searched the Cochrane Incontinence Group Specialised Trials Register (searched 8 November 2010) and the reference lists of relevant articles. All randomised or quasi-randomised controlled trials of treatment for urinary incontinence in which at least one management arm involved periurethral or transurethral injection therapy. Two review authors independently assessed methodological quality of each study using explicit criteria. Data extraction was undertaken independently and clarification concerning possible unreported data sought directly from the investigators. Excluding duplicate reports, we identified 14 trials (excluding one that was subsequently withdrawn from publication and not included in this analysis) including 2004 women that met the inclusion criteria. The limited data available were not suitable for meta-analysis because they all came from separate trials. Trials were small and generally of moderate quality.One trial of 45 women that compared injection therapy with conservative treatment showed early benefit for the injectable therapy with respect to continence grade (risk ratio (RR) 0.70, 95% confidence interval (CI) 0.52 to 0.94) and quality of life (mean difference (MD) 0.54, 95% CI 0.16 to 0.92). Another trial, comparing Injection of autologous fat with placebo, terminated early because of safety concerns. Two trials that compared injection with surgical management found significantly better objective cure in the surgical group (RR 4.77, 95% CI 1.96 to 11.64; and RR 1.69, 95% CI 1.02 to 2.79), although the latter trial data did not reach

Experiment Research of Microbial Flooding Injected Capacity and Injected Volume

NASA Astrophysics Data System (ADS)

Shi, Fang; Zhao, Yang; Tang, Qinghua; Xie, Ximing

2018-01-01

Strains of microbial enhanced oil recovery technology is the use of crude oil directly in growth and the same time the metabolites of itself, so as to enhance oil recovery. Experimental study on paper through a number of data analysis. The growth and metabolism of three kinds of oil producing bacteria in the core are determined, and the corresponding growth curve is obtained. The parameter sensitivity analysis of the microorganism flooding process by homogeneous core is studied, and the influence of injection capacity and injection volume on the oil displacement effect is studied. The same permeability, water, temperature and other conditions, microbial injection pressure has a certain degree of increase than water flooding. Injection volume depends on the actual input-output ratio, quantity is 0.3PV is more reasonable.

Adverse effect profile of lidocaine injections for occipital nerve block in occipital neuralgia.

PubMed

Sahai-Srivastava, Soma; Subhani, Dawood

2010-12-01

To determine whether there are differences in the adverse effect profile between 1, 2 and 5% Lidocaine when used for occipital nerve blocks (ONB) in patients with occipital neuralgia. Occipital neuralgia is an uncommon cause of headaches. Little is known regarding the safety of Lidocaine injections for treatment in larger series of patients. Retrospective chart analysis of all ONB was performed at our headache clinic during a 6-year period on occipital neuralgia patients. 89 consecutive patients with occipital neuralgia underwent a total of 315 ONB. All the patients fulfilled the IHS criteria for Occipital Neuralgia. Demographic data were collected including age, gender, and ethnicity. The average age of this cohort was 53.25 years, and the majority of patients were females 69 (78%). Ethnicity of patients was diverse, with Caucasian 48(54%), Hispanics 31(35%), and others 10 (11%). 69 patients had 1%, 18 patients had 2% and 29 patient were given 5% Lidocaine. All Lidocaine injections were given with 20 mg Depo-medrol and the same injection technique and location were used for all the procedures. Eight patients (9%)had adverse effects to the Lidocaine and Depo-medrol injections, of which 5 received 5% and 3 received 1% Lidocaine. Majority of patients who had adverse effects were female 7(87%), and had received bilateral blocks (75%). ONB is a safe procedure with 1% Lidocaine; however, caution should be exerted with 5% in elderly patients, 70 or older, especially when administering bilateral injections.

Relationship Between the Provision of Injection Services in Ambulatory Physician Offices and Prescribing Injectable Medicines.

PubMed

Yousefi, Naeimeh; Rashidian, Arash; Soleymani, Fatemeh; Kebriaeezade, Abbas

2017-01-01

Overuse of injections is a common problem in many low-income and middle income countries. While cultural factors and attitudes of both physicians and patients are important factors, physicians› financial intensives may play an important role in overprescribing of injections. This study was designed to assess the effects of providing injection- services in physicians› ambulatory offices on prescribing injectable medicines. This cross-sectional study was conducted in Tehran in 2012 -2013and included a random sample of general physicians, pediatricians and infectious disease specialists. We collected data on the provision of injection services in or in proximity of physician offices, and obtained data from physicians› prescriptions in the previous three-month period. We analyzed the data using ANOVA, Student›s t-test and linear regression methods. We obtained complete data from 465 of 600 sampled physicians. Overall 41.9% of prescriptions contained injectable medicines. 75% of physicians offered injection services in their offices. Male physicians and general physicians were more likely to offer the services, and more likely to prescribe injectables. We observed a clear linear relationship between the injection service working hours and the proportion of prescriptions containing injectables (p-value<0.001). Providing injection service in the office was directly linked with the proportion of prescriptions containing injectables. While provision of injection services may provide a direct financial benefit to physicians, it is unlikely to be able to substantially reduce injectable medicines› prescription without addressing the issue.

Compressed air injection technique to standardize block injection pressures : [La technique d'injection d'air comprimé pour normaliser les pressions d'injection d'un blocage nerveux].

PubMed

Tsui, Ban C H; Li, Lisa X Y; Pillay, Jennifer J

2006-11-01

Presently, no standardized technique exists to monitor injection pressures during peripheral nerve blocks. Our objective was to determine if a compressed air injection technique, using an in vitro model based on Boyle's law and typical regional anesthesia equipment, could consistently maintain injection pressures below a 1293 mmHg level associated with clinically significant nerve injury. Injection pressures for 20 and 30 mL syringes with various needle sizes ( 18G, 20G, 21 G, 22G, and 24G) were measured in a closed system. A set volume of air was aspirated into a saline-filled syringe and then compressed and maintained at various percentages while pressure was measured. The needle was inserted into the injection port of a pressure sensor, which had attached extension tubing with an injection plug clamped "off". Using linear regression with all data points, the pressure value and 99% confidence interval (CI) at 50% air compression was estimated. The linearity of Boyle's law was demonstrated with a high correlation, r = 0.99, and a slope of 0.984 (99% CI: 0.967-1.001). The net pressure generated at 50% compression was estimated as 744.8 mmHg, with the 99% CI between 729.6 and 760.0 mmHg. The various syringe/needle combinations had similar results. By creating and maintaining syringe air compression at 50% or less, injection pressures will be substantially below the 1293 mmHg threshold considered to be an associated risk factor for clinically significant nerve injury. This technique may allow simple, real-time and objective monitoring during local anesthetic injections while inherently reducing injection speed. Présentement, aucune technique normalisée ne permet de vérifier les pressions d'injection pendant les blocages nerveux périphériques. Nous voulions vérifier si une technique d'injection d'air comprimé, utilisant un modèle in vitro fondé sur la loi de Boyle et du matériel propre à l'anesthésie régionale, pouvait maintenir avec régularité les

Retention of Human-Induced Pluripotent Stem Cells (hiPS) With Injectable HA Hydrogels for Vocal Fold Engineering.

PubMed

Imaizumi, Mitsuyoshi; Li-Jessen, Nicole Y K; Sato, Yuka; Yang, David T; Thibeault, Susan L

2017-04-01

One prospective treatment option for vocal fold scarring is regeneration with an engineered scaffold containing induced pluripotent stem cells (iPS). In the present study, we investigated the feasibility of utilizing an injectable hyaluronic acid (HA) scaffold encapsulated with human-iPS cell (hiPS) for regeneration of vocal folds. Thirty athymic nude rats underwent unilateral vocal fold injury. Contralateral vocal folds served as uninjured controls. Hyaluronic acid hydrogel scaffold, HA hydrogel scaffold containing hiPS, and HA hydrogel scaffold containing hiPS with epidermal growth factor (EGF) were injected in both vocal folds immediately after surgery. One and 2 weeks after injection, larynges were excised for histology, immunohistochemistry, and fluorescence in situ hybridization (FISH). Presence of HA hydrogel was confirmed in vocal folds 1 and 2 weeks post injection. The FISH analysis confirmed the presence and viability of hiPS in the injected vocal folds. Histological results demonstrated that vocal folds injected with HA hydrogel scaffold containing EGF demonstrated less fibrosis than those with HA hydrogel only. Human-iPS survived in injured rat vocal folds. The HA hydrogel with hiPS and EGF ameliorated the fibrotic response. Additional work is necessary to optimize hiPS differentiation and further confirm the safety of hiPS for clinical applications.

Intravitreal erythropoietin injection in late-stage optic neuropathy: a safety study on human.

PubMed

Acar, Ugur; Kucuk, Bekir; Sevinc, Mehmet Koray; Aykas, Seckin; Erdurmus, Mesut; Sobaci, Gungor

2018-06-01

To evaluate the whether intravitreal erythropoietin (EPO) administration has any beneficial or adverse effect in patients with late-stage optic neuropathy (ON) or not. The study examined 16 eyes of 16 patients who had late-stage ON and ≥1/20 best-corrected visual acuity (BCVA) in their affected eye. There were nonarteritic ischemic ON in 10 (62.5%) eyes, traumatic ON in 4 (25.0%) eyes and methanol-induced ON in 2 (12.5%) eyes. Using pars plana approach, 2000 IU/0.2 ml EPO was administered intravitreally with a 30-gauge needle. Injections were administered three times with 6-week intervals. We compared the differences in the BCVA, intraocular pressure (IOP), retinal nerve fiber layer (RNFL) thickness, pattern visual evoked potentials (p-VEP) and pattern electroretinography (p-ERG) parameters performed at initial examination and final visits. The mean age of the patients was 52.38 ± 12.00 years; 2 (12.50%) of them were female, and 14 (87.50%) of them were male. The mean BCVA levels of 16 patients with optic atrophy were 1.12 ± 0.25 logMAR at the initial examination and 1.08 ± 0.26 logMAR at the final visit (p = 0.102). There was no statistically significant difference between the initial and final RNFL thicknesses, IOP values, p-ERG or p-VEP responses. Intravitreal EPO injections have no beneficial or detrimental effect on the late stage of ON. Further studies are necessary to compare our results in patients with ON in earlier stages.

Calculation method of water injection forward modeling and inversion process in oilfield water injection network

NASA Astrophysics Data System (ADS)

Liu, Long; Liu, Wei

2018-04-01

A forward modeling and inversion algorithm is adopted in order to determine the water injection plan in the oilfield water injection network. The main idea of the algorithm is shown as follows: firstly, the oilfield water injection network is inversely calculated. The pumping station demand flow is calculated. Then, forward modeling calculation is carried out for judging whether all water injection wells meet the requirements of injection allocation or not. If all water injection wells meet the requirements of injection allocation, calculation is stopped, otherwise the demand injection allocation flow rate of certain step size is reduced aiming at water injection wells which do not meet requirements, and next iterative operation is started. It is not necessary to list the algorithm into water injection network system algorithm, which can be realized easily. Iterative method is used, which is suitable for computer programming. Experimental result shows that the algorithm is fast and accurate.

Outcome and predicting factors of single and multiple intra-articular corticosteroid injections in children with juvenile idiopathic arthritis.

PubMed

Lanni, Stefano; Bertamino, Marta; Consolaro, Alessandro; Pistorio, Angela; Magni-Manzoni, Silvia; Galasso, Roberta; Lattanzi, Bianca; Calvo-Aranda, Enrique; Martini, Alberto; Ravelli, Angelo

2011-09-01

To investigate the efficacy of IA CS (IAC) therapy in single and multiple joints in children with JIA and to seek for predictors of synovitis flare. The clinical charts of patients who received their first IAC injection between January 2002 and December 2008 were reviewed. The CS used was triamcinolone hexacetonide for large joints and methylprednisolone acetate for small or difficult to access joints. Patients were stratified as follows: one joint injected; two joints injected; and three or more joints injected. Predictors included sex, age at disease onset, JIA category, age and disease duration, ANA status, iridocyclitis, general anaesthesia, number and type of injected joints, acute-phase reactants and concomitant MTX therapy. The cumulative probability of survival without synovitis flare for patients injected in one, two, or three or more joints was 70, 45 and 44%, respectively, at 1 year; 61, 32 and 30%, respectively, at 2 years; and 37, 22 and 19%, respectively, at 3 years. On Cox regression analysis, positive CRP, negative ANA and injection in the ankle were the strongest predictors for synovitis flare. The only significant side effect was skin hypopigmentation or s.c. atrophy, which occurred in <2% of patients. IAC therapy-induced sustained remission of synovitis in a substantial proportion of patients injected either in single or multiple joints, with a good safety profile. The risk of synovitis flare was higher in patients who had positive CRP, negative ANA and were injected in the ankle.

