OBJECTIVE:To discuss clinical efficacy and safety of alteplase combined with butylphthalide to the patients with acute ischemic stroke. METHODS:98 patients with acute ischemic stroke in our hospital were selected and divided into ob-servation group and control group according to random number table,with 49 patients in each group. Control group was addition-ally given Butylphthalide and sodium chloride injection 100 ml,ivgtt,bid,on the basis of routine treatment as controlling blood glucose,blood pressure,etc.;observation group additionally received Alteplase for injection 5 mg added into NS 10 ml,iv+Al-teplase for injection 45 mg added into NS 100 ml,ivgtt,qd,on the basis of control group. Both groups were treated for 2 weeks. Clinical efficacies of 2 groups were compared as well as cerebral infarction area,NIHSS score,ability score of daily liv-ing,the levels of IL-6,IL-8,IL-10,CRP,24 h urine protein,Scr and creatinine clearance rate before and after treatment. The occurrence of ADR was also recorded. RESULTS:1 patient of observation group and 2 patients of control group withdrew from the study due to severe hemorrhage. Total effective rate of observation group(95.83%)was significantly higher than that of con-trol group(80.85%),with statistical significance(P<0.05). Before treatment,there was no statistical significance in above in-dexes between 2 groups (P>0.05). The cerebral infarction area and NIHSS score were reduced significantly in observation group after treatment,ability score of daily living were increased significantly in observation group after treatment,and the im-provement of observation group was significantly better than control group,with statistical significance (P<0.05). 24 h urine protein and Scr of observation group was significantly lower than those of control group,with statistical significance(P<0.05). the level of IL-6 in observation group 1 week after treatment and the levels of IL-6,IL-8,IL-10 and CRP 2 weeks after treat-ment were significantly lower than in control group,with statistical significance(P<0.05). There was no statistical significance in the incidence of ADR between 2 groups (P>0.05). CONCLUSIONS:Alteplase combined with butylphthalide show signifi-cant therapeutic efficacy,can effectively reduce the level of serum inflammatory factors,control brain tissue ischemia and cere-bral infarction area,and improve neurologic function and pro-tect renal function in patients with acute ischemic stroke.