Abstract: OBJECTIVE: To evaluate systematically the clinical efficacy and safety of Qingkailing(QKL) injection in the treatment of acute stroke.METHODS: Searches for randomized controlled trials into acute stroke treated with QKL injection were performed in the China National Knowledge Infrastructure Database, China Science and Technology Journal Database, Wan fang Database,Chinese Biomedical Literature Database, PubMed and Cochrane Library, from January 1979 to March2013. Two reviewers independently retrieved the RCTs and extracted the information. The Cochrane risk of bias method was used to assess the quality of the included studies, and a Meta-analysis was conducted with Review Manager 5.2 software.RESULTS: A total of 13 studies with 1110participants were included. The quality of the studies was generally low. The Meta-analysis indicated that the combined use of QKL and Western Medicine was significantly superior to control group therapy in terms of the total effective rate. The relative risk(RR) in the acute cerebral hemorrhage(ACH) sub-group was 1.17 [95%confidence interval(CI)(1.08, 1.26), P=0.0001]. In the acute cerebral infarction(ACI) sub-group, RR was 1.27 [95% CI(1.14, 1.42), P

Key words: Qingkailing injection, Stroke, Acute cerebrovascular disease, Meta-analysis, Randomized controlled trials, Review