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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
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Abstract:
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 < 0.00001]显著升高，E2 [MD = 18.07, 95% CI (13.82, 22.32), P < 0.00001]显著升高，LH [MD = ？5.81, 95% CI (？6.96, ？4.65), P < 0.00001], T [MD = ？1.40, 95% CI (？1.48, ？1.33), P < 0.00001]、INS [MD = ？55.76, 95% CI (？64.38, ？47.15), P < 0.00001]和PRL [MD = ？0.44, 95% CI (？0.47, ？0.40), P < 0.00001]显著降低；中药组治疗排卵率[RR = 1.09, 95% CI (0.95, 1.25), P = 0.22]和FSH [MD = ？0.20, 95% CI (？1.06, 0.66), P = 0.65]与对照组无统计学差异。漏斗图、Begg’s检验和Egger’s检验均提示研究存在发表偏倚。Metaninf命令图及试验序贯分析证明研究结果稳定性较好。结论：在PCOS排卵障碍性不孕患者中，补肾活血类中药可以提高妊娠率、提高E2，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 < 0.00001], E2 [MD = 18.07, 95% CI (13.82, 22.32), P < 0.00001], and significantly reduce the level of LH [MD = ？5.81, 95% CI (？6.96, ？4.65), P < 0.00001], T [MD = ？1.40, 95% CI (？1.48, ？1.33), P < 0.00001], INS [MD = ？55.76, 95% CI (？64.38, ？47.15), P < 0.000 01] and PRL [MD = ？0.44, 95% CI (？0.47, ？0.40), P < 0.00001]. However, there was no statistical significance in ovulation rate [RR = 1.09, 95% CI
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