低剂量阿司匹林治疗真性红细胞增多症的疗效与安全性

Efficacy and safety of low-dose aspirin in polycythemia vera.

作者信息

Landolfi Raffaele, Marchioli Roberto, Kutti Jack, Gisslinger Heinz, Tognoni Gianni, Patrono Carlo, Barbui Tiziano

机构信息

Catholic University School of Medicine, Rome, Italy.

出版信息

N Engl J Med. 2004 Jan 8;350(2):114-24. doi: 10.1056/NEJMoa035572.

DOI:10.1056/NEJMoa035572

PMID:14711910

Abstract

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.

摘要

背景

阿司匹林用于预防真性红细胞增多症血栓形成并发症的应用存在争议。

方法

我们纳入了518例真性红细胞增多症患者，这些患者无明确的阿司匹林治疗指征且无此类治疗的禁忌证，进行了一项双盲、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。两个主要终点是无致命性心肌梗死、无致命性卒中或心血管原因死亡的累积发生率，以及无致命性心肌梗死、无致命性卒中、肺栓塞、主要静脉血栓形成或心血管原因死亡的累积发生率。平均随访时间约为3年。

结果

与安慰剂相比，阿司匹林治疗降低了无致命性心肌梗死、无致命性卒中或心血管原因死亡的复合终点风险（相对风险，0.41；95%置信区间，0.15至1.15；P = 0.09）以及无致命性心肌梗死、无致命性卒中、肺栓塞、主要静脉血栓形成或心血管原因死亡的复合终点风险（相对风险，0.40；95%置信区间，0.18至0.91；P = 0.03）。总体死亡率和心血管死亡率未显著降低。阿司匹林组严重出血事件的发生率未显著增加（相对风险，1.62；95%置信区间，0.27至9.71）。