Effectiveness and Safety of Argatroban for Acute Ischemic Stroke: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

 LIUJun-feng ¹ , LINSen ² , ZHOUHong-qing ¹ ,  LIUMing ¹

1. Department of Neurology, West China Hospital, Sichuan University, Chengdu 610041, China;
2. Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

LIUMing, Email: wyplmh@hotmail.com

Keywords：

Argatroban; Stroke; Cerebral apoplexy; Meta-analysis; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.20140142

Video：

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Objective To systematically review the effectiveness and safety of argatroban for patients with acute ischemic stroke. Methods PubMed (1966 to 2013.12), EMbase (1966 to 2013.12), CENTRAL (2013.12), CBM (1978 to 2013.12), VIP (1989 to 2013.12), CNKI (1980 to 2013.12) and CDFD (for masters and Phds, 1999 to 2013.12) were electronically searched for randomized controlled trials (RCTs) on argatroban for patients with acute ischemic stroke. Meanwhile, relevant data were retrieved by hand search and the data from pharmaceutical factories (TIPR Pharmaceutical Responsible Co. Ltd) were collected. Two reviewers independently screened literature, extracted data, and assessed the methodological quality of the included studies. Then, meta-analysis was performed using RevMan 5.2 software. Results A total of 11 RCTs involving 889 patients were finally included. The results of meta-analysis showed that the argatroban group was better than the control group in improving patients' neurologic impairment scores (SMD=0.71, 95%CI 0.56 to 0.88, P < 0.000 01), and the effectiveness of neurological function (total result:OR=2.65, 95%CI 1.84 to 3.80, P < 0.000 01; placebo-controlled trial:OR=2.18, 95%CI 1.27 to 3.72, P=0.004; non-placebo-controlled trial:OR=3.09, 95%CI 1.89 to 5.06, P < 0.000 01), all with significant differences. No significant difference was found between the argatroban group and the control group in the long/short-term motilities or dependence rates as well as in the incidence of adverse reaction (OR=1.55, 95%CI 0.60 to 4.01, P=0.37). Conclusion Current evidence shows that argatroban could improve neurologic impairment of patients with acute ischemic stroke without severe bleeding events or other adverse reaction. However, further studies are needed to confirm its effects on reducing rates of death and disability in treating acute ischemic stroke.

Citation： LIUJun-feng, LINSen, ZHOUHong-qing, LIUMing. Effectiveness and Safety of Argatroban for Acute Ischemic Stroke: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2014, 14(7): 859-866. doi: 10.7507/1672-2531.20140142 Copy

