Verso Melina, Agnelli Giancarlo, Bertoglio Sergio, Di Somma Franco C, Paoletti Francesco, Ageno Walter, Bazzan Mario, Parise Pasquale, Quintavalla Roberto, Naglieri Emanuele, Santoro Armando, Imberti Davide, Sorarù Mariella, Mosca Stefano
Sezione di Medicina Interna e Cardiovascolare, Dipartimento di Medicina Interna, Università di Perugia, Via Enrico dal Pozzo, 06123 Perugia, Italy.
J Clin Oncol. 2005 Jun 20;23(18):4057-62. doi: 10.1200/JCO.2005.06.084. Epub 2005 Mar 14.
The extent of venous thromboembolism (VTE) associated with central vein catheters (CVC) in cancer patients remains unclear. The aim of this study was to evaluate the efficacy and safety of the low molecular weight heparin, enoxaparin, in the prevention of VTE.
In a multicenter, double-blind study, consecutive cancer patients scheduled for CVC insertion were randomly assigned to receive either subcutaneous enoxaparin 40 mg once a day or placebo. Treatment was started 2 hours before CVC insertion and continued for 6 weeks. The primary end points of the study were deep vein thrombosis (DVT), confirmed by venography of the CVC limb performed 6 weeks after randomization, or clinically overt pulmonary embolism, confirmed by objective testing during the study drug administration. Patients were assessed for bleeding complications.
Three hundred eighty-five patients were randomized, of which 321 (83.4%) underwent venography. A venography was adequate for adjudication in 155 patients in each treatment group. A DVT was observed in 22 patients (14.1%) treated with enoxaparin and in 28 patients (18.0%) treated with placebo, corresponding to a relative risk of 0.78 (95% CI, 0.47 to 1.31). No major bleeding occurred. Five patients (2.6%) in the enoxaparin group and two patients (1.0%) in the placebo group died during the treatment period.
In this study, no difference in the rate of CVC-related VTE was detected between patients receiving enoxaparin and patients receiving placebo. The dose of enoxaparin used in this study proved to be safe. Clinical trials evaluating higher enoxaparin doses could optimize the efficacy of this agent for this indication.
癌症患者中与中心静脉导管（CVC）相关的静脉血栓栓塞（VTE）的程度尚不清楚。本研究的目的是评估低分子量肝素依诺肝素预防VTE的有效性和安全性。
在一项多中心、双盲研究中，计划进行CVC置入的连续癌症患者被随机分配接受皮下注射依诺肝素40mg每日一次或安慰剂。治疗在CVC置入前2小时开始，并持续6周。研究的主要终点是随机分组6周后通过CVC肢体静脉造影证实的深静脉血栓形成（DVT），或在研究药物给药期间通过客观检测证实的临床明显肺栓塞。对患者进行出血并发症评估。
385例患者被随机分组，其中321例（83.4%）接受了静脉造影。每个治疗组有155例患者的静脉造影结果适合进行判定。接受依诺肝素治疗的22例患者（14.1%）和接受安慰剂治疗的28例患者（18.0%）观察到DVT，相对风险为0.78（95%CI，0.47至1.31）。未发生大出血。依诺肝素组有5例患者（2.6%）和安慰剂组有2例患者（1.0%）在治疗期间死亡。
在本研究中，接受依诺肝素的患者与接受安慰剂的患者之间未检测到CVC相关VTE发生率的差异。本研究中使用的依诺肝素剂量被证明是安全的。评估更高依诺肝素剂量的临床试验可能会优化该药物在此适应症上的疗效。
