Van Hemelrijck Jan, Levien Lewis J, Veeckman Luc, Pitman Arkadiy, Zafirelis Zafiris, Standl Thomas
From the Department of Anesthesiology, Universitaire Ziekenhuizen Katholieke Universiteit Leuven, Leuven, Belgium; Department of Vascular Surgery, Milpark Hospital, Parktown, Johannesburg, South Africa; Independent Biostatistics Consultant, Peabody, Massachusetts; Independent Consultant, Needham, Massachusetts; Department of Anesthesiology, University Hospital, Eppendorf, Hamburg, Germany.
Anesth Analg. 2014 Oct;119(4):766-776. doi: 10.1213/ANE.0000000000000305.
We present the results of a previously unpublished hemoglobin-based oxygen carrier (HBOC) study conducted in 1998-1999.
In a multicenter, randomized, single-blind, comparative study of HBOC-201 versus allogeneic red blood cell (RBC) transfusions, no-cardiac surgery patients received HBOC-201 to a maximum of 7 units (n = 83) or RBCs (n = 77). Patients could be switched to RBCs for safety or any other reason. The efficacy end points were elimination and/or reduction of allogeneic RBC transfusions for 28 days.
The proportion of patients in the HBOC-201 group that avoided RBC transfusion was 0.427 (95% confidence interval, 0.321-0.533). Subjects in the HBOC-201 group received on average 3.2 units of RBCs versus 4.4 units in the control arm (P = 0.004). Seventy-nine (95.2%) subjects in the HBOC-201 group and 72 (93.5%) in the RBC group experienced adverse events (AEs), judged to be associated with study treatment in 59 (71.1%) and 18 (23.4%) subjects, respectively. Thirty-day mortality, 5 (6.0%) vs 4 (5.2%) patients (P = 1.00), incidence of serious AEs, 24 (28.9%) vs 20 (26.0%) (P = 0.73), or time to intensive care unit (log-rank P = 0.15) or hospital discharge (log-rank P = 0.53) were similar for the HBOC-201 and RBC groups, respectively.
Up to 7 units of HBOC-201 infused over the course of 6 days resulted in RBC transfusion avoidance in 43% of patients. There were no notable differences in mortality and serious AEs incidence. The use of HBOC-201 was associated with a notable excess of nonserious AEs.
我们展示了一项1998 - 1999年进行的此前未发表的基于血红蛋白的氧载体（HBOC）研究的结果。
在一项多中心、随机、单盲、比较HBOC - 201与异体红细胞（RBC）输血的研究中，非心脏手术患者接受HBOC - 201最多7单位（n = 83）或RBC（n = 77）。患者可因安全或任何其他原因转而接受RBC输血。疗效终点为28天内异体RBC输血的消除和/或减少。
HBOC - 201组中避免RBC输血的患者比例为0.427（95%置信区间，0.321 - 0.533）。HBOC - 201组的受试者平均接受3.2单位RBC，而对照组为4.4单位（P = 0.004）。HBOC - 201组中有79名（95.2%）受试者和RBC组中有72名（93.5%）受试者发生不良事件（AE），分别有59名（71.1%）和18名（23.4%）受试者的不良事件被判定与研究治疗相关。30天死亡率，HBOC - 201组5例（6.0%）对比RBC组4例（5.2%）患者（P = 1.00），严重AE发生率，24例（28.9%）对比20例（26.0%）（P = 0.73），或入住重症监护病房时间（对数秩检验P = 0.15）或出院时间（对数秩检验P = 0.53）在HBOC - 201组和RBC组中分别相似。
在6天内输注最多7单位的HBOC - 201可使43%的患者避免RBC输血。死亡率和严重AE发生率无显著差异。使用HBOC - 201与非严重AE的显著增加相关。
