天智颗粒治疗血管性痴呆有效性及安全性的Meta分析  

Effectiveness and Safety of Tianzhi Granules in The Treatment of Vascular Dementia:A Meta-analysis

作　　者：林伟龙 常俊昭 李跃[1] 杨宏志 吴智兵[3] 李双华[4] LIN Weilong;CHANG Junzhao;LI Yue;YANG Hongzhi;Wu Zhibing;LI Shuanghua(Department of Traditional Chinese Medicine,The Third Affiliated Hospital of Sun Yat-Sen University,Guangzhou 501630,China;Xindu Hospital of Traditional Chinese Medicine,Chengdu 610500,China;The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine,Guangzhou 510405,China;Zhujiang Hospital of Southern Medical University,Guangzhou 510282,China)

机构地区：[1]中山大学附属第三医院中医科,广东广州501630 [2]成都市新都区中医医院,四川成都610500 [3]广州中医药大学第一附属医院,广东广州510000 [4]南方医科大学珠江医院,广东广州510282

出　　处：《中药新药与临床药理》2020年第10期1250-1255,共6页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：广东省医学科研基金项目(A2019086)。

摘　　要：目的评价天智颗粒联合西药治疗血管性痴呆的有效性和安全性。方法计算机检索中国期刊网(CNKI)、万方数据库(Wanfang)、维普数据库(VIP)、中国生物医学文献数据库(SINOMED)等中文数据库及PubMed、Embase、MEDLINE、Cochrane Library等外文数据库,收集天智颗粒治疗血管性痴呆的随机对照临床试验(RCT)文献,检索时限为数据库建库至2019年5月31日。根据纳入标准、排除标准筛选和提取文献资料,采用Rev Man 5.3软件进行Meta分析。结果共纳入12篇RCT文献,共992例患者,其中天智颗粒联合西药治疗组(治疗组)507例,西医常规治疗组(对照组)485例。Meta分析结果显示,治疗组总有效率优于对照组[OR=2.58,95%C(I1.81,3.69),P<0.00001];天智颗粒治疗组能升高简易智力状态检查量表(MMSE)评分[MD=1.15;95%CI(0.77,1.53);P<0.00001]。对于日常生活活动能力量表(ADL)评分,两组疗效相当[MD=-2.00,95%CI(-4.13,0.14),P=0.07]。天智颗粒治疗血管性痴呆未见明显不良反应。结论天智颗粒能有效提高血管性痴呆临床疗效,但所纳入文献的质量不高,样本量较少,亟待开展多中心、大样本、双盲的RCT,以评价天智颗粒的长期疗效及安全性。Objective To assess the effectiveness and safety of Tianzhi granules in the treatment of vasculardementia using meta-analysis.Methods Databases including CNKI,WANFANG,VIP,SINOMED and PubMed,Embase,MEDLINE,Cochrane Library were searched for RCTs of Tianzhi granules on vascular dementia.Wecollected relevant studies which matched the inclusion standards and the exclusion standards.Finally,we performeda meta-analysis with RevMan 5.3 software.Results 12 studies involving 992 participants were included.There were507 cases in the group of Tianzhi granules and 485 cases in the group of western medicine.The meta-analysisshowed that the total effective rate of Tianzhi granule was better than the control group[OR=2.58,95%CI(1.81,3.69),P<0.00001].Tianzhi granules can elevated MMSE score[MD=1.15;95%CI(0.77,1.53);P<0.00001].The two groups has the similar effects for ADL score[MD=-2.00,95%CI(-4.13,0.14),P=0.07].No obviousadverse reactions were observed.Conclusion Tianzhi granules can effectively improve the clinical efficacy of vascular dementia,but the quality of the included literatures is not high,and the sample size is small.So it isurgent to evaluate the long-term efficacy and safety of Tianzhi granules in multi-center,larger sample size,anddouble-blinded RCT study.

关 键 词：天智颗粒 血管性痴呆 疗效 安全性 META分析 

分 类 号：R285.6[医药卫生—中药学]