鹽酸沙格雷酯治療周圍動脈疾病療效與安全性的系統評價_《中國循證醫學雜志》

作者：

高偉 ¹ , 王芳 ¹ , 劉關鍵 ² ,  冉興無 ¹

1. 四川大學華西醫院內分泌代謝科糖尿病足診治中心（成都 610041）；2. 四川大學華西醫院中國循證醫學中心（成都 610041）;

關鍵詞：

周圍動脈疾病肢體缺血潰瘍鹽酸沙格雷酯系統評價 Meta分析

DOI：

10.7507/1672-2531.20120055

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目的　系統評價鹽酸沙格雷酯治療周圍動脈疾病（peripheral arterial disease，PAD）的療效和安全性。
方法　計算機檢索CBM（1978～2010.9）、CNKI（1979～2011.5）、PubMed（1950～2011.5）、EMbase（1970～2011.5）和Cochrane圖書館（2011年第3期），納入以鹽酸沙格雷酯為干預措施治療PAD的隨機對照試驗（RCT）。按照Cochrane系統評價方法，由2位評價者按照納入標準獨立選擇試驗、提取資料并交叉核對和進行方法學質量評估后，采用RevMan5.0軟件進行Meta分析。
結果　共納入9個RCT，522例PAD患者，532條肢體，但大多數研究的方法學質量較差。Meta分析結果顯示，與常規治療相比，鹽酸沙格雷酯治療PAD能減小患者潰瘍面積［MD= –3.22，95%CI（–3.99，–2.45）］，增加踝肱指數［SMD=0.49，95%CI（0.07，0.91）］、足背動脈血流量［MD=0.16，95%CI（0.09，0.23）］和無痛性行走距離［MD=200.87，95%CI（3.39，398.36）］。有5個試驗報道了鹽酸沙格雷酯治療的不良反應，大都為輕微的胃腸道反應。
結論　鹽酸沙格雷酯治療PAD可能有一定療效，但由于缺乏高質量RCT證據支持，上述結論還需進行更多高質量的RCT研究才能確定。

引用本文： 高偉,王芳,劉關鍵,冉興無. 鹽酸沙格雷酯治療周圍動脈疾病療效與安全性的系統評價. 中國循證醫學雜志, 2012, 12(3): 341-346. doi: 10.7507/1672-2531.20120055 復制

