scholarly journals Efficacy and Safety of Sitafloxacin in the Treatment of Acute Bacterial Infection: A Meta-analysis of Randomized Controlled Trials

Antibiotics ◽  
2020 ◽  
Vol 9 (3) ◽  
pp. 106
Author(s):  
Chao-Kun Chen ◽  
I-Ling Cheng ◽  
Yu-Hung Chen ◽  
Chih-Cheng Lai
Keyword(s):  
Bacterial Infection ◽  
Clinical Response ◽  
Bacterial Infections ◽  
Response Rate ◽  
Meta Analysis ◽  
Clinical Response Rate ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Acute Bacterial Infections

This meta-analysis aimed to assess the efficacy and safety of sitafloxacin in treating acute bacterial infection. PubMed, Embase, and Cochrane databases were searched up to August 13, 2019. Only randomized controlled trials (RCTs) evaluating sitafloxacin and comparators in the treatment of acute bacterial infections were included. The outcomes were clinical and microbiological responses and the risk of adverse event (AE). Five RCTs were enrolled, including 375 and 381 patients who received sitafloxacin and the comparator, respectively. Overall, the clinical response rate of sitafloxacin in the treatment of acute bacterial infections was 94.6%, which was noninferior to that of the comparator (92.5%) (odds ratio (OR), 1.01; 95% CI, 0.24–4.32; I2 = 66%). For patients with complicated urinary tract infection (cUTI)/acute pyelonephritis (APN), the clinical response rate of sitafloxacin and the comparator was 96.9% and 91.3%, respectively (OR, 2.08; 95% CI, 0.35–12.44; I2 = 54%). For patients with pneumonia, the clinical response rate of sitafloxacin was 88.6%, which was comparable to that of the comparator (OR, 0.36; 95% CI, 0.11–1.21; I2 = 0%). The microbiological response of sitafloxacin was 82.0%, which was noninferior to that of the comparator (77.8%) (OR, 1.59; 95% CI, 0.77–3.28; I2 = 47%). The risk of treatment-emergent adverse event (TEAE), drug-related TEAE, and all-cause mortality were similar between sitafloxacin and the comparators (TEAE, OR, 1.14; 95% CI, 0.64–2.01, drug-related TEAE, OR, 1.14; 95% CI, 0.48–2.69, mortality, OR, 0.93; 95% CI, 0.09–9.44). In conclusion, sitafloxacin is noninferior to other commonly used antibiotics with respect to both clinical and microbiological response rates in patients with an acute bacterial infection, including cUTI/APN and pneumonia. In addition, sitafloxacin is also as safe as the comparators.

scholarly journals Anti-MRSA Cephalosporin versus Vancomycin-Based Treatment for Acute Bacterial Skin and Skin Structure Infection: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Antibiotics ◽  
2021 ◽  
Vol 10 (8) ◽  
pp. 1020
Author(s):  
Ching-Yi Chen ◽  
Wang-Chun Chen ◽  
Chih-Cheng Lai ◽  
Tzu-Ping Shih ◽  
Hung-Jen Tang
Keyword(s):  
Systematic Review ◽  
Clinical Response ◽  
Clinical Efficacy ◽  
Response Rate ◽  
Meta Analysis ◽  
Clinical Response Rate ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Skin Structure ◽  
Randomized Controlled

This systematic review and meta-analysis of randomized controlled trials (RCTs) compared the clinical efficacy and safety of anti-MRSA cephalosporin and vancomycin-based treatment in treating acute bacterial skin and skin structure infections (ABSSSIs). PubMed, Embase, Cochrane Central Register of Controlled Trials, Turning Research into Practice, and ClinicalTrials.gov databases were searched for relevant articles from inception to 15 June 2020. RCTs comparing the clinical efficacy and safety of anti-MRSA cephalosporin with those of vancomycin-based regimens in treating adult patients with ABSSSIs were included. The primary and secondary outcomes were clinical response at the test-of-cure assessments and risk of adverse events (AEs), respectively. Eight RCTs were enrolled. The clinical response rate was not significantly different between anti-MRSA cephalosporin and vancomycin-based treatments (odds ratio [OR], 1.05; 95% CI, 0.90–1.23; I2 = 0%). Except for major cutaneous abscesses in which anti-MRSA cephalosporin-based treatment was associated with a lower clinical response rate than vancomycin-based treatment (OR, 0.62; 95% CI, 0.40–0.97; I2 = 0%), other subgroup analyses according to the type of cephalosporin (ceftaroline or ceftobiprole), type of infection, and different pathogens did not show significant differences in clinical response. Anti-MRSA cephalosporin-based treatment was only associated with a higher risk of nausea than vancomycin-based treatment (OR, 1.41; 95% CI, 1.07–1.85; I2 = 0%). In treating ABSSSIs, the clinical efficacy of anti-MRSA cephalosporin is comparable to that of vancomycin-based treatment, except in major cutaneous abscesses. In addition to nausea, anti-MRSA cephalosporin was as tolerable as vancomycin-based treatment.

