OBJECTIVE: To observe clinical efficacy and safety of Mailuoning injection in adjunctive treatment of acute cerebral infarction. METHODS: A total of 65 patients with acute cerebral infarction selected from neurology department of our hospital were divided into control group (32 cases) and observation group (33 cases) according to random number table. Control group was given conventional treatment. Observation group was additionally given Mailuoning injection 10 mL added into 0.9% sodium chloride injection 250 mL intrnrenously, ivgtt, qd, on the basis of control group. Both group were treated for 15 d. Clinical efficacy as well as serum levels of ox-LDL, BNP and MMP-9, NIHSS score before and after treatment, the occurrence of ADR were compared between 2 groups. RESULTS: The response rate of observation group was 90.91%, which was significantly higher than 65.63%, with statistical significance (P<0.05). Before treatment, there was no statistical significance in serum levels of ox-LDL, BNP or MMP-9, NIHSS score between 2 groups (P>0.05). After treatment, serum levels of ox-LDL, BNP and MMP-9, NIHSS score in 2 groups were all decreased significantly, and the observation group was significantly lower than the control group, with statistical significance (P<0.05). There was no statistical significance in incidence of ADR between 2 groups (P>0.05). CONCLUSIONS: Mailuoning injection has significant therapeutic efficacy for acute cerebral infarction, can significantly reduce serum levels of ox-LDL, BNP and MMP-9, promotes neurological function and the recovery of patients with cerebral infarction with good safety.