噻唑烷二酮類藥物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：

代謝綜合征噻唑烷二酮類羅格列酮吡格列酮系統評價隨機對照試驗

DOI：

10.7507/1672-2531.20090105

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目的　系統評價噻唑烷二酮類藥物治療代謝綜合征的有效性和安全性。
方法　運用系統評價的方法，計算機檢索Cochrane 圖書館（2007 年，第4 期）、MEDLINE（1966 ～ 2007）、EMbase（1984 ～ 2007）、中國生物醫學文獻數據庫（1978 ～ 2007）、中國學術期刊全文數據庫（1979 ～ 2007）和中文科技期刊全文數據庫（1989 ～ 2007），并手工檢索《中華內分泌代謝雜志》等相關雜志，收集噻唑烷二酮類（TZDs）藥物治療代謝綜合征的隨機或半隨機對照試驗（RCT）。按Cochrane 系統評價標準評價納入研究質量，對同質研究采用RevMan 軟件進行Meta 分析，對不能進行Meta 分析的數據，則只進行描述性的定性分析。
結果　共納入10 個RCT，包括1 183 例MS 患者。由于大多數研究間存在臨床異質性，故僅對個別研究進行了Meta 分析。5 個研究進行了羅格列酮與安慰劑比較，但僅1 個研究報告了心血管事件（心肌梗死、冠狀動脈血管重建術）發生率，結果顯示兩組差異無統計學意義［RR= 0.50，95%CI（0.25，1.00）］；羅格列酮減少代謝綜合征患者例數及對穩態模型胰島素抵抗指數（HOMA-index）的改善優于安慰劑，而二者對TG、HDL-c 的影響差異則無統計學意義。與安慰劑比較，吡格列酮對HOMA-index、QUICKI、SBP、HDL-c 的改善優于安慰劑；二者對TG 的影響差異無統計學意義。吡格列酮+ 格列美脲與羅格列酮+ 格列美脲比較，兩者對HOMA-index、SBP/DBP、FPG、PPG 和HbA1c 的影響，其差異無統計學意義；羅格列酮+ 格列美脲對HDL-c 無影響，而對TG、HDL-c 的改善吡格列酮+ 格列美脲優于羅格列酮+ 格列美脲。與格列美脲+ 二甲雙胍比較，羅格列酮+ 二甲雙胍對HOMA-index、SBP/DBP、HDL-c、TG 的改善優于格列美脲+ 二甲雙胍，但二者對FPG、PPG、HbA1c 的影響差異無統計學意義。羅格列酮+ 二甲雙胍與吡格列酮+ 二甲雙胍比較，兩者對HOMAindex、FPG、PPG、HbA1c 的影響差異無統計學意義；羅格列酮+ 二甲雙胍對TG、HDL-c 無影響，吡格列酮+ 二甲雙胍對TG、HDL-c 的改善優于羅格列酮+ 二甲雙胍。常規治療加用羅格列酮與不加用羅格列酮比較，常規治療加用羅格列酮對HOMA-index、SBP/DBP 的改善優于常規治療。羅格列酮、吡格列酮對體重指數和腰圍無改善或使二者增高。有9 個研究報道了不良反應，結果顯示TZDs 耐受性良好，不良反應為輕至中度，無嚴重不良反應。
結論　TZDs 與安慰劑比較能提高MS 患者胰島素的敏感性；吡格列酮對HDL-c 的改善優于羅格列酮；TZDs 對血壓的療效不確定；目前尚未發現羅格列酮對TG、HDL-c 有影響；TZDs 對肥胖指標無改善，或有負性影響。由于上述結論基本來自單個研究，研究質量參差不齊，大多數研究樣本量小，因此使用結論時必須謹慎。由于對心血管事件、MS 患者比率影響的研究少、質量不高，目前TZDs 對心血管事件、MS 患者比率的療效還難以得出結論。目前尚無足夠的證據證明哪種藥物更有效，期待開展更多高質量、大樣本、長期隨訪的RCT，以提供更可靠的證據。

引用本文： 勾忠平,李秀鈞,吳泰相. 噻唑烷二酮類藥物治療代謝綜合征的系統評價. 中國循證醫學雜志, 2009, 09(5): 574-583. doi: 10.7507/1672-2531.20090105 復制

