基于血红蛋白的氧载体HBOC-201在非心脏手术患者的随机、多中心红细胞对照试验中的安全性和有效性评估。

A safety and efficacy evaluation of hemoglobin-based oxygen carrier HBOC-201 in a randomized, multicenter red blood cell controlled trial in noncardiac surgery patients.

作者信息

Van Hemelrijck Jan, Levien Lewis J, Veeckman Luc, Pitman Arkadiy, Zafirelis Zafiris, Standl Thomas

机构信息

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.

出版信息

Anesth Analg. 2014 Oct;119(4):766-776. doi: 10.1213/ANE.0000000000000305.

DOI:10.1213/ANE.0000000000000305

PMID:24977631

Abstract

BACKGROUND

We present the results of a previously unpublished hemoglobin-based oxygen carrier (HBOC) study conducted in 1998-1999.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

背景

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。

方法

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。

结果

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。