Bruscas Maria Jesús, Nieto José Antonio, Perez-Pinar Monserrat, López-Jiménez Luciano, Fernández-Capitán Carmen, López-Chuliá Francisca, Orue-Lecue Maria Teresa
Servicio de Medicina Interna, Hospital Virgen de la Luz, 16002 Cuenca, Spain.
Ann Hematol. 2007 Jul;86(7):519-26. doi: 10.1007/s00277-007-0282-x. Epub 2007 Apr 17.
The objective was to assess the use of suboptimal doses (60-149 UI kg(-1) day(-1)) of low molecular weight heparin (LMWH) in the treatment of acute venous thromboembolism (VTE) in actual clinical practice and to evaluate the outcomes compared to standard doses (> or = 150 UI kg(-1) day(-1)). Retrospective analysis of data from a multicenter registry of patients with VTE (RIETE; Registro Informatizado de Enfermedad TromboEmbólica). Patient characteristics, antithrombotic treatments, and 3-month outcomes were analyzed. We studied 12,302 patients with VTE; 10,524 patients were treated initially only with LMWH; 1,547 patients received suboptimal LMWH (mean = 122 UI kg(-1) day(-1)), and 8,977 patients received full-dose LMWH (mean = 191 UI kg(-1) day(-1)). The suboptimal group included significantly more patients with recent major bleeding, weight more than 100 kg, raised creatinine, or deep vein thrombosis. No significant differences in mortality rate (7.7 vs 7.8%), VTE recurrence (2.7 vs 2.3%), or fatal hemorrhage (0.6 vs 0.6%) occurred between the suboptimal and the standard group. Major bleeding episodes occurred more frequently in the patients with pulmonary embolism treated with suboptimal LMWH (4.5 vs 2.4%; p = 0.02). In the multivariate analysis, after adjusting for bleeding risk factors, major hemorrhage was not associated with the heparin dose. Suboptimal doses of LMWH are used in actual clinical practice in a reduced group of patients at an outcome rate not very different to that of standard doses. Bleeding episodes depend more on the patient's characteristics than on the LMWH dose. Randomized trials should be performed to corroborate these results.
目的是评估在实际临床实践中使用低分子肝素(LMWH)的次优剂量(60 - 149 UI kg⁻¹ 天⁻¹)治疗急性静脉血栓栓塞症(VTE)的情况,并与标准剂量(≥150 UI kg⁻¹ 天⁻¹)相比较评估结果。对来自VTE患者多中心注册库(RIETE;静脉血栓栓塞疾病信息注册库)的数据进行回顾性分析。分析患者特征、抗血栓治疗及3个月的结果。我们研究了12302例VTE患者;10524例患者最初仅接受LMWH治疗;1547例患者接受次优LMWH治疗(平均 = 122 UI kg⁻¹ 天⁻¹),8977例患者接受全剂量LMWH治疗(平均 = 191 UI kg⁻¹ 天⁻¹)。次优组中近期有大出血、体重超过100 kg、肌酐升高或深静脉血栓形成的患者明显更多。次优组与标准组在死亡率(7.7% 对 7.8%)、VTE复发率(2.7% 对 2.3%)或致命性出血率(0.6% 对 0.6%)方面无显著差异。接受次优LMWH治疗的肺栓塞患者中,大出血事件更频繁发生(4.5% 对 2.4%;p = 0.02)。在多变量分析中,在调整出血风险因素后,大出血与肝素剂量无关。在实际临床实践中,部分患者使用次优剂量的LMWH,其结果发生率与标准剂量的结果发生率差异不大。出血事件更多取决于患者特征而非LMWH剂量。应进行随机试验以证实这些结果。