1.	responsiveness to its antidiabetic effect. Diabets Care, 2003, 26(9): 2493-2499.
2.	Metabolic Syndrome Treated with Glimepiride: A Twelve-Month, Multicenter, Double-Blind, Randomized, Controlled, Parallel-Group Trial. Clinical Therapeutics, 2004, 26(5): 746-754.
3.	Douglas JA, Erdos MR, Watanabe RM, et al. The Peroxisome Proliferator–Activated Receptor- 2 Pro12Ala Variant: Association With Type 2 Diabetes and Trait Differences. Diabetes, 2001, 50(4): 886- 890.
4.	Viberti G, Kahn SE, Greene DA, et al. A Diabetes Outcome Progression Trial (ADOPT): An international multicenter study of the comparative efficacy of rosiglitazone, glyburide, and metformin in recently diagnosed type 2 diabetes. Diabetes Care, 2002, 25(10): l737- l743.
5.	MartensF M, VisserenF L, LemayJ, et al. Metabolic and additional vascular effects of thiazolidinediones. Drug, 2002, 62(10): 1463-1480.
6.	徐成斌. 代謝綜合征. 國外醫學內分泌學分冊. 2005, 25(1): 3-6.
7.	Dormandy JA, Charbonnel B, Eckland DJ, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trail. Lancet, 2005, 366(9493): 1279-1289.
8.	Marx N & Hombach V. Peroxisome proliferator-activated receptors (PPARs) in the vessel wall: new regulators of gene expression in vascular cells (in German). Zeitschrift für Kardiologie, 2001, 90(7): 470-477.
9.	Goetze S, XI XP, Kawano H, et al. PPAR gamma-ligands inhibit migration mediated by multiple chemoattractants in vascular smooth muscle cells. Journal of Cardiovascular Pharmacology, 1999, 33(5): 798-806.
10.	Jiang C, Ting AT, Seed B. PPAR-agonists inhibit production of monocyte inflammatory cytokines. Nature, 1998, 391(6662): 82-86.
11.	Chinetti G, Griglio S, Antonucci M, et al. Activation of proliferatoractivated receptors and induces apoptosis of human monocytederived macrophages. J Biol Chem, 1998, 273(40): 25573-25580.
12.	Koshi y ama H, Shimono D, Kuwamur a N, et al . Rapid communication: inhibitory effect of pioglitazone on carotid arterial wall thickness in type 2 diabetes. J Clin Endocrinol Metab, 2001, 86(7): 3452-3456.
13.	Satoh N, Ogawa Y, Usul T, et al. Antiatherogenic effect of pioglitazone in type 2 diabetic patients irrespective of the.
14.	Haffner SM, Greenberg AS, Weston WM, et al. Effect of rosiglitazone treatment on nontraditional markers of cardiovascular disease in patients with type 2 diabetes mellitus. Circulation, 2002, 106(6): 679-684.
15.	Pfutzner A, Marx N, Lubben G, et al. Improvement of cardiovascular risk markers by pioglitazone is independent from glycemic control: results from the pioneer study. J Am Coll Cardiol, 2005, 45(12): 1925-1931.
16.	Goldberg RB, Kendall DM, Deeg MA, et al. A comparison of lipid and glycemic effects of pioglitazone and rosiglitazone in patients with type 2 diabetes and dyslipidemia. Diabetes Care, 2005, 28(7): 1547-1554.
17.	Fullert S, Schneider F, Haak E, et al. Effects of pioglitazone in nondiabetic patients with arterial hypertension: a double-blind, placebocontrolled study. J Clin Endocrinol Metab, 2002, 87(12): 5503-5506.
18.	Raji A, Williams GH, Seely EW, et al. Rosiglitazone improves insulin sensitivity and lowers blood pressure in hypertensive patients. Diabetes Care, 2003, 26(1): 172-178.
19.	Alberti KGMM, Zimmet PZ, WHO Consultation. 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.
20.	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 Eduation Program (NECP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. J Am Med Assoc, 2001, 285(19): 2486-2497.
21.	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.
22.	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.
23.	Cao Z, Zhou YJ, Zhao YX, et al. Rosiglitazone could improve clinical outcome after coronary stent implantation in nondiabetes patients with metabolic syndrome. Chinese Medical Journal, 2006, 119(14): 1171-1175.
24.	Samaha FF, Szapary PO, Iqbal N, et al. Effects of Rosiglitazone on Lipids, Adipokines, and Inflammatory Markers in Nondiabetic Patients With Low High-Density Lipoprotein Cholesterol and Metabolic Syndrome. Arterioscler Thromb Vasc Biol, 2006, 26(3): 624-630.
25.	Derosa G, Cicero AFG, Gaddi A, et al. Metabolic Effects of Pioglitazone and Rosiglitazone in Patients with Diabetes and.
26.	Derosa G, Gaddi AV, Ciccarelli L, et al. Long-term effect of glimepiride and rosiglitazone on non-conventional cardiovascular risk factors in metformin-treated patients affected by metabolic syndrome: a randomized, double-blind clinical trial. The journal of international medical resesarch, 2005, 33(3): 284-294.
27.	Derosa G, D’Angelo A, Ragonesi PD, et al. Metformin–pioglitazone and metformin- rosiglitazone effects on non-conventional cardiovascular risk factors plasma level in type 2 diabetic patients with metabolic syndrome. Journal of Clinical Pharmacy and Therapeutics, 2006, 31(4): 375-383.
28.	Esposito K, Ciotola M, Carleo D, et al. Effect of Rosiglitazone on Endothelial Function and Inflammatory Markers in Patients With the Metabolic Syndrome. Diabetes Care, 2006, 29(5): 1071-1076.
29.	Szapary PO, Bloedon LT, Samaha FF, et al. Effects of Pioglitazone on Lipoproteins, Inflammatory Markers, and Adipokines in Nondiabetic Patients with Metabolic Syndrome. Arterioscler Thromb Vasc Biol, 2006, 26(1): 182-188.
30.	Wang TD, Chen WJ, Lin JW, et al. Effects of Rosiglitazone on Endothelial Function, C-Reactive Protein, and Components of the Metabolic Syndrome in Nondiabetic Patients With th Metabolic Syndrome. Am J Cardiol, 2004, 93(3): 362-365.
31.	Wang TD, Chen WJ, Cheng WC, et al. Relation of Improvement in Endothelium-Dependent Flow-Mediated Vasodilation After Rosiglitazone to Changes in Asymmetric Dimethylarginine, Endothelin-1, and C-Reactive Protein in Nondiabetic Patients With the Metabolic Syndrome. Am J Cardiol, 2006, 98(8): 1057-1062.
32.	徐鳳霞, 商宏偉, 李金華, 等. 羅格列酮對血糖正常的MS患者血管內皮功能和C反應蛋白的影響. 中國臨床藥理學雜志, 2005, 22(1): 15-17.
33.	Isomaa B, Almgren P, Tuonfi T, et a1. Cardiovascular morbidity and mortality associate with the metabolic syndrome. Diabetes Care, 2001, 24(4): 683-689.
34.	Lakka HM, laaksonen DE, Lakka TA, et a1. The metabolic syndrome and total and cardiovascular disease mortality in middle aged men. JAMA, 2002, 288(21): 2709-2716.
35.	Hunt KJ, Resendz 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]. Diabetes, 2003, 52(1): A221-227.

