坤泰胶囊治疗围绝经期综合征患者30例临床观察  

Clinical Observation on 30 Perimenopausal Syndrome Cases Treated by Kuntai Capsules

作　　者：陈继明[1] 高红艳[1] 李沁[1] 

机构地区：[1]苏州大学附属第三医院,江苏省常州市局前街185号213003

出　　处：《中医杂志》2015年第3期231-234,共4页Journal of Traditional Chinese Medicine

基　　金：常州市卫生创新人才培养工程(常卫科教〔2010〕368号)

摘　　要：目的观察坤泰胶囊治疗围绝经期综合征患者的临床疗效及安全性。方法将58例围绝经期综合征患者随机分为坤泰组30例和替勃龙组28例,坤泰组给予坤泰胶囊口服,每次2 g,每日3次;替勃龙组给予替勃龙片口服,每次1.25 mg,每日1次,两组均连续治疗12周。于治疗前及治疗第4、8、12周时进行Kupperman绝经指数(KMI)评分,计算KMI总分及潮热出汗评分;同时检测两组患者治疗前后肝肾功能、血脂、子宫内膜厚度及血清性激素水平变化,判定临床疗效,记录不良反应发生情况。结果两组临床疗效比较无统计学差异(P>0.05)。两组治疗第4、8、12周时KMI总分及潮热出汗评分均较本组治疗前明显下降(P<0.05)。两组患者肝肾功能、血脂、子宫内膜厚度治疗前后比较差异无统计学意义(P>0.05)。替勃龙组治疗后雌二醇(E2)水平明显高于本组治疗前,卵泡刺激素(FSH)水平明显降低(P<0.05)。坤泰组不良反应发生率为30.00%明显低于替勃龙组的60.71%(P<0.05)。结论坤泰胶囊治疗围绝经期综合征患者疗效与替勃龙片相当,能明显改善临床症状,并且坤泰胶囊不良事件的发生率更低。Objective To observe the clinical efficacy and safety of Kuntai Capsules in the treatment of perimenopausal syndrome. Methods Totally 58 patients with perimenopausal syndrome were randomly divided into Kuntai group of 30 cases with Kuntai Capsules orally,2 g each time,3 times per day and Tibolone group of 28 cases with tibolone tablets,1. 25 mg each time,one time a day,for 12 weeks. Kupperman menopause index（ KMI） and hectic fever and perspiration were scored before treatments and on week 4,8 and 12. At the mean time,liver and kidney function,blood lipids,endometrial thickness and serum hormone levels were detected to determine the clinical efficacy,with adverse reactions recorded. Results The clinical efficacy in the two groups showed no significant difference（ P〉0. 05）. The KMI scores and hectic fever and perspiration scores were significantly decreased on week4,8 and 12 compared within groups（ P〈0. 05）,and the liver and kidney function,blood lipids and endometrial thickness before and after indicated no statistical significance（ P〉0. 05）. After treatments,estradiol（ E2） levels in the Tibolone group were significantly higher,while the follicle stimulating hormone（ FSH） levels was lower（ P〈0. 05）. The incidence of adverse reactions in the Kuntai group was 30. 00%,which was significantly lower than60. 71% in the Tibolone group（ P〈0. 05）. Conclusion The clinical efficacy of Kuntai Capsules was equivalent to tibolone tablets,which can notedly reduce symptoms with less adverse effects.

关 键 词：围绝经期综合征 坤泰胶囊 Kupperman绝经指数 

分 类 号：R271.116[医药卫生—中医妇科学]