Feasibilty of in utero DNA vaccination following naked gene transfer into pig fetal muscle: transgene expression, immunity and safety.

PubMed

Rinaldi, Monica; Signori, Emanuela; Rosati, Paolo; Cannelli, Giorgio; Parrella, Paola; Iannace, Enrico; Monego, Giovanni; Ciafrè, Silvia Anna; Farace, Maria Giulia; Iurescia, Sandra; Fioretti, Daniela; Rasi, Guido; Fazio, Vito Michele

2006-05-22

The high toll of death among first-week infants is due to infections occurring at the end of pregnancy, during birth or by breastfeeding. This problem significantly concerns industrialized countries also. To prevent the typical "first-week infections", a vaccine would be protective as early as at the birth. In utero DNA immunization has demonstrated the effectiveness in inducing specific immunity in newborns. We have already published results of a 2-year follow-up showing long-term safety, protective antibody titers at birth and long-term immune memory, following intramuscular in utero anti-HBV DNA immunization in 90-days pig fetuses. We have now analyzed further parameters of short-term safety. Two different reporter genes were injected in the thigh muscles of 90-days fetuses. At 8 days following DNA injection, we found high-level of transgenes expression in all injected fetuses. A step gradient of expression from the area of injection was observed with both reporter genes. CMV promoter/enhancer produced higher levels of expression compared to SV40 promoter/enhancer. Moreover, no evidence of local or systemic flogistic alterations or fetal malformations, mortality or haemorrhage following intramuscular injection were observed. A single anti-HBV s-antigen DNA immunization in 90-days fetuses supported protective antibody levels in all immunized newborns, lasting at least up to 4 months after birth. Our report further sustains safety and efficacy of intramuscular in utero naked gene transfer and immunization. This approach may support therapeutic or prophylactic procedure in many early life-threatening pathologic conditions.

Three-Year Analysis of Value and Utilization After Development of an Ultrasound-Based Orthopedic Injection Clinic.

PubMed

Dukes, Chase; Melton, Thomas; Turner, Eric; Jackson, Andrew; Grassbaugh, Jason; Slevin, John; Arrington, Edward D; Eichinger, Josef K

2017-09-01

Sonography is an effective method of diagnosing and treating musculoskeletal conditions, and the use of ultrasound has been shown to improve the accuracy, safety, and efficacy of both therapeutic and diagnostic injections. In 2012, we established an injection clinic at our institution to address our growing need for diagnostic and therapeutic injections. We performed an analysis of value and utilization following the development of an orthopedic injection clinic. This included an evaluation of the cost of materials, equipment, and training required to develop and run the clinic, and an analysis of the services rendered and relative value units (RVUs) generated over 3 fiscal years (FYs). The cost to develop the clinic was $42,498.30. The cost to run the clinic thereafter was $16.90 to $21.60 per injection. By the end of FY 2012, 60% of providers performed at least 1 injection under ultrasound guidance. Every successive year thereafter, 100% of providers were using ultrasound guidance. In FY 2012, we performed 738 injections, 5.4% used ultrasound guidance and generated a total of 1,786.36 RVUs. In FY 2013, we performed 1,814 injections, 17.6% used ultrasound guidance, and generated a total of 7,224.5 RVUs. In FY 2014, we performed 2,821 injections, 25.2% used ultrasound guidance, and generated 13,786.82 RVUs. RVUs generated solely from ultrasound guided injections were 463.2 (2012), 3,694 (2013), 8,221.8 (2014). Injection accuracy was at least 98%. Average time until injection was 0 days. The cost to start an injection clinic is modest, with the potential for large annual growth and early return on investment, and can generate significant revenue by recapturing RVUs that would otherwise be lost to outside referrals. Furthermore, it helps to increase clinic throughput, maximize services rendered during a single patient visit improving the overall quality of their encounter, expands the clinical practice of our midlevel providers, offloads clinical time for surgical

The effect of intra-articular hyaluronate and tramadol injection on patients with adhesive capsulitis of the shoulder.

PubMed

Kim, Kyung-Hee; Suh, Jung-Woo; Oh, Ki Young

2017-08-03

Local administration of opioids causes effective analgesia without adverse effects related to the central nervous system. After the beneficial demonstration of peripheral opioid receptors in joint synovia, intra-articular opioid injections were used for pain treatment. Clinical studies have reported the safety and efficacy of hyaluronate injection in the shoulder joint of patients with osteoarthritis, periarthritis, rotator cuff tears, and adhesive capsulitis. To estimate the efficacy of intra-articular hyaluronate and tramadol injection for adhesive capsulitis of the shoulder compared with that of intra-articular hyaluronate injection alone. Thirty patients with adhesive capsulitis of the shoulder were randomized to the hyaluronate group (n= 16) or the tramadol group (n= 14). Hyaluronate group members were administered five weekly intra-articular hyaluronate injections; tramadol group members were administered three weekly intra-articular hyaluronate and tramadol injections and then two weekly intra-articular injections of hyaluronate. Visual Analog Scale (VAS), passive range of motion (PROM) of the shoulder joint, and Shoulder Pain and Disability Index (SPADI) scores were assessed at baseline and weeks 1, 2, 3, 4, and 6 after the initial injection. A significant improvement was observed in VAS, PROM, and SPADI scores between time points in both groups. In comparison in both groups at weeks 1 and 2 after the initial injection the VAS scores of the tramadol group were significantly lower than those of the hyaluronate group. Intra-articular hyaluronate with tramadol showed more rapid and strong analgesic effects than intra-articular hyaluronate alone and did not induce any adverse effects.

Relationships between Induced Seismicity and Fluid Injection: Development of Strategies to Manage Injection

NASA Astrophysics Data System (ADS)

Eichhubl, Peter; Frohlich, Cliff; Gale, Julia; Olson, Jon; Fan, Zhiqiang; Gono, Valerie

2014-05-01

Induced seismicity during or following the subsurface injection of waste fluids such as well stimulation flow back and production fluids has recently received heightened public and industry attention. It is understood that induced seismicity occurs by reactivation of existing faults that are generally present in the injection intervals. We seek to address the question why fluid injection triggers earthquakes in some areas and not in others, with the aim toward improved injection methods that optimize injection volume and cost while avoiding induced seismicity. A GIS database has been built of natural and induced earthquakes in four hydrocarbon-producing basins: the Fort Worth Basin, South Texas, East Texas/Louisiana, and the Williston Basin. These areas are associated with disposal from the Barnett, Eagle Ford, Bakken, and Haynesville Shales respectively. In each region we analyzed data that were been collected using temporary seismographs of the National Science Foundation's USArray Transportable Array. Injection well locations, formations, histories, and volumes are also mapped using public and licensed datasets. Faults are mapped at a range of scales for selected areas that show different levels of seismic activity, and scaling relationships used to extrapolate between the seismic and wellbore scale. Reactivation potential of these faults is assessed using fault occurrence, and in-situ stress conditions, identifying areas of high and low fault reactivation potential. A correlation analysis between fault reactivation potential, induced seismicity, and fluid injection will use spatial statistics to quantify the probability of seismic fault reactivation for a given injection pressure in the studied reservoirs. The limiting conditions inducing fault reactivation will be compared to actual injection parameters (volume, rate, injection duration and frequency) where available. The objective of this project is a statistical reservoir- to basin-scale assessment of fault

Needle-free injection of insulin powder: delivery efficiency and skin irritation assessment.

PubMed

Li, Chun-yu; Wang, Zhe-wei; Tu, Can; Wang, Jia-bo; Jiang, Bing-qian; Li, Qi; Zeng, Ling-na; Ma, Zhi-jie; Zhang, Ping; Zhao, Yan-ling; Zhang, Ya-ming; Yan, Dan; Tan, Rui; Xiao, Xiao-he

2014-10-01

Insulin is widely used in treating diabetes, but still needs to be administered by needle injection. This study investigated a new needle-free approach for insulin delivery. A portable powder needleless injection (PNI) device with an automatic mechanical unit was designed. Its efficiency in delivering insulin was evaluated in alloxan-induced diabetic rabbits. The skin irritation caused by the device was investigated and the results were analyzed in relation to aerodynamic parameters. Inorganic salt-carried insulin powders had hypoglycemic effects, while raw insulin powders were not effective when delivered by PNI, indicating that salt carriers play an important role in the delivery of insulin via PNI. The relative delivery efficiency of phosphate-carried insulin powder using the PNI device was 72.25%. A safety assessment test showed that three key factors (gas pressure, cylinder volume, and nozzle distance) were related to the amount of skin irritation caused by the PNI device. Optimized injection conditions caused minimal skin lesions and are safe to use in practice. The results suggest that PNI has promising prospects as a novel technology for delivering insulin and other biological drugs.

Needle-free injection of insulin powder: delivery efficiency and skin irritation assessment*

PubMed Central

Li, Chun-yu; Wang, Zhe-wei; Tu, Can; Wang, Jia-bo; Jiang, Bing-qian; Li, Qi; Zeng, Ling-na; Ma, Zhi-jie; Zhang, Ping; Zhao, Yan-ling; Zhang, Ya-ming; Yan, Dan; Tan, Rui; Xiao, Xiao-he

2014-01-01

Insulin is widely used in treating diabetes, but still needs to be administered by needle injection. This study investigated a new needle-free approach for insulin delivery. A portable powder needleless injection (PNI) device with an automatic mechanical unit was designed. Its efficiency in delivering insulin was evaluated in alloxan-induced diabetic rabbits. The skin irritation caused by the device was investigated and the results were analyzed in relation to aerodynamic parameters. Inorganic salt-carried insulin powders had hypoglycemic effects, while raw insulin powders were not effective when delivered by PNI, indicating that salt carriers play an important role in the delivery of insulin via PNI. The relative delivery efficiency of phosphate-carried insulin powder using the PNI device was 72.25%. A safety assessment test showed that three key factors (gas pressure, cylinder volume, and nozzle distance) were related to the amount of skin irritation caused by the PNI device. Optimized injection conditions caused minimal skin lesions and are safe to use in practice. The results suggest that PNI has promising prospects as a novel technology for delivering insulin and other biological drugs. PMID:25294378

Manufacturing plastic injection optical molds

NASA Astrophysics Data System (ADS)

Bourque, David

2008-08-01

ABCO Tool & Die, Inc. is a mold manufacturer specializing in the manufacturing of plastic injection molds for molded optical parts. The purpose of this presentation is to explain the concepts and procedures required to build a mold that produces precision optical parts. Optical molds can produce a variety of molded parts ranging from safety eyewear to sophisticated military lens parts, which must meet precise optical specifications. The manufacturing of these molds begins with the design engineering of precision optical components. The mold design and the related optical inserts are determined based upon the specific optical criteria and optical surface geometry. The mold manufacturing techniques will be based upon the optical surface geometry requirements and specific details. Manufacturing processes used will be specific to prescribed geometrical surface requirements of the molded part. The combined efforts result in a robust optical mold which can produce molded parts that meet the most precise optical specifications.

Distribution and regularity of injection from a multicylinder fuel-injection pump

NASA Technical Reports Server (NTRS)

Rothrock, A M; Marsh, E T

1936-01-01

This report presents the results of performance test conducted on a six-cylinder commercial fuel-injection pump that was adjusted to give uniform fuel distribution among the cylinders at a throttle setting of 0.00038 pound per injection and a pump speed of 750 revolutions per minute. The throttle setting and pump speed were then varied through the operating range to determine the uniformity of distribution and regularity of injection.

Penicillin G Procaine Injection

MedlinePlus

Penicillin G procaine injection is used to treat certain infections caused by bacteria. Penicillin G procaine injection should not be used to ... early in the treatment of certain serious infections. Penicillin G procaine injection is in a class of ...

