維格列汀與安慰劑比較治療2型糖尿病的Meta分析_《中國循證醫學雜志》

作者：

 占美 , 吳逢波 , 黃晶 , 唐堯

四川大學華西醫院藥劑科（成都?610041）;

關鍵詞：

維格列汀 2型糖尿病 Meta分析系統評價隨機對照試驗

DOI：

10.7507/1672-2531.20110178

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目的　系統評價維格列汀與安慰劑比較治療2型糖尿病的療效和安全性。
方法　計算機檢索Cochrane圖書館（2010年第2期）、PubMed（1978～2010.9），EMbase（1974～2010.9）、CNKI（1978～2010.9）、VIP（1989～2010.9）和CBM（1978～2010.9）數據庫，搜集維格列汀與安慰劑比較治療2型糖尿病的隨機對照試驗（RCT）。由兩位研究者根據納入與排除標準篩選試驗、提取資料并根據Cochrane系統評價員手冊進行質量評價后，采用RevMan 5.0軟件進行Meta分析。
結果　共納入13個RCT，Meta分析結果顯示：單藥治療時，維格列汀降低患者糖化血紅蛋白（HbA1c）的療效優于安慰劑［MD= –0.76，95%CI（–0.94，–0.58），P lt;0.000 01］，但在控制體重方面不及安慰劑［MD=0.68，95%CI（0.29，1.07），P=0.000 6］，不良反應及低血糖的發生率與安慰劑相似［OR=1.00，95%CI（0.83，1.21），P=0.98；OR=1.03，95%CI（0.65，1.65），P=0.89］。聯合其他口服降糖藥或胰島素治療時，維格列汀在改善患者HbA1c水平方面優于安慰劑組［MD= –0.76，95%CI（–0.94，–0.58），P lt;0.000 01］，而在控制患者體重、減少不良反應及低血糖發生率方面，兩組差異無統計學意義［MD=0.40，95%CI（–0.25，1.05），P=0.23；OR=0.95，95%CI（0.76，1.18），P=0.62；OR=1.11，95%CI（0.49，2.53），P=0.80］。
結論　維格列汀可以有效控制2型糖尿病患者血糖，且安全性較好。但遠期結果有待高質量大樣本長期隨訪的臨床研究予以驗證。

引用本文： 占美,吳逢波,黃晶,唐堯. 維格列汀與安慰劑比較治療2型糖尿病的Meta分析. 中國循證醫學雜志, 2011, 11(9): 1070-1077. doi: 10.7507/1672-2531.20110178 復制

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2.	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). Eur Heart J, 2007, 28(1): 88-136.
3.	Mari A, Sallas WM, He YL, et al . Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed beta-cell function in patients with type 2 diabetes. J Clin Endocrinol Metab , 2005, 90(8): 4888-4894.
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9.	Garber AJ, Schweizer A, Baron MA, et al . Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: A randomized, placebo-controlled study. Diabetes, Obesity and Metabolism , 2007, 9(2): 166-174.
10.	Garber AJ, Foley JE, Banerji MA, et al . Effects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea. Diabetes, Obesity and Metabolism , 2008, 10(11): 1047-1056.
11.	Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Hormone and metabolic research , 2009(5): 368-373.
12.	Kikuchi M, Abe N, Kato M, et al . Vildagliptin dose-dependently improves glycemic control in Japanese patients with type 2 diabetes mellitus. Diabetes research and clinical practice , 2009, 83(2): 233-240.
13.	Kikuchi M, Haneda M, Koya D, et al . Efficacy and tolerability of vildagliptin as an add-on to glimepiride in Japanese patients with Type 2 diabetes mellitus. Diabetes Res Clin Pract , 2010, 89(3): 216-223.
14.	Pi-Sunyer FX, Schweizer A, Mills D, et al . Efficacy and tolerability of vildagliptin monotherapy in drug-naïve patients with type 2 diabetes. Diabetes research and clinical practice , 2007, (1): 132-138.
15.	Pratley RE, Jauffret-Kamel S, Galbreath E, Holmes D. Twelve-week monotherapy with the DPP-4 inhibitor vildagliptin improves glycemic control in subjects with type 2 diabetes. Hormone and Metabolic Research , 2006, 38(6): 423-428.
16.	Ristic S, Byiers S, Foley J, Holmes D. Improved glycaemic control with dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes: Vildagliptin (LAF237) dose response. Diabetes, Obesity and Metabolism , 2005, 7(6): 692-698.
17.	Scherbaum WA, Schweizer A, Mari A, et al . Efficacy and tolerability of vildagliptin in drug-naive patients with type 2 diabetes and mild hyperglycaemia. Diabetes, Obesity and Metabolism , 2008, 10(8): 675-682.

