Centre of Medicine Clinical Research, Department of Pharmacy, PLA General Hospital, Beijing 100853, China; College of Pharmacy, Chongqing Medical University, Chongqing 400016, China.
College of Pharmacy, Chongqing Medical University, Chongqing 400016, China.
J Glob Antimicrob Resist. 2021 Jun;25:380-389. doi: 10.1016/j.jgar.2021.04.013. Epub 2021 May 11.
This study aimed to evaluate the efficacy and safety of oritavancin (ORI) versus comparators for the treatment of acute bacterial skin and skin-structure infections (ABSSSIs) based on available clinical studies.
PubMed, Cochrane Library and Embase were searched from database inception to 28 July 2020 to identify clinical studies assessing the efficacy and safety of ORI and comparator antibiotics for the treatment of ABSSSIs. Primary efficacy outcome, investigator-assessed clinical cure, lesion size reduction ≥20%, additional post-treatment antibiotics, and 30-day emergency room (ER) visits and readmission were assessed as efficacy outcomes. Adverse events (AEs) and mortality were assessed as safety outcomes. I statistic was calculated for heterogeneity, and a fixed-effects or random-effects model was used for estimation of the risk ratio (RR).
A total of 9213 patients from two randomised clinical trials (RCTs) and four cohort studies were included in this meta-analysis. ORI was statistically non-inferior to control agents in all efficacy and safety outcomes. Moreover, ORI significantly reduced the occurrence of 30-day readmission (RR = 0.42; P = 0.0004) and drug-related AEs (RR = 0.78; P = 0.002). In the subgroup analysis, ORI also had a lower rate of 30-day ER visits in the outpatient setting (RR = 0.34; P < 0.00001).
ORI was not inferior to comparators for the treatment of ABSSSIs. Meanwhile, it showed advantages in reducing the rate of readmission and drug-related AEs. More high-quality and large-scale RCTs are required to further confirm the efficacy and safety of ORI. [Trial registration: PROSPERO ID: CRD42020201942].
本研究旨在评估奥沙万古霉素(ORI)与对照药物治疗急性细菌性皮肤和皮肤结构感染(ABSSSIs)的疗效和安全性,基于现有临床研究。
从数据库建立到 2020 年 7 月 28 日,通过 PubMed、Cochrane 图书馆和 Embase 检索评估 ORI 和对照抗生素治疗 ABSSSIs 的疗效和安全性的临床研究。主要疗效结局为研究者评估的临床治愈率、病变大小缩小≥20%、治疗后需要额外使用抗生素以及 30 天内急诊(ER)就诊和再入院。不良事件(AE)和死亡率被评估为安全性结局。计算 I ² 统计量以评估异质性,并使用固定效应或随机效应模型估计风险比(RR)。
共有来自两项随机临床试验(RCT)和四项队列研究的 9213 名患者纳入本荟萃分析。在所有疗效和安全性结局中,ORI 与对照药物相比均无统计学上的非劣效性。此外,ORI 显著降低了 30 天再入院(RR=0.42;P=0.0004)和药物相关 AE 的发生率(RR=0.78;P=0.002)。亚组分析显示,ORI 在外用门诊环境下也降低了 30 天 ER 就诊率(RR=0.34;P<0.00001)。
ORI 治疗 ABSSSIs 不劣于对照药物。同时,它在降低再入院率和药物相关 AE 发生率方面具有优势。需要更多高质量和大规模的 RCT 进一步证实 ORI 的疗效和安全性。[临床试验注册:PROSPERO ID:CRD42020201942]。