Objectives:To investigate the effectiveness and safety of Xingnaojing Injection (XNJ,醒脑静注射液)compared with naloxone for the treatment of acute alcohol intoxication (AAI),and provide the latest evidence through evidence-based approach.Methods:Seven electro-databases including PubMed,EMBASE,Cochrane Central Register of Controlled Trials,Chinese National Knowledge Infrastructure Databases,Chinese Biomedical Literature Database,Chinese Science and Technology Periodical Database (VIP) and Wanfang Database were searched from the inception to January 2018.Randomized controlled trials (RCTs) comparing XNJ with naloxone for patients with AAI and reporting at least one of the below outcomes were included:patients\' conscious recovery time,stay length in emergency department,disappearance time of the ataxia symptom,the severity of the symptoms,the blood alcohol content as well as the adverse events.Methodological quality of included trials was assessed using the risk of bias tool which recommended by the Cochrane Collaboration.Meta-analysis was conducted by Review Manager 5.3 software.Results:Totally 141 trials with 13,901 patients were included in this review,all of them were assessed as unclear or high risk of bias.Results showed that on the basis of routine therapy,standard dose XNJ (10-20 mL) may have similar results with naloxone on the recovery time of consciousness (MD 12 min,95％ CI 7.2-17.4 min) and disappearance time of symptoms (MD 6 min,95％ Cl-13.8-25.8 min) for patients with AAI.Larger dose of XNJ Injection (21-40 mL)may speed up the time (almost 1 h earlier).Combinalion of XNJ and naloxone seemed superior to the naloxone alone for all the relevant outcomes.The average difference of time in consciousness recovery was 2 h and the number of AAI patients whose consciousness recovery within 1 h was above 50％ the combination group than in the control group (RR 1.42,95％ Cl 1.29 to 1.56).No severe adverse events or adverse reactions of XNJ were reported in the included trials.Conclusions:Low quality of evidence showed XNJ may have equal effect as naloxone and may achieve better effect as add-on intervention with naloxone for patients with AAI.We failed to evaluate the safety of XNJ Injection due to the insufficient evidence in this review.Registration number in PROSPERO (No.CRD42018087804)