养血清脑颗粒治疗急性脑梗死的Meta分析和试验序贯分析  

Meta-analysis and Experimental Sequential Analysis of Yangxue Qingnao Granules in the Treatment of Acute Cerebral Infarction

作　　者：张月婵 张云云[1] 韦紫君 曹孟欣 ZHANG Yuechan;ZHANG Yunyun;WEI Zijun;CAO Mengxin(Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China)

机构地区：[1]上海中医药大学附属岳阳中西医结合医院,上海200437

出　　处：《中西医结合心脑血管病杂志》2022年第13期2347-2354,共8页Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease

基　　金：上海市科学技术委员会中医引导项目(No.19401934900)。

摘　　要：目的系统评价养血清脑颗粒治疗急性脑梗死的有效性及安全性。方法计算机检索PubMed、EMbase、中国生物医学文献数据库(CBM)、中国知网(CNKI)、万方、重庆维普数据库(VIP)等数据库,搜集养血清脑颗粒治疗急性脑梗死的随机对照试验(RCT),检索时限为建库至2020年9月。利用RevMan 5.3软件进行Meta分析。结果共检索到相关文献213篇,最终纳入11项RCT,总样本量1180例,其中试验组591例,对照组589例。Meta分析结果显示:试验组临床疗效优于对照组[RR=1.23,95%CI(1.17,1.30),P<0.00001],治疗后美国国立卫生研究院卒中量表(NIHSS)评分低于对照组[MD=-4.51,95%CI(-6.55,-2.46),P<0.0001],治疗后Barthel指数(BI)评分高于对照组[MD=11.97,95%CI(8.33,15.60),P<0.00001];试验组治疗后血浆黏度[MD=-0.45,95%CI(-0.74,-0.17),P=0.002]、全血高切黏度[MD=-1.14,95%CI(-1.60,-0.68),P<0.00001]、纤维蛋白原[MD=-0.65,95%CI(-0.99,-0.32),P=0.0001]均低于对照组,差异均有统计学意义,而两组在降低全血低切黏度方面比较,差异无统计学意义[MD=-1.26,95%CI(-3.32,0.80),P=0.23]。两组不良反应发生率比较差异无统计学意义。试验序贯分析显示:纳入研究的总有效率穿过了传统界值,但略低于试验序贯分析界值,提示本次Meta分析可能得到假阳性结论,需要更多的临床试验以确证其疗效。结论现有研究表明,养血清脑颗粒治疗急性脑梗死,可提高临床疗效,改善神经功能缺损程度、日常生活活动能力,改善血液流变学指标,且安全性较好。Objective To evaluate the efficacy and safety of Yangxue Qingnao Granules in the treatment of acute cerebral infarction.Methods The randomized controlled trials(RCTs)of Yangxue Qingnao Granules in the treatment of acute cerebral infarction were searched from PubMed,EMbase,CBM,CNKI,WanFang,VIP,and other databases.The retrieval period was from the database construction to September 2020.RevMan 5.3 software was used for Meta-analysis.Results A total of 213 literature were searched,and 11 RCTs were finally included,with 1180 patients,including 591 patients in observation group and 589 patients in control group.Meta-analysis results showed that,the clinical efficacy of observation group was better than that of control group[RR=1.23,95%CI(1.17,1.30),P<0.00001],National Institutes of Health Stroke Scale(NIHSS)score of observation group was lower than that of control group[MD=-4.51,95%CI(-6.55,-2.46),P<0.0001],Barthel index(BI)score of observation group was higher than that of control group[MD=11.97,95%CI(8.33,15.60),P<0.00001],plasma viscosity[MD=-0.45,95%CI(-0.74,-0.17),P=0.002],whole blood high-shear viscosity[MD=-1.14,95%CI(-1.60,-0.68),P<0.00001],and fibrinogen[MD=-0.65,95%CI(-0.99,-0.32),P=0.0001]were lower than those in control group.However,there was no statistical difference in the whole blood low-shear viscosity between two groups[MD=-1.26,95%CI(-3.32,0.80),P=0.23].There was no significant difference in the incidence of adverse reactions.Sequential analysis of experiments showed that the total effective rate of the included studies passed through the traditional cut-off value,but slightly lower than the test sequential analysis threshold,suggesting that this Meta-analysis might obtain false-positive conclusions,and more clinical trials were needed in order to confirm the efficacy.Conclusion The current research indicates that Yangxue Qingnao Granules is effective in treating acute cerebral infarction,and it can improve the degree of neurological impairment,ability of daily living activities,and hemorheology ind

关 键 词：急性脑梗死 养血清脑颗粒 日常生活活动能力 血液流变学 Meta分析 试验序贯分析 

分 类 号：R74[医药卫生—神经病学与精神病学]