基于真实世界研究对依拉环素治疗中重度感染的疗效与安全性的系统综述与荟萃分析  

A systematic review and meta-analysis of the efficacy and safety of eravacycline in the treatment of moderate to severe infections based on real-world studies

作　　者：肖婷婷 喻玮[1] 王雪婷 肖永红[1] XIAO Tingting;YU Wei;WANG Xueting;XIAO Yonghong(State Key Laboratory for Diagnosis and Treatment of Infectious Diseases,National Clinical Research Center for Infectious Diseases,National Medical Center for Infectious Diseases,Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases,the First Affiliated Hospital,School of Medicine,Zhejiang University,Hangzhou 310003,China)

机构地区：[1]浙江大学医学院附属第一医院传染病诊治国家重点实验室、国家感染性疾病临床医学研究中心、国家传染病医学中心、感染性疾病诊治协同创新中心,杭州310003

出　　处：《中国感染与化疗杂志》2022年第4期408-413,共6页Chinese Journal of Infection and Chemotherapy

摘　　要：目的收集和汇总已发表的真实世界研究数据,以了解依拉环素在真实世界情况下治疗包括复杂性腹腔感染(cIAI)在内的中重度感染的疗效和安全性。方法系统检索有关依拉环素治疗感染性疾病的真实世界研究,采用系统综述和荟萃分析的方法,计算各研究合并的疗效与安全性指标,综合评价依拉环素在真实医疗环境下应用的疗效和安全性。结果最终纳入符合筛选标准的真实世界研究文献5篇,均为回顾性研究,总共包含265例不同类型感染患者的数据,其中包含腹腔感染患者共80例(30.2%)。荟萃分析显示,215例病情较重患者的综合临床有效率为69%(95%CI:62%~75%),50例病情较轻患者临床有效率达到94.0%。全部265例患者中,共29例(10.9%)发生不良事件,最常见为胃肠道反应。结论依拉环素不同给药方案在真实医疗环境下治疗不同部位感染,包括耐药菌所致的严重感染均具有良好的临床疗效。患者具有良好的安全性和耐受性,与国内外已经开展的随机对照研究结果一致。Objective Eravacycline is a novel fully-synthetic fluorocycline.This review aims to aggregate real-world studies to understand the efficacy and safety of eravacycline in the real-world settings.Methods The real-world studies on eravacycline were screened out for systematic review and meta-analysis.The efficacy and safety data in each study were described separately and collectively to obtain the overall profiles in the real clinical practice.Results Five real-world studies were included,all of which were retrospective studies.A total of 265 patients with different types of infections were analyzed,including 80 patients(30.2%)with abdominal infections.The meta-analysis showed that the overall clinical cure rate was 69%(95%CI:62%-75%)in 215 patients with severe illness.The clinical cure rate reached 94.0%in 50 outpatient subjects.Among all the 265 patients,29(10.9%)reported AEs.The most common AE was gastrointestinal reactions.Conclusions Different dosage regimens of eravacycline demonstrated favorable clinical effects in various scenarios,including severe infections caused by drug-resistant pathogens.Eravacycline was well tolerated,which is consistent with the results of global clinical trials.

关 键 词：依拉环素 复杂性腹腔感染 真实世界研究 系统综述 荟萃分析 

分 类 号：R978[医药卫生—药品]