Anderson D R
Department of Medicine, Dalhousie University and the QEII Health Sciences Centre, Halifax, NS, Canada.
Haemostasis. 1998;28 Suppl 3:120-6. doi: 10.1159/000022389.
Clinical trials evaluating antithrombotic therapy for the treatment of deep vein thrombosis require that the diagnosis is confirmed by objective testing prior to patient entry into the study. Two basic approaches may then be taken for defining endpoints to assess the efficacy of antithrombotic treatment. In the first approach, the diagnostic test is repeated at a predetermined time following the initiation of the interventional therapy. In the second approach, no further diagnostic testing is routinely performed for a minimum of 3 months following patient enrolment after the diagnosis of venous thromboembolism for evidence of symptomatic recurrent deep vein thrombosis or pulmonary embolism. This approach is used in later-phase clinical trials to examine whether a novel therapeutic agent is as safe and effective as the drugs currently used for management of venous thromboembolism. Symptomatic recurrent deep vein thrombosis and pulmonary embolism confirmed by objective testing are clinically important causes of patient morbidity, place patients at increased risk of fatal pulmonary embolism, cause increased rates of chronic thromboembolic complications and have resource consequences. Studies utilizing symptomatic recurrent deep vein thrombosis or pulmonary embolism as endpoints have been responsible for most of the treatment advances in the management of patients with venous thromboembolism that have been observed in the past 40 years. Although confirmation of recurrent venous thromboembolism is not possible in all patients, clinical trials using rigorous methodology can minimize the potential bias caused by the limitations of diagnostic test results. There is a need to develop better objective tests in the future, to distinguish previous from recurrent venous thromboembolism.
评估抗血栓治疗用于深静脉血栓形成治疗的临床试验要求在患者进入研究之前通过客观检测来确诊。然后可以采用两种基本方法来定义终点以评估抗血栓治疗的疗效。第一种方法是在介入治疗开始后的预定时间重复进行诊断检测。第二种方法是在诊断为静脉血栓栓塞后，患者入组后至少3个月内不常规进行进一步的诊断检测，以寻找有症状的复发性深静脉血栓形成或肺栓塞的证据。这种方法用于后期临床试验，以检验一种新型治疗药物是否与目前用于治疗静脉血栓栓塞的药物一样安全有效。经客观检测确诊的有症状的复发性深静脉血栓形成和肺栓塞是患者发病的重要临床原因，会使患者发生致命性肺栓塞的风险增加，导致慢性血栓栓塞并发症的发生率升高，并产生资源方面的影响。在过去40年中观察到的静脉血栓栓塞患者管理方面的大多数治疗进展都归功于以有症状的复发性深静脉血栓形成或肺栓塞为终点的研究。尽管并非所有患者都能确诊复发性静脉血栓栓塞，但采用严格方法的临床试验可以将诊断检测结果的局限性所导致的潜在偏倚降至最低。未来需要开发更好的客观检测方法，以区分既往的和复发性静脉血栓栓塞。
