中药治疗卒中后认知障碍疗效和安全性的系统评价  

Systematic Evaluation of Clinical Efficacy and Safety of Traditional Chinese Medicine forPost Stroke Cognitive Impairment

作　　者：申伟 曾子修 金香兰[2] 鲁喦[3] 王莹 李施新 赵施娇 门慧 黎明全[4] 赵建军[4] 张虎 王振垚 杨健[6] 熊昕[6] 余尚贞 石青 张允岭 SHEN Wei;ZENG Zi-xiu;JIN Xiang-lan;LU Yan;WANG Ying;LI Shi-xin;ZHAO Shi-jiao;MEN Hui;LI Ming-quan;ZHAO Jian-jun;ZHANG Hu;WANG Zhen-yao;YANG Jian;XIONG Xin;YU Shang-zhen;SHI Qing;ZHANG Yun-ling(Graduate School,Beijing University of Chinese Medicine,Beijing 100029,China;Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Affiliated Hospital of Changchun University of Chinese Medicine,Changchun 130021,China;Shunyi Hospital of Beijing Hospital of Traditional Chinese Medicine(TCM),Beijing 101300,China;Chongqing TCM Hospital,Chongqing 400011,China;Jiangmen Wuyi Hospital of TCM,Jiangmen 529000,China)

机构地区：[1]北京中医药大学研究生院,北京100029 [2]北京中医药大学东方医院,北京100078 [3]中国中医科学院西苑医院,北京100091 [4]长春中医药大学附属医院,长春130021 [5]北京中医医院顺义医院,北京101300 [6]重庆市中医院,重庆400011 [7]江门市五邑中医院,广东江门529000

出　　处：《中国实验方剂学杂志》2020年第11期185-193,共9页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家中医药管理局中医药行业科研专项(201407001-8);国家中医药管理局中医药传承与创新“百千万”人才工程(岐黄学者)——国家中医药领军人才支持计划项目(国中医药人教发[2018]12号)。

摘　　要：目的:评价中药治疗卒中后认知障碍(PSCI)的疗效与安全性。方法:计算机检索中国知网数据库,万方数据库,维普数据库,中国生物医学文献数据库,PubMed,The Cochrane library和ClinicalTrials.gov共7个数据库,纳入中药治疗PSCI的随机对照试验(RCT)。使用Cochrane偏倚风险评估工具对纳入研究的方法学质量进行评价,并对纳入研究进行描述性分析,应用RevMan 5.3软件进行Meta定量分析。结果:共纳入16项RCT,1296例受试者,干预组649例,对照组647例。研究结果显示中药联合西药组和中药组干预在改善PSCI患者蒙特利尔认知评估量表,简易精神状态检查量表,Barthel指数评定量表,日常生活能力量表,中国脑卒中临床神经功能缺损程度评分量表和美国国立卫生研究院卒中量表的评分上均优于西药组,且未见严重的不良反应。结论:中药在改善PSCI患者的认知功能水平方面具有潜在优势,对改善日常生活能力及神经功能缺损症状也有一定疗效,并未观察到严重不良事件。本文纳入研究的方法学质量不高,建议后续开展高质量的RCT来研究中药治疗PSCI的疗效和安全性,为该疾病的临床诊疗提供决策依据。Objective:To evaluate the efficacy and safety of traditional Chinese medicine(TCM)in the treatment of post stroke cognitive impairment(PSCI).Method:Seven databases,including CNKI,WanFang,VIP,CBM,PubMed,The Cochrane library and ClinicalTrials.gov,were electronically searched for relevant randomized controlled trials(RCTs)of TCM in the treatment of PSCI.The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of the included studies,descriptive analysis was carried out on the included studies,and the Meta quantitative analysis was carried out with RevMan 5.3 software.Result:A total of 16 RCTs were included with 1296 participants,and they were assigned to the intervention group(n=649)and the control group(n=647).The results showed that TCM combined with western medicine group and TCM group were better than western medicine group in improving the scores of Montreal Cognitive Assessment(MoCA),Mini-mental State Examination(MMSE),Barthel Index(BI),Activity of Daily Living(ADL),Chinese stroke scale(CSS)and National Institutes of Health stroke scale(NIHSS)of PSCI patients,and no serious adverse events were observed.Conclusion:TCM has potential advantages in improving the cognitive function of patients with PSCI,and it also has certain efficacy in improving the daily living ability and neurological impairment symptoms,and no serious adverse events have been observed.Due to the low quality of methodology included in the studies,in order to provide reliable basis for clinical decision-making,high-quality of RCTs are still needed to study the efficacy and safety of TCM for PSCI.

关 键 词：卒中后认知障碍(PSCI) 中医药 随机对照试验(RCT) Meta分析 认知功能水平 日常生活能力 神经功能缺损 

分 类 号：R277.7[医药卫生—中医学] R28