scholarly journals Novel Tetracyclines Versus Alternative Antibiotics for Treating Acute Bacterial Infection: A Meta-Analysis of Randomized Controlled Trials

Antibiotics ◽  
2019 ◽  
Vol 8 (4) ◽  
pp. 233 ◽  
Author(s):  
Shao-Huan Lan ◽  
Wei-Ting Lin ◽  
Shen-Peng Chang ◽  
Li-Chin Lu ◽  
Chih-Cheng Lai ◽  
...  
Keyword(s):  
Adverse Events ◽  
Bacterial Infections ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Control Groups ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Acute Bacterial Infections ◽  
And Control

This meta-analysis assessed the efficacy and safety of novel tetracyclines for treating acute bacterial infections. Data from PubMed, Web of Science, EBSCO, Cochrane databases, Ovid Medline, and Embase databases were accessed until 11 July 2019. Only randomized controlled trials (RCTs) comparing the efficacy of novel tetracyclines with that of other antibiotics for treating acute bacterial infections were included. Primary outcomes included the clinical response, microbiological response, and risk of adverse events (AEs). A total of eight RCTs were included, involving 2283 and 2197 patients who received novel tetracyclines and comparators, respectively. Overall, no significant difference was observed in the clinical response rate at test of cure between the experimental and control groups (for modified intent-to-treat [MITT] population, risk ratio [RR]: 1.02, 95% confidence interval [CI]: 0.99–1.05; for clinically evaluable [CE] population, RR: 1.02, 95% CI: 1.00–1.04; and for microbiological evaluable [ME] population, RR: 1.01, 95% CI: 0.99–1.04). No significant difference in the microbiological response at the end of treatment was observed between the experimental and control groups (for ME population, RR: 1.01, 95% CI: 0.99–1.03; for microbiological MITT population, RR: 1.01, 95% CI: 0.96–1.07). No difference was observed concerning the risk of treatment-emergent adverse events (TEAEs), serious adverse events, and discontinuation of treatment due to TEAEs and all-cause mortality between the two groups. In conclusion, clinical efficacy and safety profile for novel tetracyclines in the treatment of acute bacterial infections were found to be similar to those for other available antibiotics.

Comparative efficacy and safety of intravenous or subcutaneous belimumab in combination with standard therapy in patients with active systemic lupus erythematosus: a Bayesian network meta-analysis of randomized controlled trials

Lupus ◽  
2017 ◽  
Vol 27 (1) ◽  
pp. 112-119 ◽  
Author(s):  
Y H Lee ◽  
G G Song
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Placebo Group ◽  
Lupus Erythematosus ◽  
Standard Therapy ◽  
Response Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Systemic Lupus ◽  
Randomized Controlled

