CAJ | 학술논문

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。
목적：탐토곤태효낭대위절경기녀성심혈관병위험인소적영향。방법선택2013년1~3월취진우아원부과문진적위절경기부녀60례，수궤분위시험조(곤태효낭，30례)화대조조(유생소E，30례)，치료6개월，분별우치료전급치료후3개월화6개월측량치료전후적Kupperman경년기지수(KMI)、체중、초민C반응단백(hs-CRP)、저밀도지단백담고순(LDL-C)、고밀도지단백담고순(HDL-C)급당화혈홍단백(HbA1c)，병기록치료기간용약상관병발증。결과채용의향성분석(Intention-to-treat，ITT)표술결과。여대조조급치료전비교，복용곤태효낭균가유효개선녀성위절경기증상，KMI교치료전현저강저(P<0.05)；지속응용지6개월，가유효강저hs-CRP수평(P<0.05)；차hs-CRP강저적정도여KMI적개선정황구유일정적상관성(r=0.64，P<0.05)。단곤태효낭대BMI、혈지화혈당공제정황적개선칙무명현우세(P>0.05)。곤태효낭치료기간，유방창통화두훈、두통등시교상견적불량반응。결론곤태효낭능현저개선녀성위절경기증상，장기응용가강저체내염증반응，가능유익우감소심혈관불량사건적발생。
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.