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国际美西律与安慰剂抗心律失常冠状动脉试验(IMPACT):II. 24小时心电图结果。IMPACT研究小组

International Mexiletine and Placebo Antiarrhythmic Coronary Trial (IMPACT): II. Results from 24-hour electrocardiograms. IMPACT Research Group.

出版信息

Eur Heart J. 1986 Sep;7(9):749-59.

PMID:3533546
Abstract

The sustained release form of mexiletine (Mexitil-Perlongets), 360 mg b.i.d., was evaluated for antiarrhythmic efficacy in a double-blind placebo trial in 630 patients with recent documented myocardial infarction. The drug was effective in reducing the occurrence of complex forms of ventricular arrhythmias as well as frequent premature ventricular complexes during the first four months of treatment. In addition, a favourable trend in antiarrhythmic efficacy of the drug was observed after 12 months of treatment, but this was not statistically significant. The data from this study suggest that mexiletine was as effective in preventing the occurrence of frequent or complex cardiac arrhythmias as in reducing such arrhythmias present during the first four months following acute myocardial infarction. Mortality was higher in the mexiletine group (7.6%) than in the placebo group (4.8%), although the difference was not statistically significant.

摘要

在一项针对630例近期有心肌梗死记录患者的双盲安慰剂试验中,对美西律缓释剂型(慢心律-佩龙酯)每日两次、每次360毫克的抗心律失常疗效进行了评估。在治疗的前四个月,该药物在减少复杂形式室性心律失常以及频发室性早搏的发生方面有效。此外,治疗12个月后观察到该药物抗心律失常疗效有良好趋势,但这在统计学上不显著。这项研究的数据表明,美西律在预防频发或复杂心律失常的发生方面与在减少急性心肌梗死后头四个月出现的此类心律失常方面同样有效。美西律组的死亡率(7.6%)高于安慰剂组(4.8%),尽管差异无统计学意义。

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