Meta-analysis of immunogenicity and safety of human rabies vaccination under Zagreb and Essen regimens

2020 ◽  
Author(s):  
Ting Li ◽  
Xin Wang ◽  
Hongbin Cheng
Keyword(s):  
Adverse Events ◽  
Safety Profile ◽  
Meta Analysis ◽  
Neutralizing Antibody ◽  
Human Rabies ◽  
Antibody Concentration ◽  
Weighted Mean ◽  
Mean Differences ◽  
Risk Ratios ◽  
Rabies Vaccination

Aim: To assess the immunogenicity and safety of rabies vaccination under the Zagreb and Essen regimens by performing a meta-analysis. Methods: Electronic databases were searched for eligible studies. Risk ratios and weighted mean differences with 95% CIs were used to calculate estimates. Results: A total of 18 studies were included. Rabies virus neutralizing antibody concentration was comparable between the two regimens at D7 and 14. No significant differences were observed in seroconversion rates from D14 and 42. Incidence of fever was higher in Zagreb group (risk ratio: 1.55 [1.37–1.76]); but no significant differences were present for other common adverse events. Conclusion: Rabies vaccination under the Zagreb regimen was noninferior to the Essen regimen in immunogenicity and had an acceptable safety profile.

scholarly journals Efficacy and safety of sprifermin injection for knee osteoarthritis treatment: a meta-analysis

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Ni Zeng ◽  
Xin-Yuan Chen ◽  
Zhi-Peng Yan ◽  
Jie-Ting Li ◽  
Tao Liao ◽  
...  
Keyword(s):  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Meta Analysis ◽  
Placebo Treatment ◽  
Cartilage Volume ◽  
Cartilage Thickness ◽  
Random Effects Models ◽  
Structural Progression ◽  
Significant Difference ◽  
Mean Differences

Abstract Objective To perform a meta-analysis comparing the structural progression and clinical symptom outcomes as well as adverse events experienced from intra-articular injections of sprifermin compared to a placebo treatment for patients with knee osteoarthritis (KOA). Method We systematically searched the literature for studies that compared long-term outcomes between sprifermin and placebo injections for KOA treatment. Meta-analysis was performed with RevMan5.3 using an inverse variance approach with fixed or random effects models. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. Results Eight studies were included. Overall, there was significantly less improvement of WOMAC total scores in patients receiving sprifermin, compared with the placebo (mean difference (MD) = 3.23, 95% CI 0.76–5.69; I2 = 0%; P = 0.01). Further, sprifermin injection patients gained more, and lost less, cartilage thickness and volume in total femorotibial joint (cartilage thickness: standardized mean differences (SMD) = 0.55, 95% CI 0.26–0.84; I2 = 78%; P = 0.0002; cartilage volume: SMD = 0.39, 95% CI 0.20–0.58; I2 = 49%; P < 0.0001). Changes in the cartilage surface morphology of the medial tibio-femoral joint (MD = −0.30, 95% CI −0.44 to −0.16; I2 = 0%; P < 0.0001) and patello-femoral joint (MD = −0.22; 95% CI −0.37 to −0.07; I2 = 0%; P = 0.004) showed a significant difference between the sprifermin and placebo injections. Moreover, there were no significant differences between sprifermin and the placebo in the risk of treatment-emergent adverse events (OR = 1.05; 95% CI 0.52–2.14; I2 = 48%; P = 0.89). Conclusion The data from the included studies provide strong evidence to determine the effect of intra-articular sprifermin on joint structure in individuals with KOA and show no specific adverse effects. Nevertheless, intra-articular sprifermin did not likely have any positive effect on symptom alleviation.

scholarly journals Melatonin and Cardioprotection in Humans: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 8 ◽  
Author(s):  
Alberto Domínguez-Rodríguez ◽  
Pedro Abreu-González ◽  
Néstor Báez-Ferrer ◽  
Russel J. Reiter ◽  
Pablo Avanzas ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Mean Difference ◽  
Left Ventricular Ejection ◽  
Favorable Effect ◽  
Controlled Trials ◽  
Weighted Mean ◽  
Randomized Controlled ◽  
Mean Differences

