西格列汀联合二甲双胍治疗2型糖尿病效果的系统评价_《中国循证医学杂志》

作者：

李吉 ,  孙家忠 , 李广森 , 戴婧

武汉大学中南医院（武汉 430071）;

关键词：

2型糖尿病西格列汀二甲双胍系统评价 Meta分析随机对照试验

DOI：

10.7507/1672-2531.20130149

视频：

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摘要 全文 图表 视频 参考文献 施引文献 补充材料

目的　系统评价西格列汀联合二甲双胍治疗2型糖尿病（T2DM）的疗效及安全性。
方法　计算机检索PubMed、The Cochrane Library、EMbase、CNKI、WanFang Data、VIP和CBM，收集西格列汀联合二甲双胍与单用二甲双胍比较治疗T2DM的随机对照试验（RCT），检索时限均为建库至2012年11月，并追溯纳入研究的参考文献。由两位研究者按照纳入与排除标准独立筛选文献、提取资料和评价质量后，采用RevMan 5.1软件进行Meta分析。
结果　共纳入7个RCT，2 917例患者。Meta分析结果显示：西格列汀联合二甲双胍组较单用二甲双胍组能更有效地改善糖化血红蛋白水平［WMD= –0.62%，95%CI（–0.76，–0.47）， P lt;0.000 1］和空腹血糖水平［WMD= –0.7 mmol/L，95%CI（–1.03，–0.37），P lt;0.000 01］，并能提高胰岛素敏感性和β细胞功能。但两组在胃肠道反应发生率和低血糖发生率方面，差异无统计学意义。
结论　西格列汀联合二甲双胍治疗T2DM较单用二甲双胍治疗能更有效地控制血糖，提高胰岛素敏感性，改善胰岛β细胞功能，且减轻体重作用相似，但两组在胃肠道反应发生率和低血糖发生率方面差异无统计学意义。受纳入文献的方法学质量和样本量限制，上述结论尚待开展更多大样本、高质量研究予以证实。

引用本文： 李吉,孙家忠,李广森,戴婧. 西格列汀联合二甲双胍治疗2型糖尿病效果的系统评价. 中国循证医学杂志, 2013, 13(7): 836-843. doi: 10.7507/1672-2531.20130149 复制

