Safety and preliminary efficacy of hemoglobin raffimer for patients undergoing coronary artery bypass surgery
Safety and preliminary efficacy of hemoglobin raffimer for patients undergoing coronary artery bypass surgery
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DOI：
10.1053/jcan.2002.128416
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发表时间：
2002-12-01
影响因子：
2.8
通讯作者：
Grichnik, K
中科院分区：
文献类型：
--
作者：
Hill, SE;Gottschalk, LI;Grichnik, K
目的：评价在冠状动脉搭桥术（CABG）中自体献血时增加血红蛋白受体（Hemolink）剂量的安全性和初步疗效。设计：随机、对照、单盲II期剂量递增试验。环境：多机构大学环境。参与者：接受选择性冠脉搭桥手术的成人患者（60例）。干预措施：诱导麻醉后，体外循环取自体全血，使血红蛋白达到7 g/dL。患者随机接受血红蛋白增强剂（治疗组）或6% hetastarch（对照组），剂量依次递增，分别为250 mL、500 mL或750 mL。返回自体血液后，根据预定的血红蛋白触发因素输入异体红细胞。测量和主要结果：安全参数（生命体征、血液学、血液化学、凝血和不良事件）从随机分配到出院后第4周进行监测。严重不良事件在两组患者中分布均匀。治疗组血压升高更为频繁（16/28 mmHg vs 9/32 mmHg, p = 0.036）。在750-mL剂量组的40例患者中，18例治疗患者中有8例和22例对照患者中有4例避免了异基因红细胞输血（p = 0.093）。与对照组相比，治疗组输注异体红细胞的中位数体积较低（p = 0.042）。结论：血红蛋白受体耐受性良好，可有效减少冠状动脉搭桥术患者的输血。虽然围手术期高血压在接受治疗的患者中更为常见，但血压管理防止了严重的不良后遗症。需要在更大的III期试验中对疗效进行明确评估。版权所有，爱思唯尔科学（美国）。版权所有。
Objective: To evaluate the safety and preliminary efficacy of escalating doses of hemoglobin raffimer (Hemolink) with intraoperative autologous blood donation for coronary artery bypass graft (CABG) surgery.Design: Randomized, controlled, single-blind phase II dose escalation trial.Setting: Multi-institutional university setting.Participants: Adult patients (n = 60) undergoing elective CABG surgery.Interventions: After induction of anesthesia, autologous whole blood was collected to achieve a hemoglobin of 7 g/dL on cardiopulmonary bypass. Patients were randomized to receive either hemoglobin raffimer (treatment) or 6% hetastarch (control) in sequential escalating dose blocks of 250 mL, 500 mL, or 750 mL. After return of autologous blood, allogeneic red blood cells were transfused according to predetermined hemoglobin triggers.Measurements and Main Results: Safety parameters (vital signs, hematology, blood chemistry, coagulation, and adverse events) were monitored from randomization through week 4 postdischarge. Serious adverse events were distributed evenly between the 2 groups of patients. Elevated blood pressure was more frequent in the treatment group (16/28 mmHg v 9/32 mmHg, p = 0.036). In the group of 40 patients in the 750-mL dose block, 8 of the 18 treatment patients and 4 of the 22 control patients avoided allogeneic red blood cell transfusion (p = 0.093). Median volume of allogeneic red blood cells transfused was lower in treated subjects compared with controls (p = 0.042).Conclusion: Hemoglobin raffimer is well tolerated and may be effective in reducing transfusion for patients undergoing CABG surgery. Although perioperative hypertension was more frequent in the treated patients, blood pressure management prevented serious adverse sequelae. Definitive evaluation of efficacy in a larger phase III trial is warranted. Copyright 2002, Elsevier Science (USA). All rights reserved.