1.	Liu M, Wu B, Wang WZ, et al. Stroke in china:Epidemiology, prevention, and management strategies. Lancet Neurol, 2007, 6(5):456-464.
2.	World Health Organization. World health statistics 2008. Geneva, Switzerland. Available at:http://www.who.int/whosis/whostat/EN_WHS08_Full.pdf.
3.	Bonita R, Mendis S, Truelsen T, et al. The global stroke initiative. Lancet Neurol, 2004, 3:391-393.
4.	Feigin VL. Stroke epidemiology in the developing world. Lancet, 2005, 365(9478):2160-2161.
5.	Director of Public Health. Annual report. Southampton and South West Hampshire Health Commission. 1994.
6.	Adams HP Jr, Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke. Stroke, 2007, 38(5):1655-1711.
7.	Fareed J, Jeske WP. Small-molecule direct antithrombins argatroban. Best Pract Res Clin Haemato, 2004, 17(1):127-138.
8.	Kam PC, Kaur N, Thong CL. Direct thrombin inhibitors:pharmacology and clinical relevance. Anaesthesia, 2005, 60(6):565-574.
9.	张子彦.阿加曲班的研究进展.国际内科学杂志, 2007, 34(8):483-485.
10.	孔燕.阿加曲班治疗急性缺血性卒中的系统评价.中风与神经病学杂志, 2011, 28(9):800-805.
11.	中华神经科学会中华神经外科学会.各类脑血管疾病诊断要点.中华神经科杂志, 1996, 29(6):379-380.
12.	Hatano S. Experience from a multicentre stroke register:a preliminary report. Bull World Health Organ, 1976, 54(5):541-553.
13.	Higgins JPT, Altman DG. Chapter 8:Assessing risk of bias in included studies. In:Higgins JPT, Green S (editors). Cochrane handbook for systematic reviews of interventions version 5.1.0 (updated Sep 2011). The Cochrane Collaboration. 2011.
14.	孟丽莉, 殷春梅, 徐辉.阿加曲班联合舒血宁治疗急性脑梗死的有效性和安全性研究.牡丹江医学院学报, 2010, 31(04):35-36.
15.	朱远群, 阮海林.阿加曲班联合依达拉奉治疗进展性脑梗死临床分析.黑龙江医学, 2010, 34(06):438-440.
16.	李华, 于国平.阿加曲班联合疏血通治疗急性脑梗死的临床疗效及安全性观察.中国现代药物应用, 2007, 1(5):30-32.
17.	朱远群, 佘军红.阿加曲班治疗急性脑梗死58例临床分析.内科, 2010, 5(3):267-269.
18.	朱远群.阿加曲班联合脑保护治疗急性脑梗死临床观察.中国医药指南, 2010, 8(13):111-112.
19.	吕鸿杰.阿加曲班序贯于巴曲酶治疗急性缺血性卒中的临床观察.神经损伤与功能重建, 2011, 6 (4):246-249.
20.	郭明笛, 马晨, 李靖.阿加曲班联合氯比格雷治疗进展性脑梗死的临床观察.吉林医学, 2011, 32 (34):258-259.
21.	耿文娟, 王丽娟.阿加曲班治疗急性脑梗死的疗效观察.实用心脑肺血管病杂志, 2012, 20(4):625-626.
22.	Kobayashi S, Tazaki Y. Effect of the thrombin inhibitor argatroban in acute cerebral thrombosis. Seminars in Thrombosis and Hemostasis, 1997, 23(6):531-534.
23.	La-Monte MP, Nash ML, Wang DZ, et al. Argatroban anticoagulation in patients with acute ischemic stroke (ARGIS-1):a randomized, placebo-controlled safety study. Stroke, 2004, 35(7):1677-1682.
24.	Kario K, Kodama K, Koide M, et al. Thrombin inhibition in the acute phase of ischaemic stroke using argatroban. Blood Coagulation & Fibrinolysis, 1995, 6(5):423-427.
25.	Song YM, Jeong SW, Bae HJ, et al. Argatroban treatment in acute ischemic stroke:multicenter, randomized, aspirin-controlled study. J Korean Neurol Assoc, 2004, 8 (22):302-308.
26.	王德任, 刘鸣, 吴波.丁苯酞治疗急性缺血性脑卒中随机对照试验的系统评价.中国循证医学杂志, 2010, 10(2):189-195.
27.	周红清, 王德任, 张灿飞.通心络胶囊治疗急性缺血性脑卒中疗效与安全性的系统评价.中国循证医学杂志, 2013, 13(7):844-851.
28.	赵建国.脑梗死.北京:人民卫生出版社, 2006:26-30.
29.	Feng SJ, Yang QW, Liu M, et al. Edaravone for acute ischaemic stroke. Cochrane Database Syst Rev, 2011, 7(12):CD007230.
30.	Yang J, Liu M, Zhou JS, et al. Edaravone for acute intracerebral haemorrhage. Cochrane Database Syst Rev, 2011, 16(2):CD007755.
31.	阳清伟, 刘鸣, 张世洪.依达拉奉治疗急性脑梗死的系统评价.中国循证医学杂志, 2006, 6(1):18-22.
32.	吴波, 刘鸣, 张世洪.丹参类药物治疗急性缺血性脑卒中的系统评价.中国循证医学杂志, 2005, 5(2):101-105.
33.	中华人民共和国卫生部.中国卫生统计年鉴, 2000:200-260.

