Linkins Lori-Ann, Choi Peter T, Douketis James D
McMaster University, Hamilton, Ontario, Canada.
Ann Intern Med. 2003 Dec 2;139(11):893-900. doi: 10.7326/0003-4819-139-11-200312020-00007.
Clinicians should consider the clinical impact of anticoagulant-related bleeding when deciding on the duration of anticoagulant therapy in patients with venous thromboembolism.
To provide reliable estimates of the clinical impact of anticoagulant-related bleeding, defined as the case-fatality rate of major bleeding and the risk for intracranial bleeding.
MEDLINE (January 1989 to May 2003), Cochrane Controlled Trial Registry, thromboembolism experts, and reference lists; English-language literature only.
Randomized, controlled trials and prospective cohort studies that investigated patients with venous thromboembolism who received oral anticoagulant therapy (target international normalized ratio, 2.0 to 3.0) for at least 3 months and that reported major bleeding and death as primary study outcomes.
Two reviewers independently extracted data on the number of anticoagulant-related major and intracranial bleeding episodes and on whether these events were fatal or nonfatal.
The authors analyzed 33 studies involving 4374 patient-years of oral anticoagulant therapy. For all patients, the case-fatality rate of major bleeding was 13.4% (95% CI, 9.4% to 17.4%) and the rate of intracranial bleeding was 1.15 per 100 patient-years (CI, 1.14 to 1.16 per 100 patient-years). For patients who received anticoagulant therapy for more than 3 months, the case-fatality rate of major bleeding was 9.1% (CI, 2.5% to 21.7%), and the rate of intracranial bleeding was 0.65 per 100 patient-years (CI, 0.63 to 0.68 per 100 patient-years) after the initial 3 months of anticoagulation.
The clinical impact of anticoagulant-related major bleeding in patients with venous thromboembolism is considerable, and clinicians should take this into account when deciding whether to continue long-term oral anticoagulant therapy in an individual patient.
临床医生在决定静脉血栓栓塞症患者的抗凝治疗时长时，应考虑抗凝相关出血的临床影响。
提供抗凝相关出血临床影响的可靠估计值，定义为大出血的病死率和颅内出血风险。
MEDLINE（1989年1月至2003年5月）、Cochrane对照试验注册库、血栓栓塞症专家及参考文献列表；仅英文文献。
随机对照试验和前瞻性队列研究，研究对象为接受口服抗凝治疗（目标国际标准化比值为2.0至3.0）至少3个月的静脉血栓栓塞症患者，且将大出血和死亡作为主要研究结局进行报告。
两名研究者独立提取抗凝相关大出血和颅内出血事件的数量，以及这些事件是致命性还是非致命性的数据。
作者分析了33项研究，涉及4374患者年的口服抗凝治疗。对于所有患者，大出血的病死率为13.4%（95%CI，9.4%至17.4%），颅内出血发生率为每100患者年1.15例（CI，每100患者年1.14至1.16例）。对于接受抗凝治疗超过3个月的患者，在抗凝初始3个月后，大出血的病死率为9.1%（CI，2.5%至21.7%），颅内出血发生率为每100患者年0.65例（CI，每100患者年0.63至0.68例）。
静脉血栓栓塞症患者抗凝相关大出血的临床影响相当大，临床医生在决定是否对个体患者继续长期口服抗凝治疗时应考虑这一点。