1. 1 Yang W, Lu J, Weng J, et al . Prevalence of diabetes among men and women in China. N Engl J Med , 2010, 362(12): 1090-1101.
2. 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). Eur Heart J, 2007, 28(1): 88-136.
3. Mari A, Sallas WM, He YL, et al . Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed beta-cell function in patients with type 2 diabetes. J Clin Endocrinol Metab , 2005, 90(8): 4888-4894.
4. Higgins J, Green S. Cochrane handbook for systematic reviews of interventions version 5.0. 2 [updated September 2009]. The Cochrane Collaboration. 2009.
5. Ahrén B, Gomis R, Standl E, et al . Twelve- and 52-week efficacy of the dipeptidyl peptidase IV inhibitor LAF237 in metformin-treated patients with type 2 diabetes. Diabetes Care , 2004(12): 2874-2880.
6. Bosi E, Camisasca RP, Collober C, et al . Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin. Diabetes Care , 2007, 30(4): 890-895.
7. Dejager S, Razac S, Foley JE, et al . Vildagliptin in drug-naive patients with type 2 diabetes: A 24-week, double-blind, randomized, placebo-controlled, multiple-dose study. Hormone and Metabolic Research , 2007, 39(3): 218-223.
8. Fonseca V, Schweizer A, Albrecht D, et al . Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes. Diabetologia , 2007, 50(6): 1148-1155.
9. Garber AJ, Schweizer A, Baron MA, et al . Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: A randomized, placebo-controlled study. Diabetes, Obesity and Metabolism , 2007, 9(2): 166-174.
10. Garber AJ, Foley JE, Banerji MA, et al . Effects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea. Diabetes, Obesity and Metabolism , 2008, 10(11): 1047-1056.
11. Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Hormone and metabolic research , 2009(5): 368-373.
12. Kikuchi M, Abe N, Kato M, et al . Vildagliptin dose-dependently improves glycemic control in Japanese patients with type 2 diabetes mellitus. Diabetes research and clinical practice , 2009, 83(2): 233-240.
13. Kikuchi M, Haneda M, Koya D, et al . Efficacy and tolerability of vildagliptin as an add-on to glimepiride in Japanese patients with Type 2 diabetes mellitus. Diabetes Res Clin Pract , 2010, 89(3): 216-223.
14. Pi-Sunyer FX, Schweizer A, Mills D, et al . Efficacy and tolerability of vildagliptin monotherapy in drug-naïve patients with type 2 diabetes. Diabetes research and clinical practice , 2007, (1): 132-138.
15. Pratley RE, Jauffret-Kamel S, Galbreath E, Holmes D. Twelve-week monotherapy with the DPP-4 inhibitor vildagliptin improves glycemic control in subjects with type 2 diabetes. Hormone and Metabolic Research , 2006, 38(6): 423-428.
16. Ristic S, Byiers S, Foley J, Holmes D. Improved glycaemic control with dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes: Vildagliptin (LAF237) dose response. Diabetes, Obesity and Metabolism , 2005, 7(6): 692-698.
17. Scherbaum WA, Schweizer A, Mari A, et al . Efficacy and tolerability of vildagliptin in drug-naive patients with type 2 diabetes and mild hyperglycaemia. Diabetes, Obesity and Metabolism , 2008, 10(8): 675-682.

《中國循證醫學雜志》

維格列汀與安慰劑比較治療2型糖尿病的Meta分析

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《中國循證醫學雜志》

維格列汀與安慰劑比較治療2型糖尿病的Meta分析

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