The changing base line of complex ventricular arrhythmias. A new consideration in assessing long-term antiarrhythmic drug therapy.
The changing base line of complex ventricular arrhythmias. A new consideration in assessing long-term antiarrhythmic drug therapy.
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复杂室性心律失常的基线变化。
DOI：
10.1056/nejm198512053132304
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发表时间：
1985
期刊：
影响因子：
--
通讯作者：
Roberts,R
中科院分区：
文献类型：
--
作者：
Pratt,CM;Delclos,G;Wierman,AM;Mahler,SA;Seals,AA;Leon,CA;Young,JB;Quinones,MA;Roberts,R
初始基线心电图用于评估室性心律失常的治疗效果。这种方法假设在没有治疗的情况下，心律失常的频率将保持恒定。为了验证这一假设的有效性，我们研究了26例临床稳定的有症状但不危及生命的室性心律失常患者，在两个安慰剂治疗期（平均间隔17个月），与最初的安慰剂治疗期相比，室性早搏除极显著减少（50%）、成对（65%）和室性心动过速（83%）（所有比较P≤0.05）。超过三分之一的患者在第二个安慰剂治疗期内表现出接受了成功治疗，即使考虑到报告的室性心律失常的自发变异性。如果未被识别，这些心律失常频率的长期自发变化可能导致继续不必要的和潜在的毒性治疗，并导致临床试验中关于抗心律失常药物疗效的错误结论。因此，我们建议在没有治疗的情况下，每年重新评估与我们研究中相似的患者的心律失常频率。这些建议不适用于危及生命的室性心律失常患者。（N Engl J Med 1985; 313：1444-9.）
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≤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. (N Engl J Med 1985; 313:1444–9.)