目的 系统评价补肾调经法指导下补肾调经方剂联合促排卵药物治疗多囊卵巢综合征（polysystic ovary syndrome，PCOS）不孕症的有效性和安全性。方法 检索主要中英文数据库（中国知网、维普、万方、PubMed、Cochrane Library、Embase、Clinical Trials），检索时间为建库至2020年11月。根据纳入和排除标准收集补肾调经方剂联合促排卵药物治疗PCOS不孕症的随机临床对照试验（randomized controlled trial，RCT），提取数据，用"Cochrane偏倚风险评估工具"对各研究进行质量评价，采用Review Manager 5.3软件对结局指标进行Meta分析，按照GRADE标准对结局指标进行证据质量评价。结果 共纳入28项RCT，总样本数为2659例，其中试验组1337例，对照组1322例。系统评价结果显示，补肾调经方剂联合促排卵药物对比单一促排卵药物在提高排卵率、妊娠率及睾酮、促黄体生成素（luteinizing hormone，LH）水平，降低不良反应发生率，减小卵巢体积，增加子宫内膜厚度等方面疗效差异有统计学意义（P<0.01），在增加雌二醇、卵泡刺激激素（follicular stimulating hormone，FSH）方面两组差异无统计学意义（P>0.05）。对排卵率和妊娠率进行漏斗图分析，发现各研究点不对称，提示可能存在发表偏倚。根据GRADE方法评价证据质量，结果显示在排卵率和妊娠率方面质量为低级，其他方面均为极低级。结论 补肾调经法指导下的补肾调经方剂联合促排卵药物治疗PCOS不孕症临床疗效确切，安全性较好，但因纳入研究的质量较低，临床使用时仍需谨慎。

Objective To systematicly evaluate the efficacy and safety of Bushen Tiaojing Recipes combined with ovulation-induction drugs in the treatment of polycystic ovary syndrome (PCOS) infertility. Methods Databases including CNKI, VIP, Wan Fang, PubMed, Cochrane Library, Embase and Clinical Trials were searched from the establishment of the database to November, 2020. According to the inclusion and exclusion criteria, the randomized controlled trials (RCTs) of Bushen Tiaojing Recipes combined with ovulation-induction drugs in the treatment of PCOS infertility were collected, the data were extracted, and the quality of each study was evaluated with the "Cochrane bias risk assessment tool". The Meta analysis of the final indicators was analyzed by the Review Manager 5.3 software and the quality of evidence of the outcome indicators were evaluated according to the GRADE standard. Results A total of 28 RCTs with 2659 patients and 1337 cases in the treatment group and 1322 cases in the control group were enrolled. Systematic review results showed that:compared with single ovulation-induction drugs, Bushen Tiaojing Recipes combined with ovulation-induction drugs had significant effects on improving ovulation rate, pregnancy rate and androgen (T), luteinizing hormone (LH), reducing the incidence of adverse reactions and ovarian volume and increasing endometrial thickness (P<0.01). There was no significant difference in increasing estradiol (E2) and follicle stimulating hormone (FSH) between the two groups (P>0.05). The funnel plot of ovulation rate and pregnancy rate showed that each research point was asymmetric, suggesting that there might be publication bias. According to the GRADE method, the quality of evidence was low in ovulation rate and pregnancy rate and very low in other aspects. Conclusion Under the guidance of Bushen Tiaojing method, Bushen Tiaojing Recipes combined with ovulation induction drugs has fine clinical efficacy and good safety. However, due to the low quality of the included studies, clinical use still needs to be cautious.

R285.64

国家自然科学基金面上项目（30772818）