摘要
目的评价国家一类新药盐酸关附甲素(GFA)注射液治疗室性心律失常的疗效和安全性。进一步评价较长时间用药的疗效及安全性。方法随机开放多中心阳性药对照试验,由全国5个中心完成。入选不伴严重器质性心脏病的频发室性期前收缩(用动态心电图评价)病人,室性期前收缩平均每小时≥150次,伴或不伴短阵室性心动过速。采用3∶1随机对照使用GFA或盐酸普罗帕酮。采用静脉负荷加维持量的方法维持6h。GFA组6h取得疗效者延长用药至24h。用药前一天和用药日均进行24h动态心电图及心电监测进行疗效评价。监测生命体征、心电图及观察不良事件。结果共入选200例病人,用药前二组患者基线资料相匹配。减少室性期前收缩的疗效有高于盐酸普罗帕酮(分别为66.9%;54.5%)的趋势。总有效率GFA组与盐酸普罗帕酮组无统计学差异。GFA抑制室性期前收缩的程度以及控制室性期前收缩的作用出现时间好于及早于盐酸普罗帕酮组。GFA较长时间用药可使疗效提高,耐受性较好。结论GFA控制室性心律失常安全有效,其疗效相当于盐酸普罗帕酮,较长时间用药耐受性较好。
Objective To investigate the effect and safety of intravenous guanfu base A hydrochloride （GFA） in the treatment of ventricular arrhythmias. To evaluate the safety of GFA administration for prolonged infusion. Methods Patients without severe structural heart disease presenting with equal or more than 150 premature ventricular contractions per hour and/or non sustained ventricular tachycardia during drug-free Holter monitoring were recruited in this open-labelled randomized active-controlled study. Eligible patients were randomly assigned to receive GFA or propafenone intravenously in a 3：1 open-labelled manner. Intravenous bolus of the study medicine was given, followed by maintenance infusion for 6 hours. GFA administration was prolonged to 24 hours if it was considered effective by investigators during the first 6 hours infusion. Twenty-four hours continuous electrocardiographic recordings were performed to evaluate the efficacy. Vital signs, electrocardiograms and adverse events were documented before, during and after drug administration. Results A total of 200 patients in five centres were randomized to GFA or propafenone group. The demographic characteristics, the extent of ventricular arrhythmias and clinical findings were comparable between the two groups. GFA had tendency to be more efficacy than propafenone in reducing the number of ventricular ectopy. There were no significant differences in the accumulated efficacy between two groups. Significant differences in favor of GFA in the onset of action after drug administration and the power of efficacy between two drugs were noted. More patients showed arrhythmia control during prolonged GFA administration and the safety was still acceptable. Conclusions The efficacy of intravenous GFA in the treatment of premature ventrlcular contraction was comparable to Ⅳ propafenone. The prolonged GFA administration for 24 hours was more effective and safe.
出处
《中华心律失常学杂志》
2006年第2期130-134,共5页
Chinese Journal of Cardiac Arrhythmias
关键词
盐酸关附甲素
室性心律失常
Guanfu base A hydrochloride
Ventricular arrhythmias
