亚洲地区低分子量肝素与阿司匹林治疗大动脉闭塞导致的急性缺血性卒中的随机对照研究

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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
标题：亚洲地区低分子量肝素与阿司匹林治疗大动脉闭塞导致的急性缺血性卒中的随机对照研究
Authors: Prof Ka Sing Wong FRCP a , Christopher Chen FRCP b, Ping Wing Ng FRCP c, Tak Hong Tsoi FRCP d, Ho Lun Li MRCP e, Wing Chi Fong MRCP f, Jonas Yeung FRCP g, Chi Keung Wong FRCP h, Kin Keung Yip MRCP i, Hong Gao MD j and Hwee Bee Wong MSc j, for the FISS-tris Study Investigators

Resourse: Lancet Neurology 2007; 6:407-413
文章来源：柳叶刀神经病学2007; 6:407-413
Summary
摘要
Background
背景：
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.
大动脉闭塞疾病(LAOD)导致的急性卒中患者有不同的病理生理情况，并且可能对抗凝剂治疗反应不同。我们比较了低分子量肝素(LMWH)那屈肝素钙，和阿司匹林在亚洲有LAOD的急性卒中患者中的治疗作用。
Methods
方法
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.
新近出现LAOD（通过经颅多普勒显像，颈动脉双功超声扫描，或者磁共振成像扫描诊断），且卒中发病症状持续时间少于48h的急性缺血性卒中患者被纳入研究。

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 www.strokecenter.org/trials (number 493).
患者被随机分组为接受皮下注射那屈肝素钙3800Xa IU/0•4 mL每日两次或者口服阿司匹林每日160 mg，共治疗10天，然后所有组都接受一日一次的80–300 mg阿司匹林治疗，持续6个月。这项研究注册在www.strokecenter.org/trials (编号493)。

Findings
结果
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).
在纳入的603名患者中，353名(180名 给予LMWH, 173名给予阿司匹林)有LAOD情况（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）。
The proportion of patients with good outcomes at 6 months (Barthel index ≥85) was 73% in the LMWH group and 69% in the aspirin group (absolute risk reduction 4%; 95% CI −5 to 13).
6个月时结果良好的患者比例（巴塞尔指数≥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).
对预先设定的次级终点事件的分析显示，LMWH组的治疗结果在改良Rankin量表的0–1分值处各占一半，比阿司匹林组有优势（优势比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).
两组中梗塞转化为出血及出现严重不良事件的情况类似。因此对无LAOD的患者及所有接受治疗的患者进行分析，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%：79%和73%：75%）。

Interpretation
结论
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.
综上所述，结果显示对于LAOD的患者，与阿司匹林治疗相比，LMWH治疗无明显优势。但在用抗凝剂治疗大动脉粥样硬化特别是颅内动脉粥样硬化患者急性卒中方面，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。