妇科再造胶囊联合炔雌醇环丙孕酮片治疗多囊卵巢综合征临床疗效的系统评价

Systematic Review of Combinative Effects of Fuke Zaizao Capsules with Diane-35 on Polycystic Ovary Syndrome

目的:评价妇科再造胶囊联合炔雌醇环丙孕酮片治疗多囊卵巢综合征(polycystic ovary syndrome,PCOS)的临床疗效。方法:检索中国学术期刊全文数据库、万方数据库、中国生物医学文献数据库、重庆维普中文科技期刊全文数据库,收集有关妇科再造胶囊联合炔雌醇环丙孕酮片治疗多囊卵巢综合征的随机对照试验(Randomized Controlled Trail, RCT)。按照国际Cochrane协作网的系统评价方法进行评价,对符合纳入标准的试验进行质量评价和资料提取后,应用RevMan 5.3软件进行Meta分析。结果:共纳入11项符合条件的随机对照试验研究,纳入患者1353例。Meta分析结果显示妇科再造胶囊联合炔雌醇环丙孕酮片对比单用炔雌醇环丙孕酮片在治疗多囊卵巢综合征方面有一定的优势,总有效率=[RR=1.14,95%CI(1.08,1.19),I^2=40%,P<0.000 1];在降低血清睾酮(T)水平、促黄体生成素(LH)水平以及促卵细胞生成素(FSH)水平方面优于对照组。结论:妇科再造胶囊与炔雌醇环丙孕酮片联合应用于治疗多囊卵巢综合征具有一定疗效,且两药联用方案效果优于炔雌醇环丙孕酮片单药方案;但目前证据仍十分有限,尚需大样本、高质量、严格控制条件的研究,以期做出更为严谨的系统评价,进一步增加证据强度。

Objective:To review the curative effect of Fuke Zaizao Capsules with Diane-35 in treatment of polycystic ovary syndrome.Methods:CNKI, Wanfang, CBM and VIP database were searched to collect Randomized controlled trials(RCT) about cases of treating polycystic ovary syndrome using Fuke Zaizao Capsules with Diane-35. The RevMan 5.3 software was used for Meta-analysis before the quality evaluation and data extraction of the test that met the inclusion criteria, according to the systematic evaluation method of the International Cochrane Collaboration Network.Results:A total of 11 included studies were all randomized controlled trials, including 1353 patients. Meta-analysis showed thatusing Fuke Zaizao Capsules with Diane-35 in treatment of polycystic ovary syndrome was much better than using Diane-35 alone, total efficiency=[RR=1.14,95%CI(1.08,1.19),I^2=40%,P<0.000 1]. It is superior to the control group in reducing serum testosterone(T) levels, luteinizing hormone(LH) levels, and stimulating hormone(FSH) levels.Conclusion:The application of Fuke Zaizao Capsules with Diane-35 in the treatment of polycystic ovary syndrome has a certain effect. And the two-drug combination scheme is better than the single-drug regimen. However, the evidence is still very limited, and large-scale, high-qualityand strictly controlled research is needed to make a more rigorous systematic review and further increase the intensity of evidence.