OBJECTIVE: To investigate the clinical efficacy and safety of Memantine hydrochloride tablets combined with Tianzhi granules in the treatment of vascular dementia. METHODS: A total of 94 patients with vascular dementia selected from our hospital during Jun. 2014-Jun. 2016 were divided into observation group and control group according to random number table, with 47 cases each. Besides basic therapy, control group was given Tianzhi granules 5 g, po, tid. Observation group was additionally given Memantine hydrochloride tablets with initial dose of 5 mg, increasing by 5 mg every week, maintaining dose of 20 mg/d at 4th week, po, qd, on the basis of control group. Both groups received treatment for consecutive 4 weeks. Clinical efficacies as well as MMSE, MoCA, ADL scores, the levels of brain-derived neurotrophic factor(BDNF), malondialdehyde(MDA) and superoxide dismutase(SOD) before and after treatment were observed in 2 groups. The occurrence of ADR was recorded. RESULTS: Total response rate of observation group (80.85%) was significantly higher than control group (61.70%), with statistical significance (P<0.05). Before treatment, there was no statistical significance in MMSE, MoCA, ADL scores, the levels of BDNF, MDA or SOD between 2 groups (P>0.05). After treatment, MMSE, MoCA, ADL scores, the levels of BDNF and SOD in 2 groups were increased significantly, while MDA level was decreased significantly; observation group was significantly better than control group, with statistical significance (P<0.05). No obvious ADR was found in 2 groups. CONCLUSIONS: Memantine hydrochloride tablets combined with Tianzhi granules in the treatment of vascular dementia show significant therapeutic efficacy, and can improve cognitive function, daily living activity and BDNF, MDA and SOD levels of patients with good safety.