西格列汀聯合二甲雙胍治療2型糖尿病效果的系統評價_《中國循證醫學雜志》

作者：

李吉 ,  孫家忠 , 李廣森 , 戴婧

武漢大學中南醫院（武漢 430071）;

關鍵詞：

2型糖尿病西格列汀二甲雙胍系統評價 Meta分析隨機對照試驗

DOI：

10.7507/1672-2531.20130149

視頻：

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目的　系統評價西格列汀聯合二甲雙胍治療2型糖尿病（T2DM）的療效及安全性。
方法　計算機檢索PubMed、The Cochrane Library、EMbase、CNKI、WanFang Data、VIP和CBM，收集西格列汀聯合二甲雙胍與單用二甲雙胍比較治療T2DM的隨機對照試驗（RCT），檢索時限均為建庫至2012年11月，并追溯納入研究的參考文獻。由兩位研究者按照納入與排除標準獨立篩選文獻、提取資料和評價質量后，采用RevMan 5.1軟件進行Meta分析。
結果　共納入7個RCT，2 917例患者。Meta分析結果顯示：西格列汀聯合二甲雙胍組較單用二甲雙胍組能更有效地改善糖化血紅蛋白水平［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］，并能提高胰島素敏感性和β細胞功能。但兩組在胃腸道反應發生率和低血糖發生率方面，差異無統計學意義。
結論　西格列汀聯合二甲雙胍治療T2DM較單用二甲雙胍治療能更有效地控制血糖，提高胰島素敏感性，改善胰島β細胞功能，且減輕體重作用相似，但兩組在胃腸道反應發生率和低血糖發生率方面差異無統計學意義。受納入文獻的方法學質量和樣本量限制，上述結論尚待開展更多大樣本、高質量研究予以證實。

引用本文： 李吉,孫家忠,李廣森,戴婧. 西格列汀聯合二甲雙胍治療2型糖尿病效果的系統評價. 中國循證醫學雜志, 2013, 13(7): 836-843. doi: 10.7507/1672-2531.20130149 復制

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2.	潘長玉, 金文勝. 2型糖尿病流行病學. 中華內分泌雜志, 2005, 21(5)增錄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.	趙曉航. 西格列汀聯合二甲雙胍治療2型糖尿病的療效觀察. 中外醫療, 2012, 31(22): 77, 79.
28.	紀萬軍, 于立芹, 滕川. 西格列汀聯合二甲雙胍2型糖尿病的臨床研究. 中國醫藥指南, 2012, 10(18): 222-223.
29.	黃賓協. 西格列汀聯合二甲雙胍治療初發糖尿病的臨床觀察. 中國醫療前沿, 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. 潘長玉, 金文勝. 2型糖尿病流行病學. 中華內分泌雜志, 2005, 21(5)增錄5: 1-5.
3. 遲家敏. 實用糖尿病學. 第3版, 北京: 人民衛生出版社, 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. 趙曉航. 西格列汀聯合二甲雙胍治療2型糖尿病的療效觀察. 中外醫療, 2012, 31(22): 77, 79.
28. 紀萬軍, 于立芹, 滕川. 西格列汀聯合二甲雙胍2型糖尿病的臨床研究. 中國醫藥指南, 2012, 10(18): 222-223.
29. 黃賓協. 西格列汀聯合二甲雙胍治療初發糖尿病的臨床觀察. 中國醫療前沿, 2011, 6(6): 58.

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《中國循證醫學雜志》

西格列汀聯合二甲雙胍治療2型糖尿病效果的系統評價

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