Macrolane (large particle biphasic hyaluronic acid) filler injection for correction of defect contour after liposuction.

PubMed

Cerqua, Sandro; Angelucci, Francesco

2013-08-01

In a minority of patients undergoing liposuction, superficial irregularities (or skin depression) in the operated area may occur. Macrolane is a gel composed of hyaluronic acid (HA), used for volume restoration of soft tissues. In this study, the authors investigated the effectiveness, maintenance, and safety of Macrolane as a "non-surgical" treatment to correct skin depression after liposuction. Twelve female patients were included. Macrolane was injected at a subdermal superficial plane using an intramuscular or spinal needle. In all patients, Macrolane was successful in correcting skin depression. No relevant side effects were observed. At 8 months post-injection, a persistence of correction of 60-70% was still present in 90% of the patients. In conclusion, Macrolane filler injections are a predictable, safe, and long-lasting non-surgical procedure to fill contour defects that arise after liposuction, and represent a good option for patients who refuse to undergo an additional surgery to fill the arisen skin depressions.

Ocular Pain and Impending Blindness During Facial Cosmetic Injections: Is Your Office Prepared?

PubMed

Prado, Giselle; Rodríguez-Feliz, Jose

2017-02-01

Soft tissue filler injections are the second most common non-surgical procedure performed by the plastic surgeon. Embolization of intravascular material after facial injection is a rare but terrifying outcome due to the high likelihood of long-term sequela such as blindness and cerebrovascular accident. The literature is replete with examples of permanent blindness caused by injection with autologous fat, soft tissue fillers such as hyaluronic acid, PLLA, calcium hydroxyl-apatite, and even corticosteroid suspensions. However, missing from the discussion is an effective treatment algorithm that can be quickly and safely followed by injecting physicians in the case of an intravascular injection with impending blindness. In this report, we present the case of a 64-year-old woman who suffered from blindness and hemiparesis after facial cosmetic injections performed by a family physician. We use this case to create awareness that this complication has become more common as the number of injectors and patients seeking these treatments have increased exponentially over the past few years. We share in this study our experience with the incorporation of a "blindness safety kit" in each of our offices to promptly initiate treatment in someone with embolization and impending blindness. The kit contains a step-by-step protocol to follow in the event of arterial embolization of filler material associated with ocular pain and impending loss of vision. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Ultra-long-duration local anesthesia produced by injection of lecithin-coated methoxyflurane microdroplets.

PubMed

Haynes, D H; Kirkpatrick, A F

1985-11-01

This study was designed to evaluate a new drug delivery system. The authors undertook to determine if microdroplets prepared by encapsulating volatile anesthetics with a membrane of lecithin could be used for local anesthesia. Local anesthesia was determined by monitoring the response of the rat to tail clamping and electrical stimulation of the skin following the intradermal injection of the microdroplets. Microdroplets were prepared from isoflurane, enflurane, halothane, methoxyflurane, diethyl ether, chloroform, and heptane. Although all microdroplet preparations produced local anesthesia, only methoxyflurane microdroplets produced an ultra-long duration of local anesthesia (approximately 24 h). Further characterization of the methoxyflurane microdroplets revealed two important differences from conventional local anesthetics. First, the local anesthetic effect of methoxyflurane reached a plateau that did not change significantly for 20 h while the injection of lidocaine and bupivacaine resulted in a peak effect that returned to baseline within 1 and 3 h, respectively. Second, the anesthetic effect of methoxyflurane remained essentially localized to the site of injection, while the anesthetic effect of lidocaine and bupivacaine migrated 15 cm in less than 1 h. The toxicity and safety of methoxyflurane were evaluated. When administered over the dosage range 1-16% (v/v) intradermally, or by injections into muscle, or by repeat injections every 4 days for 16 days, all animals regained their pretreatment response to painful stimulations, and there was no evidence of gross injury to tissue. Deliberate intravenous injection of 0.8 ml of 6.7% (v/v) methoxyflurane microdroplets had no apparent anesthetic or toxic effect. The present study demonstrates that methoxyflurane microdroplets produce an anesthetic effect that is highly localized, stable in intensity, ultra-long in duration, and reversible.

Transanal submucosal polyacrylamide gel injection treatment of anal incontinence: a randomized controlled trial.

PubMed

Altman, Daniel; Hjern, Fredrik; Zetterström, Jan

2016-05-01

The efficacious and safe use of transurethral injections of polyacrylamide hydrogel (Bulkamid(®)) in women with stress urinary incontinence suggests that it may be suitable also for treatment of anal incontinence. We aimed to determine the effectiveness and safety of polyacrylamide hydrogel when used as a transanal submucosal bulking agent in women with anal incontinence. Thirty women with a diagnosis of anal incontinence and a Cleveland Clinic Incontinence Score (CCIS) >10 were randomized to three different techniques of transanal submucosal injections using polyacrylamide hydrogel. Follow up was performed at 2, 6 and 12 months using CCIS and the Fecal Incontinence Quality of Life scale (FIQL). In all, 29 of the 30 women completed the follow up. Approximately half of the women requested a re-injection at the 6-month visit. The overall CCIS improved significantly from baseline (14.7. SD 2.5) to 1 year (12.4. SD 3.1) (p = 0.003). There was a significant improvement with regard to the occurrence of loose fecal incontinence (p = 0.014) but not for solid fecal incontinence (p = 0.28). At 1 year the FIQL domains of coping-behavior, depression, and embarrassment showed significant improvements (p = 0.012, p = 0.007 and p = 0.007, respectively). We recorded no adverse events related either to the injection technique or the biomaterial. There were no significant differences between the treatment groups in either CCIS or FIQL scores. Transanal submucosal injection of polyacrylamide hydrogel resulted in a modest although significant overall improvement in anal incontinence symptom scores with corresponding improvements in several domains of quality of life, regardless of injection volume. © 2016 Nordic Federation of Societies of Obstetrics and Gynecology.

Supersonic Pulsed Injection

NASA Technical Reports Server (NTRS)

Cutler, A. D.; Harding, G. C.; Diskin, G. S.

2001-01-01

An injector has been developed to provide high-speed high-frequency (order 10 kHz) pulsed a supersonic crossflow. The injector nozzle is formed between the fixed internal surface of the nozzle and a freely rotating three- or four-sided wheel embedded within the device. Flow-induced rotation of the wheel causes the nozzle throat to open and close at a frequency proportional to the speed of sound of the injected gas. Measurements of frequency and mass flow rate as a function of supply pressure are discussed for various injector designs. Preliminary results are presented for wall-normal injection of helium into a Mach-2 ducted airflow. The data include schlieren images in the injectant plume in a plane normal to the flow, downstream of injection.

Development of CNG direct injection (CNGDI) clean fuel system for extra power in small engine

NASA Astrophysics Data System (ADS)

Ali, Yusoff; Shamsudeen, Azhari; Abdullah, Shahrir; Mahmood, Wan Mohd Faizal Wan

2012-06-01

A new design of fuel system for CNG engine with direct injection (CNGDI) was developed for a demonstration project. The development of the fuel system was done on the engine with cylinder head modifications, for fuel injector and spark plug openings included in the new cylinder head. The piston was also redesigned for higher compression ratio. The fuel rails and the regulators are also designed for the direct injection system operating at higher pressure about 2.0 MPa. The control of the injection timing for the direct injectors are also controlled by the Electronic Control Unit specially designed for DI by another group project. The injectors are selected after testing with the various injection pressures and spray angles. For the best performance of the high-pressure system, selection is made from the tests on single cylinder research engine (SCRE). The components in the fuel system have to be of higher quality and complied with codes and standards to secure the safety of engine for high-pressure operation. The results of the CNGDI have shown that better power output is produced and better emissions were achieved compared to the aspirated CNG engine.

Permacol™ collagen paste injection for the treatment of complex anal fistula: 1-year follow-up.

PubMed

Fabiani, B; Menconi, C; Martellucci, J; Giani, I; Toniolo, G; Naldini, G

2017-03-01

Optimal surgical treatment for anal fistula should result in healing of the fistula track and preserve anal continence. The aim of this study was to evaluate Permacol™ collagen paste (Covidien plc, Gosport, Hampshire, UK) injection for the treatment of complex anal fistulas, reporting feasibility, safety, outcome and functional results. Between May 2013 and December 2014, 21 consecutive patients underwent Permacol paste injection for complex anal fistula at our institutions. All patients underwent fistulectomy and seton placement 6-8 weeks before Permacol™ paste injection. Follow-up duration was 12 months. Eighteen patients (85.7%) had a high transsphincteric anal fistula, and three female patients (14.3%) had an anterior transsphincteric fistula. Fistulas were recurrent in three patients (14.3%). Seven patients (33%) had a fistula with multiple tracts. After a follow-up of 12 months, ten patients were considered healed (overall success rate 47.6%). The mean preoperative FISI score was 0.33 ± 0.57 and 0.61 ± 1.02 after 12 months. Permacol™ paste injection was safe and effective in some patients with complex anal fistula without compromising continence.

Effect of reduced dose schedules and intramuscular injection of anthrax vaccine adsorbed on immunological response and safety profile: a randomized trial.

PubMed

Wright, Jennifer G; Plikaytis, Brian D; Rose, Charles E; Parker, Scott D; Babcock, Janiine; Keitel, Wendy; El Sahly, Hana; Poland, Gregory A; Jacobson, Robert M; Keyserling, Harry L; Semenova, Vera A; Li, Han; Schiffer, Jarad; Dababneh, Hanan; Martin, Sandra K; Martin, Stacey W; Marano, Nina; Messonnier, Nancy E; Quinn, Conrad P

2014-02-12

We evaluated an alternative administration route, reduced schedule priming series, and increased intervals between booster doses for anthrax vaccine adsorbed (AVA). AVA's originally licensed schedule was 6 subcutaneous (SQ) priming injections administered at months (m) 0, 0.5, 1, 6, 12 and 18 with annual boosters; a simpler schedule is desired. Through a multicenter randomized, double blind, non-inferiority Phase IV human clinical trial, the originally licensed schedule was compared to four alternative and two placebo schedules. 8-SQ group participants received 6 SQ injections with m30 and m42 "annual" boosters; participants in the 8-IM group received intramuscular (IM) injections according to the same schedule. Reduced schedule groups (7-IM, 5-IM, 4-IM) received IM injections at m0, m1, m6; at least one of the m0.5, m12, m18, m30 vaccine doses were replaced with saline. All reduced schedule groups received a m42 booster. Post-injection blood draws were taken two to four weeks following injection. Non-inferiority of the alternative schedules was compared to the 8-SQ group at m2, m7, and m43. Reactogenicity outcomes were proportions of injection site and systemic adverse events (AEs). The 8-IM group's m2 response was non-inferior to the 8-SQ group for the three primary endpoints of anti-protective antigen IgG geometric mean concentration (GMC), geometric mean titer, and proportion of responders with a 4-fold rise in titer. At m7 anti-PA IgG GMCs for the three reduced dosage groups were non-inferior to the 8-SQ group GMCs. At m43, 8-IM, 5-IM, and 4-IM group GMCs were superior to the 8-SQ group. Solicited injection site AEs occurred at lower proportions in the IM group compared to SQ. Route of administration did not influence the occurrence of systemic AEs. A 3 dose IM priming schedule with doses administered at m0, m1, and m6 elicited long term immunological responses and robust immunological memory that was efficiently stimulated by a single booster vaccination at

Calcitonin Salmon Injection

MedlinePlus

Calcitonin salmon injection is used to treat osteoporosis in postmenopausal women. Osteoporosis is a disease that causes bones to weaken and break more easily. Calcitonin salmon injection is also used to ...

Introduction of cyclofem once-a-month injectable contraceptive in Mexico.

