Department of Clinical Pharmacy, School of Pharmacy, University of Colorado, Aurora, Colorado 80045, USA.
Pharmacotherapy. 2010 Nov;30(11):1117-26. doi: 10.1592/phco.30.11.1117.
To evaluate the safety and efficacy of bivalirudin compared with heparin for preventing hemofilter occlusion during continuous venovenous hemofiltration (CVVH).
Prospective, randomized, double-blind study.
University-affiliated hospital.
Ten critically ill adults (median age 58 yrs, 70% male) with acute renal failure who, without anticoagulation, experienced hemofilter survival time of 24 hours or less during CVVH.
Patients were randomized to receive bivalirudin 2 mg/hour (five patients) or heparin 400 units/hour (five patients) administered prefilter into the extracorporeal circuit.
Patients had a median Acute Physiology and Chronic Health Evaluation (APACHE) II score of 24, Sequential Organ Failure Assessment (SOFA) score of 11, and reduced antithrombin activity (75.5 units/dl). Baseline characteristics were not significantly different between groups. Study drug was administered in 40 hemofilters (18 from bivalirudin-treated patients, 22 from heparin-treated patients). The primary efficacy outcome was hemofilter survival time, defined as the interval of time between commencement of CVVH with a new extracorporeal circuit (hemofilter) and hemofilter failure. Compared with no anticoagulation, the addition of bivalirudin or heparin significantly improved hemofilter survival time (mean ± SD 10 ± 5 hrs with no anticoagulation vs 22 ± 18 hrs with anticoagulation, p=0.0005). Hemofilter survival time was significantly increased in patients receiving bivalirudin versus those receiving heparin (29.6 ± 20.7 vs 16.5 ± 13.6 hrs, p=0.045). Independent predictors of hemofilter survival were use of bivalirudin therapy and increased antithrombin III activity. No patients randomized to bivalirudin experienced any bleeding or thrombosis events; one patient who received heparin developed alveolar hemorrhage, and one developed a lower extremity deep vein thrombosis.
Compared with heparin, bivalirudin was more efficacious in prolonging hemofilter survival time and was well tolerated. Additional studies of bivalirudin for prevention of hemofilter occlusion during continuous renal replacement therapy are warranted.
评估比伐卢定与肝素预防连续性静脉-静脉血液滤过（CVVH）中血液滤器阻塞的安全性和疗效。
前瞻性、随机、双盲研究。
大学附属医院。
10 名患有急性肾衰竭的重症成人（中位年龄 58 岁，70%为男性），在未抗凝的情况下，CVVH 期间血液滤器的存活时间为 24 小时或更短。
患者被随机分为接受比伐卢定 2 毫克/小时（5 名患者）或肝素 400 单位/小时（5 名患者）预过滤到体外回路中。
患者的急性生理学和慢性健康评估（APACHE）Ⅱ评分中位数为 24，序贯器官衰竭评估（SOFA）评分为 11，抗凝血酶活性降低（75.5 单位/分）。两组之间的基线特征无显著差异。研究药物在 40 个血液滤器中使用（比伐卢定治疗的患者 18 个，肝素治疗的患者 22 个）。主要疗效结局是血液滤器的存活时间，定义为开始使用新的体外回路（血液滤器）和血液滤器失效之间的时间间隔。与无抗凝治疗相比，比伐卢定或肝素的添加显著延长了血液滤器的存活时间（无抗凝治疗的平均±标准差为 10±5 小时，抗凝治疗的为 22±18 小时，p=0.0005）。与肝素相比，接受比伐卢定治疗的患者的血液滤器存活时间显著增加（29.6±20.7 与 16.5±13.6 小时，p=0.045）。血液滤器存活的独立预测因素是使用比伐卢定治疗和增加抗凝血酶 III 活性。随机接受比伐卢定治疗的患者均未发生任何出血或血栓事件；接受肝素治疗的患者中有 1 例发生肺泡出血，1 例发生下肢深静脉血栓形成。
与肝素相比，比伐卢定更有效地延长血液滤器的存活时间，且耐受性良好。需要进一步研究比伐卢定在预防连续性肾脏替代治疗中血液滤器阻塞的作用。