1. responsiveness to its antidiabetic effect. Diabets Care, 2003, 26(9): 2493-2499.
2. Metabolic Syndrome Treated with Glimepiride: A Twelve-Month, Multicenter, Double-Blind, Randomized, Controlled, Parallel-Group Trial. Clinical Therapeutics, 2004, 26(5): 746-754.
3. Douglas JA, Erdos MR, Watanabe RM, et al. The Peroxisome Proliferator–Activated Receptor- 2 Pro12Ala Variant: Association With Type 2 Diabetes and Trait Differences. Diabetes, 2001, 50(4): 886- 890.
4. Viberti G, Kahn SE, Greene DA, et al. A Diabetes Outcome Progression Trial (ADOPT): An international multicenter study of the comparative efficacy of rosiglitazone, glyburide, and metformin in recently diagnosed type 2 diabetes. Diabetes Care, 2002, 25(10): l737- l743.
5. MartensF M, VisserenF L, LemayJ, et al. Metabolic and additional vascular effects of thiazolidinediones. Drug, 2002, 62(10): 1463-1480.
6. 徐成斌. 代謝綜合征. 國外醫學內分泌學分冊. 2005, 25(1): 3-6.
7. Dormandy JA, Charbonnel B, Eckland DJ, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trail. Lancet, 2005, 366(9493): 1279-1289.
8. Marx N & Hombach V. Peroxisome proliferator-activated receptors (PPARs) in the vessel wall: new regulators of gene expression in vascular cells (in German). Zeitschrift für Kardiologie, 2001, 90(7): 470-477.
9. Goetze S, XI XP, Kawano H, et al. PPAR gamma-ligands inhibit migration mediated by multiple chemoattractants in vascular smooth muscle cells. Journal of Cardiovascular Pharmacology, 1999, 33(5): 798-806.
10. Jiang C, Ting AT, Seed B. PPAR-agonists inhibit production of monocyte inflammatory cytokines. Nature, 1998, 391(6662): 82-86.
11. Chinetti G, Griglio S, Antonucci M, et al. Activation of proliferatoractivated receptors and induces apoptosis of human monocytederived macrophages. J Biol Chem, 1998, 273(40): 25573-25580.
12. Koshi y ama H, Shimono D, Kuwamur a N, et al . Rapid communication: inhibitory effect of pioglitazone on carotid arterial wall thickness in type 2 diabetes. J Clin Endocrinol Metab, 2001, 86(7): 3452-3456.
13. Satoh N, Ogawa Y, Usul T, et al. Antiatherogenic effect of pioglitazone in type 2 diabetic patients irrespective of the.
14. Haffner SM, Greenberg AS, Weston WM, et al. Effect of rosiglitazone treatment on nontraditional markers of cardiovascular disease in patients with type 2 diabetes mellitus. Circulation, 2002, 106(6): 679-684.
15. Pfutzner A, Marx N, Lubben G, et al. Improvement of cardiovascular risk markers by pioglitazone is independent from glycemic control: results from the pioneer study. J Am Coll Cardiol, 2005, 45(12): 1925-1931.
16. Goldberg RB, Kendall DM, Deeg MA, et al. A comparison of lipid and glycemic effects of pioglitazone and rosiglitazone in patients with type 2 diabetes and dyslipidemia. Diabetes Care, 2005, 28(7): 1547-1554.
17. Fullert S, Schneider F, Haak E, et al. Effects of pioglitazone in nondiabetic patients with arterial hypertension: a double-blind, placebocontrolled study. J Clin Endocrinol Metab, 2002, 87(12): 5503-5506.
18. Raji A, Williams GH, Seely EW, et al. Rosiglitazone improves insulin sensitivity and lowers blood pressure in hypertensive patients. Diabetes Care, 2003, 26(1): 172-178.
19. Alberti KGMM, Zimmet PZ, WHO Consultation. 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.
