中医药改善卵巢去势后低雌激素状态的系统评价及GRADE证据质量评价*

作者：赵婷玉1,2，谢 萍2，姜文晶1,2

单位：1.成都中医药大学，四川 成都 610072； 2.成都中医药大学附属医院，四川 成都 610072

引用：引用：赵婷玉，谢萍，姜文晶.中医药改善卵巢去势后低雌激素状态的系统评价及GRADE证据质量评价[J].中医药导报,2025,31(10):138-146,184.

DOI：10.13862/j.cn43-1446/r.2025.10.024

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摘要：

目的：系统评价中医药改善卵巢去势后低雌激素状态的有效性及安全性。方法：检索万方数据知识服务平台（Wanfang Data）、中国知网（CNKI）、维普中文期刊服务平台（CSTJ）、中国生物医学文献服务系统（SinoMed）、Cochrane Library、PubMed、Web of Science、Embase数据库中有关中医药改善卵巢去势后低雌激素状态的随机对照试验（RCT），检索时限为建库至2024年5月14日。利用RevMan 5.4.1软件进行数据分析，根据Cochrane偏倚风险评估工具进行偏倚风险评估，根据GRADE系统进行证据质量评估分级。结果：共纳入28项RCTs，涉及2 292例患者。Meta分析显示，与对照组比较，试验组可提高临床疗效[RR=1.35，95%CI（1.14，1.59），P=0.04]，降低Kupperman评分[MD=-4.22，95%CI（-6.60，-1.85），P=0.000 5]，改善中医证候积分[SMD=-8.32，95%CI（-12.05，-4.58），P＜0.000 01]，提高骨密度[SMD=0.26，95%CI（0.10，0.42），P=0.002]，降低不良反应发生率[RR=0.48，95%CI（0.32，0.72），P=0.000 4]，并且不增加子宫内膜厚度[MD=0.45，95%CI（-0.36，1.27），P=0.27]；两组雌二醇（E2）、卵泡刺激素（FSH）、黄体生成素（LH）、骨钙素比较，差异无统计学意义（P＞0.05）。结论：中医药对干预卵巢去势后低雌激素状态具有一定的临床有效性及安全性。但纳入研究的异质性较大，结局指标的差异性较大，仍需开展更多高质量、大规模的RCTs进一步证明中医药的有效性及安全性，为临床提供可靠的循证医学依据。

关键词：卵巢去势；低雌激素状态；中医药；随机对照试验；系统评价；Meta分析

Abstract：

Objective: To systematically evaluate the efficacy and safety of TCM in improving low estrogen status following ovarian ablation. Methods: RCTs on TCM for low estrogen status after ovarian ablation were retrieved from Wanfang Data, CNKI, CSTJ, SinoMed, Cochrane Library, PubMed, Web of Science, and Embase databases from inception to May 14, 2024. Data analysis was performed using RevMan 5.4.1. The Cochrane risk-of-bias tool was used for methodological quality assessment, and the GRADE system was used for evidence quality grading. Results: Twenty-eight RCTs involving 2 292 patients were included. Meta-analysis showed that, compared to the control group, the TCM group demonstrated superior outcomes in improving clinical efficacy [RR=1.35, 95%CI(1.14, 1.59), P=0.04], reducing Kupperman scores [MD=-4.22, 95%CI(-6.60, -1.85), P=0.000 5], improving TCM syndrome scores [SMD=-8.32, 95%CI(-12.05, -4.58), P＜0.000 01], increasing bone mineral density [SMD=0.26, 95%CI(0.10, 0.42), P=0.002], and reducing the incidence of adverse reactions [RR=0.48, 95%CI(0.32, 0.72), P=0.000 4], without increasing endometrial thickness [MD=0.45, 95%CI(-0.36, 1.27), P=0.27]. No statistically significant differences were found between groups for E2, FSH, LH, and osteocalcin levels. Conclusion: TCM shows certain clinical efficacy and safety in improving low estrogen status after ovarian ablation. However, due to significant heterogeneity among included studies and variations in outcome measures, more high-quality, large-scale RCTs are needed to further verify its efficacy and safety, providing more reliable evidence-based support for clinical practice.

Key words：ovarian ablation; low estrogen status; traditional Chinese medicine; randomized controlled trial; systematic review; Meta-analysis

发布时间：2026-01-08

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