低分子肝素与阿司匹林对于有大动脉闭塞性疾病亚洲人中患急性缺血性卒中的治疗比较
Title：Low-molecular-weight heparin compared with aspirin for the treatment of acute ischaemic stroke in Asian patients with large artery occlusive disease: a randomised study题目：低分子肝素与阿司匹林对于有大动脉闭塞性疾病亚洲人中患急性缺血性卒中的治疗比较
Author：Wong KS, Chen C, Ng PW, Tsoi TH, Li HL, Fong WC, Yeung J, Wong CK, Yip KK, Gao H, Wong HB; FISS-tris Study Investigators.
Department of Medicine, Chinese University of Hong Kong, Hong Kong SAR, China. [email]ks-wong@cuhk.edu.hk[/email]
作者：Wong KS, Chen C, Ng PW, Tsoi TH, Li HL, Fong WC, Yeung J, Wong CK, Yip KK, Gao H, Wong HB; FISS-tris Study Investigators.
中国香港特区香港大学医学部 [email]ks-wong@cuhk.edu.hk[/email]
Resource: Lancet Neurol. 2007 May;6(5):381-2.
来源：柳叶刀－神经病学.2007 May;6(5):381-2.
Abstract：BACKGROUND: Acute stroke patients with large artery occlusive disease (LAOD) have a distinct pathophysiology and may respond differently to anticoagulation treatments. We compared the efficacy of a low-molecular-weight heparin (LMWH), nadroparin calcium, with aspirin in Asian acute stroke patients with LAOD.
摘要：背景：伴有大动脉闭塞性疾病(LAOD)的急性中风患者具有不同的病理生理特征，而且对抗栓治疗的反应迥异。我们比较了亚洲患有LAOD的急性中风患者对低分子量肝素(LMWH)，即那屈肝素钙及阿司匹林的治疗效果。
METHODS: Acute ischaemic stroke patients with onset of symptoms less than 48 h and LAOD (diagnosed by transcranial doppler imaging, carotid duplex scan, or magnetic resonance angiography) were recruited. Patients were randomly assigned to receive either subcutaneous nadroparin calcium 3800 anti-factor Xa IU/0.4 mL twice daily or oral aspirin 160 mg daily for 10 days, and then all received aspirin 80-300 mg once daily for 6 months. This study is registered at [url]www.strokecenter.org/trials[/url] (number 493).
方法：以出现症状小于48h并患有LAOD（通过经颅多普勒超声检查、颈动脉双功超声扫描,或者磁共振成像扫描诊断）的急性缺血性中风患者为研究对象。患者被随机分组两组，一组每日两次进行皮下注射那屈肝素钙3800抗因子Xa IU/0.4 mL，另一组口服阿司匹林每日160 mg，共治疗10天，然后两组都接受一日一次的80–300 mg阿司匹林治疗，为期6个月。这项研究注册在[url]www.strokecenter.org/trials[/url] (编号493)。
FINDINGS: Among 603 patients recruited, 353 (180 LMWH, 173 aspirin) had LAOD (300 had intracranial LAOD only, 42 had both intracranial and extracranial disease, and 11 had extracranial disease only). The proportion of patients with good outcomes at 6 months (Barthel index >or=85) was 73% in the LMWH group and 69% in the aspirin group (absolute risk reduction 4%; 95% CI -5 to 13).
在603名患者中，353名(LMWH组180名, 阿司匹林组173名)患有LAOD（300名仅有颅内LAOD，42名既有颅内LAOD又有颅外LAOD， 11名仅有颅外LAOD）。6个月时治疗效果良好的患者比例（Barthel指数≥85) LMWH组为73%，阿司匹林组为69%（绝对风险减少4%；95% CI −5 到 13)。
Analysis of prespecified secondary outcome measures showed a benefit in outcome for LMWH versus aspirin on the modified Rankin scale dichotomised at 0-1 (odds ratio 1.55, 95% CI 1.02-2.35). Haemorrhagic transformation of infarct and severe adverse events were similar in both groups. Post-hoc analyses of patients without LAOD, and all treated patients, showed similar proportions with a good outcome in aspirin and LMWH groups (78%vs 79% and 73%vs 75%, respectively).
对事先设定的的次要观测指标分析显示，LMWH组的治疗结果在改良Rankin量表的0–1分值处，优于阿司匹林组（比数比1.55，95% CI 1.02–2.35)。两组中梗塞转化为出血及出现严重不良事件的情况类似。对无LAOD及所有治疗的患者进行事后分析，显示阿司匹林组和LMWH组的出现良性结果的比例相似（分别为78%vs79%和73%vs75%）。
INTERPRETATION: Overall, the results do not support a significant benefit of LMWH over aspirin in patients with LAOD. The benefits indicated in most outcome measures warrant further investigation into the use of anticoagulation for acute stroke in patients with large artery atherosclerosis, particularly in intracranial atherosclerosis.
解释：综上所述，结果显示在LAOD患者中，LMWH治疗与阿司匹林治疗相比无明显优势。但在抗栓治疗大动脉粥样硬化特别是颅内动脉粥样硬化患者急性中风方面，大部分结果评价中显示的优势说明值得做进一步的调查研究。
编译后：约650字
中国香港特区香港大学医学部Wong KS及其同事在伴有大动脉闭塞性疾病的急性缺血性中风亚洲患者中，比较了低分子肝素与阿司匹林的治疗效果，研究结果发表在2007.5的柳叶刀神经病学分册。伴有大动脉闭塞性疾病(LAOD)的急性中风患者具有不同的病理生理特征，而且对抗栓治疗的反应迥异。研究人员比较了亚洲患有LAOD的急性中风患者对低分子量肝素(LMWH)，即那屈肝素钙及阿司匹林的治疗效果。他们以出现症状小于48h并患有LAOD（通过经颅多普勒超声检查、颈动脉双功超声扫描,或者磁共振成像扫描诊断）的急性缺血性中风患者为研究对象。患者被随机分组两组，一组每日两次进行皮下注射那屈肝素钙3800抗因子Xa IU/0.4 mL，另一组口服阿司匹林每日160 mg，共治疗10天，然后两组都接受一日一次的80–300 mg阿司匹林治疗，为期6个月。这项研究注册在[url]www.strokecenter.org/trials[/url] (编号493)。在603名患者中，353名(LMWH组180名, 阿司匹林组173名)患有LAOD（300名仅有颅内LAOD，42名既有颅内LAOD又有颅外LAOD， 11名仅有颅外LAOD）。6个月时治疗效果良好的患者比例（Barthel指数≥85) LMWH组为73%，阿司匹林组为69%（绝对风险减少4%；95% CI −5 到 13)。对事先设定的的次要观测指标分析显示，LMWH组的治疗结果在改良Rankin量表的0–1分值处，优于阿司匹林组（比数比1.55，95% CI 1.02–2.35)。两组中梗塞转化为出血及出现严重不良事件的情况类似。对无LAOD及所有治疗的患者进行事后分析，显示阿司匹林组和LMWH组的出现良性结果的比例相似（分别为78% vs 79%和73% vs 75%）。综上所述，结果显示在LAOD患者中，LMWH治疗与阿司匹林治疗相比无明显优势。但在抗栓治疗大动脉粥样硬化特别是颅内动脉粥样硬化患者急性中风方面，大部分结果评价中显示的优势说明值得做进一步的调查研究。
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