二甲雙胍治療代謝綜合征的系統評價_《中國循證醫學雜志》

作者：

1. 四川大學華西醫院GCP中心（成都 610041）；2. 四川大學華西醫院內分泌科（成都 610041）；3. 四川大學華西醫院中國循證醫學中心（成都 610041）;

關鍵詞：

系統評價 Meta 分析隨機對照試驗代謝綜合征二甲雙胍不良反應

DOI：

10.7507/1672-2531.20080217

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目的　系統評價二甲雙胍治療代謝綜合征（MS）的有效性和安全性。
方法　計算機檢索Cochrane圖書館（2007 年第4 期）、MEDLINE（1966 ～ 2007）、EMbase（1984 ～ 2007）、CBMdisc（1978 ～ 2007）、CNKI （1979 ～ 2007）、VIP（1989 ～ 2007）等數據庫、手工檢索《中華內分泌代謝雜志》等相關雜志，收集二甲雙胍治療MS 的隨機或半隨機對照試驗。按Cochrane系統評價方法評價納入研究質量后，對同質研究采用RevMan 軟件進行Meta分析，對數據不能進行Meta分析者，則進行描述性的定性分析。
結果　共納入6個RCT，包括2 442例MS 患者。由于納入研究存在明顯的臨床異質性，未進行合并分析。3個研究為二甲雙胍與安慰劑比較，二甲雙胍組MS患者減少比率、低HDL-c、高腰圍（WC）、高空腹血糖（FPG）組分患者減少比率均高于安慰劑組［RR（95%CI）分別為1.27（1.01，1.60）、1.61（1.16，2.23）、1.64（1.06，2.55）和1.55（1.17，2.05）］，但兩組高TG、高血壓組分患者比率的差異無統計學意義，二甲雙胍對穩態模型胰島素抵抗指數（HOMA- index）、FPG的改善優于安慰劑。1個研究為二甲雙胍與低脂飲食治療比較，二甲雙胍對胰島素敏感指數、血壓、TG、FPG、餐后2 h血糖（2 hPG）的改善優于低脂飲食治療，但二者對HDL-c均無影響。另1個研究為二甲雙胍與阿卡波糖比較，二甲雙胍降低體重指數（BMI）的療效優于阿卡波糖；對TG、FPG 的影響二者差異無統計學意義；兩者對HDL-c無影響；二甲雙胍對2 hPG的改善差于阿卡波糖。再1個研究為阿替洛爾+尼群地平加用二甲雙胍與不加用二甲雙胍比較，加用二甲雙胍組新發糖尿病（DM）人數少于不加用二甲雙胍組，但差異無統計學意義［RR=0.54，95%CI（0.19，1.54）］；加用二甲雙胍組高TG、中心性肥胖、糖耐量減低（IGT）組分患者減少比率高于不加用二甲雙胍組［RR（95%CI）分別為5.57（1.56，19.84）、14.47（3.34，62.61）和16.51（6.06，45.0）］；對血壓的影響，二者差異無統計學意義；加用二甲雙胍對WC、TG的改善優于不加用二甲雙胍；兩組對HDL-c 無影響。二甲雙胍對血壓、肥胖（WC、BMI）、血脂指標的影響，各研究結果不一致。6個納入研究均未報道藥物不良反應。
結論　二甲雙胍能減少MS高FPG組分、IGT組分、中心性肥胖組分人數；對減少MS患者人數、改善胰島素敏感性有一定的作用；對血壓、肥胖、血脂指標的療效不確定。納入研究缺乏對心血管事件結局指標的報道。由于本系統評價納入研究數量少、質量較差，研究樣本量小，其結論基本來自單個研究，因此對上述結論須謹慎對待。今后有必要進一步開展高質量、大樣本、長期隨訪的二甲雙胍治療MF的隨機對照試驗。

引用本文： 勾忠平,李秀鈞,吳泰相. 二甲雙胍治療代謝綜合征的系統評價. 中國循證醫學雜志, 2008, 08(11): 980-987. doi: 10.7507/1672-2531.20080217 復制