Myocardial ischemia/reperfusion (IR) injury represents a critical problem associated with interventional approaches for coronary reperfusion. Pharmacological cardioprotective interventions are advocated to ameliorate IR injury. Melatonin is an anti-inflammatory and antioxidant agent with a wide range of therapeutic properties that may contribute to its cardioprotective effects. No systematic review or meta-analysis has compared melatonin vs. placebo as a cardioprotective agent in humans. The present study, based on a systematic review and meta-analysis, was carried out to assess melatonin's efficacy as a cardioprotective treatment. We performed a systematic review of the available literature. Randomized controlled trials (RCTs) were identified and information was extracted using predefined data extraction forms. The primary outcomes were (a) left ventricular ejection fraction (LVEF) and (b) blood troponin levels in patients who underwent myocardial revascularization and were randomized to melatonin or placebo. The inverse-variance random-effects method was used to pool the estimates. Heterogeneity and publication bias were assessed. Weighted mean differences or standardized mean differences were calculated. A total of 283 records were screened and seven RCTs met all the inclusion criteria. After the pooled analysis, the results on LVEF were consistent across all studies, and a significant heterogeneity was found in the results on troponin levels. The melatonin-treated patients had on average higher LVEF than the placebo-treated individuals with a weighted mean difference = 3.1% (95% CI 0.6–5.5, p = 0.01). Five works compared the levels of troponin after melatonin or placebo treatment. The melatonin-treated patients had lower levels of troponin with a standardized mean difference = −1.76 (95% CI −2.85 to −0.67, p = 0.002). The findings of this meta-analysis revealed that melatonin administration in humans as a cardioprotective agent attenuated heart dysfunction with a favorable effect on the LVEF.

scholarly journals Survey of fox trappers in northern Alaska for rabies antibody

1994 ◽  
Vol 113 (1) ◽  
pp. 137-141 ◽  
Author(s):  
E. H. Follmann ◽  
D. G. Ritter ◽  
M. Beller
Keyword(s):  
Rabies Virus ◽  
Neutralizing Antibody ◽  
World Health ◽  
Antibody Concentration ◽  
Alopex Lagopus ◽  
Arctic Foxes ◽  
Health Organization ◽  
Antibody Levels ◽  
Northern Alaska ◽  
Rabies Vaccination

SUMMARYThe purpose of this research was to determine whether trappers in northern Alaska acquired immunity to rabies virus from non-bite exposures while trapping and skinning arctic foxes (Alopex lagopus). In coastal Alaska recurring epizootics presumably provide trappers ample opportunity for contact with rabid animals. Serum neutralization analyses of blood samples collected from 26 individuals were conducted. All but three had negative rabies neutralizing antibody levels (< 0·05 I.U./ml). Two of these had previously received rabies vaccine but one individual who had trapped for about 47 years with an estimated harvest of over 3000 foxes and who had never received pre- or post-exposure rabies vaccination had a rabies serum neutralizing antibody concentration of 2·30 I.U./ml. This represents the first report of an unvaccinated person acquiring rabies virus antibody with a titre above the 0·5 I.U./ml level considered acceptable by the World Health Organization.

Comparison between Ologen implant and Mitomycin C in trabeculectomy: A Systematic Review and Meta-Analysis

2019 ◽  
Author(s):  
Xiaoyan Liu ◽  
Yali Du ◽  
Min Lei ◽  
Leyi Zhuang ◽  
Peng Lv
Keyword(s):  
Adverse Events ◽  
Success Rate ◽  
Data Extraction ◽  
Meta Analysis ◽  
Collagen Matrix ◽  
Current Evidence ◽  
Cochrane Library ◽  
Significant Difference ◽  
Mean Differences ◽  
Alternative Choice