PubMed

Garza-Flores, J; Moraks del Olmo, A; Fuziwara, J L; Figueroa, J G; Alonso, A; Monroy, J; Perez, M; Urbina-Fuentes, M; Guevara, S J; Cedeno, E; Barrios, R; Ferman, J J; Medina, L M; Velazquez, E; Perez-Palacios, G

1998-07-01

A large introductory study of Cyclofem, a once-a-month injectable contraceptive, was conducted in three Mexican provinces. A total of 3457 healthy women participated: 640 women from rural areas (community-based component) and 2817 women from urban and suburban areas (health center-based component). A total of 20,316 women-months of treatment experience were accumulated during a one year period. Cyclofem proved its use-effectiveness (pregnancy rate of 0.03%) and its safety under routine service conditions of family planning facilities in Mexico. The overall life table continuation rate at 1 year was 26.1%. Higher continuation rates were observed in the community-based component (36.6%) as compared to the health center component (23.7%). The most common reason for method discontinuation was change of address. Only 15% of the discontinuations were attributable to the injectable contraceptive method, with the overall 1 year discontinuation rate for bleeding problems (including amenorrhea) was < 11%. These observations underscore the importance of appropriate counseling and follow-up measures, providing convenient access to repeat injections, and other service delivery issues related to continuation of Cyclofem. The results of this trial have once again demonstrated that Cyclofem is a highly effective method with an acceptable side effect profile. In addition, the study provided the elements for its approval by local health authorities and its inclusion into the Ministry of Health Family Planning Program.

Dependence of injection locking of a TEA CO2 laser on intensity of injected radiation

NASA Technical Reports Server (NTRS)

Oppenheim, U. P.; Menzies, R. T.; Kavaya, M. J.

1982-01-01

The results of an experimental study to determine the minimum required injected power to control the output frequency of a TEA CO2 laser are reported. A CW CO2 waveguide laser was used as the injection oscillator. Both the power and the frequency of the injected radiation were varied, while the TEA resonator cavity length was adjusted to match the frequency of the injected signal. Single-longitudinal mode (SLM) TEA laser radiation was produced for injected power levels which are several orders of magnitude below those previously reported. The ratio of SLM output power to injection power exceeded 10 to the 12th at the lowest levels of injected intensity.

Unsteady boundary-layer injection

NASA Technical Reports Server (NTRS)

Telionis, D. P.; Jones, G. S.

1981-01-01

The boundary-layer equations for two-dimensional incompressible flow are integrated numerically for the flow over a flat plate and a Howarth body. Injection is introduced either impulsively or periodically along a narrow strip. Results indicate that injection perpendicular to the wall is transmitted instantly across the boundary layer and has little effect on the velocity profile parallel to the wall. The effect is a little more noticeable for flows with adverse pressure gradients. Injection parallel to the wall results in fuller velocity profiles. Parallel and oscillatory injection appears to influence the mean. The amplitude of oscillation decreases with distance from the injection strip but further downstream it increases again in a manner reminiscent of an unstable process.

Compact surface plasmon resonance biosensor utilizing an injection-molded prism

NASA Astrophysics Data System (ADS)

Chen, How-Foo; Chen, Chih-Han; Chang, Yun-Hsiang; Chuang, Hsin-Yuan

2016-05-01

Targeting at a low cost and accessible diagnostic device in clinical practice, a compact surface plasmon resonance (SPR) biosensor with a large dynamic range in high sensitivity is designed to satisfy commercial needs in food safety, environmental bio-pollution monitoring, and fast clinical diagnosis. The core component integrates an optical coupler, a sample-loading plate, and angle-tuning reflectors is injection-molded as a free-from prism made of plastic optics. This design makes a matching-oil-free operation during operation. The disposability of this low-cost component ensures testing or diagnosis without cross contamination in bio-samples.

First injection of ketamine among young injection drug users (IDUs) in three U.S. cities

PubMed Central

Lankenau, Stephen E.; Sanders, Bill; Bloom, Jennifer Jackson; Hathazi, Dodi; Alarcon, Erica; Tortu, Stephanie; Clatts, Michael C.

2007-01-01

Ketamine, a dissociative anesthetic, has emerged as an increasingly common drug among subgroups of young injection drug users (IDUs) in cities across the United States. In-depth qualitative interviews were conducted with 213 young IDUs aged 16–28 years recruited in New York, New Orleans, and Los Angeles between 2004 and 2006. While some initiated injection drug use with ketamine, the drug was more frequently injected by IDUs with extensive polydrug using histories. IDUs initiating with ketamine commonly self-injected via an intramuscular mode of administration. The injection group provided crucial knowledge and material resources that enabled the injection event to occur, including ketamine, syringes, and injection skills. Injection paraphernalia was commonly shared during the first injection of ketamine, particularly vials of pharmaceutically-packaged liquid ketamine. Injection events infrequently occurred in a rave or club and more typically in a private home, which challenges ketamine’s designation as a ‘club’ drug. The first injection of ketamine was a noteworthy event since it introduced a novel drug or new mode of administration to be further explored by some, or exposed others to a drug to be avoided in the future. Risk reduction messages directed towards young IDUs should be expanded to include ketamine. PMID:16979848

MEDICAL INJECTION

NASA Image and Video Library

1963-06-10

S62-08371 (1962) --- The automatic medical injectors carried on the Mercury-Atlas 9 flight. The injectors provide the astronaut with injection tubes of Tigan, for preventing motion sickness and Demerol, for relieving pain. The tubes encased in the block are stowed in the astronauts survival kit. The single injection tubes are placed in a pocket of the astronauts spacesuit. Photo credit: NASA

78 FR 42776 - Underground Injection Control Program; Hazardous Waste Injection Restrictions; Petition for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-17

... ENVIRONMENTAL PROTECTION AGENCY [FRL9834-8] Underground Injection Control Program; Hazardous Waste Injection Restrictions; Petition for Exemption--Class I Hazardous Waste Injection; Blanchard Refining... migration petition reissuance. SUMMARY: Notice is hereby given that a reissuance of an exemption to the land...

Ultrasound guided intra-articular ketorolac versus corticosteroid injection in osteoarthritis of the hip: a retrospective comparative study.

PubMed

Park, Ki Deok; Kim, Tai Kon; Bae, Byung Woo; Ahn, JaeKi; Lee, Woo Yong; Park, Yongbum

2015-09-01

Intra-articular steroid injection has been widely used in the management of symptomatic osteoarthritis; however, its frequent use is avoided since there is an increase in the incidence of articular infection and several mechanical side effects such as cartilage breakdown and loss of elasticity of the articular cartilage. For these reasons, nonsteroidal anti-inflammatory drugs instead of corticosteroids can be considered for intra-articular injection. On this basis, we investigated the effects and safety of ultrasound-guided intra-articular ketorolac versus corticosteroid injection for patients with osteoarthritis of the hip. This retrospective study included 98 patients with diagnoses of hip osteoarthritis who underwent ultrasound-guided intra-articular ketorolac or corticosteroid injection. Fifty patients who received ultrasound-guided intra-articular corticosteroid injection were administered a mixture of 0.5% lidocaine and triamcinolone. Forty-eight patients who received ultrasound-guided intra-articular ketorolac injection were administered 0.5% lidocaine and ketorolac. Outcome measurement was assessed using the Harris hip score and verbal numeric pain scale, which were evaluated before the injections and at 1, 3 and 6 months following the injection. Univariate analysis (using the x (2) test) and multiple logistic regression analysis were performed to evaluate the relationship between the possible outcome predictors (injected medications, patients' age, gender, pain duration and Kellgren-Lawrence classification) and the therapeutic effects. The Harris hip score and verbal numeric pain scale were improved at 1, 3 and 6 months after the injection in both groups. No statistical differences in the Harris hip score and verbal numeric pain scale were observed between the groups. The success rate was also not significantly different among the time periods of 1, 3 and 6 months. Multiple logistic regression and univariate analysis showed that injected medications

Slit injection device

DOEpatents

Alger, Terry W.; Schlitt, Leland G.; Bradley, Laird P.

1976-06-15

A laser cavity electron beam injection device provided with a single elongated slit window for passing a suitably shaped electron beam and means for varying the current density of the injected electron beam.

Adaptive engine injection for emissions reduction

DOEpatents

Reitz, Rolf D. : Sun, Yong

2008-12-16

NOx and soot emissions from internal combustion engines, and in particular compression ignition (diesel) engines, are reduced by varying fuel injection timing, fuel injection pressure, and injected fuel volume between low and greater engine loads. At low loads, fuel is injected during one or more low-pressure injections occurring at low injection pressures between the start of the intake stroke and approximately 40 degrees before top dead center during the compression stroke. At higher loads, similar injections are used early in each combustion cycle, in addition to later injections which preferably occur between about 90 degrees before top dead center during the compression stroke, and about 90 degrees after top dead center during the expansion stroke (and which most preferably begin at or closely adjacent the end of the compression stroke). These later injections have higher injection pressure, and also lower injected fuel volume, than the earlier injections.

Physics of the current injection process during localized helicity injection

NASA Astrophysics Data System (ADS)

Hinson, Edward Thomas

An impedance model has been developed for the arc-plasma cathode electron current source used in localized helicity injection tokamak startup. According to this model, a potential double layer (DL) is established between the high-density arc plasma (narc ˜ 1021 m-3) in the electron source, and the less-dense external tokamak edge plasma (nedge ˜ 10 18 m-3) into which current is injected. The DL launches an electron beam at the applied voltage with cross-sectional area close to that of the source aperture: Ainj ≈ 2 cm 2. The injected current, Iinj, increases with applied voltage, Vinj, according to the standard DL scaling, Iinj ˜ V(3/2/ inj), until the more restrictive of two limits to beam density nb arises, producing Iinj ˜ V(1/2/inj), a scaling with beam drift velocity. For low external tokamak edge density nedge, space-charge neutralization of the intense electron beam restricts the injected beam density to nb ˜ nedge. At high Jinj and sufficient edge density, the injected current is limited by expansion of the DL sheath, which leads to nb ˜ narc. Measurements of narc, Iinj , nedge, Vinj, support these predicted scalings, and suggest narc as a viable control actuator for the source impedance. Magnetic probe signals ≈ 300 degrees toroidally from the injection location are consistent with expectations for a gyrating, coherent electron beam with a compact areal cross-section. Technological development of the source has allowed an extension of the favorable Iinj ˜ V(1/2/inj) to higher power without electrical breakdown.

Parametric study of injection rates with solenoid injectors in an injection quantity and rate measuring device

DOE PAGES

Busch, Stephen; Miles, Paul C.

2015-03-31

A Moehwald HDA (HDA is a German acronym: Hydraulischer Druckanstieg: hydraulic pressure increase) injection quantity and rate measuring unit is used to investigate injection rates obtained with a fast-acting, preproduction diesel solenoid injector. Experimental parametric variations are performed to determine their impact on measured injection rate traces. A pilot–main injection strategy is investigated for various dwell times; these preproduction injectors can operate with very short dwell times with distinct pilot and main injection events. Dwell influences the main injection rate shape. Furthermore, a comparison between a diesel-like fuel and a gasoline-like fuel shows that injection rates are comparable for amore » single injection but dramatically different for multiple injections with short dwells.« less

75 FR 60457 - Underground Injection Control Program Hazardous Waste Injection Restrictions; Petition for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-30

... ENVIRONMENTAL PROTECTION AGENCY [FRL-9208-4] Underground Injection Control Program Hazardous Waste Injection Restrictions; Petition for Exemption--Class I Hazardous Waste Injection Dow Chemical Company (DOW... Petition. SUMMARY: Notice is hereby given that an exemption to the land disposal restrictions under the...

A naturalistic comparison of the efficacy and safety of intramuscular olanzapine and intramuscular haloperidol in agitated elderly patients with schizophrenia

PubMed Central

Gen, Keishi; Takahashi, Yuki

2013-01-01

Objective: This study was a comparative investigation of the clinical efficacy and safety of intramuscular (IM) olanzapine and IM haloperidol in agitated elderly patients with schizophrenia at 2 hours postdose. Methods: The subjects were 23 inpatients who had been diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Their clinical symptoms were assessed using Positive and Negative Syndrome Scale Excited Component (PANSS-EC), PANSS and Agitation Calmness Evaluation Scale (ACES), and their safety were assessed using the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) and laboratory tests. Results: The mean reduction from baseline on the PANSS-EC total score, the PANSS total score and the ACES score were significantly greater in the IM olanzapine injection group than in the IM haloperidol injection group. The mean changes from baseline on the AIMS score, the BARS score and the DIEPSS total score were significantly better in the IM olanzapine injection group than in the IM haloperidol injection group. No serious adverse events such as paralytic ileus, diabetic ketoacidosis, neuroleptic malignant syndrome or tardive dyskinesia occurred between the two groups. Conclusion: The results of this study suggest the possibility that agitated elderly patients may result in superior efficacy and safety after IM olanzapine without serious adverse events in comparison with IM haloperidol. PMID:24294484

Brentuximab Vedotin Injection

MedlinePlus

... with healthy bone marrow) or at least two treatment periods of chemotherapy. Brentuximab vedotin injection is also ... Hodgkin lymphoma) who did not respond to another treatment period of chemotherapy. Brentuximab vedotin injection is in ...