Objective In this study, we aimed to assess the relative efficacy and safety of intravenous (IV) or subcutaneous (SC) belimumab compared with those of placebo in patients with active systemic lupus erythematosus (SLE). Methods We performed a Bayesian network meta-analysis to combine the direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of belimumab 1 mg/kg and 10 mg/kg IV administration, and belimumab 200 mg SC injection, and placebo in patients with active SLE despite having received standard therapy. Results Five RCTs (3460 patients) met the inclusion criteria. The SLE Responder Index (SRI) response rate at week 52 was significantly higher in the belimumab 10 mg/kg group than in the placebo group (OR 2.63, 95% CrI 2.14–3.23). Similarly, the SRI response rates were significantly higher in the belimumab 1 mg/kg, and belimumab 200 mg SC groups than in the placebo group (OR 2.42, 95% CrI 1.90–3.09; OR 1.71, 95% CrI 1.27–2.29). Ranking probability based on surface under the cumulative ranking curve (SUCRA) indicated that belimumab 10 mg/kg had the highest probability of being the best treatment for achieving the SRI response (SUCRA = 0.9174), followed by belimumab 1 mg/kg (SUCRA = 0.7338), belimumab 200 mg SC (SUCRA = 0.3487), and placebo (SUCRA = 0.0000). However, a sensitivity test by omitting one outlier study showing low SRI response rate compared with the other three studies (11% vs. 33%, 40%, 48%) showed that belimumab 200 mg SC and belimumab 10 mg/kg had the highest probability of being the best treatment for achieving the SRI response (SUCRA = 0.7903, SUCRA = 0.7456), followed by belimumab 1 mg/kg, and placebo. The number of serious adverse events (SAEs) did not differ significantly among the four treatment options. Conclusions Belimumab at 1 and 10 mg/kg IV and belimumab 200 mg SC in combination with standard therapy was an efficacious intervention for active SLE, and was not associated with a significant risk of SAEs.

scholarly journals Efficacy and Safety of the Combination Treatment of Rituximab and Dexamethasone for Adults with Primary Immune Thrombocytopenia (ITP): A Meta-Analysis

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Jia Wang ◽  
Ya Li ◽  
Chong Wang ◽  
Yayue Zhang ◽  
Chong Gao ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Combination Treatment ◽  
Immune Thrombocytopenia ◽  
Response Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Primary Immune Thrombocytopenia

Objective.To conduct a meta-analysis, assessing the efficacy and safety of the combination treatment of dexamethasone and rituximab for adults with ITP (primary immune thrombocytopenia).Methods.Randomized controlled trials that compared rituximab and dexamethasone combination treatment to dexamethasone monotherapy in the treatment of adults with ITP were collected by searching Pubmed, Embase, Cochrane, China National Knowledge (CNKI), Wanfang database, and Sino Med. We conducted pooled analyses on OR (overall response) rate, CR (complete response) rate, PR (partial response) rate, SR (sustained response) rate, R (relapse) rate, change in Treg cell count (mean [SD]), and AE (adverse event). GRADE pro scale was used to assess the quality of the evidence. Publication bias was assessed with Egger’s test method.Results.A total of 11 randomized controlled trials were eligible for inclusion. The overall efficacy estimates favored combination arm in terms of OR rate at month 3, CR rate at week 4 and month 3, SR rate, and Treg cell count at week 2. Subgroup analysis showed that females obtained a higher OR rate than males did at week 4. No significant difference was found in pooled analysis of relapse rate between combination arm and monotherapy arm. The comparison of serious AE and other AEs showed no significant difference either. A total of 19 outcomes were assessed by GRADE pro software, of which 79% (15/19) was scaled as moderate-to-high level. Publication bias existed in studies on OR at week 4 (P=0.025), CR at week 4 (P=0.017), infection (P=0.006), and rash (P=0.028) of the AEs.Conclusion.Dexamethasone combined with rituximab can provide a better long-term response in the treatment of adults with ITP and will not increase the risk of adverse effects.

scholarly journals Efficacy and Safety of Traditional Chinese Herbal Medicine for Antipsychotic-Related Constipation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Wen-Wang Rao ◽  
Juan-Juan Yang ◽  
Han Qi ◽  
Sha Sha ◽  
Wei Zheng ◽  
...  
Keyword(s):  
Response Rate ◽  
Remission Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Regression Analyses ◽  
Traditional Chinese Herbal Medicine ◽  
Randomized Controlled ◽  
Chinese Herbal ◽  
Meta Regression

