莫西沙星治疗急性细菌性鼻窦炎疗效与安全性的Meta分析

The Meta-analysis of the efficacy and safety for moxifloxacin in the treatment of acute bacterial sinusitis

目的:系统评价莫西沙星治疗急性细菌性鼻窦炎(ABS)的疗效和安全性。方法:计算机检索英文数据库Pubmed、Embase、the Cochrane Library、Medline和中文数据库CBM、CNKI、VIP和万方数据库,并手工检索相关会议论文集和灰色文献等,纳入莫西沙星治疗急性细菌性鼻窦炎的随机对照试验(RCT)。检索时限均从各数据库建库至2013年6月。按照纳入与排除标准选择文献、评价质量及提取资料后,采用RevMan5.2软件进行Meta分析。结果:共纳入5个RCTs,2 453例患者。Meta分析结果显示:PP分析中,莫西沙星组与其他抗菌药物组治疗ABS的临床有效率有统计学意义[RR=1.03,95%CI(1.00,1.05),P=0.04];而ITT分析中,2组治疗ABS的临床有效率无统计学意义[RR=0.99,95%CI(0.96,1.03),P=0.72]。PP分析中,莫西沙星组治疗ABS细菌清除率为95.07%,其他抗菌药物组细菌清除率为90.57%,2组无统计学意义[RR=1.04,95%CI(0.97,1.11),P=0.24];ITT分析中,2组不良反应发生率无统计学意义[RR=1.09,95%CI(0.86,1.38),P=0.49]。结论:基于当前的临床证据,莫西沙星治疗ABS的临床有效性不优于其他抗菌药物,细菌清除率和安全性与其他抗菌药物相当。

OBJECTIVE To assess the efficacy and safety of moxifloxacin for the treatment of acute bacterial sinusitis （ABS）. METHODS Databases such as Pubmed, Embase, the Cochrane Library, Medline, CBM, CNKI, VIP and Wanfang were electronically searched, the relevant conference proceedings and grey literature were also hand-searched. Randomized controlled trials（RCTs） of moxifloxacin for ABS were included. The search time was up to June 2013. RCTs that included was evaluated and analyzed by the software RevMan 5.0. RESULTS A total of five RCTs involving 2 453 patients with ABS were included. The meta-analysis showed that the clinical efficient rates had statistically significant difference between moxifloxacin group and other antibiotics group in per-protocol analysis（PP analysis）ERelative risk （RR） = 1.03,95 % CI （I. 00, 1.05）, P = 0. 04], but had no statistically significant difference in intention-to-treat analysis （ITT analysis） [ RR = 0. 99,95 % CI （0. 96, 1.03）, P = 0. 72]. In PP analysis, there was no statistically significant difference of bacteriological eradication rates between moxifloxacin group（95.07%） and other antibiotics group （90. 57%） ERR= 1.04,95% CI（0. 97,1.11）,P = 0. 24]. In ITT analysis, the in- cidence of adverse reactions had no？ statistically significant difference between the two groups [RR = 1.09, 95% CI（0. 86, 1.38） ,P = 0. 49]. CONCLUSION Based on current clinical evidence, the clinical efficacy of moxifloxacin in the treatment of ABS is not superior to other antibiotics for ABS. The bacterial clearance rate and safety are similar with other antibiotics.