OBJECTIVE： To systematically evaluate the therapeutic efficacy and safety of fibrinolytic combined Xueshuantong injection in the treatment of acute ischemic stroke， and to provide evidence-based reference. METHODS： Retrieved from CJFD， Wanfang database， ScienceDirect and ELSEVIER， RCTs about fibrinolytic combined Xueshuantong injection （trial group） vs. fibrinolytic alone （control group） in the treatment of acute ischemic stroke were collected. After data extraction and quality evaluation according to modified Jadad evaluation， Meta-analysis was conducted by using Rev Man 5.2 and Stata 12.0 statistical software. RESULTS： A total of 14 RCTs were included， involving 1 342 patients. The results of Meta-analysis showed that， total response rate [RR＝1.24，95％CI（1.18，1.31），P＜0.001]， cure rate [RR＝1.59，95％CI（1.23，2.06），P＜0.001] and efficiency rate [RR＝1.41，95％CI（1.24，1.60），P＜0.001] of trial group were significantly higher than those of control group. There was no significant difference in the response rate [RR＝0.93，95％CI（0.79，1.10），P＝0.40] and the incidence of ADR [RR＝0.63，95％CI（0.17，2.36），P＝0.49] between 2 groups. CONCLUSIONS： Fibrinolytic combined Xueshuantong injection shows good therapeutic efficacy and safety for acute ischemic stroke.