The efficacy and safety of omadacycline in treating acute bacterial infections: a meta-analysis of randomized controlled trials

This study aimed to reevaluate the clinical efficacy and safety of omadacycline in treating acute bacterial infections. We searched PubMed, Embase, Cochrane Library, Web of Science, and Clinical Trials up to 1 January 2024, including only randomized controlled trials comparing OMC with other antibiotics in adults. Primary outcomes were clinical and microbiological responses; secondary outcomes included adverse events. Seven RCTs with 2957 patients met the inclusion criteria. OMC showed a slightly better clinical response at the post-therapy evaluation phase in the clinically evaluable population (RR = 1.03, 95% CI = 1.01–1.05, I² = 0%). Microbial eradication rates for Gram-positive and Gram-negative infections showed no significant differences between OMC and comparators. Safety analysis revealed no significant differences in overall AEs, treatment-related AEs, serious AEs, or drug discontinuation due to AEs. However, OMC had a lower risk of diarrhea (RR: 0.48, 95% CI = 0.23–1.00, I² = 65%). All-cause mortality did not differ significantly between OMC and comparators. OMC is a safe and effective treatment for acute bacterial infections, comparable to other antibiotics. This study has been registered in the online systematic review database (Prospective Register of Systematic Reviews [PROSPERO]), and the registration number is CRD42024575416.

本研究旨在重新评估奥马环素（omadacycline）治疗急性细菌性感染的临床疗效与安全性。我们检索了截至2024年1月1日的PubMed、Embase、考克兰图书馆（Cochrane Library）、Web of Science及Clinical Trials数据库，仅纳入对比OMC与其他抗生素治疗成人患者的随机对照试验（randomized controlled trials，以下简称RCT）。主要结局指标为临床应答与微生物学应答；次要结局指标包括不良事件（adverse events，以下简称AE）。共纳入符合纳入标准的7项RCT，涉及2957名患者。在临床可评估人群中，OMC在治疗后评估阶段的临床应答率略高于对照药物（风险比（relative risk，RR）=1.03，95%置信区间（confidence interval，CI）=1.01~1.05，I²=0%）。针对革兰阳性菌与革兰阴性菌感染的微生物清除率，OMC与对照药物之间无显著差异。安全性分析显示，两组在总体AE、治疗相关AE、严重不良事件（serious adverse events，以下简称SAE）以及因AE停药的发生率上均无显著差异。不过，OMC引发腹泻的风险更低（RR=0.48，95% CI=0.23~1.00，I²=65%）。全因死亡率在OMC组与对照组之间亦无显著差异。综上，OMC治疗急性细菌性感染安全有效，与其他抗生素疗效相当。本研究已在系统评价前瞻性注册库（Prospective Register of Systematic Reviews，PROSPERO）完成注册，注册编号为CRD42024575416。