Objective To assess the response rate, improvement in neurological function and safety of cinepazide maleate injection for patients with cerebral infarction. Methods Based on the principles and methods of Cochrane systematic reviews, we searched the Cochrane Central Register of Controlled Trials (Issue 1, 2010), PubMed (1948 to March 2010), EMbase (1966 to March 2010) and Chinese Bio-Medicine Database (1978 to March 2010). We also hand searched relevant literatures and obtained unpublished trials from pharmaceutical companies. The Cochrane Collaboration’s software RevMan5.0 was used for meta-analysis. Results Fifteen randomized controlled trials involving 1 456 patients were included. The results of meta-analyses indicated that: 1) Neurological deficits: We identified 11 trials involved 978 patients. Cinepazide maleate injection group compared with the control groups (placebo, Xuesaitong, Dansen and Nimodipine) could significantly improve the neurological deficits. The difference was statistically significant with WMD= – 4.64, 95%CI – 6.43 to – 2.85, WMD= – 2.39, 95%CI – 4.37 to – 0.42, WMD= – 3.67, 95%CI – 5.26 to – 2.07 and WMD= – 6.14, 95%CI – 8.39 to – 3.89, respectively. 2) Response rate: A total of 14 trials involved 1 349 patients were identified. Compared with control groups (placebo, Xuesaitong, Dansen and Nimodipine), cinepazide maleate injection group were more efficient, the difference was statistically significant with RR=1.33, 95%CI 1.16 to 1.54; RR=1.24, 95%CI 1.04 to 1.50; RR=1.33, 95%CI 1.23 to 1.43 and RR=1.29, 95%CI 1.12 to 1.49, respectively. 3) Adverse events: No serious adverse events were observed. But the difference of adverse events reports of headache and skin itching in cinepazide maleate injection group was statistically significant compared with the control groups. Conclusion Current evidence shows that cinepazide maleate injection can reduce neurological deficits in patients with acute cerebral infarction, improve the clinical treatment efficacy without serious adverse events. Due to limited quality of included studies, high-quality, large sample randomized controlled trials are required.