A comparison of two intensities of warfarin for the prevention of recurrent thrombosis in patients with the antiphospholipid antibody syndrome
A comparison of two intensities of warfarin for the prevention of recurrent thrombosis in patients with the antiphospholipid antibody syndrome
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DOI：
10.1056/nejmoa035241
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发表时间：
2003-09-18
影响因子：
158.5
通讯作者：
Kovacs, MJ
中科院分区：
文献类型：
--
作者：
Crowther, MA;Ginsberg, JS;Kovacs, MJ
背景技术背景：许多患有抗磷脂抗体综合征和复发性血栓形成的患者接受华法林剂量调整，以达到国际标准化比值（INR）大于3.0。然而，没有前瞻性的数据来支持这种方法，以thromboprotein.METHODS：我们进行了一项随机，双盲试验中，抗磷脂抗体和以前的血栓形成患者被分配到接受足够的华法林，以实现国际标准化比值为2.0至3.0（中等强度）或3.1至4.0（高强度）。我们的目的是证明高强度华法林在预防血栓形成方面比中等强度华法林更有效。结果：共有114名患者入组本研究，平均随访2.7年。接受高强度华法林治疗的56例患者中有6例（10.7%）发生复发性血栓形成，接受中等强度华法林治疗的58例患者中有2例（3.4%）发生复发性血栓形成（高强度组的风险比为3.1; 95%置信区间为0.6至15.0）。大出血发生在三名患者分配到接受高强度华法林和四名患者分配到接受中等强度华法林（危害比，1.0; 95%置信区间，0.2至4.8）结论：高强度华法林是不优于上级中等强度华法林的抗磷脂抗体和血栓形成患者的血栓预防。在目标INR为2.0 - 3.0的患者中，血栓复发率较低，这表明中等强度的华法林适用于抗磷脂抗体综合征患者。
BACKGROUND: Many patients with the antiphospholipid antibody syndrome and recurrent thrombosis receive doses of warfarin adjusted to achieve an international normalized ratio (INR) of more than 3.0. However, there are no prospective data to support this approach to thromboprophylaxis.METHODS: We performed a randomized, double-blind trial in which patients with antiphospholipid antibodies and previous thrombosis were assigned to receive enough warfarin to achieve an INR of 2.0 to 3.0 (moderate intensity) or 3.1 to 4.0 (high intensity). Our objective was to show that high-intensity warfarin was more effective in preventing thrombosis than moderate-intensity warfarin.RESULTS: A total of 114 patients were enrolled in the study and followed for a mean of 2.7 years. Recurrent thrombosis occurred in 6 of 56 patients (10.7 percent) assigned to receive high-intensity warfarin and in 2 of 58 patients (3.4 percent) assigned to receive moderate-intensity warfarin (hazard ratio for the high-intensity group, 3.1; 95 percent confidence interval, 0.6 to 15.0). Major bleeding occurred in three patients assigned to receive high-intensity warfarin and four patients assigned to receive moderate-intensity warfarin (hazard ratio, 1.0; 95 percent confidence interval, 0.2 to 4.8).CONCLUSIONS: High-intensity warfarin was not superior to moderate-intensity warfarin for thromboprophylaxis in patients with antiphospholipid antibodies and previous thrombosis. The low rate of recurrent thrombosis among patients in whom the target INR was 2.0 to 3.0 suggests that moderate-intensity warfarin is appropriate for patients with the antiphospholipid antibody syndrome.