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2.	潘长玉, 金文胜. 2型糖尿病流行病学. 中华内分泌杂志, 2005, 21(5)增录5: 1-5.
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6.	Setter SM, lltz JL, Thams J, et al. Metformin hydrochloride in the treatment of type 2 diabetes mellitus:a clinical review with a focus on dual therapy. ClinTher, 2003, 25(2): 2991-3026.
7.	Rosenstock J, Rood J, Cobitz A, et al. Initial treatment with rosiglitazone/metform in fixed-dose combination therapy compared with monotherapy with either rosiglitazone or metformin in patients with uncontrolled type 2 diabetes. Diabetes Obes Metab, 2006, 8(6): 650-660.
8.	Garber AJ, Donovan DS, Dandona P, et al. Efficacy of glyburide/metformin tablets compared with initial monotherapy in type 2 diabetes. J Clin Endocrinol Metab, 2003, 88(3): 3598-3604.
9.	Deeks ED, Scott LJ. Pioglitazone/metformin. Drugs, 2006, 66(4): 1863-1877.
10.	Hundal RS, Inzucchi SE. Metformin:new understandings,new uses. Drugs, 2003, 63(8): 1879-1894.
11.	Mannucci E, Ognibene A, Cremasco F, et al. Effect of metformin on glucagon-like peptide 1 (GLP-1) and leptins levels in obese nondiabetic subjects. Diabetes Care, 2001, 24(3): 489-494.
12.	Hinke SA, Kuhn-Wache K, Hoffmann T, et al. Metformin effects on dipeptidylpeptidase Ⅳ degradation of glucagon-like peptide-1. Biochem Biophys Res Commun, 2002, 291(7): 1302-1308.
13.	Lenhard JM, Croom DK, Minnnick DT. Reduced serum dipeptidyl peptidase-Ⅳ after metformin and pioglitazone treatments. Biochem Biophy Res Commun, 2004, 324(3): 92-97.
14.	Saydah SH, Fradkin J, Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA, 2004, 291(5): 335-342.
15.	Turner RC, Cull CA, Frighi V, et al. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multipletherapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA, 1999, 281(6): 2005-2012.
16.	Liebl A, Mata M, Eschwege E. Evaluation of risk factors for development of complications in type II diabetes in Europe. Diabetologia, 2002, 45(4): 23-28.
17.	Kim D, Wang L, Beconi M, et al. (2R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl) butan-2-amine:a potent, orally active dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes. J Med Chem, 2005, 48(6): 141-151.
18.	Druker DJ, Nauck MA. GLP-1R agonists(incretin mimetics) and DPP-4 inhibitors (incretin enhancers) forthe treatment of type 2 diabetes. Lancet, 2006, 368(3): 1696-1705.
19.	Williams-Herman D, Johnson J, Teng R, et al. Efficacy and safety of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes:a 54-week study. Curr Med ResOpin, 2009, 25(3): 569-583.
20.	Aschner P, Kipnes MS, Lunceford JK, et al. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care, 2006, 29(12): 2632-2637.
21.	Matthews DR, Hosker JP, Rudenski AS, et al. meostasis model assessment: insulin esistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia, 1985, 28(7): 412-419.
22.	Matthews DR, Hosker JP, Rudenski AS, et al. Homeostasis model assessment closely mirrors the glucose clamp technique in the assessment of insulin sensitivity: studiesin subjects with various degrees of glucose tolerance and insulin sensitivity. Diabetes Care, 2000, 23(1): 57-63.
23.	Williams-Herman D, Johnson J, Teng R, et al. Efficacy and safety of sitagliptin and metformin as initial combination therapy and as monotherapy over 2 years in patients with type 2 diabetes. Diabetes, Obesity and Metabolism, 2010, 23(12): 442-451.
24.	Olansky L, Reasner C, Seck TL. A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin mon-otherapy due to a low rate of addition of antihyperglycaemic agents. Diabetes, Obesity and Metabolism, 2011, 13(9): 841-849.
25.	Reasner C, Olansky L, Seck TL. The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. Diabetes, Obesity and Metabolism, 2011, 13(2): 644-652.
26.	Williams-Herman D, Xu L, Teng R, et al. Effect of initial combination therapy with sitagliptin and metformin on β-cell function in patients with type 2 diabetes. Diabetes, Obesity and Metabolism, 2012, 14(7): 67-76.
27.	赵晓航. 西格列汀联合二甲双胍治疗2型糖尿病的疗效观察. 中外医疗, 2012, 31(22): 77, 79.
28.	纪万军, 于立芹, 滕川. 西格列汀联合二甲双胍2型糖尿病的临床研究. 中国医药指南, 2012, 10(18): 222-223.
29.	黄宾协. 西格列汀联合二甲双胍治疗初发糖尿病的临床观察. 中国医疗前沿, 2011, 6(6): 58.

