探讨罗格列酮片治疗2型糖尿病的疗效和安全性

Investigation of the efficacy and safety of rosiglitazone in patients with type 2 diabetes mellitus

目的观察罗格列酮片对2型糖尿病患者的降糖作用和安全性。方法将233例服用磺脲类联合二甲双胍类治疗的2型糖尿病患者,以随机、双盲、安慰剂对照方法分为2组,分别在应用磺脲类联合二甲双胍治疗基础上,试验组(117例)加服罗格列酮片8 mg.d-1,对照组(116例)加服安慰剂,比较2组治疗前及治疗12 wk时FPG2、hPG、HbA1C等指标的变化。结果治疗12 wk后试验组FPG、2hPG、HbA1C较治疗前均下降,下降幅度分别为(1.148±1.754)、(2.200±2.785)mmol.L-1和(0.502±0.955)%;对照组下降幅度分别为(-0.379±1.498)、(-0.145±2.843)mmol.L-1和(-0.103±0.774)%,2组相比,P均<0.01。治疗后试验组空腹胰岛素下降,TC、HDL-C、LDL-C均增高,下降或增高幅度与对照组相比P<0.05。治疗前后2组肝肾功能、电解质均无变化,未发现严重不良反应。结论罗格列酮片可以有效降低2型糖尿病患者在磺脲类与二甲双胍联合治疗后的血糖,改善胰岛素抵抗且安全、耐受。

AIM To assess efficacy and safety of rosiglitazone in patients with type 2 diabetes mellitus. METHODS Two hundred and thirty three cases of type 2 diabetes mellitus treated by sulfonylurea combined with metformin were randomly and double-blindly divided into rosiglitazone treated group （n = 117, 8 mg·d^-1） or placebo treatment group （n = 116）. After 12 wk treatment, the changes of levels of fasting plasma glucose（FPG）, 2h plasma glucose, HbAIC, etc in 2 groups were compared. RESULTS After 12 wk treatment, rosiglitazone lowered FPG, 2h PG, mean HbAIC concentrations by （1. 148±1.754）, （2. 200±2.785） mmol·L^-1 and （0.502±0. 955） % respectively, compared with placebo which showed （- 0. 379±1. 498）, （ - 0. 145±2. 843）mmol·L^-1 and （ - 0. 103±0. 774） % respectively （ P 〈 0. 01）. Fasting insulin level was reduced, but TC, HDL-C and LDL-C levels were elevated in rosiglitazone treated group, compared with the changes of levels of placebo P 〈 0.05. The liver and kidney functions and blood electrolyte did not change statistically. There was no serious adverse events in this study. CONCLUSION Data from this study demonstrate that rosiglitazone effectively and safely prevents deterioration of glycemic control when added to continuing sulfonylurea combined with metformin in patients with type 2 diabetes mellitus.