A randomized prospective trial of intravenous nitroglycerin in patients with acute myocardial infarction.
A randomized prospective trial of intravenous nitroglycerin in patients with acute myocardial infarction.
复制标题
急性心肌梗死患者静脉注射硝酸甘油的随机前瞻性试验。
DOI：
10.1161/01.cir.68.3.576
复制
发表时间：
1983
期刊：
影响因子：
37.8
通讯作者：
Weisfeldt,ML
中科院分区：
文献类型：
--
作者：
Flaherty,JT;Becker,LC;Bulkley,BH;Weiss,JL;Gerstenblith,G;Kallman,CH;Silverman,KJ;Wei,JY;Pitt,B;Weisfeldt,ML
摘要：一项前瞻性随机研究对急性梗死后48小时静脉注射硝酸甘油（TNG）进行了研究，以确定是否可以证明临床改善和/或保存缺血心肌的证据。104例患者被随机分为TNG组（n= 56）和安慰剂组（n= 48）。以足以使平均动脉压降低10%的速率输注TNG，无创监测。当所有接受tng和安慰剂治疗的患者进行比较时，临床或实验室结果没有显着差异。采用tng和安慰剂治疗的患者被回顾性地细分为早期治疗组和晚期治疗组（治疗开始时间< 10小时vs症状出现后3 10小时）。早期TNG治疗与前10天内梗死并发症发生率较低相关，其定义为新的充血性心力衰竭、梗死扩展或心源性死亡(TNG早期为15%，而其他三个亚组平均为39%；p=。003)。早期接受TNG治疗组的3个月死亡率较低（15%），而其他三个亚组的平均死亡率为25% （p= NS）。在肌酸激酶（CK）峰值血水平、肌酸激酶梗死面积或连续心电图测图保存的心前R波方面没有发现显著差异。在49例接受预处理和治疗后第7至14天左心室射血分数测量的患者中，35%的早期治疗TNG患者改善了310%，而TNG晚期治疗的患者改善了6%，安慰剂早期治疗的患者改善了11%，安慰剂晚期治疗的患者改善了0% (p=。004)。同样，在68例接受配对铊闪烁图治疗的患者中，早期治疗的TNG患者中有48%的患者的电脑测定铊缺陷评分下降了75%，而晚期治疗的TNG患者为14%，早期治疗的安慰剂患者为33%，晚期治疗的安慰剂患者为0% （p=）。039)。表现出明显的星形图改善的患者较早接受治疗，往往有较轻的初始星形图异常，下位梗死而不是前位梗死，心绞痛病史较长，无心力衰竭病史。因此，当将患者群体作为一个整体进行分析时，静脉注射TNG不能显示出对临床或影像学结果的显著改善。经过回顾性亚组分析，在症状出现后10小时内开始治疗的小至中度心肌梗死患者亚群中，静脉注射TNG可以保护缺血心肌。该试验的结果还表明，未来旨在显示梗死面积减少的临床试验可能会将患者纳入限制在症状出现后早期入院的患者和入院扫描研究中有明显异常的患者。需要更大规模的研究来确定TNG治疗是否能显著降低死亡率，并进一步确定可能从这种治疗中获益最多的患者群体。《流通》第68号，第3期，1983年，576-588。
ABSTRACT A prospective randomized study of intravenous nitroglycerin (TNG) administered for 48 hr after acute infarction was undertaken to determine whether clinical improvement and/or evidence of preservation of ischemic myocardium could be demonstrated. One hundred four patients were randomly assigned to TNG (n= 56) and placebo groups (n= 48). TNG was infused at a rate sufficient to lower mean arterial pressure 10%, monitored noninvasively. When all TNG-and placebo-treated patients were compared, no significant differences in clinical or laboratory outcomes could be demonstrated. TNG-and placebo-treated patients were retrospectively subdivided into early and late treatment groups (treatment begun< 10 hr vs 3 10 hr after onset of symptoms). Early TNG treatment was associated with a lower incidence of infarct complications within the first 10 days, defined by new congestive heart failure, infarct extension, or cardiac death (15% in early TNG compared with a mean of 39% in the other three subgroups; p=. 003). Mortality at 3 months was lower in the group treated early with TNG (15%) compared with a mean of 25% in the other three subgroups (p= NS). No significant differences were found in peak creatine kinase (CK) blood levels, creatine kinase infarct size, or preservation of precordial R waves by serial electrocardiographic mapping. Among49 patients with pretreatment and day 7 to 14 posttreatment left ventricular ejection fraction measurements, improvement of 3 10% occurred in 35% of TNG patients treated early compared with 6% of those treated late with TNG, 11% of those treated early with placebo, and 0% of those treated late with placebo (p=. 004). Similarly, in 68 patients in whom paired thallium scintigrams were taken, a decrease of B75% in the computer-determined thallium defect score was seen in 48% of TNG patients treated early, compared with 14% of TNG patients treated late, 33% of placebo patients treated early and 0% of placebo patients treated late (p=. 039). Patients demonstrating significant scintigraphic improvement were treated earlier, tended to have less severe initial scintigraphic abnormalities, inferior rather than anterior infarctions, a longer history of angina, and no priorhistory of heart failure. Thus intravenous TNG couldnot be shown to result in significant improvement in clinical or scintigraphic outcomes when the patient population was analyzed as a whole. After retrospective subgroup analysis, intravenous TNG could be shown to protect ischemic myocardium in the subset of patients with small-to-moderate sized myocardial infarctions when treatment was begun within 10 hr of the onset of symptoms. The results of this trial also suggest that future clinical trials designed to show a reduction in infarct size might limit patient entry to those admitted early after symptom onset and those with significant abnormalities in their admission scintigraphic studies. Larger-scale studies are needed to determine whether TNG therapy can significantly reduce mortality and to further define the population of patients who may profit most from this treatment. Circulation 68, No. 3, 576-588, 1983.