二甲雙胍和羅格列酮聯用治療2型糖尿病的系統評價_《中國循證醫學雜志》

作者：

張俊英 ^1,2 , 馬彬 ¹ , 楊克虎 ¹ ,  程衛東 ²

1. 蘭州大學循證醫學中心，蘭州大學基礎醫學院（蘭州 730000）；2. 蘭州大學中西醫結合研究所（蘭州 730000）;

關鍵詞：

2 型糖尿病二甲雙胍羅格列酮系統評價

DOI：

10.7507/1672-2531.20090082

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目的　系統評價二甲雙胍聯合羅格列酮治療2 型糖尿病（T2DM）的療效及安全性。
方法　應用Cochrane 系統評價方法，計算機檢索Cochrane 圖書館（2008 年第4 期）、PubMed（1966 ～ 2008.10）、EMbase（1974 ～ 2008.10）、CBM（1978 ～ 2008.10）、VIP（1989 ～ 2008.10）、CNKI（1994 ～ 2008.10）、萬方數據庫（1997 ～ 2008.10），收集以二甲雙胍聯合羅格列酮（RSG/MET 組）與單用二甲雙胍（MET 組）比較治療T2DM 的
隨機對照試驗（RCT），根據Cochrane Handbook 5.0 質量評價標準評價，用RevMan 5.0 軟件進行統計學分析。
結果　共納入11 個RCT，合計2 917 例患者。Meta 分析結果顯示：RSG+MET 組較MET 組能更有效地改善糖化
血紅蛋白水平［WMD= – 0.44%，95%CI（– 0.70，– 0.17），P=0.001］、空腹血糖水平［WMD= – 1.03 mmol/L，95%CI（– 1.85，– 0.75）］，提高胰島素敏感性和β 細胞功能；在胃腸道反應發生率方面RSG+MET 組低于MET 組，但水腫發
生率高于MET 組［RR=0.82，95%CI（0.71，0.94）；RR=3.27，95%CI（1.80，5.91）］。在體重指數、至少發生一次任何不良事件的患者例數和低血糖方面兩組差異無統計學意義。
結論　RSG+MET組較單用MET能更有效地控制血糖，提高胰島索敏感性和β 細胞功能，且可以降低胃腸道反應的發生率。

引用本文： 張俊英,馬彬,楊克虎,程衛東. 二甲雙胍和羅格列酮聯用治療2型糖尿病的系統評價. 中國循證醫學雜志, 2009, 09(4): 437-445. doi: 10.7507/1672-2531.20090082 復制