20. 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 Eduation Program (NECP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. J Am Med Assoc, 2001, 285(19): 2486-2497.
21. 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.
22. 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.
23. Cao Z, Zhou YJ, Zhao YX, et al. Rosiglitazone could improve clinical outcome after coronary stent implantation in nondiabetes patients with metabolic syndrome. Chinese Medical Journal, 2006, 119(14): 1171-1175.
24. Samaha FF, Szapary PO, Iqbal N, et al. Effects of Rosiglitazone on Lipids, Adipokines, and Inflammatory Markers in Nondiabetic Patients With Low High-Density Lipoprotein Cholesterol and Metabolic Syndrome. Arterioscler Thromb Vasc Biol, 2006, 26(3): 624-630.
25. Derosa G, Cicero AFG, Gaddi A, et al. Metabolic Effects of Pioglitazone and Rosiglitazone in Patients with Diabetes and.
26. Derosa G, Gaddi AV, Ciccarelli L, et al. Long-term effect of glimepiride and rosiglitazone on non-conventional cardiovascular risk factors in metformin-treated patients affected by metabolic syndrome: a randomized, double-blind clinical trial. The journal of international medical resesarch, 2005, 33(3): 284-294.
27. Derosa G, D’Angelo A, Ragonesi PD, et al. Metformin–pioglitazone and metformin- rosiglitazone effects on non-conventional cardiovascular risk factors plasma level in type 2 diabetic patients with metabolic syndrome. Journal of Clinical Pharmacy and Therapeutics, 2006, 31(4): 375-383.
28. Esposito K, Ciotola M, Carleo D, et al. Effect of Rosiglitazone on Endothelial Function and Inflammatory Markers in Patients With the Metabolic Syndrome. Diabetes Care, 2006, 29(5): 1071-1076.
29. Szapary PO, Bloedon LT, Samaha FF, et al. Effects of Pioglitazone on Lipoproteins, Inflammatory Markers, and Adipokines in Nondiabetic Patients with Metabolic Syndrome. Arterioscler Thromb Vasc Biol, 2006, 26(1): 182-188.
30. Wang TD, Chen WJ, Lin JW, et al. Effects of Rosiglitazone on Endothelial Function, C-Reactive Protein, and Components of the Metabolic Syndrome in Nondiabetic Patients With th Metabolic Syndrome. Am J Cardiol, 2004, 93(3): 362-365.
31. Wang TD, Chen WJ, Cheng WC, et al. Relation of Improvement in Endothelium-Dependent Flow-Mediated Vasodilation After Rosiglitazone to Changes in Asymmetric Dimethylarginine, Endothelin-1, and C-Reactive Protein in Nondiabetic Patients With the Metabolic Syndrome. Am J Cardiol, 2006, 98(8): 1057-1062.
32. 徐鳳霞, 商宏偉, 李金華, 等. 羅格列酮對血糖正常的MS患者血管內皮功能和C反應蛋白的影響. 中國臨床藥理學雜志, 2005, 22(1): 15-17.
33. Isomaa B, Almgren P, Tuonfi T, et a1. Cardiovascular morbidity and mortality associate with the metabolic syndrome. Diabetes Care, 2001, 24(4): 683-689.
34. Lakka HM, laaksonen DE, Lakka TA, et a1. The metabolic syndrome and total and cardiovascular disease mortality in middle aged men. JAMA, 2002, 288(21): 2709-2716.
35. Hunt KJ, Resendz 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]. Diabetes, 2003, 52(1): A221-227.

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噻唑烷二酮類藥物治療代謝綜合征的系統評價

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《中國循證醫學雜志》

噻唑烷二酮類藥物治療代謝綜合征的系統評價

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