Abstract Objective To evaluate the effectiveness and safety of the biodegradable collagen matrix (Ologen) implant in trabeculectomy. Research design and methods We searched Pubmed, Cochrane library, Embase and Web of Science databases to find studies that met our pre-stated inclusion criteria. Reference lists of retrieved articles were also reviewed. The search was finished by February 2019. Study selection, data extraction, quality assessment, and data analyses were performed according to the Cochrane standards. Either a fixed or a random-effects model was used to calculate the overall combined risk estimates. The efficacy measures were the weighted mean differences (WMDs) for the intraocular pressure reduction (IOPR) and the glaucoma medications reduction, the odds ratio (OR) for the success rate and adverse events. Results Fifteen randomized controlled trials involved 682 eyes were included in the meta-analysis. There were no statistically differences between two groups in the IOPR at any time postoperatively. The MD of the IOPR was [MD= -0.45,95% Confidence Interval (CI), (-2.36,1.46), P=0.65] at one day, [MD= -0.82,95% CI, (-1.97, 0.33), P=0.16] at one week, [MD= -1.33, 95% CI,(-3.12, 0.47), P=0.15] at one month, [MD= 0.11,95% CI, (-1.87, 2.08), P=0.92] at three months, [MD= -0.60,95% CI, (-2.27, 1.06), P=0.48] at six months, [MD= -0.33,95% CI, (-1.99, 1.32), P=0.69] at one year, [MD= -0.13,95% CI, (-1.90, 1.65), P=0.89] at two years, [MD= 2.54,95% CI, (-2.83, 7.90), P=0.35] at three years, [MD= 3.04,95% CI, (-3.95, 10.03), P=0.39] at five years. There was no statistically significant difference between the Ologen groups and MMC groups concerned the complete success rate [OR=1.19, 95%CI, (0.83, 1.71), P=0.35]. With regard to the adverse events, no obvirously significance was observed. Seven studies reported the change of antiglaucoma medications. We found that the change of antiglaucoma medications is higher in MMC groups than that in Ologen groups [MD=-0.18, 95%CI, (-0.33, -0.03), P=0.02]. There is no significant difference in complications between the two groups. Conclusions From the current evidence, Ologen may be an alternative choice for trabeculectomy when considering the efficacy and safety. However, MMC might be the preferred choice concerned cost-effectiveness.

scholarly journals Assessment of the Clinical Trials Safety Profile of PD-1/PD-L1 Inhibitors Among Patients With Cancer: An Updated Systematic Review and Meta-Analysis

2021 ◽  
Vol 11 ◽  
Author(s):  
Yuan Tian ◽  
Alan Huang ◽  
Yue Yang ◽  
Qi Dang ◽  
Qing Wen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Safety Profile ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Control Group ◽  
Risk Of Death ◽  
Effect Model ◽  
Newcastle Ottawa Scale

BackgroundUnderstanding the safety and adverse event profiles of PD-1/PD-L1 inhibitors is important in guiding cancer immunotherapy. Consequently, we designed this meta-analysis to evaluate the safety of PD-1/PD-L1 inhibitors in clinical trials involving cancer patients.MethodsFour safety indicators comprising treatment-related adverse events, death, discontinuation of therapy and grades 3–5 adverse events were evaluated using the random effect model. The quality of enrolled trials was assessed using the Newcastle Ottawa Scale (NOS).ResultsForty-four clinical trials were included in the final meta-analysis. Compared with chemotherapy, the risk of death due to the use of PD-1/PD-L1 inhibitors was much lower than that experienced in the control group (OR = 0.65, 95%CI: [0.47, 0.91], I2 = 0%, Z = 2.52 (P = 0.01)). Similar observations were apparent regarding the other three indicators of safety and also when the use of PD-1/PD-L1 inhibitors alone is compared with the combined use of PD-1/PD-L1 and CTLA-4. When used together with chemotherapy, PD-1/PD-L1 inhibitors increased the incidence of the adverse events as compared to the use of chemotherapy alone. Increased risks for adverse events were also noticed with the use of PD-1/PD-L1 inhibitors over the use of a placebo.ConclusionThe use of PD-1/PD-L1 inhibitors alone is associated with a better safety profile compared to either the use of chemotherapy or the use of PD-1/PD-L1 inhibitors with other anticancer regimens.

scholarly journals Efficacy and safety profile of xanthines in COPD: a network meta-analysis

2018 ◽  
Vol 27 (148) ◽  
pp. 180010 ◽  
Author(s):  
Mario Cazzola ◽  
Luigino Calzetta ◽  
Peter J. Barnes ◽  
Gerard J. Criner ◽  
Fernando J. Martinez ◽  
...  
Keyword(s):  
Adverse Events ◽  
Safety Profile ◽  
Meta Analysis ◽  
Forced Expiratory Volume ◽  
Therapeutic Window ◽  
Comparable Efficacy ◽  
Chronic Obstructive ◽  
Efficacy And Safety ◽  
Quantitative Synthesis ◽  
The Impact