1.	World Health Organization. Types of Diabetes. Available from URL:http://www.who.int/diabetesactiononline/diabetes/basics/en/index1.html.
2.	世界衛生組織. 糖尿病. Available from URL: http://www.who.int/mediacentre/factsheets/fs312/zh/index.html.
3.	International Diabetes Federation (2005): Global Guidelines for type 2 diabetes. Available from URL: http://www.idf.org/webdata/docs/GGT2D%2009%20Oral%20therapy.pdf.
4.	Bailey CJ, Del Prato S, Eddy D, et al. Earlier intervention in type 2 diabetes: the case for achieving early and sustained glycaemic control. Int J Clin Pract, 2005, 59(11): 1309-1316.
5.	Garber AJ. Using dose-response characteristics of therapeutics agents for treatment decisions in type 2 diabetes. Diabetes Obes Metab, 2000, 2(3): 139-147.
6.	Inzucchi SE, Maggs DG, Spollett GR, et al. Efficacy and metabolic effects of metformin and troglitazone in type II diabetes mellitus. N Engl J Med, 1998, 338(13): 867-872.
7.	Davidson MB, Peters AL. An overview of metformin in the treatment of type 2 diabetes mellitus. Am J Med, 1997, 102(1):.
8.	Diamant M, Heine RJ. Thiazolidinediones in type 2 diabetes mellitus: current clinical evidence. Drugs, 2003, 63(13): 1373-1405.
9.	Stewart MW, Cirkel DT, Furuseth K, et al. Effect of metformin plus roziglitazone compared with metformin alone on glycaemic control in well-controlled Type 2 diabetes. Diabet Med, 2006, 23(10): 1069-1078.
10.	Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med, 1998, 15(7): 539-553.
11.	American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care, 2007, 30(Suppl 1): S4-S41.
12.	Matthews DR, Hosker JP, Rudenski AS, et al. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia, 1985, 28(7): 412-419.
13.	Matthews DR, Hosker JP, Rudenski AS, et al. Homeostasis model assessment closely mirrors the glucose clamp technique in the assessment of insulin sensitivity: studies in subjects with various degrees of glucose tolerance and insulin sensitivity. Diabetes Care, 2000, 23(1): 57-63.
14.	Rosenstock J, Rood J, Cobitz A, et al. Initial treatment with rosiglitazone/metformin 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.
15.	Stewart MW, Cirkel DT, Furuseth K, et al. Effect of metformin plus roziglitazone compared with metformin alone on glycaemic control in well-controlled Type 2 diabetes. Diabet Med, 2006, 23(10): 1069-1078.
16.	Bailey CJ, Bagdonas A, Rubes J, et al. Rosiglitazone/metformin fixed-dose combination compared with uptitrated metformin alone in type 2 diabetes mellitus: a 24-week, multicenter, randomized, double-blind, parallel-group study. Clin Ther, 2005, 27(10): 1548-1561.
17.	Weissman P, Goldstein BJ, Rosenstock J, et al. Effects of rosiglitazone added to submaximal doses of metformin compared with dose escalation of metformin in type 2 diabetes: the EMPIRE Study. Curr Med Res Opin, 2005, 21(12): 2029-2035.
18.	Gómez-Perez FJ, Fanghänel-Salmón G, Antonio Barbosa J, et al. Efficacy and safety of rosiglitazone plus metformin in Mexicans withtype 2 diabetes. Diabetes Metab Res Rev, 2002, 18(2): 127-134.
19.	Fonseca V, Rosenstock J, Patwardhan R, et al. Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: a randomized controlled trial. JAMA, 2000, 283(13): 1695-1702.
20.	Negro R, Mangieri T, Dazzi D, et al. Rosiglitazone effects on blood pressure and metabolic parameters in nondipper diabetic patients. Diabetes Res Clin Pract, 2005, 70(1): 20-25.
21.	杜其玲, 劉承芬, 唐紅英. 二甲雙胍和羅格列酮治療新診2型糖尿病的療效比較. 中外健康文摘?醫藥學刊, 2007, 4(12): 4-5.
22.	韓書宏, 胡海科, 張翼飛, 等. 羅格列酮與二甲雙胍聯用治療2型糖尿病療效觀察. 四川醫學, 2007, 28(1): 51-52.23 熱陽古麗?沙塔爾, 阿孜古力?胡達拜地. 文迪雅聯合二甲雙胍治療2型糖尿病的療效觀察. 中華臨床醫學研究雜志, 2007, 13(9): 1219.
23.	王淑芳, 曲曉紅, 趙穎. 羅格列酮和二甲雙胍治療新發2型糖尿病的療效比較. 中國糖尿病雜志, 2006, 14(6): 415-416.
24.	-110.