Parathyroid Hormone Injection

MedlinePlus

... injection is used along with calcium and vitamin D to treat low levels of calcium in the ... condition can be controlled by calcium and vitamin D alone. Parathyroid hormone injection is in a class ...

FEASIBILITY AND SAFETY OF CONTRAST-ENHANCED ULTRASOUND IN THE DISTAL LIMB OF SIX HORSES.

PubMed

Seiler, Gabriela S; Campbell, Nigel; Nixon, Britton; Tsuruta, James K; Dayton, Paul A; Jennings, Samuel; Redding, W Rich; Lustgarten, Meghann

2016-05-01

Vascular alterations play important roles in many orthopedic diseases such as osteoarthritis, tendonitis, and synovitis in both human and equine athletes. Understanding these alterations could enhance diagnosis, prognosis, and treatment. Contrast-enhanced ultrasound (CEUS) could be a valuable method for evaluation of blood flow and perfusion of these processes in the equine distal limb, however no reports were found describing feasibility or safety of the technique. The goal of this prospective, experimental study was to describe the feasibility and safety of distal limb CEUS in a sample of six horses. For each horse, CEUS of the distal limb was performed after intravenous injections of 5 and 10 ml, as well as intra-arterial injections of 0.5 and 1 ml contrast medium. Vital parameters were monitored and CEUS images were assessed qualitatively and quantitatively for degree of contrast enhancement. None of the horses had clinically significant changes in their vital parameters after contrast medium injection. One horse had a transient increase in respiratory rate, and several horses had mild increases of systolic blood pressure of short duration after intravenous, but not after intra-arterial injections. Intra-arterial injection was possible in all horses and resulted in significantly improved contrast enhancement both quantitatively (P = 0.027) and qualitatively (P = 0.019). Findings from this study indicated that CEUS is a feasible and safe diagnostic test for evaluation of the equine distal limb. Future studies are needed to assess the clinical utility of this test for horses with musculoskeletal diseases. © 2016 American College of Veterinary Radiology.

Antigen injection (image)

MedlinePlus

Leprosy is caused by the organism Mycobacterium leprae . The leprosy test involves injection of an antigen just under ... if your body has a current or recent leprosy infection. The injection site is labeled and examined ...

Evaluation of the safety and efficiency of novel metallic implant scaler tips manufactured by the powder injection molding technique.

PubMed

Chun, Kyung A; Kum, Kee-Yeon; Lee, Woo-Cheol; Baek, Seung-Ho; Choi, Hae-Won; Shon, Won-Jun

2017-07-11

Although many studies have compared the properties of ultrasonic scaling instruments, it remains controversial as to which is most suitable for implant scaling. This study evaluated the safety and efficiency of novel metallic ultrasonic scaler tips made by the powder injection molding (PIM) technique on titanium surfaces. Mechanical instrumentation was carried out using four types of metal scaler tips consisting of copper (CU), bronze (BR), 316 L stainless steel (316 L), and conventional stainless steel (SS) tips. The instrumented surface alteration image of samples was viewed with scanning electron microscope (SEM) and surface profile of the each sample was investigated with confocal laser scanning microscopy (CLSM). Arithmetic mean roughness (Ra) and maximum height roughness (Rmax) of titanium samples were measured and dissipated power of the scaler tip was estimated for scaling efficiency. The average Ra values caused by the 316 L and SS tip were about two times higher than those of the CU and BR tips (p < 0.05). The Rmax value showed similar results. The efficiency of the SS tip was about 3 times higher than that of CU tip, the 316 L tip is about 2.7 times higher than that of CU tip, and the BR tip is about 1.2 times higher than that of CU tip. Novel metallic bronze alloy ultrasonic scaler tip minimally damages titanium surfaces, similar to copper alloy tip. Therefore, this bronze alloy scaler tip may be promising instrument for implant maintenance therapy.

Medical Injection Use Among Adults and Adolescents Aged 15 to 64 Years in Kenya: Results From a National Survey

PubMed Central

Kimani, Daniel; Kamau, Rachel; Ssempijja, Victor; Robinson, Katherine; Oluoch, Tom; Njeru, Mercy; Mwangi, Jane; Njogu, David; Kim, Andrea A.

2016-01-01

Background Unsafe medical injections remain a potential route of HIV transmission in Kenya. We used data from a national survey in Kenya to study the magnitude of medical injection use, medication preference, and disposal of medical waste in the community. Methods The Kenya AIDS Indicator Survey 2012 was a nationally representative population-based survey. Among participants aged 15–64 years, data were collected regarding medical injections received in the year preceding the interview; blood samples were collected from participants for HIV testing. Results Of the 13,673 participants who answered questions on medical injections, 35.9% [95% confidence interval (CI): 34.5 to 37.3] reported receiving ≥1 injection in the past 12 months and 51.2% (95% CI: 49.7 to 52.8) preferred receiving an injection over a pill. Among those who received an injection from a health care provider, 95.9% (95% CI: 95.2 to 96.7) observed him/her open a new injection pack, and 7.4% (95% CI: 6.4 to 8.4) had seen a used syringe or needle near their home or community in the past 12 months. Men who had received ≥1 injection in the past 12 months (adjusted odds ratio, 3.2; 95% CI: 1.2 to 8.9) and women who had received an injection in the past 12 months, not for family planning purposes (adjusted odds ratio, 2.6; 95% CI: 1.2 to 5.5), were significantly more likely to be HIV infected compared with those who had not received medical injection in the past 12 months. Conclusions Injection preference may contribute to high rates of injections in Kenya. Exposure to unsafe medical waste in the community poses risks for injury and infection. We recommend that community- and facility-based injection safety strategies be integrated in disease prevention programs. PMID:24413041

76 FR 55908 - Underground Injection Control Program; Hazardous Waste Injection Restrictions; Petition for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

... of an exemption to the land disposal restrictions, under the 1984 Hazardous and Solid Waste... Waste Injection Restrictions; Petition for Exemption--Class I Hazardous Waste Injection; Great Lakes... from the injection zone for as long as the waste remains hazardous. This final decision allows the...

78 FR 23246 - Underground Injection Control Program; Hazardous Waste Injection Restrictions; Petition for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-18

... exemption to the land disposal Restrictions, under the 1984 Hazardous and Solid Waste [[Page 23247... Waste Injection Restrictions; Petition for Exemption--Class I Hazardous Waste Injection; BASF... from the injection zone for as long as the waste remains hazardous. This final decision allows the...

77 FR 26755 - Underground Injection Control Program; Hazardous Waste Injection Restrictions; Petition for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

... reissuance of an exemption to the land disposal Restrictions, under the 1984 Hazardous and Solid Waste... Waste Injection Restrictions; Petition for Exemption--Class I Hazardous Waste Injection; Diamond... from the injection zone for as long as the waste remains hazardous. This final decision allows the...

Puerarin injection for treatment of unstable angina pectoris: a meta-analysis and systematic review

PubMed Central

Gao, Zhisheng; Wei, Baozhu; Qian, Cheng

2015-01-01

Background: Puerarin is an effective ingredient isolated from Radix Puerariae, a leguminous plant. In China, a large number of early studies suggest that puerarin may be used in the treatment of coronary heart disease. In recent years, puerarin injection has been widely used to treat coronary heart disease and angina pectoris. Objective: To systematically evaluate the clinical efficacy and safety of puerarin injection in the treatment of unstable angina pectoris (UAP). Methods: Data were retrieved from digital databases, including PubMed, Excerpt Medica Database (EMBASE), China Biology Medicine (CBM), the Cochrane Library, and Chinese databases. Results: Compared with patients who were treated with conventional Western medicines alone, the patients who were treated with conventional Western medicines in combination with puerarin injection exhibited significant improvements in the incidence of angina pectoris, electrocardiogram findings, nitroglycerin consumption and plasma endothelin levels. Conclusions: Strong evidence suggests that, the use of puerarin in combination with conventional Western medicines is a better treatment option for treating UAP, compared with the use of conventional Western medicines alone. PMID:26628941

Corticotropin, Repository Injection

MedlinePlus

Corticotropin repository injection is used to treat the following conditions:infantile spasms (seizures that usually begin during the first ... of the arms, hands, feet, and legs). Corticotropin repository injection is in a class of medications called ...

Epoetin Alfa Injection

MedlinePlus

Epoetin alfa injection is used to treat anemia (a lower than normal number of red blood cells) in people ... stop working over a period of time). Epoetin alfa injection is also used to treat anemia caused ...

Darbepoetin Alfa Injection

MedlinePlus

Darbepoetin alfa injection is used to treat anemia (a lower than normal number of red blood cells) in people ... stop working over a period of time). Darbepoetin alfa injection is also used to treat anemia caused ...

Iron Dextran Injection

MedlinePlus

Iron dextran injection is used to treat iron-deficiency anemia (a lower than normal number of red blood cells ... treated with iron supplements taken by mouth. Iron dextran injection is in a class of medications called ...

Surgical versus injection treatment for injection-confirmed chronic sacroiliac joint pain

PubMed Central

Spiker, William Ryan; Lawrence, Brandon D.; Raich, Annie L.; Skelly, Andrea C.; Brodke, Darrel S.

2012-01-01

Study design: Systematic review. Study rationale: Chronic sacroiliac joint pain (CSJP) is a common clinical entity with highly controversial treatment options. A recent systematic review compared surgery with denervation, but the current systematic review compares outcomes of surgical intervention with therapeutic injection for the treatment of CSJP and serves as the next step for evaluating current evidence on the comparative effectiveness of treatments for non-traumatic sacroiliac joint pain. Objective or clinical question: In adult patients with injection-confirmed CSJP, does surgical treatment lead to better outcomes and fewer complications than injection therapy? Methods: A systematic review of the English-language literature was undertaken for articles published between 1970 and June 2012. Electronic databases and reference lists of key articles were searched to identify studies evaluating surgery or injection treatment for injection-confirmed CSJP. Studies involving traumatic onset or non-injection–confirmed CSJP were excluded. Two independent reviewers assessed the level of evidence quality using the grading of recommendations assessment, development and evaluation (GRADE) system, and disagreements were resolved by consensus. Results: We identified twelve articles (seven surgical and five injection treatment) meeting our inclusion criteria. Regardless of the type of treatment, most studies reported over 40% improvement in pain as measured by Visual Analog Scale or Numeric rating Scale score. Regardless of the type of treatment, most studies reported over 20% improvement in functionality. Most complications were reported in the surgical studies. Conclusion: Surgical fusion and therapeutic injections can likely provide pain relief, improve quality of life, and improve work status. The comparative effectiveness of these interventions cannot be evaluated with the current literature. PMID:23526911

A review of aripiprazole long-acting injection.

PubMed

Chue, Pierre; Chue, James

2016-01-01

To review the published literature on aripiprazole once monthly, a second generation antipsychotic (SGA) recently developed as a long-acting injection (LAI), in the form of a suspension of lyophilized aripiprazole reconstituted with an aqueous diluent, for intramuscular administration. An electronic database search was conducted using the key words; relevant articles were then hand searched and websites (FDA, EMA, Otsuka, Lundbeck, NIH) reviewed. Efficacy has been demonstrated in preventing relapse in a 52 week study versus placebo, and non-inferiority to oral aripiprazole in a 38 week study, as well as in the treatment of hospitalized adult patients with acutely relapsed schizophrenia. Aripiprazole LAI appears cost-effective versus other SGA-LAIs, with improved health-related quality of life and functioning in a head-to-head study with paliperidone LAI. A 6 month (pre and post), mirror-image switch study demonstrated a reduction in hospitalization and associated costs compared with previous antipsychotic treatment. Safety and tolerability are comparable to oral aripiprazole with no new safety signals. Experience with oral aripiprazole and the current availability of the long-acting formulation suggest a potential benefit in a variety of clinical scenarios and therefore consideration as a treatment option in the treatment of schizophrenia.

