低剂量阿司匹林与低剂量阿司匹林联合低强度华法林在抗磷脂抗体阳性患者（ALIWAPAS）中的血栓预防作用：一项前瞻性、多中心、随机、开放、对照试验。
Low-dose aspirin vs low-dose aspirin plus low-intensity warfarin in thromboprophylaxis: a prospective, multicentre, randomized, open, controlled trial in patients positive for antiphospholipid antibodies (ALIWAPAS).
机构信息
Lupus Research Unit, Rayne Institute, St Thomas' Hospital, London SE1 7EH, UK.
出版信息
Rheumatology (Oxford). 2014 Feb;53(2):275-84. doi: 10.1093/rheumatology/ket313. Epub 2013 Oct 4.
OBJECTIVES
The objectives of this study are to examine the efficacy and safety of low-dose aspirin (LDA) vs LDA plus low-intensity warfarin (LDA + W) in the primary thrombosis prevention of aPL-positive patients with SLE and/or obstetric morbidity and the role of clinical and serological markers in the development of thrombosis.
METHODS
In this 5-year prospective, randomized, open, controlled trial, 166 patients with aPL were randomly assigned using a minimization protocol to receive treatment with LDA (n = 82) or LDA + W [international normalized ratio (INR) = 1.5] (n = 84). Sixty-six patients who declined randomization were followed up in an observational arm. Clinical and laboratory characteristics and medication side effects were recorded.
RESULTS
There were no differences in the number of thromboses between patients treated with LDA (4/82) or LDA + W (4/84) [hazard ratio (HR) 1.07, 95% CI 0.27, 4.3]. The incidence of thrombosis in the randomized patients was 8/166 (1.8 events/100 person-years) (HR 1.07, 95% CI 0.27, 4.3) and in the observational arm was 7/66 (4.9 events/100 person-years) (HR 2.43, 95% CI 0.87, 6.79). Sixty-five of 66 patients included in the observational arm received LDA. None of the examined clinical or serological factors appeared to predict thrombosis. Medication side effects included mild gastrointestinal symptoms in the LDA group (n = 2) and bleeding in the LDA + W group (n = 11; 1 nasal and 10 menorrhagia). The risk difference for bleeding was 13% (CI 6, 20).
CONCLUSION
No differences in the number of thromboses were observed between patients treated with LDA vs those treated with LDA + W. More episodes of bleeding were detected in the LDA + W group. The LDA + W regime was significantly less safe and not as acceptable as LDA alone.
TRIAL REGISTRATION
ISRCTN81818945; http://isrctn.org/.
目的
本研究旨在探讨低剂量阿司匹林（LDA）与 LDA 联合低强度华法林（LDA+W）在预防抗磷脂抗体（aPL）阳性的系统性红斑狼疮（SLE）和/或产科并发症患者原发性血栓形成中的疗效和安全性，并探讨临床和血清学标志物在血栓形成中的作用。
方法
本 5 年前瞻性、随机、开放、对照试验中，采用最小化方案将 166 例 aPL 阳性患者随机分为 LDA 治疗组（n=82）或 LDA+W 治疗组[国际标准化比值（INR）=1.5]（n=84）。66 例拒绝随机分组的患者在观察臂中进行随访。记录临床和实验室特征以及药物副作用。
结果
LDA 治疗组（4/82）与 LDA+W 治疗组（4/84）患者的血栓形成数量无差异[风险比（HR）1.07，95%可信区间（CI）0.27，4.3]。随机患者的血栓形成发生率为 166 例中的 8/166（1.8 例/100 人年）（HR 1.07，95% CI 0.27，4.3），观察臂中为 66 例中的 7/66（4.9 例/100 人年）（HR 2.43，95% CI 0.87，6.79）。观察臂中 66 例患者中有 65 例接受了 LDA 治疗。未发现任何检查的临床或血清学因素可预测血栓形成。药物副作用包括 LDA 组（n=2）出现轻度胃肠道症状和 LDA+W 组（n=11）出现出血（1 例为鼻出血，10 例为月经过多）。出血风险差异为 13%（CI 6，20）。
结论
与 LDA 治疗相比，LDA+W 治疗患者的血栓形成数量无差异。LDA+W 组出血事件更多。LDA+W 方案的安全性明显较差，不如单独使用 LDA 方案可接受。
试验注册
ISRCTN81818945；http://isrctn.org/。
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