Circulation. 1997 Jul 1;96(1):192-201.
Previous studies suggested that RheothRx (poloxamer 188) reduces infarct size and improves left ventricular (LV) function in acute myocardial infarction (AMI). We therefore evaluated the effects of various doses of RheothRx in 2948 patients presenting with AMI.
Patients were randomized to a control group (n = 963) or to receive RheothRx. Patients receiving RheothRx were allocated to receive a 1-hour bolus only (regimen A, n = 844), an additional 11-hour infusion at a low dose (target serum concentration of 0.5 mg/mL) (regimen Y, n = 490), or an additional 23-hour infusion at a low dose (regimen B, n = 483). Three higher doses (1-hour bolus+low-dose infusion for 47 hours, 1-hour bolus+high dose, target serum concentration of 1.0 mg/ml for 24 hours, or 1-hour bolus+high dose for 48 hours) were discontinued because of high rates of renal dysfunction (8.8%). Renal dysfunction was also observed at lower doses (regimen A, 3.1%; Y, 2.7%; and B, 4.1%) compared with the control patients (1.0%). There was no significant difference in the composite outcome of death, cardiogenic shock, or reinfarction at 35 days (all RheothRx, 13.6%; control, 12.7%). There was a higher incidence of sinus tachycardia (24.7% versus 21.6%, P = .02), atrial flutter (3.0% versus 1.3%, P = .019), atrial fibrillation (10.2% versus 7.3%, P = .082), pericarditis (6.6% versus 4.7%, P = .055), and clinical (21.9% versus 17.9%, P = .005) and radiological (15.3% versus 12.3%, P = .12) evidence of heart failure. This was associated with a lower LV ejection fraction (n = 1053) in treated patients (by = -0.02, P = .026), but there was little difference (P = .34) in infarct size (n = 1088).
In this study of nearly 3000 patients, RheothRx had no effect on mortality, reinfarction, or cardiogenic shock and an adverse effect on renal function, LV ejection fraction, and various clinical manifestations of LV dysfunction or heart failure.
既往研究表明，流变Rx（泊洛沙姆188）可缩小急性心肌梗死（AMI）患者的梗死面积并改善左心室（LV）功能。因此，我们评估了不同剂量的流变Rx对2948例AMI患者的影响。
患者被随机分为对照组（n = 963）或接受流变Rx治疗。接受流变Rx治疗的患者被分配接受仅1小时的静脉推注（方案A，n = 844）、额外11小时的低剂量输注（目标血清浓度为0.5 mg/mL）（方案Y，n = 490）或额外23小时的低剂量输注（方案B，n = 483）。三种更高剂量（1小时静脉推注+47小时低剂量输注、1小时静脉推注+高剂量，目标血清浓度为1.0 mg/ml持续24小时或1小时静脉推注+高剂量持续48小时）因肾功能不全发生率高（8.8%）而停用。与对照组患者（1.0%）相比，较低剂量组（方案A为3.1%；方案Y为2.7%；方案B为4.1%）也观察到肾功能不全。35天时死亡、心源性休克或再梗死的复合结局无显著差异（所有接受流变Rx治疗的患者为13.6%；对照组为12.7%）。窦性心动过速（24.7%对21.6%，P = .02）、心房扑动（3.0%对1.3%，P = .019）、心房颤动（10.2%对7.3%，P = .082）、心包炎（6.6%对4.7%，P = .055）以及心力衰竭的临床（21.9%对17.9%，P = .005）和影像学证据（15.3%对12.3%，P = .12）的发生率更高。这与治疗患者较低的左心室射血分数（n = 1053）相关（β = -0.02，P = .026），但梗死面积（n = 1088）差异不大（P = .34）。
在这项近3000例患者的研究中，流变Rx对死亡率、再梗死或心源性休克无影响，但对肾功能、左心室射血分数以及左心室功能障碍或心力衰竭的各种临床表现有不良影响。