Injectable nanocomposite cryogels for versatile protein drug delivery.

PubMed

Koshy, Sandeep T; Zhang, David K Y; Grolman, Joshua M; Stafford, Alexander G; Mooney, David J

2018-01-01

Sustained, localized protein delivery can enhance the safety and activity of protein drugs in diverse disease settings. While hydrogel systems are widely studied as vehicles for protein delivery, they often suffer from rapid release of encapsulated cargo, leading to a narrow duration of therapy, and protein cargo can be denatured by incompatibility with the hydrogel crosslinking chemistry. In this work, we describe injectable nanocomposite hydrogels that are capable of sustained, bioactive, release of a variety of encapsulated proteins. Injectable and porous cryogels were formed by bio-orthogonal crosslinking of alginate using tetrazine-norbornene coupling. To provide sustained release from these hydrogels, protein cargo was pre-adsorbed to charged Laponite nanoparticles that were incorporated within the walls of the cryogels. The presence of Laponite particles substantially hindered the release of a number of proteins that otherwise showed burst release from these hydrogels. By modifying the Laponite content within the hydrogels, the kinetics of protein release could be precisely tuned. This versatile strategy to control protein release simplifies the design of hydrogel drug delivery systems. Here we present an injectable nanocomposite hydrogel for simple and versatile controlled release of therapeutic proteins. Protein release from hydrogels often requires first entrapping the protein in particles and embedding these particles within the hydrogel to allow controlled protein release. This pre-encapsulation process can be cumbersome, can damage the protein's activity, and must be optimized for each protein of interest. The strategy presented in this work simply premixes the protein with charged nanoparticles that bind strongly with the protein. These protein-laden particles are then placed within a hydrogel and slowly release the protein into the surrounding environment. Using this method, tunable release from an injectable hydrogel can be achieved for a variety of

Transitions from injecting to non-injecting drug use: potential protection against HCV infection

PubMed Central

Des Jarlais, Don C.; McKnight, Courtney; Arasteh, Kamyar; Feelemyer, Jonathan; Perlman, David C.; Hagan, Holly; Cooper, Hannah L. F.

2013-01-01

Transitions from injecting to non-injecting drug use have been reported from many different areas, particularly in areas with large human immunodeficiency virus (HIV) epidemics. The extent to which such transitions actually protect against HIV and HCV has not been determined. A cross-sectional survey with HIV and hepatitis C (HCV) testing was conducted with 322 former injectors (persons who had injected illicit drugs but permanently transitioned to non-injecting use) and 801 current injectors recruited in New York City between 2007 and 2012. There were no differences in HIV prevalence, while HCV prevalence was significantly lower among former injectors compared to current injectors. Years injecting functioned as a mediating variable linking former injector status to lower HCV prevalence. Transitions have continued well beyond the reduction in the threat of AIDS to injectors in the city. New interventions to support transitions to non-injecting drug use should be developed and supported by both drug treatment and syringe exchange programs. PMID:24161262

Sterile syringe access and disposal among injection drug users newly enrolled in methadone maintenance treatment: a cross-sectional survey

PubMed Central

McNeely, Jennifer; Arnsten, Julia H; Gourevitch, Marc N

2006-01-01

Background We sought to assess injection practices, means of acquiring and disposing of syringes, and utilization and knowledge of harm reduction resources among injection drug users (IDUs) entering methadone maintenance treatment (MMT). Methods Interviews with 100 consecutive patients, including 35 IDUs, entering a MMT program in the Bronx, NY. Results Utilization of unsafe syringe sources was reported by 69% of IDUs in our sample. Most (80%) IDUs reused syringes, and syringe sharing was also common. Fewer than half knew that non-prescription pharmacy purchase of syringes was possible. The most common means of disposing of injecting equipment were the trash (63%) and syringe exchange programs (49%). Conclusions These findings indicate that drug users entering treatment under-utilize sanctioned venues to obtain sterile syringes or safely dispose of used injection equipment. Programs providing services to drug users should adopt a proactive stance to address the safety and health issues faced by injectors. PMID:16503997

Syringe injectable electronics

PubMed Central

Hong, Guosong; Zhou, Tao; Jin, Lihua; Duvvuri, Madhavi; Jiang, Zhe; Kruskal, Peter; Xie, Chong; Suo, Zhigang; Fang, Ying; Lieber, Charles M.

2015-01-01

Seamless and minimally-invasive three-dimensional (3D) interpenetration of electronics within artificial or natural structures could allow for continuous monitoring and manipulation of their properties. Flexible electronics provide a means for conforming electronics to non-planar surfaces, yet targeted delivery of flexible electronics to internal regions remains difficult. Here, we overcome this challenge by demonstrating syringe injection and subsequent unfolding of submicrometer-thick, centimeter-scale macroporous mesh electronics through needles with a diameter as small as 100 micrometers. Our results show that electronic components can be injected into man-made and biological cavities, as well as dense gels and tissue, with > 90% device yield. We demonstrate several applications of syringe injectable electronics as a general approach for interpenetrating flexible electronics with 3D structures, including (i) monitoring of internal mechanical strains in polymer cavities, (ii) tight integration and low chronic immunoreactivity with several distinct regions of the brain, and (iii) in vivo multiplexed neural recording. Moreover, syringe injection enables delivery of flexible electronics through a rigid shell, delivery of large volume flexible electronics that can fill internal cavities and co-injection of electronics with other materials into host structures, opening up unique applications for flexible electronics. PMID:26053995

Analysis of efficacy and safety of treatment with collagenase Clostridium histolyticum among subgroups of patients with Dupuytren contracture.

PubMed

Raven, Raymond B; Kushner, Harvey; Nguyen, Dat; Naam, Nash; Curtin, Catherine

2014-09-01

Collagenase Clostridium histolyticum (CCH) injection is a nonoperative treatment of hand contractures from Dupuytren disease. This study assessed the efficacy and safety of CCH in several subgroups of patients with increased surgical risk.Data were pooled from 3 randomized, placebo-controlled, double-blind trials. This analysis included 271 patients with metacarpophalangeal (n = 167) or proximal interphalangeal (n = 104) joint contractures greater than or equal to 20 degrees treated with CCH (0.58 mg collagenase per injection). Subgroups included age, sex, and diabetes status. End points included rate of clinical success (reduction in contracture to 0-5 degrees of normal) and percentage of adverse events.There was no significant difference in clinical success by age, diabetes status, or sex with 63% reaching the end point. There was no difference in adverse events among the subgroups, with peripheral edema, contusion, and injection-site hemorrhage being most common.High-risk subgroups do not demonstrate differences in efficacy or safety with CCH treatment of Dupuytren-related contractures.

Endoscopic injection therapy.

PubMed

Kim, Sang Woon; Lee, Yong Seung; Han, Sang Won

2017-06-01

Since the U.S. Food and Drug Administration approved dextranomer/hyaluronic acid copolymer (Deflux) for the treatment of vesicoureteral reflux, endoscopic injection therapy using Deflux has become a popular alternative to open surgery and continuous antibiotic prophylaxis. Endoscopic correction with Deflux is minimally invasive, well tolerated, and provides cure rates approaching those of open surgery (i.e., approximately 80% in several studies). However, in recent years a less stringent approach to evaluating urinary tract infections (UTIs) and concerns about long-term efficacy and complications associated with endoscopic injection have limited the use of this therapy. In addition, there is little evidence supporting the efficacy of endoscopic injection therapy in preventing UTIs and vesicoureteral reflux-related renal scarring. In this report, we reviewed the current literature regarding endoscopic injection therapy and provided an updated overview of this topic.

Extraforaminal needle tip position reduces risk of intravascular injection in CT-fluoroscopic lumbar transforaminal epidural steroid injections

PubMed Central

Yu, Robinson K.; Ghodadra, Anish; Agarwal, Vikas

2016-01-01

Background Lumbar transforaminal epidural steroid injection is a common and effective tool for managing lumbar radicular pain, although accidental intravascular injection can rarely result in paralysis. The purpose of this study is to determine the safest needle tip position for computed tomography (CT)-guided lumbar transforaminal epidural steroid injections as determined by incidence of intravascular injection. Methods Three radiologists, in consensus, reviewed procedural imaging for consecutive CT-fluoroscopic lumbar transforaminal epidural steroid injections performed during a 16-month period. Intravascular injections were identified and categorized by needle tip position, vessel type injected, intravascular injection volume and procedural phase containing the intravascular injection. Pearson chi-square and logistic regression testing were used to assess differences between groups, as appropriate. Results Intravascular injections occurred in 9% (52/606) of injections. The intravascular injection rate was significantly lower (P<0.001) for extraforaminal needle position (0%, 0/109) compared to junctional (8%, 27/319) and foraminal (14%, 25/178) needle tip positions. Of the intravascular injections, 4% (2/52) were likely arterial, 35% (18/52) were likely venous, and 62% (32/52) were indeterminate for vessel type injected. 46% (24/52) of intravascular injections were large volume, 33% (17/52) were small volume, and 21% (11/52) were trace volume. 56% (29/52) of intravascular injections occurred with the contrast trial dose, 29% (15/52) with the steroid/analgesic cocktail, and 15% (8/52) with both. Conclusions An extraforaminal needle position for CT-fluoroscopic lumbar transforaminal epidural steroid injections decreases the risk of intravascular injection and therefore may be safer than other needle tip positions. PMID:28097241

Intra-discal injection of autologous, hypoxic cultured bone marrow-derived mesenchymal stem cells in five patients with chronic lower back pain: a long-term safety and feasibility study.

PubMed

Elabd, Christian; Centeno, Christopher J; Schultz, John R; Lutz, Gregory; Ichim, Thomas; Silva, Francisco J

2016-09-01

Chronic low back pain due to disc degeneration represents a major social and economic burden worldwide. The current standard of care is limited to symptomatic relief and no current approved therapy promotes disc regeneration. Bone marrow-derived mesenchymal stem cells (MSCs) are easily accessible and well characterized. These MSCs are multipotent and exhibit great tissue regenerative potential including bone, cartilage, and fibrous tissue regeneration. The use of this cell-based biologic for treating protruding disc herniation and/or intervertebral disc degeneration is a promising therapeutic strategy, due to their known regenerative, immuno-modulatory and anti-inflammatory properties. Five patients diagnosed with degenerative disc disease received an intra-discal injection of autologous, hypoxic cultured, bone marrow-derived mesenchymal stem cells (15.1-51.6 million cells) as part of a previous study. These patients were re-consented to participate in this study in order to assess long-term safety and feasibility of intra-discal injection of autologous, hypoxic cultured, bone marrow-derived mesenchymal stem cells 4-6 years post mesenchymal stem cell infusion. The follow-up study consisted of a physical examination, a low back MRI, and a quality of life questionnaire. Patients' lower back MRI showed absence of neoplasms or abnormalities surrounding the treated region. Based on the physical examination and the quality of life questionnaire, no adverse events were reported due to the procedure or to the stem cell treatment 4-6 years post autologous, hypoxic cultured mesenchymal stem cell infusion. All patients self-reported overall improvement, as well as improvement in strength, post stem cell treatment, and four out of five patients reported improvement in mobility. This early human clinical data suggests the safety and feasibility of the clinical use of hypoxic cultured bone marrow-derived mesenchymal stem cells for the treatment of lower back pain due to

Efficacy, tolerability, and safety of aripiprazole once-monthly versus other long-acting injectable antipsychotic therapies in the maintenance treatment of schizophrenia: a mixed treatment comparison of double-blind randomized clinical trials.