1.	Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation, 2004, 110(6): 738-743.
2.	Guan H, Li YJ, Xu ZR, et al. Prevalence and risk factors of peripheral arterial disease in diabetic patients over 50 years old in China. Chin Med Sci J, 2007, 22(2): 83-88.
3.	王椿, 余婷婷, 王艷, 等. 糖尿病患者下肢動脈病變篩查及危險因素分析. 中國糖尿病雜志, 2007, 15(11): 643-646.
4.	Leng GC, Lee AJ, Fowkes FG, et al. Incidence, natural history and cardiovascular events in symptomatic and asymptomatic peripheral arterial disease in the general population. Int J Epidemiol, 1996, 25(6): 1172-1181.
5.	Steg PG, Bhatt DL, Wilson PW, et al. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA, 2007, 297(11): 1197-1206.
6.	Heald CL, Fowkes FG, Murray GD, et al. Risk of mortality and cardiovascular disease associated with the ankle-brachial index: Systematic review. Atherosclerosis, 2006, 189(1): 61-69.
7.	Barradas MA, Gill DS, Fonseca VA, et al. Intraplatelet serotonin in patients with diabetes mellitus and peripheral vascular disease. Eur J Clin Invest, 1988, 18(4): 399-404.
8.	Hoyer D, Clarke DE, Fozard JR, et al. International union of pharmacology classification of receptors for 5-hydroxytryptamine (serotonin). Pharmacol Rev, 1999, 46(2): 157-201.
9.	Nagatomo T, Rashid M, Muntasir HA, et al. Functions of 5-HT2A receptor and its antagonists in the cardiovascular system. Pharmacol Ther, 2004, 104(1): 59-81.
10.	Golino P, Piscione F, Willerson JT, et al. Divergent effects of serotonin on coronary-artery dimensions and blood flow in patients with coronary atherosclerosis and control patients. N Engl J Med, 1991, 324: 64-68.
11.	Saxena PR, Villalon CM. Cardiovascular effects of serotonin agonists and antagonists. J Cardiovasc Pharmacol, 1990, 15 Suppl 7: S17-S34.
12.	Roth BL, Willins DL, Kristiansen K, et al. 5-hydroxytryptamine 2 family receptors (5-hydroxytryptamine2A, 5-hydroxytryptamine2B, 5-hydroxytryptamine2C): where structure meets function. Pharmacol Ther, 1998, 79(3): 231-257.
13.	Banes A, Florian JA, Watts SW. Mechanisms of 5-hydroxytryptamine (2A) receptor activation of the mitogen-activated protein kinase pathway in vascular smooth muscle. J Pharmacol Exp Ther, 1999, 291(3): 1179-1187.
14.	Keegan A, Morecroft I, Smillie D, et al. Contribution of the 5-HT(1B) receptor to hypoxia-induced pulmonary hypertension: converging evidence using 5-HT(1B)-receptor knockout mice and the 5-HT(1B/1D)-receptor antagonist GR127935. Circ Res, 2001, 89(12): 1231–1239.
15.	Hara H, Kitajima A, Shimada H, et al. Antithrombic effect of MCI-9042, a new antiplatelet agent on experimental thrombosis models. Thromb Haemost, 1991, 66(4): 484-488.
16.	Yamashita T, Kitamori K, Hashimoto M, et al. Conjunctive effects of 5HT2 receptor antagonist, sarpogrelate, on thrombolysis with modified tissue plasminogen activator in different laser-induced thrombosis models. Haemostasis, 2000, 30(6): 321-332.
17.	Hara H, Osakabe M, Kitajima A, et al. MCI-9042, a new antiplatelet agent is a selective S2-serotonergic receptor antagonist. Thromb Haemost, 1991, 65(4): 415-420.
18.	Nakamura K, Kariyazono H, Moriyama Y, et al. Effects of sarpogrelate hydrochloride on platelet aggregation, and its relation to the release of serotonin and P-selectin. Blood Coagul Fibrinolysis, 1999, 10(8): 513-519.
19.	Sharma SK, Zahradka P, Chapman D, et al. Inhibition of serotonin-induced vascular smooth muscle cell proliferation by sarpogrelate. J Pharmacol Exp Ther, 1999, 290(3): 1475-1481.
20.	Miyazaki M, Higashi Y, Goto C, et al. Sarpogrelate Hydrochloride, a Selective 5-HT2A Antagonist, Improves Vascular Function in Patients With Peripheral Arterial Disease. J Cardiovasc Pharmacol, 2007, 49(4): 221-227.
21.	Higashi Y, Miyazaki M, Goto C, et al. Sarpogrelate Hydrochloride, a Selective Sarpogrelate hydrochloride, a selective 5-hydroxytryptamine (2A) antagonist, augments autologous bone marrow mononuclear cell implantation-induced improvement in endothelium-dependent vasodilation in patients with critical limb ischemia. J Cardiovasc Pharmacol, 2010, 55(1): 56-61.
22.	古川欽一(Furukawa K), 中島光好, 田辺達三ら. 塩酸サルポグレラート(MCI-9042)の慢性動脈閉塞癥に対する臨床効果. 臨床醫薬, 1991, 7(6): 1206-1226.
23.	宋曉華, 莊舜玖, 戚韶紅, 等. 鹽酸沙格雷酯治療下肢動脈硬化性閉塞癥的療效. 藥學服務與研究, 2002, 2(2): 97-98.
24.	吳誼青, 初韋江. 鹽酸沙格雷酯治療2型糖尿病下肢血管病變的臨床觀察. 臨床薈萃, 2003, 18(16): 941.
25.	Norgren L, Jawien A, Matyas L, et al. European MCI-9042 Study Group. Sarpogrelate, a 5-hT2A receptor antagonist in intermittent claudication. A phase II European study. Vasc Med, 2006, 11(2): 75-83.
26.	李波, 房澤慧, 張瑛琦. 鹽酸沙格雷酯治療糖尿病足表淺性潰瘍30例臨床分析. 哈爾濱醫藥, 2008, 28(5) : 15.
27.	王玉珍, 李翔, 許樟榮, 等. 沙格雷酯與阿司匹林治療糖尿病下肢血管病變的隨機、對照臨床研究. 中華內分泌代謝雜志, 2009, 6: 595-597.
28.	吳心池, 施廣德, 黃文龍, 等. 沙格雷酯與西洛他唑治療2型糖尿病下肢血管病變的臨床對照研究. 中國糖尿病雜志, 2010, 18(8): 607-610.
29.	Ito K, Notsu T. Effect of sarpogrelate hydrochloride (MCI-9042) on peripheral circulation of chronic arterial occlusive disease. J Clin Ther Med, 1991, 7: 1243-1251.
30.	Nakamura K, Kariyazono H, Masuda H, et al. Effects of sarpogrelate hydrochloride on adenosine diphosphate- or collagen-induced platelet responses in arteriosclerosis obliterans. Blood Coagul Fibrinolysis, 2001, 12(5): 391–397.
31.	許樟榮, 敬華. 糖尿病足國際臨床指南. 北京: 人民軍醫出版社, 2003: 45-47.
32.	Higgins TPT, Altman DG (editors). Chapter 8: Assessing risk of bias in included studies. In: Higgins IPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.0 (updated February 2008). The Cochrane Collaboration, 2008. Available from: www.cochrane-handbook.org.
33.	王曉軍, 劉文星, 徐麗梅. 沙格雷酯治療糖尿病下肢動脈硬化性閉塞癥的療效觀察—附58例臨床報告. 新醫學, 2006, 37(4): 225-227.
34.	Hotta N, Nakamura J, SumitaY, et al. Effects of Anplag, a Selective 5-HT2A Antagonist in diabetic complications. Clin Drug Invest, 1999, 18(3): 199-207.
35.	Shinohara Y, Nishimaru K, Sawada T. Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A Randomized, Double-Blind, Aspirin-Controlled Trial. Strok, 2008, 39(6): 1827-1833.

1. Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation, 2004, 110(6): 738-743.
2. Guan H, Li YJ, Xu ZR, et al. Prevalence and risk factors of peripheral arterial disease in diabetic patients over 50 years old in China. Chin Med Sci J, 2007, 22(2): 83-88.
3. 王椿, 余婷婷, 王艷, 等. 糖尿病患者下肢動脈病變篩查及危險因素分析. 中國糖尿病雜志, 2007, 15(11): 643-646.
4. Leng GC, Lee AJ, Fowkes FG, et al. Incidence, natural history and cardiovascular events in symptomatic and asymptomatic peripheral arterial disease in the general population. Int J Epidemiol, 1996, 25(6): 1172-1181.
5. Steg PG, Bhatt DL, Wilson PW, et al. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA, 2007, 297(11): 1197-1206.
6. Heald CL, Fowkes FG, Murray GD, et al. Risk of mortality and cardiovascular disease associated with the ankle-brachial index: Systematic review. Atherosclerosis, 2006, 189(1): 61-69.
7. Barradas MA, Gill DS, Fonseca VA, et al. Intraplatelet serotonin in patients with diabetes mellitus and peripheral vascular disease. Eur J Clin Invest, 1988, 18(4): 399-404.
8. Hoyer D, Clarke DE, Fozard JR, et al. International union of pharmacology classification of receptors for 5-hydroxytryptamine (serotonin). Pharmacol Rev, 1999, 46(2): 157-201.
9. Nagatomo T, Rashid M, Muntasir HA, et al. Functions of 5-HT2A receptor and its antagonists in the cardiovascular system. Pharmacol Ther, 2004, 104(1): 59-81.
10. Golino P, Piscione F, Willerson JT, et al. Divergent effects of serotonin on coronary-artery dimensions and blood flow in patients with coronary atherosclerosis and control patients. N Engl J Med, 1991, 324: 64-68.
11. Saxena PR, Villalon CM. Cardiovascular effects of serotonin agonists and antagonists. J Cardiovasc Pharmacol, 1990, 15 Suppl 7: S17-S34.
12. Roth BL, Willins DL, Kristiansen K, et al. 5-hydroxytryptamine 2 family receptors (5-hydroxytryptamine2A, 5-hydroxytryptamine2B, 5-hydroxytryptamine2C): where structure meets function. Pharmacol Ther, 1998, 79(3): 231-257.
13. Banes A, Florian JA, Watts SW. Mechanisms of 5-hydroxytryptamine (2A) receptor activation of the mitogen-activated protein kinase pathway in vascular smooth muscle. J Pharmacol Exp Ther, 1999, 291(3): 1179-1187.
14. Keegan A, Morecroft I, Smillie D, et al. Contribution of the 5-HT(1B) receptor to hypoxia-induced pulmonary hypertension: converging evidence using 5-HT(1B)-receptor knockout mice and the 5-HT(1B/1D)-receptor antagonist GR127935. Circ Res, 2001, 89(12): 1231–1239.
15. Hara H, Kitajima A, Shimada H, et al. Antithrombic effect of MCI-9042, a new antiplatelet agent on experimental thrombosis models. Thromb Haemost, 1991, 66(4): 484-488.
16. Yamashita T, Kitamori K, Hashimoto M, et al. Conjunctive effects of 5HT2 receptor antagonist, sarpogrelate, on thrombolysis with modified tissue plasminogen activator in different laser-induced thrombosis models. Haemostasis, 2000, 30(6): 321-332.
17. Hara H, Osakabe M, Kitajima A, et al. MCI-9042, a new antiplatelet agent is a selective S2-serotonergic receptor antagonist. Thromb Haemost, 1991, 65(4): 415-420.
