Thrombosis Program, Division of Hematology, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Am J Med. 2014 Jan;127(1):82-6.e1. doi: 10.1016/j.amjmed.2013.09.015. Epub 2013 Oct 5.
The administration of anticoagulant thromboprophylaxis for all patients with cancer who are hospitalized for acute medical illness is considered standard practice and strongly recommended in clinical guidelines. These recommendations are extrapolated from randomized controlled prophylaxis trials not specifically conducted in cancer cohorts. Because hospitalized patients with cancer constitute a unique population with increased risk of venous thromboembolic events and major hemorrhage, validation of the efficacy and safety of primary thromboprophylaxis in this population is critical. We sought to summarize the rates of venous thromboembolic events and major bleeding episodes among hospitalized patients with cancer who were receiving anticoagulant therapy compared with placebo.
A systematic literature search strategy was conducted using MEDLINE, EMBASE, and the Cochrane Register of Controlled Trials. Two reviewers independently extracted data onto standardized forms. The primary end points were all venous thromboembolic events. Secondary end points included major bleeding episodes and symptomatic venous thromboembolic events. Pooled analysis with relative risk using a random effect model was used as the primary measurement.
A total of 242 citations were identified by the literature search. Of these, 3 placebo-controlled randomized trials included venous thromboembolic events as a primary outcome and were analyzed according to cancer subgroups. The pooled relative risk of venous thromboembolic events was 0.91 (95% confidence interval, 0.21-4.0; I(2): 68%) among hospitalized patients with cancer who were receiving thromboprophylaxis compared with placebo. None of the trials reported the rates of symptomatic venous thromboembolic events or major bleeding episodes according to cancer status.
The risks and benefits of primary thromboprophylaxis with anticoagulant therapy in hospitalized patients with cancer are not known. This is especially relevant because numerous Medicare-type pay-for-performance incentives mandate prophylaxis specifically in patients with cancer.
对于所有因急性内科疾病住院的癌症患者，给予抗凝血栓预防治疗被认为是标准做法，并在临床指南中得到强烈推荐。这些建议是从专门针对癌症患者队列的随机对照预防试验中推断出来的。由于患有癌症的住院患者构成了一个具有更高静脉血栓栓塞事件和大出血风险的独特人群，因此验证这种人群中初级血栓预防的疗效和安全性至关重要。我们旨在总结接受抗凝治疗的癌症住院患者与安慰剂相比静脉血栓栓塞事件和大出血事件的发生率。
采用 MEDLINE、EMBASE 和 Cochrane 对照试验登记库进行了系统文献检索策略。两名评审员独立地将数据提取到标准化表格上。主要终点是所有静脉血栓栓塞事件。次要终点包括大出血事件和有症状的静脉血栓栓塞事件。采用随机效应模型的相对风险进行汇总分析作为主要测量方法。
通过文献检索确定了 242 条引用。其中，3 项安慰剂对照随机试验将静脉血栓栓塞事件作为主要结局，并根据癌症亚组进行了分析。与安慰剂相比，接受血栓预防治疗的癌症住院患者静脉血栓栓塞事件的汇总相对风险为 0.91（95%置信区间，0.21-4.0；I²：68%）。没有一项试验根据癌症状况报告有症状的静脉血栓栓塞事件或大出血事件的发生率。
对于癌症住院患者，初级抗凝血栓预防治疗的风险和益处尚不清楚。这一点尤其重要，因为许多类似于医疗保险的绩效付费激励措施专门针对癌症患者规定了预防措施。
