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[加味血府逐瘀汤联合西药治疗子宫肌瘤的系统评价与序贯Meta分析]

[Systematic evaluation and sequential Meta-analysis of modified Xuefu Zhuyu Decoction combined with Western medicine in treatment of leiomyoma].

作者信息

Zeng Lei, Ji Shu-Liang, Chen Hui-Qi, Luo Song-Ping

机构信息

Maternity and Child Center, the First Affiliated Hospital of Guangzhou University of Chinese Medcine, Lingnan Medical Research Center, Guangzhou University of Chinese Medicine Guangzhou 510405, China.

the First Clinical College,Guangzhou University of Chinese Medcine Guangzhou 510405, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2021 Jan;46(1):225-236. doi: 10.19540/j.cnki.cjcmm.20200401.501.

DOI:10.19540/j.cnki.cjcmm.20200401.501
PMID:33645074
Abstract

CNKI, PubMed and other databases were retrieved to extract eligible randomized controlled trial(RCT) about modified Xuefu Zhuyu Decoction(MXZD) combined with Western medicine(trial group) versus Western medicine alone(control group) in the treatment of leiomyoma. Therefore, a total of 25 RCTs were included, involving 2 328 patients. Bias risk evaluation tool in Cochrane Handbook 5.1.0 was used for evaluating the quality of these RCTs. Meta-analysis was performed for the reported indicators, including total efficiency, serum hormone level [progesterone(P), luteinizing hormone(LH), estradiol(E_2), follicle stimulating hormone(FSH)], uterine size, fibroids size and adverse reactions by using Stata 14.0 software. Meta-analysis showed that the total efficiency(RR=1.21,95%CI[1.17,1.25],P<0.05) of trial group was better than that of control group. Serum hormone level(WMD_P=-3.86,95%CI[-4.31,-3.41],P<0.05; WMD_(LH)=-3.64,95%CI[-4.47,-2.82],P<0.05; WMD_(E_2)=-39.99,95%CI[-53.45,-26.52],P<0.05; WMD_(FSH)=-3.79,95%CI[-4.86,-2.72],P<0.05), uterine size(WMD=-50.02,95%CI[-55.98,-44.06],P<0.05), fibroids size(WMD=-15.79,95%CI[-18.11,-13.46],P<0.05) and adverse reactions(RR=0.65,95%CI[0.48,0.88],P<0.05) of trial group were all lower than those of control group, with statistical significances. Trial sequential analysis(TSA) was performed by using TSA 0.9 software, and showed a reliable therapeutic effect of the experimental group. In short, our study indicated that modified Xuefu Zhuyu Decoction combined with Western medicine had a better therapeutic effect on leiomyoma than Western medicine alone, but more high-quality studies are needed to verify this conclusion in the future.

摘要

检索中国知网、PubMed等数据库,提取关于加味血府逐瘀汤联合西药(试验组)与单纯西药(对照组)治疗子宫肌瘤的合格随机对照试验(RCT)。共纳入25项RCT,涉及2328例患者。采用Cochrane手册5.1.0中的偏倚风险评估工具对这些RCT的质量进行评估。使用Stata 14.0软件对报道的指标进行Meta分析,包括总有效率、血清激素水平[孕酮(P)、黄体生成素(LH)、雌二醇(E₂)、卵泡刺激素(FSH)]、子宫大小、肌瘤大小及不良反应。Meta分析结果显示,试验组的总有效率(RR = 1.21,95%CI[1.17,1.25],P < 0.05)优于对照组。试验组的血清激素水平(WMD_P = -3.86,95%CI[-4.31,-3.41],P < 0.05;WMD_(LH) = -3.64,95%CI[-4.47,-2.82],P < 0.05;WMD_(E₂) = -39.99,95%CI[-53.45,-26.52],P < 0.05;WMD_(FSH) = -3.79,95%CI[-4.86,-2.72],P < 0.05)、子宫大小(WMD = -50.02,95%CI[-55.98,-44.06],P < 0.05)、肌瘤大小(WMD = -15.79,95%CI[-18.11,-13.46],P < 0.05)及不良反应(RR = 0.65,95%CI[0.48,0.88],P < 0.05)均低于对照组,差异具有统计学意义。采用TSA 0.9软件进行试验序贯分析(TSA),结果显示试验组疗效可靠。总之,本研究表明加味血府逐瘀汤联合西药治疗子宫肌瘤的效果优于单纯西药,但未来还需要更多高质量研究来验证这一结论。

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