利拉鲁肽对新诊断的糖化血红蛋白＞9％的2型糖尿病患者的有效性及安全性  

The efficacy and safety of human glucagon-like peptide-1 analogue liraglutide in newly diagnosed type 2 diabetes with glycosylated hemoglobin A1c 〉 9%

作　　者：陈频[1,2] 陈晨[2] 邵珠林 徐向进[2] 黄勤[1] 

机构地区：[1]第二军医大学附属长海医院内分泌科,350025 [2]南京军区福州总医院内分泌科,350025

出　　处：《中华内科杂志》2015年第4期307-312,共6页Chinese Journal of Internal Medicine

基　　金：福建省科技计划重点项目（2011Y0047）;全军医学科学技术研究“十二五”计划（CWSIIJ254）

摘　　要：目的 观察对新诊断的糖化血红蛋白（HbA1c） ＞9％的2型糖尿病患者采用利拉鲁肽治疗的有效性及安全性.方法 采用开放、随机、平行、对照方法,纳入新诊断HBA1c＞9％的2型糖尿病患者随机接受利拉鲁肽治疗组（LIRA组,25例）和甘精胰岛素治疗组（IGla组,24例）,联用二甲双胍和瑞格列奈片治疗18个月后评价有效性及安全性.结果 （1）与基线比较,治疗结束时LIRA组体重、BMI、腰围均明显下降（P＜0.01）,而IGla组体重、BMI、腰围均增加（P＜0.01）.（2）LIRA组和IGla组空腹血糖（FPG）、糖负荷后2h血糖（2hPG）、HbA1c均呈显著下降（P＜ 0.01）;LIRA组2hPG显著低于IGla组（P＜0.01）,而且24 h平均血糖水平（MBG）、24h最大血糖波动幅度（LAGE）、24 h平均血糖漂移幅度（MAGE）均明显下降（P＜0.05或P＜0.01）.（3）与基线比较,LIRA组△I30/△G30[△I30为口服葡萄糖耐量试验（OGTT）中30min胰岛素（I30）与空腹胰岛素的差值,△G30为30 min血糖（G30）与FPG的差值]、3hOGTT中180 min内C肽AUC（AUCcP180）、胰岛素敏感指数（Matsuda指数）明显增高（分别为4.88±1.55比7.60±1.91,9.23±2.66比13.18±2.72,39.28±20.35比54.64±23.34,P值均＜0.01）,稳态模型法评估的胰岛素抵抗指数（HOMA-IR）降低（4.41±1.58比3.52±1.44,P＜0.05）;IGla组仅HOMA-IR降低（4.92±1.84比4.57±1.80,P＜0.05）;LIRA组△I30/△G30、AUCCP180 Matsuda指数均高于IGla组（分别为7.60±1.91比4.18±1.00,13.18±2.72比10.53±2.68,54.64±23.34比41.65±17.84,P值均＜0.05）,HOMA-IR低于IGla组（3.52±1.44比4.57±1.80,P＜0.05）.（4） LIRA组HbA1c≤6.5％的达标率及联用口服降糖药用量明显优于IGla组.（5）两组低血糖事件和不良反应发生率差异无统计学意义.结论 对新诊断HbA1c＞9％的2型糖尿病采用利拉鲁肽在平稳改善糖代谢、恢复胰岛分泌功能及胰岛素敏感性的作用优于甘精胰岛素.Objective To evaluate the efficacy and safety of human glucagon-like peptide-1 analogue liraglutide in newly diagnosed type 2 diabetes mellitus （T2DM） with glycosylated hemoglobin A1c （HbA1c） 〉 9%.Methods This was an open-labelled,randomized,parallel-group,treat-to-target trial.Newly diagnosed T2DM patients with HbA1c 〉 9% were enrolled.These patients were treated with metformin with repaglinide and randomized to receive once-daily liraglutide （LIRA,n =25） or the insulin glargine （IGla,n =24） at bedtime.Efficacy and safety were assessed and compared after 18-month treatment.Results （1） Compared with the baseline,patients with LIRA had significantly reduced mean body weight,BMI and waist circumference （P 〈 0.01）,whereas,the above indexes were increased （P 〈 0.01） in patients treated with IGla.（2） After 18 months of treatment,fasting plasma glucose （FPG）,2-hour plasma glucose after a 75g oral glucose load（2hPG） and HbA1c were significantly improved in all patients （P 〈 0.01）,with 2hPG,mean blood glucose （MBG）,the largest amplitude of glycemic excursions （LAGE）,mean amplitude of glycemic excursions （MAGE） were significantly lower in LIRA group than in IGla group （all P 〈 0.05）.（3） HOMA-IR decreased in both groups （P 〈 0.05）.However,△I30/△G30,AUCCP180 and Matsuda index were only significantly increased in patients treated with LIRA （respectively,4.88 ± 1.55 vs 7.60 ± 1.91,9.23 ± 2.66 vs 13.18 ± 2.72,39.28 ± 20.35 vs 54.64 ± 23.34,all P 〈 0.01）,while HOMA-IR reduced（4.41 ± 1.58 vs 3.52 ± 1.44,P 〈0.05）.But in IGla group only HOMAIR was reduced （4.92 ± 1.84 vs 4.57 ± 1.80,P 〈0.05）.The index of △I30/△G30,AUCCP180 and Matsuda index in LIRA group are higher than those of indexes in IGla group（respectively,7.60 ± 1.91 vs 4.18 ± 1.00,13.18 ± 2.72 vs 10.53 ± 2.68,54.64 ± 23.34 vs 41.65 ± 17.84,all P 〈 0.05）,while HOMA-IR is lower （3.52 ± 1.44 vs 4.57 ± 1.80,P 〈 0.05）.（4） The rate of HbA

关 键 词：糖尿病 2型 利拉鲁肽 

分 类 号：R587.1[医药卫生—内分泌]