坤泰胶囊治疗妇女更年期综合征的临床研究

目的:评价中成药坤泰胶囊治疗更年期综合征疗效以及卵巢功能状态对其影响.方法:采用两中心随机、双盲、双模拟平行对照研究3个月,共入组147例,完成123例.每日潮热3次以上的更年期妇女随机分为试验组(坤泰胶囊4粒,tid,n=77)和对照组(戊酸雌二醇片0.5 mg,qd,n=70),按照停经时间再分为绝经过渡期和绝经后2个亚组.用药时间为3个月.研究期间患者记录症状、阴道出血、乳胀等,随访时进行改良Kupperman症状(K)评分评估更年期症状,检测血清雌二醇(E2)、阴道脱落细胞评估治疗反应.结果:治疗3个月时,试验组和对照组K评分临床有效率分别为86.2%和78.9%,潮热评分有效率分别为92.3%和96.5%,两组之间均无显著性差异(P＞0.05).试验组过渡期亚组K评分临床有效率高于对照组,分别为96.5%和71.4%(P＜0.05).治疗3个月时试验组绝经过渡期亚组的E2水平和阴道上皮细胞成熟指数显著增加(P＜0.01,P＜0.05),但增加程度低于对照组.两组均无严重不良反应.结论:坤泰胶囊对改善更年期综合征症状有效,绝经过渡期卵巢尚存有一定功能时效更佳.安全性好,无严重不良反应.

A randomized, mutlti-center, double blind and parallel controlled clinical trial for Kuntai capsules in the treatment of climacteric syndromes

Objective:To evaluate the efficacy and safety of Kuntai capsules,a Chinese Traditional Medicine,in the treatment of climacteric syndrome.Methods:A randomized,double blind,multi-center and parallel control clinical study enrolled 147 menopausal women with hot flushes more than 3 times a day,who were randomly administered with either Kuntai capsules(4 capsules,tid,n=77) or estradiol valerate(E_2V) tablets(0.5 mg,qd,n=70) for 3 months.The patients were stratified according to their perimenopasual and postmenopausal stage in each arm group.The patients were requested to record their climacteric symptoms,vaginal spotting and breast tender on the daily basis,and were assessed in the improvement of climacteric symptoms using the Kupperman Menopausal Scores(KMS) at each scheduled study visit.The serum estradiol(E_2) level and vaginal epithelial maturation index were measured at the beginning and the end of the study.Results:Compared to the estradiol therapy,the Kuntai-treated patients showed no significant difference in the improvement of climacteric symptoms based on the KMS evaluation in the 3-month course of the therapy(86.2% vs.78.9%,P>0.05).The hot flushes were significantly decreased in both groups(92.3% vs.96.5,P>0.05).The E_2 levels and vaginal epithelial cell maturation index were significantly increased in the Kuntai group at the end of therapy,compared with the pre-therapy(P<0.01 and P<0.05,respectively).No serious adverse events were reported.Conclusion:Kuntai capsules provide an alternative therapy for women with climacteric symptoms,and show more efficacies for perimenopausal women than for postmenopausal women.