国产5%咪喹莫特乳膏治疗生殖器疣荟萃分析

A meta-analysis of the effectiveness of 5% Imiquimod cream made in china in the treatment of Genital warts

目的:以循证医学的方法对国产5%咪喹莫特乳膏治疗生殖器疣的疗效、安全性以及预防生殖器疣复发的效果进行系统性评价。方法:检索中文科技期刊数据库(CNKI)、中国生物医学文献数据库(CBMDisc),由两名评价者独立提取资料并进行方法学质量评估。试验数据的统计分析采用Co-chrane协作网提供的RevMan4.2.8软件进行。结果:咪喹莫特乳膏单疗组,最终纳入8个临床随机对照试验,Meta分析结果显示,与安慰剂比较,疗效差异有统计学意义;与2.5%氟尿嘧啶软膏比较,疗效差异没有统计学意义。没有严重系统性不良反应的报道。咪喹莫特乳膏联合物理治疗组,最终纳入12个临床随机对照试验,Meta分析结果显示,以观察3个月或6个月没有在原位复发作为痊愈标准,与安慰剂组比较,疗效差异有统计学意义。结论:现有临床证据表明,国产5%咪喹莫特乳膏治疗生殖器疣有确切的疗效和较好的安全性,对预防生殖器疣复发也有确切的疗效。

Objective：To evaluate the efficacy and safety of 5% imiquimod cream made in China in the treatment of genital warts. Methods：The CNKI and CBMDisc were searched. The randomized controlled trials （RCT） comparing 5% imiquimod cream versus placebo or fluorouracil cream were included, and two authors independently reviewed the data and assessed the quality. The data were inputted and analyzed by RevMan 4.2.8 software supplied by the Cochrane Collaboration. Results： Among imiquimod cream mono - treatment groups eight trials ranked high quality were included. Meta - analysis of the treatment of genital warts with 5% imiquimod cream showed the clinical effective rates were significantly different between 5% imiquimod cream and placebo, while were not between 5% imiquimod and 2.5% fluorouracil cream. No serious systematical adverse reaction was recorded. Among imiquimod cream combined with physiotherapy groups, twelve trials ranked high quality were included. Meta - analysis of the treatment of genital warts with 5% imiquimod cream combined with physiotherapy showed the clinical effective rates were significantly different between 5% imiquimod cream and placebo. Conclusion：5% imiquimod cream is an effective and safe agent for the treatment of genital warts; topically using 5% imiquimod cream is effective in preventing genital warts relapse after physiotherapy.