天芪降糖胶囊联合二甲双胍治疗老年2型糖尿病伴脑微血管病变的临床观察

摘要

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.%目的:观察天芪降糖胶囊联合二甲双胍治疗老年2型糖尿病伴脑微血管病变的疗效和安全性.方法:96例老年2型糖尿病伴脑微血管病变患者随机分为对照组(48例)和观察组(48例).对照组患者给予盐酸二甲双胍片0.5 g,口服,每日3次;观察组患者在对照组治疗的基础上给予天芪降糖胶囊1.6 g,口服,每日3次.两组均用药4周.观察两组患者的临床疗效,治疗前后中医证候总积分、血糖水平[空腹血糖(FPG)、餐后2 h血糖(2 hPG)、糖化血红蛋白(HbA1c)]、血脂水平[总胆固醇(TC)、三酰甘油(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)]、超敏C反应蛋白(hs-CRP)和内皮素-1(ET-1)水平、血液流变学指标、氧化应激指标[丙二醛(MDA)、超氧化物歧化酶(SOD)]及不良反应发生情况.结果:观察组患者总有效率显著高于对照组(89.58%vs.70.83%),差异有统计学意义(P<0.05).治疗后,两组患者中医证候总积分和血糖、hs-CRP、ET-1、TC、TG、LDL-C、血液流变学指标、MDA水平均显著低于同组治疗前,且观察组中医证候总积分、FPG、2 hPG、hs-CRP、ET-1、TC、TG、LDL-C、血液流变学指标、MDA水平均显著低于对照组;两组患者SOD水平均显著高于同组治疗前,且观察组显著高于对照组,同时观察组HDL-C水平显著高于同组治疗前及对照组,差异均有统计学意义(P<0.05).两组患者治疗期间均未见明显不良反应发生.结论:天芪降糖胶囊联合二甲双胍治疗老年2型糖尿病伴脑微血管病变的疗效显著,可降低血糖、血脂水平,改善机体血液流变学状态及氧化应激反应,且安全性较好.