Flaherty J T, Pitt B, Gruber J W, Heuser R R, Rothbaum D A, Burwell L R, George B S, Kereiakes D J, Deitchman D, Gustafson N
Johns Hopkins Medical Institutions, Baltimore, Md.
Circulation. 1994 May;89(5):1982-91. doi: 10.1161/01.cir.89.5.1982.
Animal studies have demonstrated a burst of oxygen free radical generation after reperfusion of ischemic myocardium that could be blocked by administration of the free radical scavenger recombinant human superoxide dismutase (h-SOD). A multicenter, randomized, placebo-controlled clinical trial was designed to test the hypothesis that free radical-mediated reperfusion injury could be reduced by intravenous administration of h-SOD begun before percutaneous transluminal coronary angioplasty (PTCA) in patients with acute transmural myocardial infarction.
One hundred twenty patients were randomized to receive placebo (n = 59) or h-SOD (n = 61) given as a 10-mg/kg intravenous bolus followed by a 60-minute infusion of 0.2 mg.kg-1.min-1. Left ventricular function was analyzed via paired contrast left ventriculograms performed before PTCA and after 6 to 10 days and paired radionuclide ventriculograms performed within 24 hours of PTCA and after 4 to 6 weeks. Both h-SOD- and placebo-treated patients showed improvement in global and regional left ventricular function after successful reperfusion. Compared with the placebo group, no additional improvement was observed in the patients treated with h-SOD.
The results of this clinical trial failed to demonstrate a beneficial effect of h-SOD on global or regional left ventricular function in patients who underwent successful PTCA for treatment of acute myocardial infarction.
动物研究表明，缺血心肌再灌注后会产生一阵氧自由基，而自由基清除剂重组人超氧化物歧化酶（h-SOD）的给药可阻断这种现象。一项多中心、随机、安慰剂对照的临床试验旨在检验这样一个假设：对于急性透壁性心肌梗死患者，在经皮腔内冠状动脉成形术（PTCA）前开始静脉注射h-SOD可减少自由基介导的再灌注损伤。
120例患者被随机分为两组，分别接受安慰剂（n = 59）或h-SOD（n = 61）治疗。h-SOD组给予10 mg/kg静脉推注，随后以0.2 mg·kg-1·min-1的速度输注60分钟。通过PTCA术前及术后6至10天进行的配对对比左心室造影，以及PTCA术后24小时内及4至6周后进行的配对放射性核素心室造影来分析左心室功能。成功再灌注后，h-SOD治疗组和安慰剂治疗组患者的整体及局部左心室功能均有所改善。与安慰剂组相比，接受h-SOD治疗的患者未观察到额外的改善。
该临床试验结果未能证明h-SOD对接受成功PTCA治疗急性心肌梗死患者的整体或局部左心室功能有有益作用。
