Scheininger M, Dziersk J, Kullak W, Kors A, Köhler J A, Theisen K
Klinikum Innenstadt, Ludwig-Maximilians-Universität München.
Z Kardiol. 1991 Oct;80(10):630-6.
We studied the effect of barucainide, an investigational class lb antiarrhythmic drug, on ventricular arrhythmias and left-ventricular ejection fraction in 10 patients with frequent and complex ventricular arrhythmias (Lown grade 4a/4b). The study was conducted as a single-blind and placebo-controlled trial. With placebo, mean frequency of ventricular arrhythmias was 6238 VPB/24 h, 510 couplets/24 h, and 24 salvos/24 h. Mean left-ventricular ejection fraction was 37.6%, ranging from 18% to 58%. Therapy with barucainide (300-400 mg/day) resulted in a significant reduction of ventricular arrhythmias in 7 of 10 patients; in one patient barucainide had a clear proarrhythmic effect. Over all, left-ventricular ejection fraction (37.6% +/- 12% with placebo vs 36.1% +/- 11% with barucainide) was not significantly altered. In one patient, however, it was depressed by more than 5%; one patient complained of shortness of breath during exercise. None of the four patients with an initial ejection fraction below 35% showed a drop of ejection fraction during therapy with barucainide. The only main adverse effect was a small, but significant (p less than 0.005) rise of serum-kreatinine (1.13 +/- 0.26 vs 1.39 +/- 0.38 mg%) in all patients. We conclude that barucainide has a good antiarrhythmic effect and is usually well tolerated in patients with markedly depressed left-ventricular function. The mechanism causing the rise of serum-kreatinin, however, needs to be clarified in further studies.
我们研究了一种处于试验阶段的1b类抗心律失常药物巴鲁卡胺对10例频发复杂性室性心律失常（洛恩分级4a/4b级）患者室性心律失常及左心室射血分数的影响。该研究以单盲、安慰剂对照试验的方式进行。使用安慰剂时，室性心律失常的平均频率为每24小时6238次室性早搏、每24小时510次成对室性早搏和每24小时24次连发室性早搏。左心室平均射血分数为37.6%，范围在18%至58%之间。使用巴鲁卡胺（300 - 400毫克/天）治疗后，10例患者中有7例室性心律失常显著减少；1例患者使用巴鲁卡胺后有明确的促心律失常作用。总体而言，左心室射血分数（安慰剂组为37.6%±12%，巴鲁卡胺组为36.1%±11%）无显著变化。然而，有1例患者的射血分数下降超过5%；1例患者在运动时出现气短症状。4例初始射血分数低于35%的患者在使用巴鲁卡胺治疗期间均未出现射血分数下降。唯一的主要不良反应是所有患者血清肌酐有小幅但显著（p＜0.005）升高（从1.13±0.26毫克%升至1.39±0.38毫克%）。我们得出结论，巴鲁卡胺具有良好的抗心律失常作用，对于左心室功能明显受损的患者通常耐受性良好。然而，血清肌酐升高的机制需要在进一步研究中阐明。
