坤泰胶囊与激素替代疗法对绝经早期妇女认知功能及心理状态影响的随机对照临床研究  

Effects of Kuntai Capsule and hormone replacement therapy on cognitive function and mental symptoms of early postmenopausal women:a randomized controlled trial

作　　者：李文娟[1] 许良智[1] 刘宏伟[1] 张静 唐柳林[1] 周玲玲[1] 庄静[1] 刘颖[1] 刘晓芳[1] 

机构地区：[1]四川大学华西第二医院妇产科,四川成都610041

出　　处：《中西医结合学报》2010年第4期321-327,共7页Journal of Chinese Integrative Medicine

基　　金："十五"国家医学科技攻关课题资助项目(No.2004BA720A08;No.JH2006311542241)

摘　　要：背景:结合雌激素(conjugated equine estrogen,CEE)是激素替代疗法常用药物之一,在围绝经期和绝经后妇女中应用由于安全性问题而受到限制。对于有激素替代疗法禁忌证和慎用证的患者,中药治疗成为另一选择。目的:比较中成药坤泰胶囊和CEE对绝经早期妇女认知功能及心理状态的影响并评估其安全性。设计、场所、对象和干预措施:收集四川大学华西妇女儿童医院绝经早期门诊患者57例,将其随机分为坤泰组28例和激素组29例,治疗并观察1年。坤泰组给予坤泰胶囊(每粒0.5 g),2 g/次,3次/d;激素组给予CEE 0.6 mg/d与0.3 mg/d交替使用(平均0.45 mg/d),有子宫者,加用醋酸甲羟孕酮,2 mg/d。主要结局指标:自给药日起每3个月评价一次认知功能及心理状态,记录不良反应,以意向性分析(intentionto treat,ITT)法和符合方案集(per-protoeol set,PPS)法分别分析。结果:两组治疗后各时点简易智能精神状态量表(Mini-Mental State Examination,MMSE)的认知功能、Kupperman指数及绝经后生存质量(quality of life,QOL)量表的心理状态评分与治疗前相比,差异有统计学意义(P<0.05),但激素组与坤泰组治疗后上述评分比较,差异无统计学意义(P>0.05)。两组MMSE评分呈逐步上升趋势,Kupperman指数与QOL心理症状评分呈逐步下降趋势。治疗过程中两组均无严重不良事件发生,除阴道出血发生率激素组(39.3%)高于坤泰组(11.1%),且差异有统计学意义(x^2=5.750,P=0.029),其余不良反应比较,两组差异均无统计学意义。结论:坤泰胶囊与CEE在维持绝经早期妇女的正常认知功能和改善心理症状方面有一定作用。Background：Conjugated equine estrogen（CEE） treatment,a hormone replacement therapy,is restricted for use in perimenopausal and postmenopausal women because of security issues.Consequently,traditional Chinese herbal medicine has become an alternative choice for the patients with contraindications to hormone replacement therapy. Objective：To evaluate the efficacy and safety of Kuntai Capsule and CEE in treating cognitive function disorder and mental symptoms of early postmenopausal women. Design,setting,participants and interventions：A total of 57 cases of early postmenopausal women from Outpatient Department of West China Women and Children＇s Hospital were included.The subjects were randomly divided into two groups：Kuntai group with 28 cases and CEE group with 29 cases.The patients in Kuntai group received 6 g Kuntai capsules three times a day.The patients in CEE group received CEE 0.3 mg and 0.6 mg alternately once a day（average dose of 0.45 mg/d）.The patients with intact uterus in CEE group were treated with 2 mg medroxyprogesterone acetate daily. Main outcome measures：In one-year treatment course,the recognition function and mental symptoms of each patient were investigated by questionnaires of Mini-Mental State Examination（MMSE）,Kupperman,and quality of life（QOL） every three months.Both intention-to-treat（ITT） and per-protocol set（PPS） analyses were done. Results：The MMSE,Kupperman index and QOL scores at each time point were improved as compared with those before treatment（P0.05）,however there were no statistical differences between the two groups （P0.05）.The MMSE scores showed a tendency to escalate while mental symptoms investigated by Kupperman index and QOL scale showed a downtrend.No severe adverse effects occurred in the study phase and no statistical difference in incidence of side effects between the two groups was found except for vaginal bleeding.The incidence rates of vaginal bleeding in CEE and Kuntai groups were 39.3%and 11.1%respectively （P=0.029�

关 键 词：绝经早期 中药 雌激素替代疗法 认知 随机对照试验 

分 类 号：R711.75[医药卫生—妇产科学]