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.	張子彥.阿加曲班的研究進展.國際內科學雜志, 2007, 34(8):483-485.
10.	孔燕.阿加曲班治療急性缺血性卒中的系統評價.中風與神經病學雜志, 2011, 28(9):800-805.
11.	中華神經科學會中華神經外科學會.各類腦血管疾病診斷要點.中華神經科雜志, 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.	孟麗莉, 殷春梅, 徐輝.阿加曲班聯合舒血寧治療急性腦梗死的有效性和安全性研究.牡丹江醫學院學報, 2010, 31(04):35-36.
15.	朱遠群, 阮海林.阿加曲班聯合依達拉奉治療進展性腦梗死臨床分析.黑龍江醫學, 2010, 34(06):438-440.
16.	李華, 于國平.阿加曲班聯合疏血通治療急性腦梗死的臨床療效及安全性觀察.中國現代藥物應用, 2007, 1(5):30-32.
17.	朱遠群, 佘軍紅.阿加曲班治療急性腦梗死58例臨床分析.內科, 2010, 5(3):267-269.
18.	朱遠群.阿加曲班聯合腦保護治療急性腦梗死臨床觀察.中國醫藥指南, 2010, 8(13):111-112.
19.	呂鴻杰.阿加曲班序貫于巴曲酶治療急性缺血性卒中的臨床觀察.神經損傷與功能重建, 2011, 6 (4):246-249.
20.	郭明笛, 馬晨, 李靖.阿加曲班聯合氯比格雷治療進展性腦梗死的臨床觀察.吉林醫學, 2011, 32 (34):258-259.
21.	耿文娟, 王麗娟.阿加曲班治療急性腦梗死的療效觀察.實用心腦肺血管病雜志, 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, 劉鳴, 吳波.丁苯酞治療急性缺血性腦卒中隨機對照試驗的系統評價.中國循證醫學雜志, 2010, 10(2):189-195.
27.	周紅清, 王德任, 張燦飛.通心絡膠囊治療急性缺血性腦卒中療效與安全性的系統評價.中國循證醫學雜志, 2013, 13(7):844-851.
28.	趙建國.腦梗死.北京:人民衛生出版社, 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.	陽清偉, 劉鳴, 張世洪.依達拉奉治療急性腦梗死的系統評價.中國循證醫學雜志, 2006, 6(1):18-22.
32.	吳波, 劉鳴, 張世洪.丹參類藥物治療急性缺血性腦卒中的系統評價.中國循證醫學雜志, 2005, 5(2):101-105.
33.	中華人民共和國衛生部.中國衛生統計年鑒, 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. 張子彥.阿加曲班的研究進展.國際內科學雜志, 2007, 34(8):483-485.
10. 孔燕.阿加曲班治療急性缺血性卒中的系統評價.中風與神經病學雜志, 2011, 28(9):800-805.
11. 中華神經科學會中華神經外科學會.各類腦血管疾病診斷要點.中華神經科雜志, 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. 孟麗莉, 殷春梅, 徐輝.阿加曲班聯合舒血寧治療急性腦梗死的有效性和安全性研究.牡丹江醫學院學報, 2010, 31(04):35-36.
15. 朱遠群, 阮海林.阿加曲班聯合依達拉奉治療進展性腦梗死臨床分析.黑龍江醫學, 2010, 34(06):438-440.
16. 李華, 于國平.阿加曲班聯合疏血通治療急性腦梗死的臨床療效及安全性觀察.中國現代藥物應用, 2007, 1(5):30-32.
17. 朱遠群, 佘軍紅.阿加曲班治療急性腦梗死58例臨床分析.內科, 2010, 5(3):267-269.
18. 朱遠群.阿加曲班聯合腦保護治療急性腦梗死臨床觀察.中國醫藥指南, 2010, 8(13):111-112.
19. 呂鴻杰.阿加曲班序貫于巴曲酶治療急性缺血性卒中的臨床觀察.神經損傷與功能重建, 2011, 6 (4):246-249.
20. 郭明笛, 馬晨, 李靖.阿加曲班聯合氯比格雷治療進展性腦梗死的臨床觀察.吉林醫學, 2011, 32 (34):258-259.
21. 耿文娟, 王麗娟.阿加曲班治療急性腦梗死的療效觀察.實用心腦肺血管病雜志, 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, 劉鳴, 吳波.丁苯酞治療急性缺血性腦卒中隨機對照試驗的系統評價.中國循證醫學雜志, 2010, 10(2):189-195.
27. 周紅清, 王德任, 張燦飛.通心絡膠囊治療急性缺血性腦卒中療效與安全性的系統評價.中國循證醫學雜志, 2013, 13(7):844-851.
28. 趙建國.腦梗死.北京:人民衛生出版社, 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. 陽清偉, 劉鳴, 張世洪.依達拉奉治療急性腦梗死的系統評價.中國循證醫學雜志, 2006, 6(1):18-22.
32. 吳波, 劉鳴, 張世洪.丹參類藥物治療急性缺血性腦卒中的系統評價.中國循證醫學雜志, 2005, 5(2):101-105.
33. 中華人民共和國衛生部.中國衛生統計年鑒, 2000:200-260.

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

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