坤泰胶囊与雌激素替代疗法联合治疗围绝经期综合征的疗效分析

目的:观察坤泰胶囊联合雌激素替代疗法治疗围绝经期综合征（MPS）的临床疗效及安全性。方法:选取160例MPS病人，按照随机数字法随机分为对照组和观察组，每组80例。对照组给予常规药物戊酸雌二醇2 mg，1次/天；观察组给予戊酸雌二醇1 mg，1次/天，且口服坤泰胶囊4粒/次，3次/天，2组均于治疗后10 d给予安宫黄体酮口服，每次2 mg，每天1次。2组均治疗3个治疗周期。观察2组治疗前后的改良Kupperman症状评分及检测其治疗前后血清雌激素（E₂）、阴道细胞成熟值、子宫内膜厚度、血脂等情况。记录消化道、阴道出血、乳房胀痛症状。结果:治疗后2组Kupperman评分均较治疗前明显下降（P<0.01），且观察组下降更为明显（P<0.01）。治疗3个月后，观察组治疗总有效率为90.0%，高于对照组的72.5%（P<0.01）。2组治疗后卵泡刺激素、黄体生成素、E₂与治疗前相比均显著变化（P<0.01），且观察组治疗后卵泡刺激素、E₂改善情况优于对照组治疗后（P<0.05）。观察组不良反应率为3.75%，低于对照组的12.50%（P<0.05）。结论:坤泰胶囊联合小剂量雌激素替代疗法治疗MPS，不仅可显著改善病人的临床症状，且安全性高，值得临床推广。

The curative effect of Kuntai capsule combined with estrogen replacement therapy in the treatment of menopause syndrome

Objective:To observe the clinical effects and safety of the Kuntai capsule combined with estrogen in the treatment of menopause syndrome(MPS).Methods:One hundred and sixty MPS patients were randomly divided into the control group and observation group according to the random number method(80 cases each group).The control group was treated with conventional drug(2 mg/d of pentanoic acid estradiol),and the observation group was treated with 1 mg/d of pentanoic acid estradiol(once a day) combined with Kuntai capsule(4 granules/time,3 times/d) by oral.After 10 d of treatment,two groups were treated with medroxyprogesterone acetate(2 mg/time,once a day) by oral for 3 treatment cycles.The Kupperman symptom score,serum level of estrogen(E₂),vaginal cell mature value,endometrial thickness and blood lipid in two groups between before and after treatment were compared,and the digestive tract,vaginal bleeding and breast pain symptoms in two groups were recorded.Results:After treatment,the Kupperman scores in two groups significantly decreased compared with before treatment(P<0.01),which in observation group was more significant(P<0.01).After 3 months of treatment,the total effective rate in observation group(90.0%) was higher than that in control group(72.5%)(P<0.01).After treatment,there were significant changes in follicle stimulating hormone,luteinizing hormone and E₂(P<0.01),and the improvement of follicle stimulating hormone and E₂ in observation group was better than that in control group(P<0.05).The adverse reaction rate in observation group(3.75%) was lower than that in control group(12.50%)(P<0.05).Conclusions:Kuntai capsule combined with small dose of estrogen replacement therapy in treating MPS can significantly improve the patient's clinical symptoms,which is safe and worthy of clinical promotion.