1. Nathan DM, Buse JB, Davidson MB, et al. Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy A consensus statement of the American Diabetes Association and the European Association forthe Study of Diabetes. Diabetes Care, 2009, 32(1): 193-203.
2. 潘长玉, 金文胜. 2型糖尿病流行病学. 中华内分泌杂志, 2005, 21(5)增录5: 1-5.
3. 迟家敏. 实用糖尿病学. 第3版, 北京: 人民卫生出版社, 2009: 1-5.
4. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35):prospective observational study. BMJ, 2000, 321(4): 405-412.
5. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med, 1993, 329(5): 977-986.
6. Setter SM, lltz JL, Thams J, et al. Metformin hydrochloride in the treatment of type 2 diabetes mellitus:a clinical review with a focus on dual therapy. ClinTher, 2003, 25(2): 2991-3026.
7. Rosenstock J, Rood J, Cobitz A, et al. Initial treatment with rosiglitazone/metform in fixed-dose combination therapy compared with monotherapy with either rosiglitazone or metformin in patients with uncontrolled type 2 diabetes. Diabetes Obes Metab, 2006, 8(6): 650-660.
8. Garber AJ, Donovan DS, Dandona P, et al. Efficacy of glyburide/metformin tablets compared with initial monotherapy in type 2 diabetes. J Clin Endocrinol Metab, 2003, 88(3): 3598-3604.
9. Deeks ED, Scott LJ. Pioglitazone/metformin. Drugs, 2006, 66(4): 1863-1877.
10. Hundal RS, Inzucchi SE. Metformin:new understandings,new uses. Drugs, 2003, 63(8): 1879-1894.
11. Mannucci E, Ognibene A, Cremasco F, et al. Effect of metformin on glucagon-like peptide 1 (GLP-1) and leptins levels in obese nondiabetic subjects. Diabetes Care, 2001, 24(3): 489-494.
12. Hinke SA, Kuhn-Wache K, Hoffmann T, et al. Metformin effects on dipeptidylpeptidase Ⅳ degradation of glucagon-like peptide-1. Biochem Biophys Res Commun, 2002, 291(7): 1302-1308.
13. Lenhard JM, Croom DK, Minnnick DT. Reduced serum dipeptidyl peptidase-Ⅳ after metformin and pioglitazone treatments. Biochem Biophy Res Commun, 2004, 324(3): 92-97.
14. Saydah SH, Fradkin J, Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA, 2004, 291(5): 335-342.
15. Turner RC, Cull CA, Frighi V, et al. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multipletherapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA, 1999, 281(6): 2005-2012.
16. Liebl A, Mata M, Eschwege E. Evaluation of risk factors for development of complications in type II diabetes in Europe. Diabetologia, 2002, 45(4): 23-28.
17. Kim D, Wang L, Beconi M, et al. (2R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl) butan-2-amine:a potent, orally active dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes. J Med Chem, 2005, 48(6): 141-151.
18. Druker DJ, Nauck MA. GLP-1R agonists(incretin mimetics) and DPP-4 inhibitors (incretin enhancers) forthe treatment of type 2 diabetes. Lancet, 2006, 368(3): 1696-1705.
19. Williams-Herman D, Johnson J, Teng R, et al. Efficacy and safety of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes:a 54-week study. Curr Med ResOpin, 2009, 25(3): 569-583.
20. Aschner P, Kipnes MS, Lunceford JK, et al. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care, 2006, 29(12): 2632-2637.
21. Matthews DR, Hosker JP, Rudenski AS, et al. meostasis model assessment: insulin esistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia, 1985, 28(7): 412-419.
22. Matthews DR, Hosker JP, Rudenski AS, et al. Homeostasis model assessment closely mirrors the glucose clamp technique in the assessment of insulin sensitivity: studiesin subjects with various degrees of glucose tolerance and insulin sensitivity. Diabetes Care, 2000, 23(1): 57-63.
23. Williams-Herman D, Johnson J, Teng R, et al. Efficacy and safety of sitagliptin and metformin as initial combination therapy and as monotherapy over 2 years in patients with type 2 diabetes. Diabetes, Obesity and Metabolism, 2010, 23(12): 442-451.
24. Olansky L, Reasner C, Seck TL. A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin mon-otherapy due to a low rate of addition of antihyperglycaemic agents. Diabetes, Obesity and Metabolism, 2011, 13(9): 841-849.
25. Reasner C, Olansky L, Seck TL. The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. Diabetes, Obesity and Metabolism, 2011, 13(2): 644-652.
26. Williams-Herman D, Xu L, Teng R, et al. Effect of initial combination therapy with sitagliptin and metformin on β-cell function in patients with type 2 diabetes. Diabetes, Obesity and Metabolism, 2012, 14(7): 67-76.
27. 赵晓航. 西格列汀联合二甲双胍治疗2型糖尿病的疗效观察. 中外医疗, 2012, 31(22): 77, 79.
28. 纪万军, 于立芹, 滕川. 西格列汀联合二甲双胍2型糖尿病的临床研究. 中国医药指南, 2012, 10(18): 222-223.
29. 黄宾协. 西格列汀联合二甲双胍治疗初发糖尿病的临床观察. 中国医疗前沿, 2011, 6(6): 58.

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《中国循证医学杂志》

西格列汀联合二甲双胍治疗2型糖尿病效果的系统评价

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