背景:儿童中频繁的室性早搏(PVC)通常被认为是良性的。症状和/或左心室功能障碍是使用抗心律失常药物(AAD)治疗的适应症。
目的:评价氟卡尼与美托洛尔在减少儿童PVCs方面的疗效。
方法:一项随机开放标签交叉试验,儿童在Holter上的PVC负担>15%;连续接受美托洛尔和氟卡尼治疗,反之亦然,至少两周的无药物间隔。在AAD开始之前和之后重复Holter测量。
结果:筛选了60例患者,可纳入19名患者。中位年龄为13.9岁(IQR5.5岁)。在开始使用氟卡尼之前,平均基线PVC负荷为21.7%(N=18,SD±14.0),在开始使用美托洛尔之前为21.2%(N=17,SD±11.5)。在混合模型分析中,氟卡尼的PVC负荷估计平均降低为10.6个百分点(95%-CI5.8-15.3),美托洛尔为2.4个百分点(95%-CI-2.7-7.5)。差异有8.2个百分点(95%-CI为0.86-15.46,P=0.031)。探索性分析显示,9/18患者接受氟卡尼治疗,1/17患者接受美托洛尔治疗,PVC负荷降低到5%以下。没有发现氟卡尼应答者和非应答者之间的区别因素;平均血浆水平没有显着差异(0.34mg/L与0.52mg/L,P=0.277)。
结论:在患有频繁PVC的儿童中,氟卡尼导致PVC负担显着降低,与美托洛尔相比.氟卡尼仅对患者亚组有效,这似乎与血浆水平无关。(荷兰审判登记号26689)。
BACKGROUND: Frequent premature ventricular contractions (PVCs) in children are usually considered benign. Symptoms and/or left ventricular dysfunction are indications for treatment with anti-arrhythmic drugs (AAD).
OBJECTIVE: To evaluate the efficacy of flecainide versus metoprolol in reducing PVCs in children.
METHODS: A randomized open label cross-over trial children with a PVC-burden of >15% on Holter; successively treated with metoprolol and flecainide or vice versa, with a drug free interval of at least two weeks. Holter measurements were repeated before and after the start of the AAD.
RESULTS: Sixty patients were screened, 19 patients could be included. Median age was 13.9 years (IQR 5.5 years). Mean baseline PVC-burden was 21.7% (N=18, SD±14.0) before the start of flecainide and 21.2% (N=17, SD±11.5) before the start of metoprolol. In a mixed model analysis the estimated mean
reduction in PVC-burden was 10.6 percentage-points (95%-CI 5.8-15.3) for flecainide and 2.4 percentage-points (95%-CI -2.7-7.5) for metoprolol, with a significant difference of 8.2 percentage-points (95%-CI of 0.86-15.46, P=0.031). Exploratory analysis revealed that 9/18 patients treated with flecainide and 1/17 patients treated with metoprolol, had a
reduction to a PVC-burden below 5%. No discriminating factors between flecainide-responders and non-responders were found; the mean plasma level was not significantly different (0.34 mg/L versus 0.52 mg/L, P=0.277).
CONCLUSIONS: In children with frequent PVCs flecainide led to a significant greater
reduction of PVC-burden, compared to metoprolol. Flecainide was effective in only a subgroup of patients, which appears to be unrelated to the plasma level. (Dutch Trial Register number 26689).