九味镇心颗粒治疗妇女围绝经期症状的随机对照研究

Randomized controlled trial of Jiuwei Zhenxin Keli in the treatment of women's perimenopausal symptoms

目的以坤泰胶囊为对照,探讨九味镇心颗粒治疗妇女围绝经期症状的疗效及安全性。方法将64例围绝经期症状妇女随机分为试验组(予九味镇心颗粒)31例和对照组(予坤泰胶囊)33例,治疗时间均为3个月,治疗前后采用改良Kupperman评分评估治疗效果,并检测外周血雌二醇变化情况。结果试验组治疗有效率为84%,对照组治疗有效率为85%,2组治疗有效率比较无显著性差异(P=0.906)。但在失眠及头痛症状改善程度方面,试验组略优于对照组(P均<0.05),而在阴道干痛症状的改善程度方面,试验组略逊于对照组(P<0.01)。试验组治疗前后外周血雌二醇水平无明显变化,对照组治疗后雌二醇水平较治疗前明显升高(P<0.05),且高于试验组(P<0.05)。治疗后2组患者均无严重药物不良反应发生。结论九味镇心颗粒对改善妇女围绝经期症状的总疗效及安全性与坤泰胶囊相当,而且对部分症状的改善效果各有优势。

Objective It is to explore the efficacy and safety of Jiuwei Zhenxin Keli compared to Kuntai Capsules in the treatment of women＇ s perimenopausal symptoms. Methods 64- women with perimenopausal symptoms were randomly divided into the trail group （n = 31 , treated with Jiuwei Zhenxin Keli） and the control group （n = 33, treated with Kuntai Capsules） , both groups were treated for 3months. The modified Kupperman index was used to evaluate the efficacy and the changes of the estradiol concentration in peripheral blood were detected. Results The total effective rat was 84% in trail group and 85% in control group, there was no significant difference between the two groups in the effective rate （P = 0. 906）. Whereas the trail group showed better improvements of symptoms of insomnia and headache （ P 〈 0.05 ） , and the improvements of vagina pain and dry symptom in control group were better（P 〈 0.01 ）. There was no significant changes of estradiol concentration after treatment in trail group, but the post-treatment estradiol concentration in control group increased significantly （P 〈 0.05 ） , and was higher than that of the trail group （P 〈 0.05）. No serious side effect was happened in patients of both groups. Conclu- sion Jiuwei Zhenxin Keli has an equivalent total efficacy on women＇ s perimenopausal symptoms compared to Kuntai Capsules and both medicines have their own advantages on some symptoms.