摘要
目的研究盐酸关附甲素终止阵发性室上性心动过速（PSVT）的疗效、作用机制及不良事件。方法随机开放对照多中心试验。入选标准为18-70岁，体重45-80kg的自发或经食管起搏心房诱发的PSVT患者，持续15min以上，心室率〉120次／min患者。排除标准为病态窦房结综合征、房室阻滞或室内阻滞，停服影响心脏电生理的药物不足5个半衰期等。采用3：1随机静脉注射观察药盐酸关附甲素或对照药普罗帕酮。盐酸关附甲素按4mg／kg的剂量，普罗帕酮按1mg／kg的剂量于5min静脉注射完毕。转复为窦性心律则终止注射，若第一剂治疗无效补充注射第二剂。部分患者用食管导联心电监测。结果入选盐酸关附甲素组137例，普罗帕酮组46例。用药前两组间患者人口统计学资料及基线特征相似。盐酸关附甲素组与普罗帕酮组转复率分别为68．6％（94／137）和93．5％（43／46），P=0．0009。在房室反复型室上性心动过速，盐酸关附甲素转复率为67．9％，而房室结折返型为75．0％。食管导联监测发现两种类型室上性心动过速，转复中止部位均包括交界区前传和旁路逆传以及慢径前传和快径逆传。用药两组总体不良事件发生率相近，盐酸关附甲素组为12例（8．8％），严重程度均为轻度，无严重不良事件。结论本研究所采用的盐酸关附甲素的剂量可以有效转复阵发性室上性心动过速，在目前所使用的剂量下与普罗帕酮相比疗效稍差，无严重不良反应。
Objective The clinical effect and mechanism of intravenous acehytisine hydrochloride were in-vestigated in patients with paroxysmal supraventricular tachycardia （PSVT） in an open-labeled, randomized study. Methods Patients of 18-70 years old presenting with either spontaneous or induced sustained supraventricular tachycardia lasting at least 15 mins were recruited. Exclusion criteria included sick sinus syndrome,atrial ventricular block or intraventricular block ,less than 5 half-lives from previous anti-arrhythmic agents ,etc. Eligible patients were randomly assigned to receive acehytisine hydrochloride or propafenone intravenously according to aproportion of 3 ： 1 in a open-labeled manner. The dosing regime of acehytisine Hydrochloride was 4 mg/kg IV in 5 min followed by the same dose if no response occurred. Propafenone was given lmg/kg IV with the same protocol. Conversion times ,vital signs,electrocardiograms and in selected cases esophagus-lead electrocardiograms were documented before and after drug administration. Results A total of 183 patients were randomized to acehytisine hydrochloride（n = 137）group or propafenone（n = 46）group. The demographic characteristics and clinical findings were comparable between the groups. In the acehytisine hydrochloride group, 68. 6% （94/137） episodes of PSVT were terminated without recur- rence. In the propafenone group,93. 5% （43/46）were terminated（P =0. 0009）. According to esophagus-lead menitoring,acehytisine hydrochloride both terminated the tachycardia in the anterior-grade and posterior-grade directions. 12/137（8. 8% ）patients in the acehytisine hydrochloride group and 3/46 （6. 5% ,P = 0. 7644）in the propafenone group experienced mild transient side effects, which disappeared soon without intervention. Conclusions With the dosage used in the present study,a seemingly poor efficacy of intravenous acehytisine hydrochloride compared with propafenone in the acute termination of PSVT is observed without concurrent serious side-effects.
出处
《中华心律失常学杂志》
2007年第4期280-282,共3页
Chinese Journal of Cardiac Arrhythmias
基金
基金项目：国家科技部863计划项目（2002AA223102）.
