RESUMEN
OBJECTIVE:To observe clinical efficacy and safety of Tianqi jiangtang capsules combined with metformin in the treatment of elderly patients with type 2 diabetes mellitus complicated with cerebral microvascular lesions. METHODS:A total of 96 elderly patients with type 2 diabetes mellitus complicated with cerebral microvascular lesions were randomly divided into control group(48 cases)and observation group(48 cases). Control group was given Metformin hydrochloride tablets 0.5 g orally,3 times a day. Observation group was additionally given Tianqi jiangtang capsules 1.6 g orally,3 times a day,on the basis of control group. Both groups received treatment for 4 weeks. Clinical efficacies of 2 groups were observed as well as total score of TCM symptoms,the levels of blood glucose(FPG,2 hPG,HbA1c),blood lipid(TC,TG,HDL-C,LDL-C),hs-CRP,ET-1,blood rheology and oxidative stress indexes(MDA,SOD),the occurrence of ADR. RESULTS:The total response rate of observation group was significantly higher than that of control group(89.58% vs. 70.83%),with statistical significance(P<0.05). After treat-ment,total score of TCM symptoms,the levels of blood glucose,hs-CRP,ET-1,TC,TG,LDL-C,blood rheology indexes and MDA in 2 groups were significantly lower than before;total score of TCM symptoms,the levels of FPG,2 hPG,hs-CRP,ET-1, TC,TG,LDL-C,blood rheology indexes and MDA in observation group were significantly lower than control group;the level of SOD in 2 groups were significantly higher than before,and the observation group was significantly higher than control group,and the level of HDL-C in observation group was significantly higher than before treatment and control group,with statistical signifi-cance(P<0.05). No obvious ADR was found in 2 groups during treatment. CONCLUSIONS:Tianqi jiangtang capsules combined with metformin show significant therapeutic efficacy in the treatment of elderly patients with type 2 diabetes mellitus,and can re-duce the levels of blood glucose and lipid,improve blood rheology and oxidative stress reaction,with goud safety.