基于试验序贯分析的补肾活血类中药治疗PCOS排卵障碍性不孕RCT的Meta分析  

Meta-Analysis of Randomized Controlled Trials on the Effectiveness of Nourishing Kidney and Activating Blood Medications in the Treatment of Ovulatory Disorder Infertility with PCOS Based on Trial Sequential Analysis

作　　者：冀凡 常惠[2] 

机构地区：[1]黑龙江中医药大学研究生院,黑龙江 哈尔滨 [2]黑龙江中医药大学附属第一医院妇科,黑龙江 哈尔滨

出　　处：《临床医学进展》2024年第6期975-989,共15页Advances in Clinical Medicine

摘　　要：目的:系统评价补肾活血类中药治疗PCOS排卵障碍性不孕的有效性和安全性。方法:检索主要英文数据库(PubMed, Embase, Cochrane Library)及中文数据库(中国知网、维普、万方),检索时间为建库至2023年12月,根据纳入和排除标准检索补肾活血类中药治疗PCOS排卵障碍性不孕的RCT,采用Revman5.4进行Meta分析及风险偏倚评估,Stata16.0进行发表偏倚评估,TSA0.9进行试验序贯分析。结果:共纳入16篇RCTs,总样本量1327例,中药组为口服补肾活血类中药患者共665例,对照组为口服氯米芬患者共662例。Meta分析结果显示,与对照组比较,中药组治疗妊娠率[RR = 2.02, 95% CI (1.72, 2.38), P 2 [MD = 18.07, 95% CI (13.82, 22.32), P 2,降低P、LH、T、INS和PRL,但受研究质量限制,仍需大样本、多中心、高质量RCTs进一步验证结果的可靠性。Objective: To make a system evaluation regarding the safety and effectiveness of “Nourishing Kidney and Activating blood” medications in the management of ovulatory disorder infertility with polycystic ovarian syndrome (PCOS). Methods: We searched databases including PubMed, Embase, Cochrane Library, CNKI, VIP, Wan Fang and the time limit was from establishment of databases to December 2023. According to the inclusion and exclusion criteria, the randomized controlled trials (RCTs) of “Nourishing Kidney and Activating blood” medications in the treatment of ovulatory disorder infertility with polycystic ovary syndrome (PCOS) was retrieved and collected. Revman5.4 was used for meta-analysis and risk bias evaluation, Stata15.0 for publication bias evaluation and TSA0.9 for sequential analysis. Results: 16 RCTs were included with a sample size of 1327 cases. The traditional Chinese medicine group had 665 cases of oral “Nourishing Kidney and Activating blood” medications, while the control group included 662 cases of oral clomiphene. Meta- analysis showed that compared with control group, the traditional Chinese medicine group could significantly improve the pregnancy rate [RR = 2.02, 95% CI (1.72, 2.38), P 2 [MD = 18.07, 95% CI (13.82, 22.32), P 2, and it could decrease the level of P, LH, T, INS and PRL in the treatment of ovulatory disorder infertility with PCOS. However, this study still needed more large samples, multi-center, and high-quality RCT to be further verified due to limitation of literature quality.

关 键 词：补肾活血 多囊卵巢综合征 不孕 META分析 试验序贯分析 

分 类 号：R71[医药卫生—妇产科学]