坤泰胶囊和激素替代治疗围绝经期综合征患者的有效性及安全性荟萃分析  

Meta Analysis of Efficacy and Safety between Kuntai Capsule and Hormone Replacement Therapy for Patients with Perimenopausal Syndrome

作　　者：杜晓琴[1] 衡明莉[2] 徐玲[1] 

机构地区：[1]天津市中心妇产科医院,300100 [2]天津市中医药大学

出　　处：《国际妇产科学杂志》2016年第3期267-271,共5页Journal of International Obstetrics and Gynecology

摘　　要：目的:探讨坤泰胶囊和激素替代疗法治疗围绝经期综合征患者的有效性和安全性。方法:计算机检索Cochrane系统评价数据库、Pub Med、中国知网、维普数据库、万方数据库及其他相关数据库。收集2004年11月—2015年2月间国内公开发表的坤泰胶囊和激素替代疗法治疗围绝经期综合征患者的文献,筛选出随机对照临床试验,且治疗时间至少3个月。通过Meta分析比较2种疗法的有效性和安全性。有效性指标主要包括治疗3个月时的总有效率、Kupperman症状评分、血雌二醇(E2)水平、血卵泡刺激素(FSH)水平。安全性指标主要包括不良反应(胃肠道不适、乳房胀痛和阴道出血等)的发生率。结果:共纳入了15篇文献,包括1 243例患者。2组间总有效率及血FSH水平的变化值比较差异无统计学意义(P>0.05);激素替代组患者Kupperman症状评分、血E2水平高于坤泰组,差异有统计学意义(P<0.05);激素替代组患者的不良反应发生率高于坤泰组,差异有统计学意义(P<0.05)。结论:坤泰胶囊能改善围绝经期综合征患者的临床症状,安全可靠。Objective： To evaluate the efficacy and safety between Kuntai capsule and hormone replacement in treating patients with perimenopausal syndrome. Methods： Such databases as the Cochrane Library, Pub Med, CNKI, VIP and Wanfang Data and others were electronically searched. A systemic review and meta-analysis of publication from November 2004 to February 2015 was performed. The review was limited to randomized controlled trials that compared Kuntai capsule and hormone replacement therapy in treatment of perimenopausal syndrome and therapy period was at least 3 months. The primary outcome assessed was the efficacy at 3 month-time point,including the effective rate of Kupperman Menopausal Scores,blood E2 and FSH level. Safety index mainly includes the incidence of adverse reactions（such as gastrointestinal complains,breast distending pain or vaginal bleeding,etc）. Results： Fifteen studies,including 1 243 total participants were included. The total effective rate and change of blood FSH level showed no significant difference between Kuntai capsule group and the hormone replacement therapy group（P〈0.05）. The Kupperman Menopausal Scores and blood E2 level in the hormone replacement therapy group were higher than Kuntai capsule group（P〈0.05）. Adverse reaction,such as gastrointestinal complains,breast distending pain or vaginal bleeding,Kuntai capsule group was inferior to hormone replacement therapy group in terms of adverse reactions（P0.05）. Conclusions： The current limited evidence showed that, Kuntai capsule could also improve climacteric symptoms and reduce the incidence of adverse reaction.

关 键 词：坤泰胶囊 激素替代疗法 围绝经期 药物疗法 Meta分析 

分 类 号：R711.75[医药卫生—妇产科学]