瑞格列奈联合二甲双胍对比单用瑞格列奈治疗2型糖尿病疗效和安全性的Meta分析
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摘要
目的:系统评价瑞格列奈联合二甲双胍对比单用瑞格列奈治疗2型糖尿病的疗效和安全性,以为临床治疗提供循证参考。方法:计算机检索Pub Med、EMBase、Medline、Cochrane图书馆、中国期刊全文数据库、中文科技期刊数据库、万方数据库等,收集瑞格列奈联合二甲双胍(试验组)对比单用瑞格列奈(对照组)治疗2型糖尿病的随机对照试验(RCT),提取数据和评价质量后,采用Rev Man 5.2统计软件进行Meta分析。结果:共纳入7项RCT,合计824例患者。Meta分析结果显示,试验组患者糖化血红蛋白[MD=-0.94,95%CI(-1.05,-0.83),P<0.000]、空腹血糖[MD=-1.59,95%CI(-1.77,-1.41),P<0.000]和餐后2 h血糖[MD=-0.93,95%CI(-1.48,-0.38),P<0.000]均显著优于对照组,两组比较差异有统计学意义;试验组患者低血糖发生率[OR=2.40,95%CI(0.89,6.48),P=0.08]和胃肠道反应发生率[OR=0.77,95%CI(0.40,1.50),P=0.44]与对照组比较,差异无统计学意义。结论:瑞格列奈联合二甲双胍治疗2型糖尿病的疗效优于单用瑞格列奈,且安全性相当。由于纳入研究数量较少、质量一般,该结论有待大样本、高质量、长疗程的RCT进一步验证。
OBJECTIVE:To systematically evaluate the efficacy and safety of repaglinide combined with metformin versus repaglinide alone in treatment of type 2 diabetes and provide evidence-based reference for the clinic. METHODS:Pub Med,EMBase,Medline,Cochrane Library,CJFD,VIP and Wanfang database were retrieved to collect randomized controlled trail(RCT)about repaglinide combined with metformin(trial group)and repaglinide alone(control group)in treatment of type 2 diabetes. Meta-analysis was performed by Rev Man 5.2 software after data extraction and quality evaluation. RESULTS:A total of 7 RCT were included,involving 824 patients. Meta-analysis showed that Hb A1c[MD=-0.94,95%CI(-1.05,-0.83),P<0.000],FPG[MD=-1.59,95%CI(-1.77,-1.41),P<0.000] and 2 h PG[MD=-0.93,95% CI(-1.48,-0.38),P<0.000] in trial group were significantly better than that of control group,there was significant difference. There were no significant difference in the incidence of hypoglycemia [OR=2.40,95% CI(0.89,6.48),P=0.08] and gastrointestinal disorders [OR=0.77,95% CI(0.40,1.50),P=0.44] in trial group. CONCLUSIONS:Repaglinide combined with metformin in treatment of type 2 diabetes is more effective than repaglinide alone with similar safety. Due to the small number and general quality of included studies,it remains to be further verified by largesample and high-quality RCT.
OBJECTIVE:To systematically evaluate the efficacy and safety of repaglinide combined with metformin versus repaglinide alone in treatment of type 2 diabetes and provide evidence-based reference for the clinic. METHODS:Pub Med,EMBase,Medline,Cochrane Library,CJFD,VIP and Wanfang database were retrieved to collect randomized controlled trail(RCT)about repaglinide combined with metformin(trial group)and repaglinide alone(control group)in treatment of type 2 diabetes. Meta-analysis was performed by Rev Man 5.2 software after data extraction and quality evaluation. RESULTS:A total of 7 RCT were included,involving 824 patients. Meta-analysis showed that Hb A1c[MD=-0.94,95%CI(-1.05,-0.83),P<0.000],FPG[MD=-1.59,95%CI(-1.77,-1.41),P<0.000] and 2 h PG[MD=-0.93,95% CI(-1.48,-0.38),P<0.000] in trial group were significantly better than that of control group,there was significant difference. There were no significant difference in the incidence of hypoglycemia [OR=2.40,95% CI(0.89,6.48),P=0.08] and gastrointestinal disorders [OR=0.77,95% CI(0.40,1.50),P=0.44] in trial group. CONCLUSIONS:Repaglinide combined with metformin in treatment of type 2 diabetes is more effective than repaglinide alone with similar safety. Due to the small number and general quality of included studies,it remains to be further verified by largesample and high-quality RCT.
引文
[1]Moses R,Slobodniuk R,Boyages S,et al.Effect of repaglinide addition to metformin monotherapy on glycemic control in patients with type 2 diabetes[J].Diabetes Care,1999,22(1):119.
[2]Reboussin DM,Goff DC,Lipkin EW,et al.The combination and nutritional treatment of late-onset diabetes mellitus(CONTROL DM)trial results[J].Diabet Med,2004,21(10):1 082.
[3]Wang W,Bu R,Su Q,et al.Randomized study of repaglinide alone and in combination with metformin in Chinese subjects with type 2 diabetes naive to oral antidiabetes therapy[J].Pharmacother,2011,12(18):2 791.
[4]张秉涛,尹士男.瑞格列奈与二甲双胍对初诊2型糖尿病氧化应激反应的影响[J].中国医刊,2008,43(11):36.
[5]查宝艳,尹玉磊,薛长春.瑞格列奈与二甲双胍治疗2型糖尿病临床疗效探讨[J].现代中西医结合杂志,2011,20(35):4 498.
