Ferretti Gianluigi, Bria Emilio, Giannarelli Diana, Carlini Paolo, Felici Alessandra, Mandalà Mario, Ciccarese Mariangela, Papaldo Paola, Fabi Alessandra, Cognetti Francesco
Department of Medical Oncology, Regina Elena Cancer Institute, Rome, Italy.
Thromb Res. 2007;119(4):525-9. doi: 10.1016/j.thromres.2006.04.009. Epub 2006 Jun 14.
To evaluate the safety (major bleedings) of long-term treatment of symptomatic venous thromboembolism (VTE) using low molecular weight heparin (LMWH) compared with oral anticoagulant therapy (OAT) given for at least 3 months, we analyzed 10 randomized clinical trials enrolling a total of 2817 patients with objectively diagnosed symptomatic deep vein thrombosis, pulmonary embolism or both. The relative risk (RR, incidence of recurrent symptomatic VTE) was combined across the studies, using the inverse variance and the Mantel-Haenszel method. During treatment, major bleeding complications occurred in 2.8% of the patients in the LMWH arm versus 4% in the OAT arm: no statistically significant difference was observed (p=0.31). No differences in major bleeding were registered in the additional 3-9 months of follow-up (p=0.98). Long-term treatment with LMWH does not seem to be significantly safer than OAT. However, no conclusive interpretation from different studies with different designs is possible.
为评估与至少3个月的口服抗凝治疗（OAT）相比，使用低分子量肝素（LMWH）对有症状静脉血栓栓塞（VTE）进行长期治疗的安全性（严重出血），我们分析了10项随机临床试验，这些试验共纳入2817例经客观诊断为有症状的深静脉血栓形成、肺栓塞或两者皆有的患者。采用逆方差法和Mantel-Haenszel法合并各研究中的相对风险（RR，复发性有症状VTE的发生率）。治疗期间，LMWH组2.8%的患者发生严重出血并发症，而OAT组为4%：未观察到统计学上的显著差异（p=0.31）。在额外的3 - 9个月随访中，严重出血情况无差异（p=0.98）。长期使用LMWH治疗似乎并不比OAT显著更安全。然而，由于不同研究设计不同，无法得出结论性解释。
