OBJECTIVE： To observe clinical efficacy and safety of edaravone combined with butyl phthalide in the treatment of acute ischemic stroke （AIS）. METHODS： 258 AIS patients were randomly divided into observation group and control group， with 129 cases in each group. Both groups were given routine treatment as antiplatelet， improving microcirculation， controlling blood pressure， lowering blood glucose， regulating blood lipid， keeping plaque stable， nourishing brain cells. Control group was additionally given Butyl phthalide capsules orally， 200 mg， tid. Observation group was additionally given Edaravone injection 30 mg added into Sodium chloride injection 100 ml， ivgtt， bid， on the basis of control group. Both groups continuously received 14 days of treatment. The serum inflammatory factor， miR-222 and neurologic impairment score of 2 groups were observed before treatment， 7， 14 d after treatment. Clinical efficacies and the occurrence of ADR were compared between 2 groups. RESULTS： There was no statistical significance in the serum inflammatory factor， miR-222 and neurologic impairment score between 2 groups before treatment （P＞0.05）. The serum inflammatory factor and neurologic impairment score of 2 groups were decreased significantly 7， 14 d after treatment， while serum levels of miR-222 were increased significantly； the observation group was significantly better than the control group， with statistical significance （P＜0.05）. Total effective rate of observation group was 92.2％， which was significantly higher than that of control group （69.8％）， with statistical significance （P＜0.05）. No obvious ADR was found in 2 groups. CONCLUSIONS： Edaravone combined with butyl phthalide is effective in the treatment of AIS， and can significantly decrease serum inflammatory factor level， promote the expression of miR-222 and improve neurologic function with good safety.