PubMed

Majer, Istvan M; Gaughran, Fiona; Sapin, Christophe; Beillat, Maud; Treur, Maarten

2015-01-01

Treatment with long-acting injectable (LAI) antipsychotic medication is an important element of relapse prevention in schizophrenia. Recently, the intramuscular once-monthly formulation of aripiprazole received marketing approval in Europe and the United States for schizophrenia. This study aimed to compare aripiprazole once-monthly with other LAI antipsychotics in terms of efficacy, tolerability, and safety. A systematic literature review was conducted to identify relevant double-blind randomized clinical trials of LAIs conducted in the maintenance treatment of schizophrenia. MEDLINE, MEDLINE In-Process, Embase, the Cochrane Library, PsycINFO, conference proceedings, clinical trial registries, and the reference lists of key review articles were searched. The literature search covered studies dating from January 2002 to May 2013. Studies were required to have ≥24 weeks of follow-up. Patients had to be stable at randomization. Studies were not eligible for inclusion if efficacy of acute and maintenance phase treatment was not reported separately. Six trials were identified (0.5% of initially identified studies), allowing comparisons of aripiprazole once-monthly, risperidone LAI, paliperidone palmitate, olanzapine pamoate, haloperidol depot, and placebo. Data extracted included study details, study duration, the total number of patients in each treatment arm, efficacy, tolerability, and safety outcomes. The efficacy outcome contained the number of patients that experienced a relapse, tolerability outcomes included the number of patients that discontinued treatment due to treatment-related adverse events (AEs), and that discontinued treatment due to reasons other than AEs (e.g., loss to follow-up). Safety outcomes included the incidence of clinically relevant weight gain and extrapyramidal symptoms. Data were analyzed by applying a mixed treatment comparison competing risks model (efficacy) and using binary models (safety). There was no statistically significant

Deformational injection rate measuring method

NASA Astrophysics Data System (ADS)

Marčič, Milan

2002-09-01

After completing the diesel engine endurance testing, we detected various traces of thermal load on the walls of combustion chambers located in the engine pistons. The engines were fitted with ω combustion chambers. The thermal load of different intensity levels occurred where the spray of fuel, fuel vapor, and air interacted with the combustion chamber wall. The uneven thermal load distribution of the combustion chamber wall results from varying injection rates in each injection nozzle hole. The most widely applied controlling methods so far for injection rate measurement, such as the Zeuch and Bosch concepts, allow measurement of only the total injection rate in multihole nozzles, without providing any indication whatsoever of the injection rate differences in individual injection nozzle holes. The new deformational measuring method described in the article allows the injection rate to be measured in each hole of the multihole nozzle. The results of the measurements using this method showed that the differences occurred in injection rates of individual injection nozzle holes. These differences may be the cause of various thermal loads on the combustion chamber walls. The criterion for injection rate is the deformation of the membrane due to an increase in the fuel quantity in the measuring space and due to the pressure waves resulting from the fuel being injected into the measuring space. The membrane deformation is measured using strain gauges, glued to the membrane and forming the Wheatstone's bridge. We devoted special attention to the temperature compensation of the Wheatstone's bridge and the membrane, heated up during the measurements.

Institutional ethical review and ethnographic research involving injection drug users: a case study.

PubMed

Small, Will; Maher, Lisa; Kerr, Thomas

2014-03-01

Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators' responses to the committee's concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork, and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. Copyright © 2013 Elsevier Ltd. All rights reserved.

Localized mold heating with the aid of selective induction for injection molding of high aspect ratio micro-features

NASA Astrophysics Data System (ADS)

Park, Keun; Lee, Sang-Ik

2010-03-01

High-frequency induction is an efficient, non-contact means of heating the surface of an injection mold through electromagnetic induction. Because the procedure allows for the rapid heating and cooling of mold surfaces, it has been recently applied to the injection molding of thin-walled parts or micro/nano-structures. The present study proposes a localized heating method involving the selective use of mold materials to enhance the heating efficiency of high-frequency induction heating. For localized induction heating, a composite injection mold of ferromagnetic material and paramagnetic material is used. The feasibility of the proposed heating method is investigated through numerical analyses in terms of its heating efficiency for localized mold surfaces and in terms of the structural safety of the composite mold. The moldability of high aspect ratio micro-features is then experimentally compared under a variety of induction heating conditions.

In vitro fertilization/intracytoplasmic sperm injection for male infertility

PubMed Central

Merchant, Rubina; Gandhi, Goral; Allahbadia, Gautam N.

2011-01-01

Progress in the field of assisted reproduction, and particularly micromanipulation, now heralds a new era in the management of severe male factor infertility, not amenable to medical or surgical correction. By overcoming natural barriers to conception, in vitro fertilization and embryo transfer (IVF-ET), subzonal sperm insemination, partial zona dissection, and intracytoplasmatic injection of sperm (ICSI) now offer couples considered irreversibly infertile, the option of parenting a genetically related child. However, unlike IVF, which necessitates an optimal sperm number and function to successfully complete the sequence of events leading to fertilization, micromanipulation techniques, such as ICSI, involving the direct injection of a spermatozoon into the oocyte, obviate all these requirements and may be used to alleviate severe male factor infertility due to the lack of sperm in the ejaculate due to severely impaired spermatogenesis (non-obstructive azoospermia) or non-reconstructable reproductive tract obstruction (obstructive azoospermia). ICSI may be performed with fresh or cryopreserved ejaculate sperm where available, microsurgically extracted epididymal or testicular sperm with satisfactory fertilization, clinical pregnancy, and ongoing pregnancy rates. However, despite a lack of consensus regarding the genetic implications of ICSI or the application and efficacy of preimplantation genetic diagnosis prior to assisted reproductive technology (ART), the widespread use of ICSI, increasing evidence of the involvement of genetic factors in male infertility and the potential risk of transmission of genetic disorders to the offspring, generate major concerns with regard to the safety of the technique, necessitating a thorough genetic evaluation of the couple, classification of infertility and adequate counseling of the implications and associated risks prior to embarking on the procedure. The objective of this review is to highlight the indications, advantages

New Reconstruction Technologies Of Safety Pillar In Mines / Nowoczesne Technologie Odbudowy Filara Bezpieczeństwa w Kopalniach

NASA Astrophysics Data System (ADS)

Gonet, Andrzej; Stryczek, Stanisław; Brudnik, Krzysztof

2012-11-01

Safety pillars are made around mines as a protection measure. This is especially important in salt mines where the surrounding waters are most hazardous. Without maintaining safe conditions the mine may be water-flooded as it was the case in one of the Polish mine "Wapno". An original technology linking pipeline injection and hole injection methods has been used for the reconstruction of a safety pillar in the Salt Mine "Wieliczka". This solution turned out to be successful when on 13 April 1992 the mine was saved from flooding after a disastrous water flux to the transverse working Mina. The presented technology can be efficiently used in various mines at the stage of designing, though their exploitation to the closing stage.

Generally Recognized as Safe: Uncertainty Surrounding E-Cigarette Flavoring Safety.

PubMed

Sears, Clara G; Hart, Joy L; Walker, Kandi L; Robertson, Rose Marie

2017-10-23

Despite scientific uncertainty regarding the relative safety of inhaling e-cigarette aerosol and flavorings, some consumers regard the U.S. Food and Drug Administration's "generally recognized as safe" (GRAS) designation as evidence of flavoring safety. In this study, we assessed how college students' perceptions of e-cigarette flavoring safety are related to understanding of the GRAS designation. During spring 2017, an online questionnaire was administered to college students. Chi-square p -values and multivariable logistic regression were employed to compare perceptions among participants considering e-cigarette flavorings as safe and those considering e-cigarette flavorings to be unsafe. The total sample size was 567 participants. Only 22% knew that GRAS designation meant that a product is safe to ingest, not inhale, inject, or use topically. Of participants who considered flavorings to be GRAS, the majority recognized that the designation meant a product is safe to ingest but also considered it safe to inhale. Although scientific uncertainty on the overall safety of flavorings in e-cigarettes remains, health messaging can educate the public about the GRAS designation and its irrelevance to e-cigarette safety.

A prospective randomized trial of 1 versus 2 injections during EUS-guided celiac plexus block for chronic pancreatitis pain.

PubMed

LeBlanc, Julia K; DeWitt, Jon; Johnson, Cynthia; Okumu, Wycliffe; McGreevy, Kathleen; Symms, Michelle; McHenry, Lee; Sherman, Stuart; Imperiale, Thomas

2009-04-01

The efficacy of 1-injection versus a 2-injections method of EUS-guided celiac plexus block (EUS-CPB) in patients with chronic pancreatitis is not known. To compare the clinical effectiveness and safety of EUS-CPB by using 1 versus 2 injections in patients with chronic pancreatitis and pain. The secondary aim is to identify factors that predict responsiveness. A prospective randomized study. EUS-CPB was performed by using bupivacaine and triamcinolone injected into 1 or 2 sites at the level of the celiac trunk during a single EUS-CPB procedure. Duration of pain relief, onset of pain relief, and complications. Fifty [corrected] subjects were enrolled (23 received 1 injection, 27 [corrected] received 2 injections). The median duration of pain relief in the 31 responders was 28 days (range 1-673 days). [corrected] Fifteen [corrected] of 23 (65%) [corrected] subjects who received 1 injection [corrected] had relief from pain compared with 16 of 27 (59%) [corrected] subjects who received 2 injections [corrected] (P = .67). [corrected] The median times to onset in the 1-injection and 2-injections groups were 21 and 14 days, respectively (P = .99). No correlation existed between duration of pain relief and time to onset of pain relief or onset within 24 hours. Age, sex, race, prior EUS-CPB, and smoking or alcohol history did not predict duration of pain relief. Telephone interviewers were not blinded. There was no difference in duration of pain relief or onset of pain relief in subjects with chronic pancreatitis and pain when the same total amount of medication was delivered in 1 or 2 injections during a single EUS-CPB procedure. Both methods were safe.

Changes in Retinal Nerve Fiber Layer Thickness after Multiple Injections of Novel VEGF Decoy Receptor Conbercept for Various Retinal Diseases.

PubMed

Zhang, Zhihua; Yang, Xiaolu; Jin, Huiyi; Qu, Yuan; Zhang, Yuan; Liu, Kun; Xu, Xun

2016-12-06

Conbercept is a recombinant fusion protein with high affinity for all vascular endothelial growth factor isoforms and placental growth factor. The repeated intravitreal injection of conbercept may cause intraocular pressure (IOP) fluctuations and long-term suppression of neurotrophic cytokines, which could lead to retinal nerve fiber layer (RNFL) damage. This retrospective fellow-eye controlled study included 98 eyes of 49 patients. The changes in IOP and RNFL thickness as well as the correlation between RNFL changes and associated factors were evaluated. The IOP value between the baseline and the last follow-up visit in the injection group and the IOP value of the last follow-up visit between the injection and non-injection groups were not significantly different (p = 0.452 and 0.476, respectively). The global average thickness of the RNFL (μm) in the injection group decreased from 108.9 to 106.1; however, the change was not statistically significant (p = 0.118). No significant difference in the average RNFL thickness was observed at the last follow-up visit between the injection and non-injection groups (p = 0.821). The type of disease was the only factor associated with RNFL thickness changes. In conclusion, repeated intravitreal injections with 0.05 mL conbercept revealed an excellent safety profile for RNFL thickness, although short-term IOP changes were observed.

PSR Injection Line Upgrade

NASA Astrophysics Data System (ADS)

Blind, Barbara; Jason, Andrew J.

1997-05-01

We describe the new injection line to be implemented for the Los Alamos Proton Storage Ring in the change from a two-step process to direct H- injection. While obeying all geometrical constraints imposed by the existing structures, the new line has properties not found in the present injection line. In particular, it features decoupled transverse phase spaces downstream of the skew bend and a high degree of tunability of the beam at the injection foil. A comprehensive set of error studies has dictated the component tolerances imposed and has indicated the expected performance of the system.

Parents' adherence to pediatric health and safety guidelines: Importance of patient-provider relationships.

PubMed

Fuzzell, Lindsay N; LaJoie, A Scott; Smith, Kyle T; Philpott, Sydney E; Jones, Katherine M; Politi, Mary C

2018-05-01

To examine 1) parent-provider communication about pediatric health/safety guidelines, 2) trust in child's provider, 3) comfort discussing guidelines, 4) agreement with guideline advice, 5) self-efficacy following guidelines, and their impact on guideline adherence. 256 parents of children ages 0-6 completed an online survey about sunscreen use, newborn Vitamin K injections, influenza vaccination, routine vaccination, car seats, infant safe sleep, furniture anchoring, large trampoline use, and firearm safety. Multivariable models regressed: 1) communication about each guideline on parents' corresponding guideline adherence; 2) trust, comfort discussing guidelines, agreement with guideline advice, self-efficacy, on parents' total guideline adherence. Communication about furniture anchoring (OR = 2.26), sunscreen (OR = 5.28), Vitamin K injections (OR = 3.20), influenza vaccination (OR = 13.71), routine vaccination (OR = 6.43), car seats (OR = 6.15), and infant safe sleep (OR = 3.40) related to corresponding guideline adherence (ps < 0.05). Firearm safety communication was not related to adherence (OR = 1.11, n.s.). Trampoline communication related to lower likelihood of trampoline guideline adherence (OR = 0.24, p = 0.001). Agreement with guideline advice (β = 0.35), trust (β = 0.34), self-efficacy (β = 0.45), comfort discussing guidelines (β = 0.35) positively related to total guideline adherence (ps < 0.001). Findings underscore the importance of provider communication about health/safety guidelines. Providers should respectfully engage and build relationships with parents to support health/safety guideline adherence. Copyright © 2018. Published by Elsevier B.V.

