摘要OBJECTIVE:To systematically evaluate the efficacy and safety of Angong Niuhuang pill(安宫牛黄丸,ANP)in the treatment of acute stroke.This can provide ideas and basis for the treatment of this disease with integrated Traditional Chinese and Western Medicine.METHODS:Randomized controlled trials(RCTs)of China National Knowledge Infrastructure Database,Wanfang Database,Chinese BioMedical Literature Database,PubMed,Embase,and the Cochrane Library were searched from the establishment to March 2022.Two researchers screened the literature and extracted the data according to inclusion and exclusion criteria.Meta-analysis was performed using RevMan 5.3 software.RESULTS:A total of 28 RCTs were included,including 2745 patients in the acute stage of stroke(1375 in the experimental group and 1370 in the control group).Meta-analysis showed that compared with conventional treatment,combined treatment with ANP could improve the effective rate of acute stroke patients[relative risk(RR)=1.26,95％confidence interval(Cl)(1.21,1.31)],Glasgow Coma Scale scores[mean difference(MD)=2.01,95％Cl(1.04,2.98)],Mini-mental State Examination scores[MD=4.79,95％Cl(2.22,7.37)],Activities of Daily Living scores[MD=15.70,95％Cl(14.05,17.36)]and the Barthel index scores[MD=13.89,95％Cl(12.12,15.65)],reduce National Institute of Health stroke scale scores[MD=-3.90,95％CI(-4.96,-2.84)]and serum brain natriuretic peptide[MD=-38.50,95％Cl(-46.85,-30.15)].In terms of safety,the incidence of adverse reactions showed no statistical differences between the two groups[RR=0.71,95％Cl(0.43,1.15),P=0.16],and no serious adverse reactions/events were observed,indicating a good safety.CONCLUSIONS:Existing clinical research evidence shows that ANP has good efficacy and safety in the treatment of acute stroke,which can provide a basis for the treatment of integrated Traditional Chinese and Western Medicine.However,the quality of included research methodology needs to be improved,and the above conclusions need to be verified by more high-quality studies.