Seals A A, Haider R, Leon C, Francis M, Young J B, Roberts R, Pratt C M
Circulation. 1987 Apr;75(4):800-8. doi: 10.1161/01.cir.75.4.800.
This was a prospective single-blind, placebo-controlled study of cibenzoline in 21 patients with five or more runs of nonsustained ventricular tachycardia (VT) and left ventricular dysfunction (mean left ventricular ejection fraction 36 +/- 24%). Ambulatory electrocardiographic monitoring revealed a baseline of 616 +/- 431 runs of VT/day on placebo. Of the 18 patients tolerating the drug, 14 (77%) patients initially had a 75% or greater reduction in VT (177 +/- 164 runs of VT/day, p less than .05). A repeat ambulatory electrocardiogram documented long-term suppression of VT in 13 of 14 patients at 1 month (2.1 +/- 1.3 runs VT/day, p less than .01), in 10 of 14 patients at 3 months (2.5 +/- 1.9 runs VT/day, p less than .01), and in nine of 14 patients at 6 months (1.5 +/- 0.8 runs VT/day, p less than .01). Aggravation of arrhythmia or drug failure was seen in four of 18 (22%) patients (new onset of sudden cardiac death, two patients; sustained VT, two patients). Hemodynamic measurements were obtained with the use of right heart catheterization in patients at rest and exercising during the placebo phase and after 60 hr of oral cibenzoline. Group hemodynamic variables, both measured and derived, showed no detrimental effect of cibenzoline. However, in three of 21 patients (mean ejection fraction 21%), cibenzoline was discontinued due to severe depression of left ventricular function. Caution is recommended in the use of cibenzoline in patients with left ventricular ejection fractions of less than 25%.
这是一项前瞻性单盲、安慰剂对照研究,纳入了21例有5次或更多次非持续性室性心动过速(VT)且伴有左心室功能不全(平均左心室射血分数36±24%)的患者,给予其西苯唑啉治疗。动态心电图监测显示,安慰剂治疗期VT的基线水平为每天616±431次。在18例耐受该药的患者中,14例(77%)患者最初VT减少了75%或更多(每天177±164次VT,p<0.05)。重复动态心电图显示,14例患者中有13例在1个月时VT得到长期抑制(每天2.1±1.3次VT,p<0.01),14例中有10例在3个月时得到抑制(每天2.5±1.9次VT,p<0.01),14例中有9例在6个月时得到抑制(每天1.5±0.8次VT,p<0.01)。18例患者中有4例(22%)出现心律失常加重或药物治疗失败(2例新发心源性猝死;2例持续性VT)。在安慰剂治疗期以及口服西苯唑啉60小时后,对患者静息和运动时进行右心导管检查以获取血流动力学测量值。测量和推导得到的组血流动力学变量均显示西苯唑啉无有害作用。然而,21例患者中有3例(平均射血分数21%)因左心室功能严重抑制而停用西苯唑啉。对于左心室射血分数低于25%的患者,建议谨慎使用西苯唑啉。