Eur Heart J. 2000 Sep;21(18):1537-46. doi: 10.1053/euhj.1999.2439.
To compare the effect of trimetazidine (TMZ) versus placebo administered during the acute phase of myocardial infarction on long- and short-term mortality.
EMIP-FR (European Myocardial Infarction Project - Free Radicals) was a prospective, double-blind, European multicentre trial in which 19 725 patients, presenting symptoms of acute myocardial infarction within the previous 24 h were randomized. Stratification was according to thrombolytic therapy (56%) or not (44%). An intravenous bolus injection of trimetazidine (40 mg) was given just before or simultaneously with thrombolysis, followed by continuous infusion (60 mg. 24 h(-1)) for 48 h. Overall, no difference was found between trimetazidine and placebo for the main end-point, short-term (35-day) mortality, (P = 0.98) in an intention-to-treat analysis. This was the result of opposing trends in the two strata. Thrombolysed patients showed a tendency towards more short-term deaths with trimetazidine, compared to placebo (trimetazidine: 11.3%, placebo: 10.5%, P = 0.15) and non-thrombolysed patients the converse (trimetazidine: 14.0%, placebo: 15.1%, P = 0.14). In a per-protocol analysis the beneficial effect of trimetazidine for non-thrombolysed patients became statistically significant (trimetazidine: 13.3%, placebo: 15.1%, P = 0.027).
Trimetazidine does not reduce mortality in patients undergoing thrombolytic therapy; however, it might have some beneficial effect for non-thrombolysed patients.
比较在心肌梗死急性期使用曲美他嗪（TMZ）与安慰剂对长期和短期死亡率的影响。
欧洲心肌梗死自由基项目（EMIP-FR）是一项前瞻性、双盲、欧洲多中心试验，19725例在过去24小时内出现急性心肌梗死症状的患者被随机分组。根据是否接受溶栓治疗（56%接受，44%未接受）进行分层。在溶栓前或溶栓同时静脉推注曲美他嗪（40毫克），随后持续输注（60毫克·24小时⁻¹）48小时。在意向性分析中，总体上曲美他嗪和安慰剂在主要终点短期（35天）死亡率方面未发现差异（P = 0.98）。这是两个分层中相反趋势的结果。与安慰剂相比，接受溶栓治疗的患者使用曲美他嗪后短期死亡倾向更高（曲美他嗪：11.3%，安慰剂：10.5%，P = 0.15），而未接受溶栓治疗的患者情况相反（曲美他嗪：14.0%，安慰剂：15.1%，P = 0.14）。在符合方案分析中，曲美他嗪对未接受溶栓治疗患者的有益作用具有统计学意义（曲美他嗪：13.3%，安慰剂：15.1%，P = 0.027）。
曲美他嗪不能降低接受溶栓治疗患者的死亡率；然而，它可能对未接受溶栓治疗的患者有一些有益作用。
