Efficacy and safety of low-dose aspirin in polycythemia vera
Efficacy and safety of low-dose aspirin in polycythemia vera
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DOI：
10.1056/nejmoa035572
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发表时间：
2004-01-08
影响因子：
158.5
通讯作者：
Collins, R
中科院分区：
文献类型：
--
作者：
Landolfi, R;Marchioli, R;Collins, R
背景：使用阿司匹林预防真性红细胞增多症的血栓并发症是有争议的。方法：我们招募了518例真性红细胞增多症患者，没有明确的阿司匹林治疗指征，也没有禁忌症，这样的治疗在一个双盲，安慰剂对照，随机试验，以评估低剂量阿司匹林（每日100毫克）预防的安全性和有效性。两个主要终点是非致死性心肌梗死、非致死性卒中或心血管原因死亡的累积发生率，以及非致死性心肌梗死、非致死性卒中、肺栓塞、严重静脉血栓形成或心血管原因死亡的累积发生率。平均随访时间为3年。结果：与安慰剂相比，阿司匹林治疗可降低非致命性心肌梗死、非致命性卒中或心血管原因死亡的联合终点的风险（相对危险度，0.41; 95%置信区间，0.15至1.15; P=0.09）和非致死性心肌梗死、非致死性卒中、肺栓塞、严重静脉血栓形成、或心血管原因死亡（相对危险度，0.40; 95%置信区间，0.18 - 0.91; P=0.03）。总死亡率和心血管死亡率没有显著降低。大出血事件的发生率在阿司匹林组中没有显著增加（相对危险度，1.62; 95%可信区间，0.27 ~ 9.71）。结论：小剂量阿司匹林可以安全地预防真性红细胞增多症患者的血栓并发症，这些患者没有此类治疗的禁忌症。
Background:The use of aspirin for the prevention of thrombotic complications in polycythemia vera is controversial.Methods:We enrolled 518 patients with polycythemia vera, no clear indication for aspirin treatment, and no contraindication to such treatment in a double-blind, placebo-controlled, randomized trial to assess the safety and efficacy of prophylaxis with low-dose aspirin (100 mg daily). The two primary end points were the cumulative rate of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes and the cumulative rate of nonfatal myocardial infarction, nonfatal stroke, pulmonary embolism, major venous thrombosis, or death from cardiovascular causes. The mean duration of follow-up was about three years.Results:Treatment with aspirin, as compared with placebo, reduced the risk of the combined end point of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes (relative risk, 0.41; 95 percent confidence interval, 0.15 to 1.15; P=0.09) and the risk of the combined end point of nonfatal myocardial infarction, nonfatal stroke, pulmonary embolism, major venous thrombosis, or death from cardiovascular causes (relative risk, 0.40; 95 percent confidence interval, 0.18 to 0.91; P=0.03). Overall mortality and cardiovascular mortality were not reduced significantly. The incidence of major bleeding episodes was not significantly increased in the aspirin group (relative risk, 1.62; 95 percent confidence interval, 0.27 to 9.71).Conclusions:Low-dose aspirin can safely prevent thrombotic complications in patients with polycythemia vera who have no contraindications to such treatment.