坤泰胶囊对围绝经期女性心血管病危险因素的影响

目的：探讨坤泰胶囊对围绝经期女性心血管病危险因素的影响。方法选择2013年1~3月就诊于我院妇科门诊的围绝经期妇女60例，随机分为试验组（坤泰胶囊，30例）和对照组（维生素E，30例），治疗6个月，分别于治疗前及治疗后3个月和6个月测量治疗前后的Kupperman更年期指数（KMI）、体重、超敏C反应蛋白（hs-CRP）、低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）及糖化血红蛋白（HbA1c），并记录治疗期间用药相关并发症。结果采用意向性分析（Intention-to-treat，ITT）表述结果。与对照组及治疗前比较，服用坤泰胶囊均可有效改善女性围绝经期症状，KMI较治疗前显著降低（P〈0.05）；持续应用至6个月，可有效降低hs-CRP水平（P〈0.05）；且hs-CRP降低的程度与KMI的改善情况具有一定的相关性（r=0.64，P〈0.05）。但坤泰胶囊对BMI、血脂和血糖控制情况的改善则无明显优势（P〉0.05）。坤泰胶囊治疗期间，乳房胀痛和头晕、头痛等是较常见的不良反应。结论坤泰胶囊能显著改善女性围绝经期症状，长期应用可降低体内炎症反应，可能有益于减少心血管不良事件的发生。

Effects of Kun-Tai capsule on the cardiovascular risk factors in menopausal women

Objective To explore the potential effects of Kun-Tai capsule on the cardiovascular risk factors in climacteric women. Methods Sixty menopausal women of Gynaecology Outpatient Department in our hospital from January 2013 to March 2013 were enrolled. Patients were randomly divided into experimental group （Kun-Tai capsule, KT group, n=30） and control group （vitamin E as placebo, PA group, n=30）. The treatment lasted for 6 months and Kupperman index （KMI） and weight of patients were recorded and blood samples were collected to moni-tor the changes of hs-CRP, LDL-C, HDL-C and HbA1c at pre-treatment, 3 months and 6 months after the treatment. Additionally, drug related adverse events were recorded during the treatment. Results All results were calculated and explained with intention-to-treat （ITT） sample. Compared with PA group and the baseline of KT group, Kun-Tai capsule significantly improved the menopausal symptoms with a markedly decreased of KMI at 3 months after treat-ment （P〈0.05）. Besides, hs-CRP was significantly decreased when the treatment continued to 6 months （P〈0.05）. In-terestingly, the correlation of the change of hs-CRP and KMI was observed （r=0.64, P〈0.05）. However, no more marked improvements of BMI, LDL-C, HDL-C, and HbA1c were detected （P〉0.05）. Breasts distending pain, dizzi-ness and headache were the common adverse events during the treatment. Conclusion Treatment using Kun-Tai capsule can improve the menopausal symptoms and the lower hs-CRP level, suggesting a cardiovascular protective effect might benefit the patients with a long-term treatment.