流变学疗法（RheothRx）对急性心肌梗死患者死亡率、发病率、左心室功能及梗死面积的影响。流变学疗法评估协作组织（CORE）。

Effects of RheothRx on mortality, morbidity, left ventricular function, and infarct size in patients with acute myocardial infarction. Collaborative Organization for RheothRx Evaluation (CORE).

出版信息

Circulation. 1997 Jul 1;96(1):192-201.

Abstract

BACKGROUND

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.

METHODS AND RESULTS

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).

CONCLUSIONS

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.

摘要

背景

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。

方法与结果

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）。