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复杂室性心律失常的变化基线。评估长期抗心律失常药物治疗的新考量。

The changing base line of complex ventricular arrhythmias. A new consideration in assessing long-term antiarrhythmic drug therapy.

作者信息

Pratt C M, Delclos G, Wierman A M, Mahler S A, Seals A A, Leon C A, Young J B, Quinones M A, Roberts R

出版信息

N Engl J Med. 1985 Dec 5;313(23):1444-9. doi: 10.1056/NEJM198512053132304.

Abstract

Initial base-line electrocardiograms are used to assess the efficacy of treatment for ventricular arrhythmias. This approach assumes that in the absence of treatment the frequency of arrhythmia would remain constant. To test the validity of this assumption, we studied 26 clinically stable patients with symptomatic but not life-threatening ventricular arrhythmias, during two periods of placebo treatment separated by a mean of 17 months. As compared with the initial placebo period, there were significant reductions in ventricular premature depolarizations (50 per cent), pairs (65 per cent), and ventricular tachycardia (83 per cent) during the second period of placebo administration (P less than or equal to 0.05 for all comparisons). Over one third of the patients gave the appearance of receiving successful therapy during the second placebo period, even when the reported spontaneous variability of ventricular arrhythmia was taken into consideration. If unrecognized, these long-term spontaneous changes in the frequency of arrhythmia could result in continuation of unnecessary and potentially toxic therapy and lead to incorrect conclusions regarding the efficacy of antiarrhythmic drugs in clinical trials. We therefore recommend that the frequency of arrhythmia be reassessed annually in the absence of treatment in patients similar to those in our study. These recommendations should not be applied to patients with life-threatening ventricular arrhythmias.

摘要

初始基线心电图用于评估室性心律失常的治疗效果。这种方法假定在未进行治疗的情况下,心律失常的频率将保持不变。为了检验这一假设的有效性,我们对26例有症状但无生命危险的室性心律失常的临床稳定患者进行了研究,在两个安慰剂治疗期之间平均间隔17个月。与初始安慰剂期相比,在第二个安慰剂给药期,室性早搏(减少50%)、成对室性早搏(减少65%)和室性心动过速(减少83%)均有显著减少(所有比较P均≤0.05)。即使考虑到所报道的室性心律失常的自发变异性,超过三分之一的患者在第二个安慰剂期看起来像是接受了成功的治疗。如果未被认识到,心律失常频率的这些长期自发变化可能导致不必要的、有潜在毒性的治疗持续进行,并导致关于抗心律失常药物在临床试验中疗效的错误结论。因此,我们建议对于与我们研究中的患者类似的未接受治疗的患者,每年重新评估心律失常的频率。这些建议不适用于有生命危险的室性心律失常患者。

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