罗格列酮和二甲双胍对伴有血脂紊乱的2型糖尿病患者血糖、血脂、血压和体质量的影响

摘要

背景:胰岛素抵抗是2型糖尿病患者疾病进展和大血管并发症发生的一个主要病因,以胰岛素增敏剂(二甲双胍和罗格列酮)治疗能减轻胰岛素抵抗,但其对心血管其他危险因素(血脂、血压、体质量)的影响仍有待研究.目的:观察罗格列酮和二甲双胍治疗伴有血脂紊乱的2型糖尿病患者时对血糖、血脂,血压和体质量的影响.设计:临床观察试验.对象:选择2006-06/09于南京医科大学附属南京第一医院内分泌科门诊就诊的42例2型糖尿病伴血脂紊乱患者.纳入标准:①2型糖尿病均符合美国糖尿病协会2006年的诊断标准.②血脂紊乱的诊断标准为:总胆固醇(TC)＞4.68 mmol/L,三酰甘油(TG)＞1.7 mmol/L,低密度脂蛋白胆固醇(LDL)＞2.68 mmol/L,高密度脂蛋白胆固醇(HDL)＜0.9 mmol/L(女性),＜1.0 mmol/L(男性).男27例,女15例,年龄30～70岁,平均(58±12)岁.所有患者对治疗和检测项目知情同意.方法:①药物治疗:所有患者在12周治疗期间均给予同样剂量的二甲双胍(江苏恒瑞医药股份有限公司生产,批号为051110和051214,剂型为0.25 g/片)0.75 g,2次/d和罗格列酮(江苏恒瑞医药股份有限公司生产,批号为0511101,剂型为2 mg/片)2 mg,2次/d.②相关指标测量:所有患者在治疗前及治疗第8,12周分别测量体质量指数,比色法检测血脂(总胆固醇、三酰甘油、高密度脂蛋白胆固醇和低密度脂蛋白胆固醇),空腹及餐后血糖,血压.主要观察指标:①空腹血糖和餐后血糖的变化.②患者血脂、血压、体质量指数的变化.结果:纳入2型糖尿病伴血脂紊乱患者42例,3例患者退出实验,1例患者出现严重水样泻,1例为严重腹胀,1例尿路感染,其余39例均进入结果分析.①空腹血糖和餐后血糖的变化:治疗12周后患者空腹血糖及餐后血糖较治疗前下降(P＜0.01).②患者血脂、血压、体质量的变化:治疗12周后患者总胆固醇较治疗前轻度升高(P＜0.05),低密度脂蛋白胆固醇较治疗前轻度下降(P＜0.01),高密度脂蛋白胆固醇较治疗前轻度上升(P＜0.01),血压较治疗前无变化(P＞0.05),体质量指数较治疗前轻度上升(P＜0.01).结论:罗格列酮、二甲双胍治疗能显著地改善血糖控制,轻度增加总胆固醇,降低低密度脂蛋白胆固醇,升高高密度脂蛋白胆固醇,对三酰甘油、血压无显著影响.体质量增加轻微.安全可耐受.%BACKGROUND: Insulin resistance (IR) is associated with type 2 diabetes mellitus and its macrovascular complications. Euglycemic agent (rosiglitazone and metformin) can ameliorate IR, but its influences on other cardiovascular risk factors, including blood lipid, blood pressure and body mass need to be further studied.OBJECTIVE: To observe the effects of rosiglitazone and metformin on the blood glucose, blood lipid, blood pressure and body mass of patients with type 2 diabetes mellitus complicated by blood lipid disturbance.DESIGN: A clinical observation.SETTING: Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University.PARTICIPANTS: Forty-two patients with type 2 diabetes mellitus complicated by dyslipideamia, who received treatment in the Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University between June and September 2006 were recruited in this study. The involved patients, 27 male and 15 female, averaged (58±2)years ranging from 30 to 70 years old. Inclusive criteria:①Type 2 diabetes mellitus all met the diagnostic criteria of American Diabetes Association (2006).② Diagnostic criteria of blood lipid disturbance : total cholesterol(TC)＞ 4.68 mmol/L, triglyceride (TG) ＞ 1.7 mmol/L, low density lipoprotein cholesterol (LDL-C) ＞ 2.68 mmol/L, high density lipoprotein cholesterol (HDL-C) ＜ 0.9 mmol/L (female), ＜ 1.0 mmol/L (male). Informed consents were obtained from all the patients.METHODS：①Drug treatment：Dudng the 12-week treatment,all the patients received 0．75 g metformin(Lot No．051110 and 051214,0.25 g，lablel,Jiangsu Hengrui Medicine Co.，Ltd)and 4 mg rosiglitazone (Lot No．0511101,2 mg／tablet，Jiangsu Hengrui Medicine Co.，Ltd) daily．②Physical and laboratory measurements：Body mass index，blood pressure were taken，and blood lipid profile(TC,TG,C-LDL and C-HDL)，fasting and postprandial blood glucose were measured by colodmetdc method before,8 and 12 weeks after treatment．MAIN OUTCOME MEASURES：①Fasting and postprandial blood glucose level change．②Blood lipid，blood pressure and body mass index change．RESULTS：Forty-two patients with type 2 diabetes mellitus complicated by dyslipideamia were recruited，and three dropped out the experiment，one patient suffered from severe watery stool, one patient from severe abdominal distention,one patient from urinary tract infection, and the other thirty-nine patients completed the observation in the final analysis．Compared with pretraatment data,fasting and postprandial blood glucose levels 12 weeks after treatment were decreased(P＜0．01),TC increased(P＜0．05)，LDL-C decreased(P＜0．01)，HDL-C increased(P＜0．01),blood pressure did not change(P＞0．05) and body mass index increased(P＜0．01)．CONCLUSION： Combinatin of rosiglitazone and metformin significantly decreases blood glucose，decreases LDL-C,increases TC，HDL-C,body mass index,and has no obvious effects on TG and blood pressure．It is safe and bearable for type 2 diabetes mellitus patients with dyslipideamia．