Theophylline can still have a role in the management of stable chronic obstructive pulmonary disease (COPD), but its use remains controversial, mainly due to its narrow therapeutic window. Doxofylline, another xanthine, is an effective bronchodilator and displays a better safety profile than theophylline. Therefore, we performed a quantitative synthesis to compare the efficacy and safety profile of different xanthines in COPD.The primary end-point of this meta-analysis was the impact of xanthines on lung function. In addition, we assessed the risk of adverse events by normalising data on safety as a function of person-weeks. Data obtained from 998 COPD patients were selected from 14 studies and meta-analysed using a network approach.The combined surface under the cumulative ranking curve (SUCRA) analysis of efficacy (change from baseline in forced expiratory volume in 1 s) and safety (risk of adverse events) showed that doxofylline was superior to aminophylline (comparable efficacy and significantly better safety), bamiphylline (significantly better efficacy and comparable safety), and theophylline (comparable efficacy and significantly better safety).Considering the overall efficacy/safety profile of the investigated agents, the results of this quantitative synthesis suggest that doxofylline seems to be the best xanthine for the treatment of COPD.

Efficacy of Conversion to Aflibercept for Diabetic Macular Edema Previously Refractory to Bevacizumab or Ranibizumab: A Meta-analysis of High-Quality Nonrandomized Studies

2020 ◽  
Vol 54 (8) ◽  
pp. 750-756
Author(s):  
Kang Xiao ◽  
Fu-Zhen Li ◽  
Shen-Zhi Liang ◽  
Jiong Wang ◽  
Cheng Qian ◽  
...  
Keyword(s):  
Adverse Events ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Meta Analysis ◽  
Sensitivity Analyses ◽  
Cochrane Library ◽  
Science Data ◽  
Study Heterogeneity ◽  
Mean Differences ◽  
The Cochrane Library

Background: Aflibercept has been widely used in treating diabetic macular edema (DME). However, the effect of aflibercept in treating DME refractory to bevacizumab or ranibizumab has not been well established. Objective: To assess the therapeutic effect of switching from bevacizumab or ranibizumab to aflibercept in the treatment of refractory DME. Methods: Relevant studies were searched from 3 databases: the Cochrane Library, PubMed, and Web of Science. Data on changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and adverse events within the follow-up period were collected and pooled using weighted mean differences (WMDs) with corresponding 95% CIs in a random effects model. The between-study heterogeneity was tested using the χ2 test and the I2 statistic, and funnel plots were used to evaluate the publication bias. Results: A total of 11 nonrandomized trials met the inclusion criteria and were included in the meta-analysis. Our studies showed significant improvements in the BCVA (WMD = 100.55; 95% CI = 68.46 to 132.63; P < 0.01) and reduction in CMT (WMD = 0.09; 95% CI = 0.03 to 0.14; P < 0.01) after switching to aflibercept. Although a large amount of heterogeneity was detected in the CMT results among these studies, the sensitivity analyses showed the reliability and stability of our results. Conclusion and Relevance: There were significant improvements in both visual and anatomical outcomes after switching from bevacizumab or ranibizumab to aflibercept, without risk of adverse events. Thus, switching therapy may be a safe and effective treatment for patients with refractory DME.

scholarly journals Evaluation of the safety profile of COVID-19 vaccines: a rapid review

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Qianhui Wu ◽  
Matthew Z. Dudley ◽  
Xinghui Chen ◽  
Xufang Bai ◽  
Kaige Dong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Safety Profile ◽  
Meta Analysis ◽  
Safety Data ◽  
Rapid Review ◽  
Protein Subunit ◽  
Serious Adverse Events ◽  
Systemic Reactions ◽  
Reporting Rates

Abstract Background The rapid process of research and development and lack of follow-up time post-vaccination aroused great public concern about the safety profile of COVID-19 vaccine candidates. To provide comprehensive overview of the safety profile of COVID-19 vaccines by using meta-analysis technique. Methods English-language articles and results posted on PubMed, Embase, Web of Science, PMC, official regulatory websites, and post-authorization safety surveillance data were searched through June 12, 2021. Publications disclosing safety data of COVID-19 candidate vaccines in humans were included. A meta-analysis of proportions was performed to estimate the pooled incidence and the pooled rate ratio (RR) of safety outcomes of COVID-19 vaccines using different platforms. Results A total of 87 publications with safety data from clinical trials and post-authorization studies of 19 COVID-19 vaccines on 6 different platforms were included. The pooled rates of local and systemic reactions were significantly lower among inactivated vaccines (23.7%, 21.0%), protein subunit vaccines (33.0%, 22.3%), and DNA vaccines (39.5%, 29.3%), compared to RNA vaccines (89.4%, 83.3%), non-replicating vector vaccines (55.9%, 66.3%), and virus-like particle vaccines (100.0%, 78.9%). Solicited injection-site pain was the most common local reactions, and fatigue and headache were the most common systemic reactions. The frequency of vaccine-related serious adverse events was low (< 0.1%) and balanced between treatment groups. Vaccine platforms and age groups of vaccine recipients accounted for much of the heterogeneity in safety profiles between COVID-19 vaccines. Reporting rates of adverse events from post-authorization observational studies were similar to results from clinical trials. Crude reporting rates of adverse events from post-authorization safety monitoring (passive surveillance) were lower than in clinical trials and varied between countries. Conclusions Available evidence indicates that eligible COVID-19 vaccines have an acceptable short-term safety profile. Additional studies and long-term population-level surveillance are strongly encouraged to further define the safety profile of COVID-19 vaccines.