1. Liu M, Wu B, Wang WZ, et al. Stroke in china:Epidemiology, prevention, and management strategies. Lancet Neurol, 2007, 6(5):456-464.
2. World Health Organization. World health statistics 2008. Geneva, Switzerland. Available at:http://www.who.int/whosis/whostat/EN_WHS08_Full.pdf.
3. Bonita R, Mendis S, Truelsen T, et al. The global stroke initiative. Lancet Neurol, 2004, 3:391-393.
4. Feigin VL. Stroke epidemiology in the developing world. Lancet, 2005, 365(9478):2160-2161.
5. Director of Public Health. Annual report. Southampton and South West Hampshire Health Commission. 1994.
6. Adams HP Jr, Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke. Stroke, 2007, 38(5):1655-1711.
7. Fareed J, Jeske WP. Small-molecule direct antithrombins argatroban. Best Pract Res Clin Haemato, 2004, 17(1):127-138.
8. Kam PC, Kaur N, Thong CL. Direct thrombin inhibitors:pharmacology and clinical relevance. Anaesthesia, 2005, 60(6):565-574.
9. 张子彦.阿加曲班的研究进展.国际内科学杂志, 2007, 34(8):483-485.
10. 孔燕.阿加曲班治疗急性缺血性卒中的系统评价.中风与神经病学杂志, 2011, 28(9):800-805.
11. 中华神经科学会中华神经外科学会.各类脑血管疾病诊断要点.中华神经科杂志, 1996, 29(6):379-380.
12. Hatano S. Experience from a multicentre stroke register:a preliminary report. Bull World Health Organ, 1976, 54(5):541-553.
13. Higgins JPT, Altman DG. Chapter 8:Assessing risk of bias in included studies. In:Higgins JPT, Green S (editors). Cochrane handbook for systematic reviews of interventions version 5.1.0 (updated Sep 2011). The Cochrane Collaboration. 2011.
14. 孟丽莉, 殷春梅, 徐辉.阿加曲班联合舒血宁治疗急性脑梗死的有效性和安全性研究.牡丹江医学院学报, 2010, 31(04):35-36.
15. 朱远群, 阮海林.阿加曲班联合依达拉奉治疗进展性脑梗死临床分析.黑龙江医学, 2010, 34(06):438-440.
16. 李华, 于国平.阿加曲班联合疏血通治疗急性脑梗死的临床疗效及安全性观察.中国现代药物应用, 2007, 1(5):30-32.
17. 朱远群, 佘军红.阿加曲班治疗急性脑梗死58例临床分析.内科, 2010, 5(3):267-269.
18. 朱远群.阿加曲班联合脑保护治疗急性脑梗死临床观察.中国医药指南, 2010, 8(13):111-112.
19. 吕鸿杰.阿加曲班序贯于巴曲酶治疗急性缺血性卒中的临床观察.神经损伤与功能重建, 2011, 6 (4):246-249.
20. 郭明笛, 马晨, 李靖.阿加曲班联合氯比格雷治疗进展性脑梗死的临床观察.吉林医学, 2011, 32 (34):258-259.
21. 耿文娟, 王丽娟.阿加曲班治疗急性脑梗死的疗效观察.实用心脑肺血管病杂志, 2012, 20(4):625-626.
22. Kobayashi S, Tazaki Y. Effect of the thrombin inhibitor argatroban in acute cerebral thrombosis. Seminars in Thrombosis and Hemostasis, 1997, 23(6):531-534.
23. La-Monte MP, Nash ML, Wang DZ, et al. Argatroban anticoagulation in patients with acute ischemic stroke (ARGIS-1):a randomized, placebo-controlled safety study. Stroke, 2004, 35(7):1677-1682.
24. Kario K, Kodama K, Koide M, et al. Thrombin inhibition in the acute phase of ischaemic stroke using argatroban. Blood Coagulation & Fibrinolysis, 1995, 6(5):423-427.
25. Song YM, Jeong SW, Bae HJ, et al. Argatroban treatment in acute ischemic stroke:multicenter, randomized, aspirin-controlled study. J Korean Neurol Assoc, 2004, 8 (22):302-308.
26. 王德任, 刘鸣, 吴波.丁苯酞治疗急性缺血性脑卒中随机对照试验的系统评价.中国循证医学杂志, 2010, 10(2):189-195.
27. 周红清, 王德任, 张灿飞.通心络胶囊治疗急性缺血性脑卒中疗效与安全性的系统评价.中国循证医学杂志, 2013, 13(7):844-851.
28. 赵建国.脑梗死.北京:人民卫生出版社, 2006:26-30.
29. Feng SJ, Yang QW, Liu M, et al. Edaravone for acute ischaemic stroke. Cochrane Database Syst Rev, 2011, 7(12):CD007230.
30. Yang J, Liu M, Zhou JS, et al. Edaravone for acute intracerebral haemorrhage. Cochrane Database Syst Rev, 2011, 16(2):CD007755.
31. 阳清伟, 刘鸣, 张世洪.依达拉奉治疗急性脑梗死的系统评价.中国循证医学杂志, 2006, 6(1):18-22.
32. 吴波, 刘鸣, 张世洪.丹参类药物治疗急性缺血性脑卒中的系统评价.中国循证医学杂志, 2005, 5(2):101-105.
33. 中华人民共和国卫生部.中国卫生统计年鉴, 2000:200-260.

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Effectiveness and Safety of Argatroban for Acute Ischemic Stroke: A Systematic Review

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