18. Nakamura K, Kariyazono H, Moriyama Y, et al. Effects of sarpogrelate hydrochloride on platelet aggregation, and its relation to the release of serotonin and P-selectin. Blood Coagul Fibrinolysis, 1999, 10(8): 513-519.
19. Sharma SK, Zahradka P, Chapman D, et al. Inhibition of serotonin-induced vascular smooth muscle cell proliferation by sarpogrelate. J Pharmacol Exp Ther, 1999, 290(3): 1475-1481.
20. Miyazaki M, Higashi Y, Goto C, et al. Sarpogrelate Hydrochloride, a Selective 5-HT2A Antagonist, Improves Vascular Function in Patients With Peripheral Arterial Disease. J Cardiovasc Pharmacol, 2007, 49(4): 221-227.
21. Higashi Y, Miyazaki M, Goto C, et al. Sarpogrelate Hydrochloride, a Selective Sarpogrelate hydrochloride, a selective 5-hydroxytryptamine (2A) antagonist, augments autologous bone marrow mononuclear cell implantation-induced improvement in endothelium-dependent vasodilation in patients with critical limb ischemia. J Cardiovasc Pharmacol, 2010, 55(1): 56-61.
22. 古川欽一(Furukawa K), 中島光好, 田辺達三ら. 塩酸サルポグレラート(MCI-9042)の慢性動脈閉塞癥に対する臨床効果. 臨床醫薬, 1991, 7(6): 1206-1226.
23. 宋曉華, 莊舜玖, 戚韶紅, 等. 鹽酸沙格雷酯治療下肢動脈硬化性閉塞癥的療效. 藥學服務與研究, 2002, 2(2): 97-98.
24. 吳誼青, 初韋江. 鹽酸沙格雷酯治療2型糖尿病下肢血管病變的臨床觀察. 臨床薈萃, 2003, 18(16): 941.
25. Norgren L, Jawien A, Matyas L, et al. European MCI-9042 Study Group. Sarpogrelate, a 5-hT2A receptor antagonist in intermittent claudication. A phase II European study. Vasc Med, 2006, 11(2): 75-83.
26. 李波, 房澤慧, 張瑛琦. 鹽酸沙格雷酯治療糖尿病足表淺性潰瘍30例臨床分析. 哈爾濱醫藥, 2008, 28(5) : 15.
27. 王玉珍, 李翔, 許樟榮, 等. 沙格雷酯與阿司匹林治療糖尿病下肢血管病變的隨機、對照臨床研究. 中華內分泌代謝雜志, 2009, 6: 595-597.
28. 吳心池, 施廣德, 黃文龍, 等. 沙格雷酯與西洛他唑治療2型糖尿病下肢血管病變的臨床對照研究. 中國糖尿病雜志, 2010, 18(8): 607-610.
29. Ito K, Notsu T. Effect of sarpogrelate hydrochloride (MCI-9042) on peripheral circulation of chronic arterial occlusive disease. J Clin Ther Med, 1991, 7: 1243-1251.
30. Nakamura K, Kariyazono H, Masuda H, et al. Effects of sarpogrelate hydrochloride on adenosine diphosphate- or collagen-induced platelet responses in arteriosclerosis obliterans. Blood Coagul Fibrinolysis, 2001, 12(5): 391–397.
31. 許樟榮, 敬華. 糖尿病足國際臨床指南. 北京: 人民軍醫出版社, 2003: 45-47.
32. Higgins TPT, Altman DG (editors). Chapter 8: Assessing risk of bias in included studies. In: Higgins IPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.0 (updated February 2008). The Cochrane Collaboration, 2008. Available from: www.cochrane-handbook.org.
33. 王曉軍, 劉文星, 徐麗梅. 沙格雷酯治療糖尿病下肢動脈硬化性閉塞癥的療效觀察—附58例臨床報告. 新醫學, 2006, 37(4): 225-227.
34. Hotta N, Nakamura J, SumitaY, et al. Effects of Anplag, a Selective 5-HT2A Antagonist in diabetic complications. Clin Drug Invest, 1999, 18(3): 199-207.
35. Shinohara Y, Nishimaru K, Sawada T. Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A Randomized, Double-Blind, Aspirin-Controlled Trial. Strok, 2008, 39(6): 1827-1833.

《中國循證醫學雜志》

鹽酸沙格雷酯治療周圍動脈疾病療效與安全性的系統評價

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鹽酸沙格雷酯治療周圍動脈疾病療效與安全性的系統評價

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