坤泰胶囊与激素替代疗法治疗更年期综合征有效性和安全性比较的Meta分析

目的通过Meta分析比较坤泰胶囊与激素替代疗法治疗更年期综合征的有效性和安全性。方法 计算机检索PubMed、EMbase、The Cochrane Library、中国生物医学文献数据库（CBM）、中国期刊全文数据库（CNKI）、中国博士学位论文全文数据库、中国优秀硕士学位论文全文数据库、维普数据库、万方数据库；手工检索相关资料。按照Cochrane系统评价的方法，逐一评价纳入研究的质量，提取有效数据，采用Revman 5.0.2软件进行Meta分析。结果共纳入了8个随机对照试验，包括675例患者。结果显示，坤泰胶囊组与雌激素治疗组比较，Kupperman症状评分变化值［MD =1.91，95%CI （－0.31， 4.12）］与有效率［OR=1.37，95%CI （0.66， 2.85）］相近（P>0.05）；雌二醇（E2）水平变化值［MD =－12.8，95%CI（－22.85，－2.76）］ 与FSH水平变化值［MD=17.96，95%CI（3.03， 32.88）］方面低于雌激素治疗组；坤泰胶囊组与雌激素治疗组比较，在总不良反应发生率［OR =0.41，95%CI（0.24， 0.73）］、乳房胀痛发生率［OR =0.65，95%CI（0.42， 1.00）］以及阴道出血发生率［OR合并=0.26，95%CI（0.17， 0.40）］方面，均明显低于雌激素治疗组。结论现有有限证据表明，与雌激素治疗组比较，坤泰胶囊也能一定程度地改善更年期妇女的临床症状，在改善体内激素水平方面不及雌激素治疗组，但对减少总不良反应以及乳房胀痛、阴道出血发生率上存有一定优势。

英文摘要:

Objective To evaluate the efficacy and safety of Kuntai Capsule （KC） and hormone replacement therapy （HRT） in treating menopause syndrome by Meta analysis. Methods Randomized controlled trials were electronically retrieved from PubMed， EMbase， The Cochrane Library， CBM， CNKI， Chinese Doctoral Dissertation Full Text Database， Chinese Outstanding Masters′ Dissertation Full Text Database， and VIP database， Wanfang Database， and some other related papers were manually checked. All papers were assessed according to the Cochrane Handbook for Systematic Reviews of interventions and then effective data were analyzed by RevMan 5.0.2 Software. Results Eight randomized control trials involving 675 patients were included. Results of Meta analysis showed that there was no statistical difference in the Kupperman Menopausal Scores ［MD=1.91， 95%CI （－0.31， 4.12）］ and the effective rate of Kupperman Menopausal Scores ［OR=1.37， 95%CI （0.66， 2.85）］ between the KC group and the estrogen replacement therapy group （P>0.05）. Compared with the KC group， the E2 level ［MD=－12.8， 95%CI （－22.85，－2.76）］ and the FSH level ［MD=17.96， 95%CI （3.03， 32.88）］ could be significantly improved in the estrogen replacement therapy group. Compared with the estrogen replacement group， KC could significantly reduce the total incidence of adverse reactions ［OR=0.41， 95%CI （0.24， 0.73）］， the incidence of breast distending pain ［OR=0.65，95%CI （0.42， 1.00）］， and the incidence of vaginal bleeding ［OR=0.26， 95%CI （0.17， 0.40）］（P<0.05）. Conclusions The current limited evidence showed that， when compared with the estrogen replacement therapy group， KC could also improve climacteric symptoms. It was inferior to the estrogen replacement therapy group in improving in vivo〖QX）〗 hormone levels. But it was superior in reducing the incidence of adverse reactions， breast distending pain， and vaginal bleeding.

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