Background: Constipation is a common but often ignored side effect of antipsychotic treatment, although it is associated with adverse outcomes. The results of the efficacy and safety of traditional Chinese herbal medicine (TCM) in treating constipation are mixed across studies. This is a systematic review and meta-analysis of randomized controlled trials (RCTs) of the efficacy and safety of TCM compared to Western medicine (WM) in treating antipsychotic-related constipation.Methods: Major international electronic (PubMed, EMBASE, Cochrane Library, and Web of Science) and Chinese (Wanfang, WeiPu VIP, SinoMed, and CNKI) databases were searched from their inception to November 29, 2020. Meta-analysis was performed using the random-effects model.Results: Thirty RCTs with 52 arms covering 2,570 patients in the TCM group and 2,511 patients in the WM group were included. Compared with WM, TCM alone was superior regarding the moderate response rate [risk ratio (RR) = 1.165; 95% confidence interval (CI): 1.096–1.238; P < 0.001], marked response rate (RR = 1.437; 95% CI: 1.267–1.692; P < 0.001), and remission rate (RR = 1.376; 95% CI: 1.180–1.606; P < 0.001) for constipation, while it was significantly associated with lower risk of rash (RR = 0.081; 95% CI: 0.019–0.342; P = 0.001). For the moderate response rate, meta-regression analyses revealed that publication year (β = −0.007, P = 0.0007) and Jadad score (β = 0.067, P < 0.001) significantly moderated the results. For the remission rate, subgroup and meta-regression analyses revealed that the geographical region (P = 0.003), inpatient status (P = 0.035), and trial duration (β = 0.009, P = 0.013) significantly moderated the results.Conclusions: The efficacy of TCM for antipsychotic-related constipation appeared to be greater compared to WM, while certain side effects of TCM, such as rash, were less frequent.

The efficacy and safety of anti-PD-1/PD-L1 antibodies for treatment of advanced or refractory cancers: A meta-analysis.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e23075-e23075 ◽  
Author(s):  
Tengfei Zhang ◽  
Ruitai Fan ◽  
Ni Shi ◽  
Wang Ma
Keyword(s):  
Adverse Effect ◽  
Clinical Response ◽  
Response Rate ◽  
Smoking Status ◽  
Meta Analysis ◽  
Response Rates ◽  
Clinical Response Rate ◽  
Efficacy And Safety ◽  
Antibody Treatment ◽  
Random Effects Models

e23075 Background: Immunotherapy based on anti-PD-1 (Programmed death 1)/PD-L1 (PD-1 Ligand 1) antibodies have achieved significant successes from bench to clinic. In this study, we systematically evaluate the overall efficacy and safety of current anti-PD-1/PD-L1 antibodies for treatment of patients with advanced or refractory cancer. Methods: Clinical trials reporting response or safety of anti-PD-1/PD-L1 antibodies for advanced or refractory cancer patients published were searched in PubMed and EMBASE database. Meta-analyses using random effects models were used to calculate the overall estimate. Results: Fifty-one trials including 6,800 patients were included. The overall response rates for melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC) were 29% (95% CI: 1.53-2.41), 21% (95% CI: 17%-25%) and 21% (95% CI: 16%-27%) respectively. While the overall adverse effects rate for melanoma, NSCLC, RCC were 16% (95% CI: 6%-28%), 11% (95% CI: 8%-14%) and 20% (95% CI: 11%-32%) respectively. Tumor PD-L1 expression and patient smoking status might serve as biomarkers to predict response of anti-PD-1/PD-L1 antibody treatment. Compared to tumors with negative PD-L1 expression, tumors with positive PD-L1 expression had a significantly higher clinical response rate (41.4% versus 26.5%) with RR = 1.92 (95% CI: 1.53-2.41, P< 0.001). Smoker patients also showed a significantly higher response rate (33.7%) than patients who never smoked (4.2%) with RR = 6.02 (95% CI: 1.22-29.75, P= 0.028). Nivolumab and Pembrolizumab were associated with significantly increased response rate (RR = 2.89, 95% CI: 2.46-3.40, P< 0.001), reduced death risk (HR = 0.53; 95% CI: 0.48-0.57; P< 0.001), and decreased adverse effect rate (RR = 0.49, 95% CI: 0.30-0.80, P= 0.004) compared with other therapies. Conclusions: Anti-PD-1/PD-L1 antibodies have high response rates and low adverse effect rates for advanced or refractory cancers. PD-L1 expression was associated with better clinical response of anti-PD-1/PD-L1 antibody based immunotherapy.

scholarly journals Efficacy and Safety of Oncolytic Viruses in Randomized Controlled Trials: A Systematic Review and Meta-Analysis

