补肾活血中药干预多囊卵巢综合征致不孕症的Meta分析

A Meta-analysis of Reinforcing Kidney and Activating Blood Chinese Herbal Medicine in the Treatment of Infertility Caused by Polycystic Ovary Syndrome

目的对近10年来补肾活血中药干预多囊卵巢综合征致不孕症的文献进行Meta分析,以期评价补肾活血类中药干预多囊卵巢综合征的有效性和安全性。方法以"补肾活血(reinforcing kidney and activating blood)""多囊卵巢综合征(PCOS)""不孕(infertility)"等为主题词,在中国期刊全文数据库(CNKI)、维普数据库(VIP)、万方数据知识服务平台、Pub Med、Medline、Springer Link等中检索含有补肾活血类中药干预的随机对照试验或临床对照试验,并对文献结果进行Meta分析。结果共有22篇临床研究文献入选,其中18篇文献为补肾活血中药联合西药与西药治疗进行比较,5篇文献为单用补肾活血中药与西药治疗进行比较。(1)补肾活血中药+西药组与西药组比较:在总有效率方面,18篇RCT文献总有效例数分别为729/863,422/693,异质性检验χ2=18.44,合并效应值OR=3.83,95%置信区间[2.95,4.96],差异具有统计学意义;在妊娠率方面,妊娠例数分别为438/863,210/693,异质性检验χ2=30.46,合并效应值OR=2.83,95%置信区间[2.06,3.88],差异有统计学意义。(2)补肾活血中药组与西药组比较:在总有效率方面,5篇R CT文献总有效例数分别为97/137,90/132,异质性检验χ2=8.42,合并效应值O R=1.10,95%置信区间[0.65,1.87],无统计学差异;在妊娠率方面,总妊娠例数分别为45/137,26/132,异质性检验χ2=2.89,合并效应值OR=2.22,95%置信区间[1.24,3.98],差异具有统计学意义。(3)在安全性方面,10篇RCT文献报道不良反应例数在补肾活血中药+西药组与西药组中分别为23/412,57/319,异质性检验χ2=18.32,合并效应值OR=0.26,95%置信区间[0.09,0.80],差异有统计学意义。结论补肾活血中药联合西药治疗多囊卵巢综合征在改善临床症状、体征及妊娠方面明显优于单用西药治疗,且中西药联合应用安全性要明显高于西药单用;而补肾活血中药单用于多囊卵巢综合征改善临床症状及体征上与西药比较无明显优势,但在妊娠率上有明显优势,但是由于纳入文献数量较少且文献质量评分较低,其有效性需要进一步观察及验证。

Objective To evaluate the effect and safety of reinforcing kidney and activating blood Chinese herbal in the treatment of infertility caused by PCOS by means of system evaluating literature published for 10 years. Methods The Cochrane Library, PubMed, SpringLink, CBM, VIP, CNKI, Wanfang databases were searched through key words ＂ reinforcing kidney and activating blood＂ , ＂ PCOS＂ , and ＂ infertility＂ . The Cochrane collaborations software RevMan 5.3 was used for inate-analysis. Results A total of 22 clinical studies were selected, 18 of which were coInpared with Chinese herbal coinbined with western drug versus western drug on treating PCOS, and 5 studies were colnpared with Chinese herbal versus western drug on treatlnent for PCOS. The results of each group analysis showed that： Chinese herbal colnbined with western drug VS western drug： in the aspect of total effective rate, total effective nulnbers respectively were 729/863, 422/693 in forlner and latter, and heterogeneity test x =18.44, OR=3.83, 95% CI （2.95, 4.96） . It has statistical significance. Chinese herbal colnbined with western drug VS western drug： in the aspect of the pregnancy rate, total pregnancy cases respectively were 438/863, 210/693, in former and latter, and heterogeneity test x =30.46, OR=2.83, 95% CI （2.06, 3.88） . It has no statistical significance. Chinese herbal VS western drug： in the aspect of total effective rate, total effective cases respectively were 97/137, 90/132, in forlner and latter, and heterogeneity test x =8.42, O11=1.10, 95% CI （0.65, 1.87） . It has statistical significance. Chinese herbal VS western drug： in the aspect of the pregnancy rate, total pregnancy cases respectively were 45/137, 26/132, in former and latter, and heterogeneity test x =2.89, Oll=2.22, 95% CI （1.24, 3.98） . It has statistical significance. Safety： 10 studies reported adverse effects. The group of Chinese herbal eoinbined with western drug had lower adverse reaction rate than the western drug [x =18.32, O11=0.26, 95% CI （0.09, 0.80）] . It has statistical significance. Conclusion Reinforcing kidney and activating blood Chinese herbal combined with western drug were better than western drug in aspect of improving clinical symptoms and signs, promoting the pregnancy, safety on treatment of infertility caused by PCOS. Chinese herbal was only better than western drug in aspect of promoting the pregnancy. However, inferior quality and high risk of bias the reports involved in this study limits the reliability of this conclusion.