摘要
目的系统评价脉血康胶囊治疗急性脑梗死(acute cerebral infarction,ACI)的临床疗效和安全性,以期为ACI的临床治疗提供参考。方法计算机检索国内外7大数据库,收集脉血康胶囊治疗ACI随机对照试验(randomized controlled trial,RCT),采用Cochrane5.1.0偏倚风险评估工具进行方法学质量评价,采用RevMan5.3软件对临床有效率、神经功能评分、血浆纤维蛋白原(fibrinogen,FIB)及不良反应等结局指标进行Meta分析,运用GRADE(grading of recommendations,assessment,development and evaluation)系统对关键结局指标的证据质量和推荐等级进行分级。结果纳入文献19篇,Meta分析结果显示:(1)脉血康胶囊+西医常规治疗提高临床总有效率[RRNIHSS=1.17,95%CI(1.07,1.28),P=0.0008;RRNDS=1.24,95%CI(1.14,1.34),P<0.00001;RR临床症状=1.55,95%CI(1.20,2.00),P=0.0007]、改善神经功能[MD重度卒中=−6.24,95%CI(−6.86,−5.62),P<0.00001;MD中度卒中=−1.97,95%CI(−2.91,−1.03),P<0.0001;MDNDS=−5.11,95%CI(−7.36,−2.85),P<0.00001]、降低FIB[MD=−0.86,95%CI(−1.13,−0.59),P<0.00001]均优于单独西医常规治疗,两组不良反应发生率[RR=0.58,95%CI(0.29,1.18),P=0.13]差异无统计学意义。(2)脉血康胶囊+动脉溶栓术+西医常规治疗以临床神经功能缺损程度评分标准(clinical nerve deficiency scale,NDS)为疗效评定标准的临床总有效率[RRNDS=1.30,95%CI(1.14,1.47),P<0.0001]、改善神经功能评分优于动脉溶栓术+西医常规治疗,且差异具有统计学意义(P<0.05),两组比较在以美国国立卫生研究院卒中量表(national institutes of health stroke scale,NIHSS)为疗效评定标准的临床总有效率[RRNIHSS=1.15,95%CI(0.97,1.37),P=0.11]、降低FIB[MD=−0.16,95%CI(−0.33,−0.00),P=0.05]、不良反应发生率(P=0.50)方面差异无统计学意义。(3)脉血康胶囊+重组人组织型纤溶酶原激活剂(rt-PA)静脉溶栓+西医常规治疗降低FIB、改善神经功能缺损优于rt-PA静脉溶栓+西医常规治疗,差异�
Objective To systematically evaluate the efficacy and safety of Maixuekang Capsule(脉血康胶囊)in the treatment of acute cerebral infarction(ACI).Methods Randomized controlled trials(RCT)were retrieved from seven databases.The methodological quality of the included studies was evaluated by using the Cochrane 5.1.0 bias tool.Meta-analysis was performed to analyze the result indexes of clinical effective rate,neurological function score,fibrinogen(FIB),and adverse drug reaction using RevMan5.3 software.The evidence quality was evaluated according to the GRADE profile.Results A total of 19 articles were included.The results of Meta analysis showed that MXK+western medicine treatment(WMT)could significantly improve the clinical efficacy[RRNIHSS=1.17,95%CI[1.07,1.28],P=0.0008;RRNDS=1.24,95%CI[1.14,1.34],P<0.00001;RRclinical symptoms=1.55,95%CI[1.20,2.00],P=0.0007],neurological function[MDsevere stroke=−6.24,95%CI[−6.86,−5.62],P<0.00001;MDmoderate stroke=−1.97,95%CI[−2.91,−1.03],P<0.0001;MDNDS=−5.11,95%CI[−7.36,−2.85],P<0.00001],and decrease plasma fibrinogen content[MD=−0.86,95%CI[−1.13,−0.59],P<0.00001].In terms of adverse reaction rate,there was no statistic difference between the combination of MXK+WMT and WMT[RR=0.58,95%CI[0.29,1.18],P=0.13].MXK+arterial thrombolysis+WMT could improve the clinical efficacy evaluated by clinical nerve deficiency scale(NDS)[RRNDS=1.30,95%CI[1.14,1.47],P<0.0001]and neurological function.In terms of improving the clinical efficacy evaluated by NIHSS and decreasing the plasma fibrinogen content and adverse reaction rate,there was no statistic difference between the combination of MXK+arterial thrombolysis+WMT and arterial thrombolysis+WMT[MD=−0.16,95%CI[−0.33,−0.00],P=0.05;RRNIHSS=1.15,95%CI[0.97,1.37],P=0.11].MXK+rt-PA+WMT could improve neurological function and decrease plasma fibrinogen content with a statistically significant difference between the two groups(P<0.05).Conclusion In treating ACI,MXK+WMT could improve the clinical efficiency,neurologi
作者
李婷婷
孙千惠
王博远
刘伟地
王思锦
李明轩
高颖
LI Ting-ting;SUN Qian-hui;WANG Bo-yuan;LIU Wei-di;WANG Si-jin;LI Ming-xuan;GAO Ying(Dongzhimen Hospital of Beijing University of Chinese Medicine,Beijing 100700,China;Beijing University of Chinese Medicine,Beijing 100029,China)
出处
《中草药》
CAS
CSCD
北大核心
2021年第2期483-494,共12页
Chinese Traditional and Herbal Drugs
基金
国家重点研发计划(2018YFC1705001)。
关键词
脉血康胶囊
急性脑梗死
系统评价
GRADE评价
不良反应
Maixuekang Capsule
acute cerebral infarction
Meta analysis
grading of recommendations assessment,development,and evaluation
adverse reaction