1. World Health Organization. Types of Diabetes. Available from URL:http://www.who.int/diabetesactiononline/diabetes/basics/en/index1.html.
2. 世界衛生組織. 糖尿病. Available from URL: http://www.who.int/mediacentre/factsheets/fs312/zh/index.html.
3. International Diabetes Federation (2005): Global Guidelines for type 2 diabetes. Available from URL: http://www.idf.org/webdata/docs/GGT2D%2009%20Oral%20therapy.pdf.
4. Bailey CJ, Del Prato S, Eddy D, et al. Earlier intervention in type 2 diabetes: the case for achieving early and sustained glycaemic control. Int J Clin Pract, 2005, 59(11): 1309-1316.
5. Garber AJ. Using dose-response characteristics of therapeutics agents for treatment decisions in type 2 diabetes. Diabetes Obes Metab, 2000, 2(3): 139-147.
6. Inzucchi SE, Maggs DG, Spollett GR, et al. Efficacy and metabolic effects of metformin and troglitazone in type II diabetes mellitus. N Engl J Med, 1998, 338(13): 867-872.
7. Davidson MB, Peters AL. An overview of metformin in the treatment of type 2 diabetes mellitus. Am J Med, 1997, 102(1):.
8. Diamant M, Heine RJ. Thiazolidinediones in type 2 diabetes mellitus: current clinical evidence. Drugs, 2003, 63(13): 1373-1405.
9. Stewart MW, Cirkel DT, Furuseth K, et al. Effect of metformin plus roziglitazone compared with metformin alone on glycaemic control in well-controlled Type 2 diabetes. Diabet Med, 2006, 23(10): 1069-1078.
10. Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med, 1998, 15(7): 539-553.
11. American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care, 2007, 30(Suppl 1): S4-S41.
12. Matthews DR, Hosker JP, Rudenski AS, et al. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia, 1985, 28(7): 412-419.
13. Matthews DR, Hosker JP, Rudenski AS, et al. Homeostasis model assessment closely mirrors the glucose clamp technique in the assessment of insulin sensitivity: studies in subjects with various degrees of glucose tolerance and insulin sensitivity. Diabetes Care, 2000, 23(1): 57-63.
14. Rosenstock J, Rood J, Cobitz A, et al. Initial treatment with rosiglitazone/metformin 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.
15. Stewart MW, Cirkel DT, Furuseth K, et al. Effect of metformin plus roziglitazone compared with metformin alone on glycaemic control in well-controlled Type 2 diabetes. Diabet Med, 2006, 23(10): 1069-1078.
16. Bailey CJ, Bagdonas A, Rubes J, et al. Rosiglitazone/metformin fixed-dose combination compared with uptitrated metformin alone in type 2 diabetes mellitus: a 24-week, multicenter, randomized, double-blind, parallel-group study. Clin Ther, 2005, 27(10): 1548-1561.
17. Weissman P, Goldstein BJ, Rosenstock J, et al. Effects of rosiglitazone added to submaximal doses of metformin compared with dose escalation of metformin in type 2 diabetes: the EMPIRE Study. Curr Med Res Opin, 2005, 21(12): 2029-2035.
18. Gómez-Perez FJ, Fanghänel-Salmón G, Antonio Barbosa J, et al. Efficacy and safety of rosiglitazone plus metformin in Mexicans withtype 2 diabetes. Diabetes Metab Res Rev, 2002, 18(2): 127-134.
19. Fonseca V, Rosenstock J, Patwardhan R, et al. Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: a randomized controlled trial. JAMA, 2000, 283(13): 1695-1702.
20. Negro R, Mangieri T, Dazzi D, et al. Rosiglitazone effects on blood pressure and metabolic parameters in nondipper diabetic patients. Diabetes Res Clin Pract, 2005, 70(1): 20-25.
21. 杜其玲, 劉承芬, 唐紅英. 二甲雙胍和羅格列酮治療新診2型糖尿病的療效比較. 中外健康文摘?醫藥學刊, 2007, 4(12): 4-5.
22. 韓書宏, 胡海科, 張翼飛, 等. 羅格列酮與二甲雙胍聯用治療2型糖尿病療效觀察. 四川醫學, 2007, 28(1): 51-52.23 熱陽古麗?沙塔爾, 阿孜古力?胡達拜地. 文迪雅聯合二甲雙胍治療2型糖尿病的療效觀察. 中華臨床醫學研究雜志, 2007, 13(9): 1219.
23. 王淑芳, 曲曉紅, 趙穎. 羅格列酮和二甲雙胍治療新發2型糖尿病的療效比較. 中國糖尿病雜志, 2006, 14(6): 415-416.
24. -110.

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二甲雙胍和羅格列酮聯用治療2型糖尿病的系統評價

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《中國循證醫學雜志》

二甲雙胍和羅格列酮聯用治療2型糖尿病的系統評價

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