[关键词]
[摘要]
运用网状Meta分析方法筛选中药联合激素治疗卵巢早衰(POF)的最优方案,为POF的临床治疗提供循证依 据。【方法】计算机检索知网(CNKI)、维普数据库(VIP)、万方(Wanfang)数据库、中国生物医学文献服务系统(CBM)、 PubMed、Cochrane、Embase、Web of Science等国内外主要数据库中有关中药联合激素治疗卵巢早衰的临床随机对照试验 (randomized controlled trials,RCTs)。采用Cochrane 推荐的质量评价工具与Jadad 量表以评估文献质量。采用Rstudio、 StataSE 15.1统计软件对数据进行网状Meta分析并绘制图表。【结果】共纳入文献50篇,涉及8种干预措施。纳入研究总体偏 倚风险较低,但文献质量总体偏低。网状Meta分析结果显示,在有效率方面,7种中药联合激素干预措施均优于对照组的常 规治疗(激素替代疗法),暖宫七味散+常规治疗均优于其余6种中药联合激素干预措施;基于累积排序概率曲线下面积 (SUCRA)值,8种干预措施有效率的疗效排序由高到低依次为暖宫七味散+常规治疗(SUCRA=81.2)、滋肾育胎丸+常规治疗 (SUCRA=80.0)、左归丸加减+常规治疗(SUCRA=66.1)、安坤种子丸+常规治疗(SUCRA=49.6)、坤泰胶囊+常规治疗 (SUCRA=45.2)、二仙汤加减+常规治疗(SUCRA=39.5)、六味地黄丸+常规治疗(SUCRA=37.4)、常规治疗(SUCRA=1.0)。在 改善血清卵泡刺激素(FSH)水平方面,左归丸加减+常规治疗优于其余7种干预措施;疗效排序为左归丸加减+常规治疗 (SUCRA=97.0)、常规治疗(SUCRA=77.9)、六味地黄丸+常规治疗(SUCRA=76.6)、坤泰胶囊+常规治疗(SUCRA=46.5)、暖宫 七味散+常规治疗(SUCRA=38.9)、安坤种子丸+常规治疗(SUCRA=29.9)、二仙汤加减+常规治疗(SUCRA=18.1)、滋肾育胎 丸+常规治疗(SUCRA=15.1)。【结论】与常规治疗(激素替代治疗)相比,各种中药联合激素的干预措施在改善卵巢早衰(POF) 患者的主要结局指标方面,疗效均较佳。具有最优方案概率最大值的提高有效率的干预措施为暖宫七味散+常规治疗,具有 最优方案概率最大值的降低血清FSH水平的干预措施为左归丸加减+常规治疗。但由于纳入研究的质量较低,未来需要开展 更多设计严谨的大样本、高质量的随机对照试验,以提供确凿的循证依据。
[Key word]
[Abstract]
To screen the optimal regimen of Chinese medicine combined with hormones for the treatment of premature ovarian failure(POF)using network meta-analysis and to provide an evidence-based basis for the clinical treatment of POF. Methods The randomized controlled trials(RCTs)of Chinese medicine combined with hormones in the treatment of POF were retrieved from thhe domestic and oversea databases of CNKI,VIP, Wanfang,CBM,PubMed,Cochrane,Embase,and Web of Science. The quality of the literature was assessed using the tools for analysis of bias recommended by Cochrane Reviewer’s Handbook and by Jadad scale scores. Rstudio and StataSE 15.1 statistical software were used to perform network meta- analysis and graphical presentation of the data. Results A total of 50 RCTs were included,covering 8 intervention methods. The overall risk of bias of the included studies was low, but the quality of the literature was generally low. The results of combined with hormone was superior to the conventional treatment(hormone replacement therapy,HRT)in the control group, and Nuangong Qiwei Powder+HRT was superior to the remaining 6 kinds of Chinese medicines combined with HRT;with reference to the values of the surface under the cumulative ranking curve(SUCRA), the efficiencies of the effective rate of the 8 intervention methods in descending order were Nuangong Qiwei Powder+ HRT(SUCRA=81.2), Zishen Yutai Pills + HRT(SUCRA=80.0), modified Zuogui Pills + HRT(SUCRA= 66.1),Ankun Zhongzi Pills + HRT(SUCRA=49.6),Kuntai Capsules + HRT(SUCRA=45.2),modified Erxian Decoction + HRT(SUCRA=39.5), Liuwei Dihuang Pills + HRT(SUCRA=37.4)and HRT(SUCRA=1.0). In terms of improving serum follicle-stimulating hormone(FSH)levels,modified Zuogui Pills + HRT was superior to the remaining 7 intervention methods; with reference to the values of the SUCRA , the efficiencies of the 8 intervention methods in descending order were modified Zuogui Pills + HRT(SUCRA=97.0),HRT(SUCRA= 77.9), Liuwei Dihuang Pills + HRT(SUCRA=76.6), Kuntai Capsules + HRT(SUCRA=46.5), Nuangong Qiwei Powder+HRT(SUCRA=38.9),Ankun Zhongzi Pills + HRT(SUCRA=29.9),modified Erxian Decoction + HRT (SUCRA=18.1), and Zishen Yutai Pills + HRT (SUCRA=15.1). Conclusion All kinds of Chinese medicines combined with HRT exert stronger effect on improving the primary outcome indicators than HRT alone for the treatment of POF. The intervention with Nuangong Qiwei Powder+HRT exerts the highest probability of the optimal regimen for enhancing the efficiency, and the intervention with Zuogui Pills + HRT exerts the highest probability of the optimal regimen for lowering the serum FSH level. However, due to the low quality of the included studies,more rigorously-designed,large sample-size,and high-quality randomized controlled trials need to be conducted in the future to provide conclusive evidence-based evidence.
[中图分类号]
R271.11
[基金项目]
广东省中医药局科研项目(编号:20212203);深圳市福田区卫生公益科研项目(编号:FTWS2021008,FTWS2020037)