阿托伐他汀联合二甲双胍对血脂正常2型糖尿病患者疗效和安全性的随机对照研究

Randomized controlled study on efficacy and safety of atorvastatin Combined with metformin in type 2 diabetic patients with normal blood lipid

目的探讨阿托伐他汀联合二甲双胍对血脂正常2型糖尿病患者疗效和安全性。方法随机将238例血脂正常2型糖尿病患者随机分为2组,B组119例给予二甲双胍治疗,A组119例在B组的基础上给予阿托他汀治疗,治疗时间8周。观察2组治疗前后空腹血糖(FPG)、餐后2h血糖(2hPG)、糖化血红蛋白(HbAlC)、总胆固醇(TC)、低密度脂蛋白(LDL-C)、胰岛素抵抗指数(HOMA-IR)、白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)、超敏C反应蛋白(hsCRP)、一氧化氮(NO)、内皮素-1(ET-1)、颈动脉内膜中层厚度(IMT),统计2组治疗过程中的不良反应发生率。结果 A组治疗后TC、LDL-C、IL-6、TNF-α、hs-CRP、ET-1、IMT水平均显著低于B组(P<0.05);NO水平显著高于B组(P<0.05);2组治疗后FPG、2hPG、HbAlC、HOMA-IR和不良反应率相比较差异均无统计学意义(P>0.05)。结论阿托伐他汀联合二甲双胍可降低血脂正常2型糖尿病患者体内微炎症状态,改善血管内皮功能,有利于降低动脉粥样硬化发生,且安全性良好,值得临床推广应用。

Objective To study the efficacy and safety of atorvastatin Combined with mefformin in type 2 diabetic patients with normal blood lipid. 238 type 2 diabetic patients with normal blood lipid were randomly divided into two groups. 119 patients in B group were treated with mefformin, and 119 patients in A group were treatd with atorvastatin Combined with metformin, and were treated for 8 weeks. The fasting plasma glucose（ FPG）, 2 h postprandial blood glucose （2hPG）, glycosylated hemoglobin （HbA1C）, total cholester- ol （T C）, low density lipoprotein （LDL-C） and insulin resistance index （HOMA-IR）, interleukin -6 （IL-6}, tumor necrosis factor alpha （TNF-alpha） and hypersensitivity C protein {hs-CRP）, nitric oxide （NO）, endothelin-1 （ET-1）, carotid artery intima- media thickness {IMT） of two groups at before and after treatment were observed, and the incidence of adverse reactions during treat- ment was analyzed. Results The levels of TC, LDL-C, IL-6, TNF-α, hs-CRP, ET-1 and IMT of A group were significantly lower than those of B group （p〈0.05 }. The NO level of A group was significantly higher than that of B group （p〈0. 05 ）. There were no signif- icant difference in FPG, 2hPG, HbA1C, HOMA-IR after treatment and incidence of adverse reactions during treatment between two groups （p〉0.051. Conclusion The atorvastatin Combined with metformin in treatment of type 2 diabetic patients with nounal blood lipid can reduce the micro inflammatory state, improve the vascular endothelial function, helps to reduce atherosclerosis, has confirmed the good safety, and is worthy of clinical application.