西格列他钠对2型糖尿病患者的疗效和安全性:多中心、随机、双盲、平行对照临床试验  

Efficacy and safety of chiglitazar in type 2 diabetes: a multi-center, randomized, double-blind, and parallel group clinical trial

作　　者：吕肖锋 高勇义[2] 朱旅云[3] 杨刚毅[4] 王长江[5] 罗佐杰[6] Lyu Xiaofeng;Gao Yongyi;Zhu Lyuyun;Yang Gangyi;Wang Changjiang;Luo Zuojie(Department of Endocrinology, The Seventh Medical Center of PLA General Hospital, Beijing 100700, China;Department of Endocrinology, Hainan Provincial People′s Hospital, Haikou 570311, China;Department of Endocrinology, Bethune International Peace Hospital of PLA, Shijiazhuang 500082, China;Department of Endocrinology, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China;Department of Endocrinology, First Affiliated Hospital of Anhui Medical University, Hefei 230022, China;Department of Endocrinology, First Affiliated Hospital of Guangxi Medical University, Nanning 530021, China)

机构地区：[1]解放军总医院第七医学中心内分泌科,北京100700 [2]海南省人民医院内分泌科,海口570311 [3]解放军白求恩国际和平医院内分泌科,石家庄500082 [4]重庆医科大学附属第二医院内分泌科,400010 [5]安徽医科大学第一附属医院内分泌科,合肥230022 [6]广西医科大学第一附属医院内分泌科,南宁530021

出　　处：《中华糖尿病杂志》2019年第5期334-340,共7页CHINESE JOURNAL OF DIABETES MELLITUS

摘　　要：目的以吡格列酮为对照,评价西格列他钠治疗2型糖尿病(T2DM)患者的有效性和安全性。方法采用多中心、随机、双盲、平行对照法,于2009年11月至2010年11月从全国6家三甲医院选取新诊断T2DM且糖化血红蛋白(HbA1c)为7%~10%的患者200例,随机分为西格列他钠32、40、48 mg组和吡格列酮30 mg组,各50例。于基线和第16周检测各组HbA1c、空腹血糖(FPG)、餐后2 h静脉血糖(2h-PPG)、空腹胰岛素(FINS)和血脂变化。观察不良事件发生率,监测血压、心率、血尿常规、肝肾功能和心电图等指标变化。组间比较采用方差分析,组内比较采用配对t检验。结果西格列他钠32、40、48 mg组与吡格列酮30 mg组HbA1c、FPG、2h-PPG治疗第16周均较基线显著下降(t=-8.16^-3.58,均P<0.05)。第16周相对基线变化的最小二乘均数及其95%CI分别为HbA1c:-1.03%(-1.30,-0.77)%、-1.22%(-1.48,-0.96)%、-1.11%(-1.37,-0.85)%和-1.18%(-1.44,-0.91)%;FPG:[-1.79(-2.43,-1.16)、-1.82(-2.44,-1.20)、-1.76(-2.37,-1.14)和-2.01(-2.64,-1.39)]mmol/L;2h-PPG:[-2.42(-3.37,-1.47)、-2.09(-3.01,-1.16)、-2.77(-3.70,-1.84)和-3.11(-4.06,-2.17)]mmol/L。各指标16周时较基线变化值四组间差异无统计学意义(F=0.40~0.75,均P>0.05),西格列他钠40及48 mg组甘油三酯、西格列他钠32 mg组总胆固醇及四组高密度脂蛋白胆固醇治疗前后组内比较,差异有统计学意义(t=-2.74~3.88,均P<0.05)。四组各血脂指标治疗前后变化值组间比较,差异无统计学意义(F=0.28~2.45,均P>0.05)。四组不良事件发生率比较,差异无统计学意义(χ2=3.04,P=0.39)。结论与吡格列酮比较,西格列他钠降低T2DM患者的HbA1c和血糖水平呈非劣效,且安全性和耐受性良好。Objective To evaluate the efficacy and safety of chiglitazarin type 2 diabetic patients with pioglitazone as control group. Methods A multi-center (6 hospitals), randomized, double-blind, and parallel controlled clinical trial was carried out from November 2009 to November 2010. A total of 200 patients with newly diagnosed type 2 diabetes [glycated hemoglobin A1c (HbA1c): 7%-10%] were randomized to take 32, 40, 48 mg chiglitazar or 30 mg pioglitazone, respectively. At baseline and the 16th week, the levels of HbA1c, fasting plasma glucose (FPG), 2 h post prandial piasma glucose (2h-PPG), insulin and lipid profiles were measured and adverse events were observed. Analysis of variance was used for comparison between groups and paired t-test was used for intra-group comparison. Results The reduction differences were statistically significant from baseline to the 16th week at doses of 32, 40, 48 mg chiglitazar or 30 mg pioglitazone groups (t=-8.16-3.58, all P<0.05), but not among these 4 groups (F=0.40-0.75, all P>0.05). The least squares mean and 95% confidence intervals of HbA1c, FPG and 2h-PPG in the four groups were as follow respectively: HbA1c [-1.03%(-1.30,-0.77)%,-1.22%(-1.48,-0.96)%,-1.11%(-1.37,-0.85)% and -1.18%(-1.44,-0.91)%];FPG[-1.79 (-2.43,-1.16),-1.82 (-2.44,-1.20),-1.76 (-2.37,-1.14) and -2.01(-2.64,-1.39)] mmol/L;2h-PPG[-2.42 (-3.37,-1.47),-2.09 (-3.01,-1.16),-2.77 (-3.70,-1.84) and -3.11 (-4.06,-2.17)] mmol/L. Significant reductions from baseline to the 16th week were observed in triglycerides dose of 40 and 48 mg chiglitazar group and in cholesterol at dose of 32 mg chiglitazar group, while a slightly significant increase in HDL-C was observed in each of these 4 groups (t=2.40-3.88, all P<0.05). Moreover, the incidences of adverse events were similar among these 4 groups (P>0.05). Conclusion Chiglitazar is noninferior to pioglitazone in hypoglycemin effects for patients with type 2 diabetes. Both drugs have similar safety and tolerance.

关 键 词：糖尿病 2型 西格列他钠 有效性 安全性 

分 类 号：R587[医药卫生—内分泌]