天泰1号治疗轻度认知障碍前瞻性多中心随机双盲对照临床研究  

A Prospective Multicenter Randomized Double-blinded Controlled Clinical Trial on Effects of Tiantai No.1 in Treating Mild Cognitive Impairment

作　　者：吴正治[1] 钟琪 孙苏萍 李明[1] 张琼芳[1] 曹美群[1] 贾秀琴[1] 李耀芳[1] 陈蔓茵[1] 

机构地区：[1]南方医科大学附属深圳医院,广东518035 [2]广东省广州市番禺区老人院 [3]广东省珠海市慈安护老中心

出　　处：《中国中西医结合杂志》2010年第3期255-258,共4页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：国家中医药科技专项计划项目(No.02-03LP41);广东省科技厅中医药现代化重大专项课题(No.2006B35630007)

摘　　要：目的观察天泰1号对临床干预轻度认知障碍(mild cognitive impairment,MCI)的有效性及安全性。方法参照目前国际公认的MCI诊断标准,筛选出128例MCI患者,随机分为天泰1号治疗组(简称治疗组,65例)和安慰剂对照组(简称对照组,63例),服药6个月,观察用药前后综合认知功能及即刻记忆、短程记忆、计算能力、时空定向、语言理解等能力的变化及不同中医证候疗效。另选30名健康老年人为正常对照组(简称正常组)。结果MCI患者的认知功能较正常组明显降低(P<0.01)。用药后治疗组综合认知能力及即刻记忆、短程记忆、计算能力、地点定向、语言理解等明显提高(P<0.05,P<0.01),且优于对照组(P<0.01),治疗组的临床疗效指数高于对照组,虚证组综合认知能力优于虚实夹杂证组(P<0.05);治疗结束后随访1年,治疗组向阿尔茨海默病(Alzheimer′s disease,AD)的转化例数(2例)少于对照组(9例,P<0.01)。结论天泰1号可以显著改善MCI患者的认识障碍,并能降低MCI向AD的转化。Objective To observe the clinical effectiveness and safety of Tiantai No. 1 （TT1 ） in treating mild cognitive impairment （MCI）. Methods With randomized double-blinded method adopted, the 128 MCI patients, selected according to the commonly accepted standard for MCI diagnosis, were assigned to 2 groups, the treatment group （65 cases） treated with TT1 and the control group （63 cases） treated with placebo for six months. Besides, a normal control group with 30 healthy elders was set up. Changes of comprehensive cognitive function, instant memory, short-term memory, calculation ability, orientating ability of time and space, language understanding ability as well as Chinese medicine syndromes before and after treatment were observed and compared. Results The cognitive function of MCI patients was significantly lower than that of healthy elders （ P 〈 0.01 ）. The comprehensive cognitive function, and all the above-mentioned abilities were significantly improved （P〈0.05, P〈0.01 ） in the TT1 treated group after treatment, with an effect significantly better than that in the placebo treated group （ P 〈 0.01 ）. Overall evaluation of effect and safety suggested that the clinical effectiveness index （CEI） of TT1 was notably higher than that of the placebo. And it was found in one-year follow-up that the incidence of developing to Alzheimer＇s disease （AD） in the treatment group was strikingly lower than that in the control group （ P 〈0.01 ）. Conclusion TT1 can significantly improve the cognitive function of MCI patients, and reduce their incidence of developing to AD.

关 键 词：天泰1号 轻度认知障碍 认知功能 随机 双盲 多中心临床研究 

分 类 号：R277.7[医药卫生—中医学]