The 2nd Department of Coronary Artery Disease, Institute of Cardiology, Spartanska 1, 02-637 Warsaw, Poland.
Europace. 2017 Oct 1;19(10):1637-1642. doi: 10.1093/europace/euw384.
The aim of the study was to assess the clinical efficacy of antazoline, a first-generation anti-histaminic agent, in the rapid conversion of paroxysmal non-valvular atrial fibrillation (AF) to sinus rhythm in patients without heart failure.
This study was a single center, randomized, double blind, placebo-controlled, superiority clinical trial. We enrolled patients with an AF episode lasting less than 43 h, in stable cardiopulmonary condition. Subjects who fulfilled the selection criteria were randomly assigned to receive intravenously either a placebo or up to 250 mg of antazoline. The primary end point was the conversion of AF to sinus rhythm confirmed in electrocardiogram (ECG). We enrolled 74 patients: 36 (48.6%) in the antazoline group and 38 (51.4%) in the control group. The mean age was 68 ± 12 years (range 31-90 years), 39 (53.3%) patients were male. The successful conversion of AF to sinus rhythm during the observation period was achieved in 26 (72.2%) patients treated with antazoline and 4 (10.5%) in the control group: RR 6.86 (95% CI: 2.66-17.72, P < 0.0001). Median time to conversion was 16.0 min in antazoline and 72.5 min in the control group (P = 0.0246). There were no cases of atrial tachycardia/flutter in the antazoline group.
Intravenous antazoline was effective and safe in the rapid conversion of non-valvular paroxysmal atrial fibrillation to sinus rhythm in patients without heart failure. Clinical Trial Registration number: NCT01527279.
本研究旨在评估第一代抗组胺药苯海拉明在无心力衰竭的阵发性非瓣膜性心房颤动（AF）患者中快速转为窦性心律的临床疗效。
这是一项单中心、随机、双盲、安慰剂对照的优效性临床试验。我们纳入了 AF 发作持续时间少于 43 小时且心肺状况稳定的患者。符合入选标准的患者被随机分为静脉注射安慰剂或高达 250mg 的苯海拉明。主要终点是心电图（ECG）证实的 AF 转为窦性心律。我们共纳入 74 例患者：苯海拉明组 36 例（48.6%），对照组 38 例（51.4%）。平均年龄为 68±12 岁（范围 31-90 岁），39 例（53.3%）为男性。在观察期间，26 例（72.2%）接受苯海拉明治疗的患者成功转为窦性心律，而对照组中仅有 4 例（10.5%）：RR 6.86（95%CI：2.66-17.72，P<0.0001）。苯海拉明组转为窦性心律的中位时间为 16.0 分钟，对照组为 72.5 分钟（P=0.0246）。苯海拉明组无房性心动过速/颤动病例。
静脉注射苯海拉明可有效、安全地使无心力衰竭的非瓣膜性阵发性心房颤动快速转为窦性心律。临床试验注册号：NCT01527279。