Cancers ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1416 ◽  
Author(s):  
Zengbin Li ◽  
Zeju Jiang ◽  
Yingxuan Zhang ◽  
Xiaotian Huang ◽  
Qiong Liu
Keyword(s):  
Randomized Controlled Trials ◽  
Objective Response Rate ◽  
Response Rate ◽  
Meta Analysis ◽  
Objective Response ◽  
Oncolytic Viruses ◽  
Oncolytic Virotherapy ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled

Oncolytic virotherapy is a promising antitumor therapeutic strategy. It is based on the ability of viruses to selectively kill cancer cells and induce host antitumor immune responses. However, the clinical outcomes of oncolytic viruses (OVs) vary widely. Therefore, we performed a meta-analysis to illustrate the efficacy and safety of oncolytic viruses. The Cochrane Library, PubMed, and EMBASE databases were searched for randomized controlled trials (RCTs) published up to 31 January 2020. The data for objective response rate (ORR), overall survival (OS), progression-free survival (PFS), and adverse events (AEs) were independently extracted by two investigators from 11 studies that met the inclusion criteria. In subgroup analyses, the objective response rate benefit was observed in patients treated with oncolytic DNA viruses (odds ratio (OR) = 4.05; 95% confidence interval (CI): 1.96–8.33; p = 0.0002), but not in those treated with oncolytic RNA viruses (OR = 1.00, 95% CI: 0.66–1.52, p = 0.99). Moreover, the intratumoral injection arm yielded a statistically significant improvement (OR = 4.05, 95% CI: 1.96–8.33, p = 0.0002), but no such improvement was observed for the intravenous injection arm (OR = 1.00, 95% CI: 0.66–1.52, p = 0.99). Among the five OVs investigated in RCTs, only talimogene laherparepvec (T-VEC) effectively prolonged the OS of patients (hazard ratio (HR), 0.79; 95% CI: 0.63–0.99; p = 0.04). None of the oncolytic virotherapies improved the PFS (HR = 1.00, 95% CI: 0.85–1.19, p = 0.96). Notably, the pooled rate of severe AEs (grade ≥3) was higher for the oncolytic virotherapy group (39%) compared with the control group (27%) (risk difference (RD), 12%; risk ratio (RR), 1.44; 95% CI: 1.17–1.78; p = 0.0006). This review offers a reference for fundamental research and clinical treatment of oncolytic viruses. Further randomized controlled trials are needed to verify these results.

scholarly journals Efficacy and safety of interleukin-17A inhibitors in patients with ankylosing spondylitis: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Author(s):  
Peng Wang ◽  
Shuo Zhang ◽  
Binwu Hu ◽  
Weijian Liu ◽  
Xiao Lv ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Randomized Controlled Trials ◽  
Fixed Effects ◽  
Response Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Interleukin 17A ◽  
Mean Differences

AbstractTo assess the efficacy and safety of interleukin (IL)-17A inhibitors in patients with ankylosing spondylitis (AS). PubMed, EMBASE, and Web of Science were searched up to 5 February 2020 for randomized controlled trials (RCTs) that assessed the efficacy and safety of IL-17A inhibitors in patients with AS. We used a meta-analytic approach to perform a random effects analysis or fixed effects analysis according to heterogeneity. Subgroup analyses between studies included medication, time to primary endpoint, and data source. Odds ratios (ORs) or mean differences (MDs) were used to assess the efficacy and safety of IL-17A inhibitors in AS. A total of ten RCTs with 2613 patients were eligible for inclusion in the analysis (six for secukinumab, two for ixekizumab, one for netakimab, and one for bimekizumab). Compared to placebo, IL-17A inhibitors improved ASAS20 response rate (OR = 2.58; p < 0.01) and ASAS40 response rate (OR = 2.80; p < 0.01), and significantly increased the risk of AEs (OR = 1.23; p = 0.03) and nasopharyngitis (OR = 1.72; p < 0.01), but not SAEs (OR = 0.87; p = 0.60). IL-17A inhibitors demonstrated better efficacy in patients with AS in several evaluation indicators. However, the safety of IL-17A inhibitors remains to be further studied in studies with larger sample size and longer follow-up times.

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