莫西沙星治疗慢性支气管炎急性发作疗效与安全性的Meta分析

Efficacy and Safety of Moxifloxacin in the Treatment of Acute Exacerbation of Chronic Bronchitis:A Meta-analysis

目的:系统评价莫西沙星(MFX)治疗慢性支气管炎急性发作(AECB)的疗效和安全性,为临床合理应用MFX提供循证参考。方法:计算机检索Pub Med、EMBase、Cochrane图书馆、Medline、中国生物医学文献数据库、中国期刊全文数据库、中文科技期刊数据库和万方数据库,并手工检索相关会议论文集和灰色文献等,纳入MFX(试验组)对比其他抗菌药物(对照组)治疗AECB的随机对照试验(RCT),按照纳入与排除标准选择文献、提取资料和评价质量后,采用Rev Man 5.2统计软件进行Meta分析,同时应用意向性分析(Intention-to-treat analysis,ITT分析)和符合方案集分析(Per-protocol analysis,PP分析)两种方法。结果:共纳入14项RCT,合计6 058例患者。PP分析结果显示,试验组患者临床有效率与对照组相当[RR=1.02,95%CI(1.00,1.04),P=0.06],而细菌清除率显著高于对照组[RR=1.07,95%CI(1.04,1.11),P<0.001]。ITT分析结果显示,试验组患者临床有效率显著高于对照组[RR=1.03,95%CI(1.00,1.06),P=0.03],而细菌清除率[RR=1.02,95%CI(0.92,1.12),P=0.73]和不良反应发生率[RR=0.97,95%CI(0.87,1.08),P=0.52]与对照组比较,差异均无统计学意义。结论:MFX治疗AECB的疗效不劣于其他抗菌药物,安全性与其他抗菌药物相当。

OBJECTIVE：To systematically review the efficacy and safety of Moxifloxacin（MFX）in the treatment of acute exacerbation of chronic bronchitis（AECB）,and provide evidence-based reference for Tational use of MFX. METHODS：Retrieved from Pub Med,EMBase,Cochrane Library,Medline,CBM,CJFD,VIP and Wanfang Database,the relevant conference proceedings and grey literature were also hand-searched,randomized controlled trials（RCT）about MFX（test group）versus other antibiotics（control group） in the treatment of AECB were collected. Meta-analysis was performed by using Rev Man 5.2 software with ITT analysis and PP analysis after literature selection,data extraction and quality evaluation. RESULTS：Totally 14 RCTs were included,involving 6 058 patients. Results of PP analysis showed,the clinical effective rate in test group was similar to that of control group [RR=1.02,95%CI（1.00,1.04）,P=0.06],while bacteria clearance rate was significantly higher than control group [RR=1.07,95%CI（1.04,1.11）,P〈0.001]. Results of ITT analysis showed,the clinical effective rate in test group was significantly higher than control group [RR=1.03,95%CI（1.00,1.06）,P=0.03],while there was no significant difference in the bacteria clearance rate [RR=1.02,95%CI（0.92,1.12）,P=0.73] and the incidence of adverse reactions [RR=0.97,95%CI（0.87,1.08）,P=0.52] between 2 groups. CONCLUSIONS：The efficacy of MFX is not inferior to other antibiotics in the treatment of AECB,safety is similar to other antibiotics.