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背景近20%的不明原因的静脉栓塞病人停止口服抗凝剂后2年内会再发,若延长抗凝剂的使用期限,尽管可预防再发,却与出血风险关联。阿司匹林用于预防静脉栓塞再发的获益性尚不清楚。方法采用多中心、研究者指导、双盲临床研究,将完成6～18个月抗凝剂治疗的首发不明原因静脉血栓的病人随机分组:阿司匹林治疗组(100 mg/d)和安慰剂组,时间2年。主要效应结果为静脉栓塞的再发率,主要安全结果为大出血。结果阿司匹林组的205例病人中有28例,安慰剂组197例病人中有43例出现静脉栓塞再发〔6.6%/年vs.11.2%/年,HR=0.58,95%CI(0.36,0.93),中位研究时间为24.6个月〕。中位治疗时间23.9个月期间,阿司匹林组有23例、安慰剂组有23例病人静脉栓塞再发。两组均有1例病人发生大出血,其他负性事件两组相似。结论阿司匹林减少了已停用抗凝剂治疗、不明原因静脉栓塞病人的再发风险,未显示大出血风险增加。
Background Nearly 20% of patients with unexplained venous thromboembolism will relapse within 2 years after stopping oral anticoagulants. However, prolonged use of anticoagulants, although preventable from recurrence, is linked to the risk of bleeding. The benefits of aspirin for preventing the recurrence of venous thrombosis are not clear. Methods A multicenter, investigator-guided, double-blind clinical study randomized 6 to 18-month anticoagulant-treated patients with unidentified venous thrombosis to aspirin-treated (100 mg / d) and placebo Time 2 years. The main effect is the rate of recurrent venous thrombosis, the main safety result for major bleeding. Results Out of 205 patients in the aspirin group, 28 developed in the placebo group and 43 of the 197 placebo patients developed recurrent venous embolism (6.6% vs 11.2% per year, HR 0.58, 95% CI 0.36, 0.93 ), The median study time was 24.6 months]. Twenty-three patients in the aspirin group and 23 in the placebo group relapsed after 23.9 months of median treatment. One patient in both groups had major bleeding and other negative events were similar in both groups. Conclusions Aspirin reduces the risk of recurrence of patients with unexplained venous thrombosis who have discontinued anticoagulant therapy and does not show an increased risk of major bleeding.