坤泰胶囊与戊酸雌二醇对更年期综合征各种症状的不同疗效分析

目的分析中成药坤泰胶囊与西药戊酸雌二醇(E2V)对更年期综合征各种症状的不同疗效。方法选择2002年4月至2003年8月在北京协和医院和北京大学第一临床医院就诊的更年期综合征患者147例,进行随机、双盲、双模拟平行对照研究3个月,将每日潮热3次以上的更年期妇女随机分为坤泰组(坤泰胶囊4粒,每日3次,77例)和E2V组(协坤片0.5 mg,每晚1次,70例),按照停经时间再分为绝经过渡期和绝经后两亚组。研究期间患者记录症状日记,随访时由专人进行改良Kupperman症状(K)评分评估更年期症状。结果①治疗3个月时,坤泰组和E2V组K评分较治疗前均有统计学意义(P<0.05)。坤泰组、E2V组K评分临床有效率分别为86.2%、78.9%,两组比较差异无统计学意义(P>0.05)。坤泰过渡期组、绝经后组K评分临床有效率分别为96.5%、77.7%,两组比较差异有统计学意义(P<0.05)。②两种药物对不同停经时间亚组患者的潮热评分疗效比较差异无统计学意义(P>0.05)。随治疗时间延长,两组的各种症状治疗有效率均明显提高。除头晕、阴道干涩外,两种药物对K评分中其余10项症状的疗效均无统计学意义(P>0.05)。过渡期组患者感觉异常、忧郁、头晕、疲乏、肌肉关节痛、头痛6项症状,在治疗1周和1个月时坤泰组疗效优于E2V组。结论坤泰胶囊和E2V对改善更年期综合征症状均有效。坤泰胶囊对过渡期患者的疲乏、头痛等症状疗效优于小剂量E2V,而对绝经后患者的阴道干涩疗效后者优于前者。

Effects of Kuntai Capsule and Estradiol Valerate on Different Symptoms of Climacteric Syndrome

Objective To analyze the different effects of Kuntai capsule,a traditional Chinese preparation and estradiol valerate on different symptoms of climacteric syndrome.Methods One hundred and fortyseven perimenopausal women with hot flushes more than 3 times a day from Peking Union Medical College Hospital and the First Hospital Affiliated to Peking University from Apr.2002 to Aug.2003 were randomly assigned to the Kuntai group(4,tid,77 cases) and estradiol valerate(E2V) group(0.5 mg,qn,70 cases) for 3 months.The patients were assigned to subgroup according the time of menostasis.Climacteric symptoms were recorded daily in diary.Kupperman score(KS) were assessed by a specified doctor.Results ①KS were significantly decreased in both groups at similar extent after 3 months treatment comparing with the baseline(P < 0.05).The KS clinical efficiency of kuntai group and E2V group was respectively 86.2%,78.9%,no significant differences between the two groups(P > 0.05).The KS clinical effective rate in perimenopausal period and postmenopausal period of kuntai group was 96.5% vs 77.7%(P < 0.05).②Two kinds of drugs effect on hot flashes score of different menopause stage patients has no significant difference(P > 0.05).With time prolonging,the symptoms and treatment efficiency of the two groups were significantly improved.Except dizziness,vaginal dryness,efficacy on the remaining 10 symptoms in K score of two kinds of drugs had no statistically significant difference(P > 0.05).Transition period group of patients often had the symptoms of abnormal sensation of dizziness,fatigue,depression,headache,muscle and joint pain,after treatment of 1 week and 1 month Kuntai group effect was better than that of E2V group.Conclusion Kuntai capsule and E2V are both efficient for climacteric syndrome.Kuntai capsule is more efficient than E2V for symptoms such as lasstitude and dizzeness in perimenopausal women,but the latter was more efficient for vaginal dryness in postmenopausal women.