1.	Reaven GM. Banting lecture 1988. Role of insulin resistance in human disease. Diabetes, 1988, 37(12): 1595-1607.
2.	Glueck CJ, Wang P, Fontaine R, et al. Metfomun-induced resumption of normal menses in 39 of 43(91%) previously a menorrheic women with the polycystic ovary syndrome. Metabolism, 1999, 48(4): 511-519.
3.	YuanL, Reinhard Z, Andreas H, et al. Metformin modulates insulin post-receptor signaling transduction in chronically insulin-treated HepG2 cells. Acta Pharrnacol Sin, 2003, 24(1): 55-64.
4.	李益明, 段文瀾, 朱禧星, 等. 二甲雙胍對糖尿病大鼠骨骼肌GLUT4基因表達的影響. 上海醫科大學學報, 1998, 25(6): 409-414.
5.	HeG, Pedesen SB, Bruno JM, et al . Metforrnin, but not thiazolidinediones, inhibits plasminogen activator inhibitor-1 production in human adipose tissue in vitro. Horm Metab Res, 2003, 35(1): 18-27.
6.	Stefanovic V, Antic S, Mitic-Zlatkovic M, et al. Reversal of increased lymphocyte PC-1 activity in patients with type2 diabetes treated with metformin. Diabetes Metab Res Rev, 1999, 15(6): 400-409.
7.	Stolar MV. Insulin resistance, diabetes, and the adipocyte. Am J Health Syst Pharm, 2002, 59 (Suppl 9): S3-S9.
8.	Yasuda N, Inoue T, Nagakum T, et al. Enhanced secretion of glucagon like peptide-1 by biguanide compounds. Biochem Biophys Res Commun, 2002, 298(5): 779-787.
9.	Kay JP, Alemzadeh R, Iangley G, et al. Beneficial effects of metformin in normoglycemic morbidly obese adolescents. Metabolism, 2001, 50(12): 1457-1464.
10.	McNulty SJ, Ur E, Williams G, et al. A randomized trial of sibutramine in the management of obese type2 diabetic patients treated with metformin. Diabetes Care, 2003, 26(1): 125-132.
11.	Johansen K. Efficacy of metformin in the treatment of NIDDM. Meta analysis. Diabetes Care, 1999, 22(l): 33-39.
12.	Carlsen SM, Rossvoll O, Bjeve KS, et al. Metformin improves blood lipid patern in nondiabetic patients with coronary heart disease. J Intern Med, 1996, 239(3): 227- 235.
13.	鄧宏明, 肖常青, 夏寧, 等. 二甲雙胍治療2型糖尿病人對血壓影響的研究. 高血壓雜志, 2002, 10(3): 197-10.
14.	Alberti KGMM, Zimmet PZ, WHO Consultation. Definition, diagnos is 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): 539-553.
15.	Expert Panel on Detection, Evaluation, and Treatment of High Blood cholesterol in Adults (Adult treatment Panel Ⅲ). Executive summary of the third report of the National Cholesteral Education Program (NECP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. J Am Med Assoc, 2001, 285(19): 2486-2497.
16.	Barclay L. Medscape Medical News. New definition of the metabolic syndrome: a newsmaker interview with Sir George Alberti, MA, DPhil, BMBCh. Available at: http: //www. medscape. com/ viewarticle/504382 Accessed July 8, 2005.
17.	吳泰相, 劉關鍵. 隱蔽分組（分配隱藏）和盲法的概念、實施與報告. 中國循證醫學雜志, 2007, 7(3): 222-225.
