Department of Anesthesia and Intensive Care, Karolinska Institutet and Karolinska University Hospital, Solna, Stockholm, Sweden.
Anesthesiology. 2011 May;114(5):1048-63. doi: 10.1097/ALN.0b013e318215e198.
MP4OX (oxygenated polyethylene glycol-modified hemoglobin) is an oxygen therapeutic agent with potential applications in clinical settings where targeted delivery of oxygen to ischemic tissues is required. The primary goal of this study was to investigate MP4OX for preventing hypotensive episodes. An additional goal was to establish the safety profile of MP4OX in a large surgical population.
Patients (n = 367) from 18 active study sites in six countries, undergoing elective primary hip arthroplasty with spinal anesthesia, were randomized to receive MP4OX or hydroxyethyl starch 130/0.4. Patients received a 250-ml dose at induction of spinal anesthesia and a second 250-ml dose if the protocol-specified trigger (predefined decrease in systolic blood pressure) was reached. The primary end point was the proportion of patients who developed one or more hypotensive episodes.
The proportion of patients with one or more hypotensive episodes was significantly lower (P < 0.0001) in the MP4OX group (66.1%) versus controls receiving hydroxyethyl starch 130/0.4 (90.2%). More MP4OX-treated patients experienced adverse events compared with controls (72.7% vs. 61.4%; P = 0.026). Transient elevations in laboratory values (e.g., alanine aminotransferase, aspartate aminotransferase, lipase, and troponin concentrations) occurred more frequently in the MP4OX group. There were no significant differences in the incidence of serious adverse events or in the composite morbidity and ischemia outcome end points, but nausea and hypertension were reported more often in MP4OX-treated patients.
MP4OX significantly reduced the incidence of hypotensive episodes in patients undergoing hip arthroplasty, but the adverse event profile does not support use in routine low-risk surgical patients for the indication evaluated in this study.
MP4OX（氧合聚乙二醇修饰血红蛋白）是一种氧疗剂，具有在需要向缺血组织靶向输送氧气的临床环境中应用的潜力。本研究的主要目的是研究 MP4OX 预防低血压发作的效果。另一个目标是在大量手术人群中确定 MP4OX 的安全性概况。
来自六个国家的 18 个活跃研究地点的 367 名患者，在脊髓麻醉下进行择期初次髋关节置换术，随机接受 MP4OX 或羟乙基淀粉 130/0.4 治疗。患者在脊髓麻醉诱导时接受 250 毫升剂量，如果达到方案规定的触发（定义为收缩压下降），则再接受 250 毫升剂量。主要终点是发生一次或多次低血压发作的患者比例。
与接受羟乙基淀粉 130/0.4 的对照组（90.2%）相比，MP4OX 组（66.1%）发生一次或多次低血压发作的患者比例显著降低（P < 0.0001）。与对照组相比，更多的 MP4OX 治疗患者出现不良事件（72.7% vs. 61.4%；P = 0.026）。MP4OX 组更频繁地出现实验室值升高（如丙氨酸氨基转移酶、天冬氨酸氨基转移酶、脂肪酶和肌钙蛋白浓度）等短暂升高。严重不良事件的发生率或复合发病率和缺血结局终点无显著差异，但在接受 MP4OX 治疗的患者中，恶心和高血压更为常见。
MP4OX 可显著降低髋关节置换术患者低血压发作的发生率，但不良事件谱不支持在本研究评估的适应证下常规用于低风险手术患者。