[6]柯晓燕,何小杰,张妍,等.二甲双胍对初诊2型糖尿病患者颈动脉内膜中层厚度的影响及机制探讨[J].医学信息,2012,25(2):122.
[7]白玫.瑞格列奈与二甲双胍治疗2型糖尿病临床疗效分析[J].内蒙古中医药,2012,31(22):33.
[8]吴万龄.快速胰岛素促分泌剂降糖作用的评价[J].国外医学内分泌学分册,2002,22(3):153.
[9]Bailey CJ,Turner RC.Metformin[J].N Engl J Med,1996,334(9):574.
[10]UK Prospective Diabetes Study Group.Effect of intensive blood glucose control with metformin on complications in overweight patients with type 2 diabetes[J].Lancet,1998,352(9 131):854.
[11]杨文英.二甲双胍联合早相胰岛素促泌剂的理论基础及临床证据[J].中国糖尿病杂志,2012,20(11):877.
[12]冉兴无.餐时调节剂:瑞格列奈[J].国外医学内分泌学分册,2000,20(5),225.
[13]Sebastien C,Mirjam JK,Leopold F,et al.Impact of orlistat initiation on cardiovascular treatment use:a 6-year population-based cohort study[J].Eur J Preven Cardiol,2012,19(3):484.
[14]Suyog SJ,Sunita JR,Jaiprakash BR,et al.Evaluation of efficacy and safety of orlistat in obese patients[J].Indian J Endocrinol Metab,2011,15(2):99.
[15]Ryden L,Standl E,Bartnik M,et al.Guidelines on diabetes,pre-diabetes,and cardiovascular diseases:executive summary.The task force on diabetes and cardiovascular diseases of the european society of cardiology(ESC)and of the European association for the study of diabetes(EASD)[J].Eur Heart J,2007,28(1):88.
[16]Schramm TK,Gislason GH,Kber L,et al.Diabetes patients requiring glucose-lowering therapy and nondiabetics with a prior myocardial infarction carry the same cardiovascular risk:a population study of 3.3 million people[J].Circulation,2008,117(15):1 945.
[17]魏强,彭国辉.单个大样本随机对照试验与小样本随机对照试验Meta分析的比较[J].中国循证医学,2002,2(2):104.
[2]Reboussin DM,Goff DC,Lipkin EW,et al.The combination and nutritional treatment of late-onset diabetes mellitus(CONTROL DM)trial results[J].Diabet Med,2004,21(10):1 082.
[3]Wang W,Bu R,Su Q,et al.Randomized study of repaglinide alone and in combination with metformin in Chinese subjects with type 2 diabetes naive to oral antidiabetes therapy[J].Pharmacother,2011,12(18):2 791.
[4]张秉涛,尹士男.瑞格列奈与二甲双胍对初诊2型糖尿病氧化应激反应的影响[J].中国医刊,2008,43(11):36.
[5]查宝艳,尹玉磊,薛长春.瑞格列奈与二甲双胍治疗2型糖尿病临床疗效探讨[J].现代中西医结合杂志,2011,20(35):4 498.
[6]柯晓燕,何小杰,张妍,等.二甲双胍对初诊2型糖尿病患者颈动脉内膜中层厚度的影响及机制探讨[J].医学信息,2012,25(2):122.
[7]白玫.瑞格列奈与二甲双胍治疗2型糖尿病临床疗效分析[J].内蒙古中医药,2012,31(22):33.
[8]吴万龄.快速胰岛素促分泌剂降糖作用的评价[J].国外医学内分泌学分册,2002,22(3):153.
[9]Bailey CJ,Turner RC.Metformin[J].N Engl J Med,1996,334(9):574.
[10]UK Prospective Diabetes Study Group.Effect of intensive blood glucose control with metformin on complications in overweight patients with type 2 diabetes[J].Lancet,1998,352(9 131):854.
[11]杨文英.二甲双胍联合早相胰岛素促泌剂的理论基础及临床证据[J].中国糖尿病杂志,2012,20(11):877.
[12]冉兴无.餐时调节剂:瑞格列奈[J].国外医学内分泌学分册,2000,20(5),225.
[13]Sebastien C,Mirjam JK,Leopold F,et al.Impact of orlistat initiation on cardiovascular treatment use:a 6-year population-based cohort study[J].Eur J Preven Cardiol,2012,19(3):484.
[14]Suyog SJ,Sunita JR,Jaiprakash BR,et al.Evaluation of efficacy and safety of orlistat in obese patients[J].Indian J Endocrinol Metab,2011,15(2):99.
[15]Ryden L,Standl E,Bartnik M,et al.Guidelines on diabetes,pre-diabetes,and cardiovascular diseases:executive summary.The task force on diabetes and cardiovascular diseases of the european society of cardiology(ESC)and of the European association for the study of diabetes(EASD)[J].Eur Heart J,2007,28(1):88.
[16]Schramm TK,Gislason GH,Kber L,et al.Diabetes patients requiring glucose-lowering therapy and nondiabetics with a prior myocardial infarction carry the same cardiovascular risk:a population study of 3.3 million people[J].Circulation,2008,117(15):1 945.
[17]魏强,彭国辉.单个大样本随机对照试验与小样本随机对照试验Meta分析的比较[J].中国循证医学,2002,2(2):104.