Ducted fuel injection: A new approach for lowering soot emissions from direct-injection engines

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

Mueller, Charles J.; Nilsen, Christopher W.; Ruth, Daniel J.

Designers of direct-injection compression-ignition engines use a variety of strategies to improve the fuel/charge-gas mixture within the combustion chamber for increased efficiency and reduced pollutant emissions. Strategies include the use of high fuel-injection pressures, multiple injections, small injector orifices, flow swirl, long-ignition-delay conditions, and oxygenated fuels. This is the first journal publication paper on a new mixing-enhancement strategy for emissions reduction: ducted fuel injection. The concept involves injecting fuel along the axis of a small cylindrical duct within the combustion chamber, to enhance the mixture in the autoignition zone relative to a conventional free-spray configuration (i.e., a fuel spray thatmore » is not surrounded by a duct). Finally, the results described herein, from initial proof-of-concept experiments conducted in a constant-volume combustion vessel, show dramatically lower soot incandescence from ducted fuel injection than from free sprays over a range of charge-gas conditions that are representative of those in modern direct-injection compression-ignition engines.« less

Ducted fuel injection: A new approach for lowering soot emissions from direct-injection engines

DOE PAGES

Mueller, Charles J.; Nilsen, Christopher W.; Ruth, Daniel J.; ...

2017-07-18

Designers of direct-injection compression-ignition engines use a variety of strategies to improve the fuel/charge-gas mixture within the combustion chamber for increased efficiency and reduced pollutant emissions. Strategies include the use of high fuel-injection pressures, multiple injections, small injector orifices, flow swirl, long-ignition-delay conditions, and oxygenated fuels. This is the first journal publication paper on a new mixing-enhancement strategy for emissions reduction: ducted fuel injection. The concept involves injecting fuel along the axis of a small cylindrical duct within the combustion chamber, to enhance the mixture in the autoignition zone relative to a conventional free-spray configuration (i.e., a fuel spray thatmore » is not surrounded by a duct). Finally, the results described herein, from initial proof-of-concept experiments conducted in a constant-volume combustion vessel, show dramatically lower soot incandescence from ducted fuel injection than from free sprays over a range of charge-gas conditions that are representative of those in modern direct-injection compression-ignition engines.« less

Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis.

PubMed

Davis, Tim; Loudermilk, Eric; DePalma, Michael; Hunter, Corey; Lindley, David; Patel, Nilesh; Choi, Daniel; Soloman, Marc; Gupta, Anita; Desai, Mehul; Buvanendran, Asokumar; Kapural, Leonardo

2018-01-01

Osteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain. This is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention. There were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events. This study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection. ClinicalTrials.gov (NCT02343003).

Sensor for Injection Rate Measurements

PubMed Central

Marcic, Milan

2006-01-01

A vast majority of the medium and high speed Diesel engines are equipped with multi-hole injection nozzles nowadays. Inaccuracies in workmanship and changing hydraulic conditions in the nozzles result in differences in injection rates between individual injection nozzle holes. The new deformational measuring method described in the paper allows injection rate measurement in each injection nozzle hole. The differences in injection rates lead to uneven thermal loads of Diesel engine combustion chambers. All today known measuring method, such as Bosch and Zeuch give accurate results of the injection rate in diesel single-hole nozzles. With multihole nozzles they tell us nothing about possible differences in injection rates between individual holes of the nozzle. At deformational measuring method, the criterion of the injected fuel is expressed by the deformation of membrane occurring due to the collision of the pressure wave against the membrane. The pressure wave is generated by the injection of the fuel into the measuring space. For each hole of the nozzle the measuring device must have a measuring space of its own into which fuel is injected as well as its measuring membrane and its own fuel outlet. During measurements procedure the measuring space must be filled with fuel to maintain an overpressure of 5 kPa. Fuel escaping from the measuring device is conducted into the graduated cylinders for measuring the volumetric flow through each hole of the nozzle.The membrane deformation is assessed by strain gauges. They are glued to the membrane and forming the full Wheatstone's bridge. We devoted special attention to the membrane shape and temperature compensation of the strain gauges.

Influence of design parameters in Water-Alternating-Gas Injection on enhancement of CO2 trapping in heterogeneous formations: A numerical study

NASA Astrophysics Data System (ADS)

Joodaki, S.; Yang, Z.; Niemi, A. P.

2016-12-01

CO2 trapping in saline aquifers can be enhanced by applying specific injection strategies. Water-alternating-gas (WAG) injection, in which intermittent slugs of CO2 and water are injected, is one of the suggested methods to increase the trapping of CO2 as a result of both capillary forces (residual trapping) and dissolution into the ambient water (dissolution trapping). In this study, 3D numerical modeling was used to investigate the importance of parameters needed to design an effective WAG injection sequence including (i) CO2 and water injection rates, (ii) WAG ratio, (iii) number of cycles and their duration. We employ iTOUGH2-EOS17 model to simulate the CO2 injection and subsequent trapping in heterogeneous formations. Spatially correlated random permeability fields are generated using GSLIB based on available data at the Heletz, a pilot injection site in Israel, aimed for scientifically motivated CO2 injection experiments. Hysteresis effects on relative permeability and capillary pressure function are taken into account based on the Land model (1968). The results showed that both residual and dissolution trapping can be enhanced by increasing in CO2 injection rate due to the fact that higher CO2 injection rate reduces the gravity segregation and increases the reservoir volume swept by CO2. Faster water injection will favor the residual and dissolution trapping due to improved mixing. Increasing total amount of water injection will increase the dissolution trapping but also the cost of the injection. It causes higher pressure increases as well. Using numerical modeling, it is possible to predict the best parameter combination to optimize the trapping and find the balance between safety and cost of the injection process.

2.4-3.2 GHz robust self-injecting injection-locked phase-locked loop

NASA Astrophysics Data System (ADS)

Yang, Jincheng; Zhang, Zhao; Qi, Nan; Liu, Liyuan; Liu, Jian; Wu, Nanjian

2018-04-01

In this paper, we propose a robust self-injecting injection-locked phase-locked loop (SI-ILPLL). It adopts a phase alignment loop (PAL) based on a subsampling phase frequency detector to align the phase between the injected pulse and the voltage-controlled oscillator (VCO) output. With the proposed phase frequency detector, the PAL performs phase alignment and the pulse generator can self-inject pulses into the VCO for injection locking. The subsampling phase detection and self-injection locking techniques can suppress the phase noise of the SI-ILPLL. The SI-ILPLL shows excellent robustness to environmental interference. The SI-ILPLL is implemented in 65 nm CMOS technology. It occupies an active area of 0.7 mm2. The measured root-mean-square (RMS) jitters at 3.2 GHz output without and with injection locking are 216 and 131 fs, respectively. When the supply voltage varies from 1.17 to 1.23 V and the temperature varies from 0 to 80 °C, the maximum jitter variation of all the output frequencies is less than 50 fs. The measured results demonstrate that even when a large interference appears at the supply voltage and unlocks the SI-ILPLL, the SI-ILPLL can self-recover its injection-locked state rapidly after the disturbance disappears, whereas the conventional ILPLL cannot self-recover its locked state after losing it. The power consumption of the SI-ILPLL is 7.4 mW under a 1.2 V supply voltage. The SI-ILPLL achieves a figure of merit (FOM) of -249 dB.

Syringe-injectable electronics.

PubMed

Liu, Jia; Fu, Tian-Ming; Cheng, Zengguang; Hong, Guosong; Zhou, Tao; Jin, Lihua; Duvvuri, Madhavi; Jiang, Zhe; Kruskal, Peter; Xie, Chong; Suo, Zhigang; Fang, Ying; Lieber, Charles M

2015-07-01

Seamless and minimally invasive three-dimensional interpenetration of electronics within artificial or natural structures could allow for continuous monitoring and manipulation of their properties. Flexible electronics provide a means for conforming electronics to non-planar surfaces, yet targeted delivery of flexible electronics to internal regions remains difficult. Here, we overcome this challenge by demonstrating the syringe injection (and subsequent unfolding) of sub-micrometre-thick, centimetre-scale macroporous mesh electronics through needles with a diameter as small as 100 μm. Our results show that electronic components can be injected into man-made and biological cavities, as well as dense gels and tissue, with >90% device yield. We demonstrate several applications of syringe-injectable electronics as a general approach for interpenetrating flexible electronics with three-dimensional structures, including (1) monitoring internal mechanical strains in polymer cavities, (2) tight integration and low chronic immunoreactivity with several distinct regions of the brain, and (3) in vivo multiplexed neural recording. Moreover, syringe injection enables the delivery of flexible electronics through a rigid shell, the delivery of large-volume flexible electronics that can fill internal cavities, and co-injection of electronics with other materials into host structures, opening up unique applications for flexible electronics.

Syringe-injectable electronics

NASA Astrophysics Data System (ADS)

Liu, Jia; Fu, Tian-Ming; Cheng, Zengguang; Hong, Guosong; Zhou, Tao; Jin, Lihua; Duvvuri, Madhavi; Jiang, Zhe; Kruskal, Peter; Xie, Chong; Suo, Zhigang; Fang, Ying; Lieber, Charles M.

2015-07-01

Seamless and minimally invasive three-dimensional interpenetration of electronics within artificial or natural structures could allow for continuous monitoring and manipulation of their properties. Flexible electronics provide a means for conforming electronics to non-planar surfaces, yet targeted delivery of flexible electronics to internal regions remains difficult. Here, we overcome this challenge by demonstrating the syringe injection (and subsequent unfolding) of sub-micrometre-thick, centimetre-scale macroporous mesh electronics through needles with a diameter as small as 100 μm. Our results show that electronic components can be injected into man-made and biological cavities, as well as dense gels and tissue, with >90% device yield. We demonstrate several applications of syringe-injectable electronics as a general approach for interpenetrating flexible electronics with three-dimensional structures, including (1) monitoring internal mechanical strains in polymer cavities, (2) tight integration and low chronic immunoreactivity with several distinct regions of the brain, and (3) in vivo multiplexed neural recording. Moreover, syringe injection enables the delivery of flexible electronics through a rigid shell, the delivery of large-volume flexible electronics that can fill internal cavities, and co-injection of electronics with other materials into host structures, opening up unique applications for flexible electronics.

Comparison of incidence of intravascular injections during transforaminal epidural steroid injection using different needle types

PubMed Central

Lee, Yong Ho

2014-01-01

Background Infrequent but serious complications of transforaminal epidural steroid injection (TFESI) occur due to inadvertent intravascular injections. A few studies reported that the different needle types can influence on the occurrences of intravascular incidence in TFESI. This study prospectively evaluated whether short-bevel needle can reduce the incidences of intravascular injection of TFESI compared to long-bevel needles. Methods From March 2013 to December 2013, 239 consecutive patients were enrolled and received 249 fluoroscopically guided TFESI using the classic technique. Confirmation of intravascular spread was done initially with real time fluoroscopy and then with digital subtraction angiography method in a same patient. Injection technique for TFESI was the same for both short-bevel and long-bevel needle types. Results The incidences of intravascular injections with the long-bevel and short-bevel needles were 15.0% (21/140) and 9.2% (4/140), respectively. More than half of intravascular injections occurred simultaneously with epidural injections (8.0%, 20/249). There were no statistically significant differences between the long-bevel and the short-bevel needles in the rates of intravascular injections (P = 0.17). Conclusions Short-bevel needles did not demonstrate any benefits in reducing the incidence of intravascular injection. PMID:25302096

Hydrogeology and results of injection tests at waste-injection test sites in Pinellas County, Florida

USGS Publications Warehouse