scholarly journals Immune Checkpoints Inhibitors and Chemotherapy as First-Line Treatment for Metastatic Urothelial Carcinoma: A Network Meta-Analysis of Randomized Phase III Clinical Trials

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1484
Author(s):  
Hsiao-Ling Chen ◽  
Vinson Wai-Shun Chan ◽  
Yu-Kang Tu ◽  
Erica On-Ting Chan ◽  
Hsiu-Mei Chang ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Adverse Events ◽  
Urothelial Carcinoma ◽  
Safety Profile ◽  
Survival Benefit ◽  
Meta Analysis ◽  
Phase Iii ◽  
Immune Checkpoints ◽  
Metastatic Urothelial Carcinoma ◽  
Grade 3

Immune checkpoints inhibitors (ICIs) were considered as second-line treatments in metastatic urothelial carcinoma (mUC) based on better survival benefit and safety profile than chemotherapy (CTX). We aimed to assess different ICIs regimens in the efficacy and safety for front-line treatments in mUC patients. A comprehensive literature search was performed and Phase II-III randomized controlled trials (RCTs) on ICIs for patients with mUC were included. The outcome was evaluated by overall survival (OS), progression of free survival (PFS), objective response rate (ORR), and grade 3–5 adverse events. Network meta-analysis was used to estimate the effect size. Surface under cumulative ranking curves (SUCRAs) were applied to rank the included treatments for each outcome. Results: The survival benefit of a single ICI was non-inferiority to chemotherapy (CTX). Although no superior effects were indicated, combination therapy (either ICIs plus CTX or ICIs plus ICIs) presented better OS compared with CTX alone. In terms of PFS, combination therapy produced a noticeable benefit over CTX. Regarding the SUCRA ranking, atezolizumab plus CTX was associated with the best ranking for OS and pembrolizumab plus CTX was the best in PFS. In terms of safety, a single ICI had better safety profile than CTX and combination therapy had a similar risk of grade 3–5 adverse events with CTX. Conclusions: Our NMA results revealed that combination therapy has better ranking compared with monotherapy in OS and acceptable AEs. ICIs alone present non-inferior OS but a lower incidence of AEs compared with CTX.

DERIVING TREATMENT RECOMMENDATIONS FROM EVIDENCE WITHIN RANDOMIZED TRIALS The Role and Limitation of Meta-Analysis

1999 ◽  
Vol 15 (2) ◽  
pp. 304-315 ◽  
Author(s):  
Nick Freemantle ◽  
James Mason ◽  
Martin Eccles
Keyword(s):  
Meta Analysis ◽  
Development Project ◽  
Weighted Mean ◽  
The North ◽  
Guidelines Development ◽  
Substantial Investment ◽  
Mean Differences ◽  
Meta Analyses ◽  
Robust Measures ◽  
Choice Of Therapy

Meta-analysis is commonly used in reviews of the effectiveness of medical technologies, but this approach has not been used in direct support of guidelines development groups. This paper describes the approach of the North of England Guidelines Development Project in describing the evidence using meta-analyses that were conducted explicitly to address questions on the choice of therapy raised by the guidelines development groups. Particular emphasis is placed on the context within which the contributing trials were conducted and the extent to which systematic differences between trials (heterogeneity) was observed, described, and explained. There is a trade-off between internal and external validity for different metrics when presenting the results of trials. More interpretable metrics, such as risk differences or weighted mean differences, are confounded by study design issues and strong assumptions. More robust measures such as odds ratios or standardized weighted mean differences are difficult to interpret physically. Individual patient data may prove particularly helpful in addressing pivotal questions on the magnitude of effects of interventions, though accessing and reanalyzing these data requires a substantial investment in time and other resources.

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