盐酸关附甲素与普罗帕酮对比终止阵发性室上性心动过速的随机双盲多中心试验

Efficacy of intravenous Acehytisine Hydrochloride versus propafenone on terminating paroxysmal supraventricular tachycardia:a double-blinded,randomized multi-center study

目的比较盐酸关附甲素(AHH)与普罗帕酮注射液终止阵发性室上性心动过速(PSVT)的疗效及不良事件发生率。方法随机双盲对照试验。入选自发或经食管调搏心房诱发的PSVT 患者,采用1:1随机静脉注射观察药 AHH 或对照药普罗帕酮;AHH 剂量为4 mg/kg,普罗帕酮为1 mg/kg。若转复为窦性心律,随时终止注射,无效则补充第二剂。记录是否转复以及转复前后参数。结果入选 AHH 组101例,普罗帕酮组100例。用药前两组间患者人口统计学资料及基线特征相似。AHH 组在40min 内转复为窦性心律的患者为72例(71.3%),普罗帕酮组为73例(73.0%),P=0.6368。AHH 组平均转复时间为(9.62±8.39)min,普罗帕酮组为(10.61±9.47)min,P=0.5035。转复后各参数如自然窦房结恢复时间等两组差异无统计学意义。AHH 组出现不良事件的患者为11例(10.9%),普罗帕酮组为18例(18.0%),P=0.1653。AHH 组最常见的不良事件为口唇、舌、手发麻。结论在研究所采用的剂量下,AHH 终止 PSVT 安全有效,其疗效和不良事件的发生率与普罗帕酮相当。

Objective In this double-blinded, randomized, parallel study, we investigated the clinical efficacy of intravenous Acehytisine Hydrochloride （AHH） and propafenone on terminating paroxysmal supraventricular tachycardia （ PSVT）. Methods Patients （ 18 - 70 years old ） with either spontaneous or induced sustained supraventricular tachycardia lasted at least 15 rain were recruited in this study. Exclusion criteria included sick sinus syndrome, atrial ventricular block or intraventricular block, etc. Eligible patients were randomly assigned to receive intravenously AHH （ n = 101 ） or propafenone （ n = 100） according to a proportion of 1：1 in a double-blinded manner. AHH （4 mg/kg, iv. ） or propafenone （PRO, 1 mg/kg,iv. ） was administered in 5 rain followed by the same dose if no response was observed. Conversion times, vital signs, electrocardiograms were documented before and after drug administration. Results Except for age, the demographic characteristics and clinical features were comparable between the two groups. Efficacy on PSVT termination was comparable between AHH （72/101, 71.3% ） and PRO group （73/100, 73.0%, P = 0. 6368）. The average time from drug administration to conversion was also similar [ AHH： （9. 62± 8.39 ） rain vs. PRO ： （ 10. 61 ± 9. 47 ） min, P = 0. 5035 ]. In the AHH group, 59/72 episodes of PSVT were terminated by the first dose, and 66/72 were terminated prematurely. The average AHH dose in the 72 converted patients was （ 273. 7 ± 111.2 ） rag. In the PRO group, 54/73 episodes of PSVT were terminated by the first dose. The electrocardiographic parameters, such as sinus recovery time, longest PP and RR interval, PR interval, QRS interval, QT interval after conversion were similar between the two groups. Transient adverse events were reported in 11/101 （10. 9% ） patients in the AHH group and in 18/100 （ 18.0%, ） in the PRO group （ P = 0. 1653 ）. Conclusion With the dosage used in the present study, the efficacy on terminating PSVT was comparable between AHH and PRO.