18.	郭冀珍, 龔艷春, 章建梁, 等. 高血壓病伴代謝綜合征患者463例的干預治療研究. 中華心血管病雜志, 2005, 33(21): 32-36.
19.	向群, 姚強, 熊正南, 等. 二甲雙胍對代謝綜合征患者血壓的影響. 高血壓雜志, 2005, 13(11): 687-610.
20.	齊昆青, 馬麗, 樊永亮. 阿卡波糖和二甲胍治療糖耐量異常合并代謝綜合征的比較. 第四軍醫大學學報, 2005, 26(16): 687-688.
21.	de Aguiar LG, Bahia LR, Villela N, et al. Metformin Improves Endothelial Vascular Reactivity in First-Degree Relatives of Type 2 Diabetic Patients With Metabolic Syndrome and Normal Glucose Tolerance. Diabetes Care, 2006, 29(5): 1083-1089.
22.	Vitale C, Mercuro G, Cornoldi A, et al. Metformin improves endothelial function in patients with metabolic syndrome. J Intern Med, 2005, 258(3): 250-256.
23.	Orchard TJ, Temprosa M, Goldberg R, et al. A lifestyle intervention or metformin prevented or delayed the onset of the metabolic syndrome in persons at risk. Ann Intern Med, 2005, 142(8): 611-619.
24.	Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med, 2002, 346(6): 393-403.
25.	Isomaa B, Almgren P, Tuomi T, et al. Cardiovascular morbidity and mortality associated with the metabolic syndrome. Diabetes Care, 2001, 24(4): 683-689.
26.	Lakka HM, Laaksonen DE, Lakka TA, et al. The metabolic syndrome and total and cardiovascular disease mortality in middle-aged men. JAMA, 2002, 288(21): 2709-2716.
27.	Hunt KJ, Resendez RG, Williams K, et al. NCEP versus WHO metabolic syndrome in relation to all cause and cardiovascular mortality in the San Antonio Heart Study (SAHS)[abstract] . Circulation, 2004, 110(10): 1251-1257.
28.	Despres JP, Lamarche B, Mauriege P, et al. Hyperinsulinemia as an independent risk factor for ischemic heart disease. N Engl J Med, 1996, 334(15): 952-957.
29.	Haffner SM. Epidemiology of insulin resistance and its relation to coronary artery disease. Am J Cardiol, 1999, 84(1A): 11J-14J.
30.	Deedwania PC. Metabolic syndrome and vascular disease: is nature or nurture leading the new epidemic of cardiovascular disease. Circulation, 2004, 109(1): 2-4.
31.	Kay JP, Alemzadeh R, Iangley G, et al. Beneficial effects of metformin in normoglycemic morbidly obese adolescents. Metabolism, 2001, 50(12): 1457-1467.
32.	McNulty SJ, Ur E, Williams G, et al. A randomized trial of sibutramine in the management of obese type2 diabetic patients treated with metformin. Diabetes Care, 2003, 26(1): 125-133.
33.	Despres JP. Potential contribution of metformin to the management of cardiovascular disease risk in patients with abdominal obesity, the metabolic syndrome and type 2 diabetes. Diabetes Metab, 2003, 29(4pt 2): 6S53-6S61.
34.	UK Prospective Diabetes Study (UKPDS) Group: Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet, 1998, 352 (9131): 854-865.
35.	Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med, 2002, 346(6): 393-403.

