益肾祛痰活血法治疗血管性痴呆的有效性与安全性评价  

Efficacy and Safety of Kidney-tonifying,Phlegm and Blood Stasis-Removing Method in Treatment of Vascular Dementia

作　　者：董新刚[1] 芦锰[2] 赵云[2] 李伟峰[2,3] DONG Xingang;LU Meng;ZHAO Yun;LI Weifeng(The Finst Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou Henan China 450000;Henan University of Chinese Medicine,Zhengzhou Henan China 450046;The Third Affiliated Hospital of Chinese Medicine,Zhengzhou Henan China 450008)

机构地区：[1]河南中医药大学第一附属医院,河南郑州450000 [2]河南中医药大学,河南郑州450046 [3]河南中医药大学第三附属医院,河南郑州450008

出　　处：《中医学报》2022年第2期439-446,共8页Acta Chinese Medicine

基　　金：河南省科技攻关项目(212102311142);河南省中医药科学研究专项重点课题项目(20-21ZY1054)。

摘　　要：目的:系统评价益肾活血祛痰法治疗血管性痴呆的临床疗效及安全性,寻找循证医学证据支撑。方法:通过计算机检索维普、万方数据、中国知网、SINOMED、Cochrance Library、Embase和PubMed等医学数据库,检索时间跨度从各库建库之日起至2020年6月30日,由两名评价员独立完成文献检索筛和资料提取,应用RevMan 5.3软件分析采集数据,GRADE 3.2软件对纳入研究结局指标进行证据质量评级。结果:本次共纳入15项临床研究,累计1345例患者,其中观察组和对照组分别为623例和722例。Meta结果显示,益肾活血祛痰方药或联合西药治疗血管性痴呆在简易精神状态评价量表(simplified mental state assessment scale,MMSE)[MD=2.76,95%CI(1.56,3.97),P<0.00001]、临床疗效[RR=1.22,95%CI(1.12,1.34),P<0.00001]、日常生活能力量表(activities of daily living,ADL)(亚组)干预时间[MD=-4.28,95%CI(-4.89,-3.66),P<0.00001]、长谷川痴呆量表(Hasegawa dementia scale,HDS)(亚组)干预时间≥60 d[MD=4.83,95%CI(3.85,5.8),P<0.00001]等指标改善方面优于单纯西药对照组,差异具有统计学意义(P<0.05)。安全性方面,1项研究报告了对照组不良事件;1项研究报告了两组均出现不良事件,两组比较,差异无统计学意义(P>0.05),且两项研究均不影响临床治疗。结论:益肾活血祛痰法治疗血管性痴呆安全有效,不良事件发生率低,疗效较为明显。Objective:To systematically evaluate the clinical efficacy and safety of Kidney-tonifying,phlegm and Blood stasis-removing method in the treatment of vascular dementia,and seek evidence-based medical evidence.Method:The medical databases such as VIP,Wanfang Data,CNKI,SINOMED,Cochrane Library,EMBASE,and PubMed were searched from the date of establishment of each database to June 30,2020.The two evaluators independently completed literature search screening and data extraction,and Revman(5.3)was used to analyze data.Grade 3.2 was used to evaluate the evidence quality of the included research outcome indicators.Results:A total of 15 clinical studies were included,involving 1345 patients with 623 patients in the treatment group and 722 patients in the control group,respectively.Meta results showed that the treatment of vascular dementia with kidney-reinforcing,blood-activating and phlegm and Blood-removing prescriptions or combined with western medicine was in the simplified mental state assessment scale(MMSE)[MD=2.76,95%CI(1.56,3.97),P<0.00001],clinical efficacy[RR=1.22,95%CI(1.12,1.34),P<0.00001],activities of daily living(ADL)(subgroup)intervention time[MD=-4.28,95%CI(-4.89,-3.66),P<0.00001],Hasegawa dementia scale(HDS)(subgroup)intervention time≥60 d[MD=4.83,95%CI(3.85,5.8),P<0.00001]and other indicators were better than the western medicine control group in improvement,and the difference was statistically significant(P<0.05).In terms of safety,one study reported adverse events in the control group,and the other study reported adverse events in both groups,But the difference between the two groups was not statistically significant(P>0.05),and neither of the two studies affected clinical treatment.Conclusion:The method of tonifying the kidney and promoting blood circulation and removing phlegm is safe and effective in treating vascular dementia,with a low incidence of adverse events and obvious curative effects.

关 键 词：血管性痴呆 益肾祛痰活血法 META分析 

分 类 号：R277.743[医药卫生—中医学]