1. Reaven GM. Banting lecture 1988. Role of insulin resistance in human disease. Diabetes, 1988, 37(12): 1595-1607.
2. Glueck CJ, Wang P, Fontaine R, et al. Metfomun-induced resumption of normal menses in 39 of 43(91%) previously a menorrheic women with the polycystic ovary syndrome. Metabolism, 1999, 48(4): 511-519.
3. YuanL, Reinhard Z, Andreas H, et al. Metformin modulates insulin post-receptor signaling transduction in chronically insulin-treated HepG2 cells. Acta Pharrnacol Sin, 2003, 24(1): 55-64.
4. 李益明, 段文瀾, 朱禧星, 等. 二甲雙胍對糖尿病大鼠骨骼肌GLUT4基因表達的影響. 上海醫科大學學報, 1998, 25(6): 409-414.
5. HeG, Pedesen SB, Bruno JM, et al . Metforrnin, but not thiazolidinediones, inhibits plasminogen activator inhibitor-1 production in human adipose tissue in vitro. Horm Metab Res, 2003, 35(1): 18-27.
6. Stefanovic V, Antic S, Mitic-Zlatkovic M, et al. Reversal of increased lymphocyte PC-1 activity in patients with type2 diabetes treated with metformin. Diabetes Metab Res Rev, 1999, 15(6): 400-409.
7. Stolar MV. Insulin resistance, diabetes, and the adipocyte. Am J Health Syst Pharm, 2002, 59 (Suppl 9): S3-S9.
8. Yasuda N, Inoue T, Nagakum T, et al. Enhanced secretion of glucagon like peptide-1 by biguanide compounds. Biochem Biophys Res Commun, 2002, 298(5): 779-787.
9. Kay JP, Alemzadeh R, Iangley G, et al. Beneficial effects of metformin in normoglycemic morbidly obese adolescents. Metabolism, 2001, 50(12): 1457-1464.
10. McNulty SJ, Ur E, Williams G, et al. A randomized trial of sibutramine in the management of obese type2 diabetic patients treated with metformin. Diabetes Care, 2003, 26(1): 125-132.
11. Johansen K. Efficacy of metformin in the treatment of NIDDM. Meta analysis. Diabetes Care, 1999, 22(l): 33-39.
12. Carlsen SM, Rossvoll O, Bjeve KS, et al. Metformin improves blood lipid patern in nondiabetic patients with coronary heart disease. J Intern Med, 1996, 239(3): 227- 235.
13. 鄧宏明, 肖常青, 夏寧, 等. 二甲雙胍治療2型糖尿病人對血壓影響的研究. 高血壓雜志, 2002, 10(3): 197-10.
14. Alberti KGMM, Zimmet PZ, WHO Consultation. Definition, diagnos is 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): 539-553.
15. Expert Panel on Detection, Evaluation, and Treatment of High Blood cholesterol in Adults (Adult treatment Panel Ⅲ). Executive summary of the third report of the National Cholesteral Education Program (NECP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. J Am Med Assoc, 2001, 285(19): 2486-2497.
16. Barclay L. Medscape Medical News. New definition of the metabolic syndrome: a newsmaker interview with Sir George Alberti, MA, DPhil, BMBCh. Available at: http: //www. medscape. com/ viewarticle/504382 Accessed July 8, 2005.
17. 吳泰相, 劉關鍵. 隱蔽分組（分配隱藏）和盲法的概念、實施與報告. 中國循證醫學雜志, 2007, 7(3): 222-225.
18. 郭冀珍, 龔艷春, 章建梁, 等. 高血壓病伴代謝綜合征患者463例的干預治療研究. 中華心血管病雜志, 2005, 33(21): 32-36.
19. 向群, 姚強, 熊正南, 等. 二甲雙胍對代謝綜合征患者血壓的影響. 高血壓雜志, 2005, 13(11): 687-610.
20. 齊昆青, 馬麗, 樊永亮. 阿卡波糖和二甲胍治療糖耐量異常合并代謝綜合征的比較. 第四軍醫大學學報, 2005, 26(16): 687-688.
21. de Aguiar LG, Bahia LR, Villela N, et al. Metformin Improves Endothelial Vascular Reactivity in First-Degree Relatives of Type 2 Diabetic Patients With Metabolic Syndrome and Normal Glucose Tolerance. Diabetes Care, 2006, 29(5): 1083-1089.
22. Vitale C, Mercuro G, Cornoldi A, et al. Metformin improves endothelial function in patients with metabolic syndrome. J Intern Med, 2005, 258(3): 250-256.
23. Orchard TJ, Temprosa M, Goldberg R, et al. A lifestyle intervention or metformin prevented or delayed the onset of the metabolic syndrome in persons at risk. Ann Intern Med, 2005, 142(8): 611-619.
24. Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med, 2002, 346(6): 393-403.
25. Isomaa B, Almgren P, Tuomi T, et al. Cardiovascular morbidity and mortality associated with the metabolic syndrome. Diabetes Care, 2001, 24(4): 683-689.
26. Lakka HM, Laaksonen DE, Lakka TA, et al. The metabolic syndrome and total and cardiovascular disease mortality in middle-aged men. JAMA, 2002, 288(21): 2709-2716.
27. Hunt KJ, Resendez RG, Williams K, et al. NCEP versus WHO metabolic syndrome in relation to all cause and cardiovascular mortality in the San Antonio Heart Study (SAHS)[abstract] . Circulation, 2004, 110(10): 1251-1257.
28. Despres JP, Lamarche B, Mauriege P, et al. Hyperinsulinemia as an independent risk factor for ischemic heart disease. N Engl J Med, 1996, 334(15): 952-957.
29. Haffner SM. Epidemiology of insulin resistance and its relation to coronary artery disease. Am J Cardiol, 1999, 84(1A): 11J-14J.
30. Deedwania PC. Metabolic syndrome and vascular disease: is nature or nurture leading the new epidemic of cardiovascular disease. Circulation, 2004, 109(1): 2-4.
31. Kay JP, Alemzadeh R, Iangley G, et al. Beneficial effects of metformin in normoglycemic morbidly obese adolescents. Metabolism, 2001, 50(12): 1457-1467.
32. McNulty SJ, Ur E, Williams G, et al. A randomized trial of sibutramine in the management of obese type2 diabetic patients treated with metformin. Diabetes Care, 2003, 26(1): 125-133.
33. Despres JP. Potential contribution of metformin to the management of cardiovascular disease risk in patients with abdominal obesity, the metabolic syndrome and type 2 diabetes. Diabetes Metab, 2003, 29(4pt 2): 6S53-6S61.
34. UK Prospective Diabetes Study (UKPDS) Group: Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet, 1998, 352 (9131): 854-865.
35. Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med, 2002, 346(6): 393-403.

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二甲雙胍治療代謝綜合征的系統評價

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