盐酸关附甲素注射液治疗室性心律失常的多中心随机双盲试验

目的 评价国家一类新药盐酸关附甲素注射液（GFA）治疗室性心律失常的疗效和安全性.方法 随机双盲多中心阳性药对照试验,由全国8家临床药理基地完成.入选不伴严重器质性心脏病的频发室性早搏（室早）患者,室早平均每小时≥150次（用Holter评价）,伴或不伴短阵室性心动过速.采用1∶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6 h.用药前一天和用药日均进行24 h Holter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201例患者,用药前两组在病史、体检、实验室检查、室早数量、短阵室性心动过速数量差异均无统计学意义.GFA组与盐酸普罗帕酮组室早减少百分数和总有效率差异无统计学意义.室早减少百分数分层分析,GFA有优于盐酸普罗帕酮的趋势,达到统计学差异临界值（P=0.0609）.GFA抑制室早的程度以及控制室早的作用出现时间与盐酸普罗帕酮差异无统计学意义.GFA静脉应用耐受性较好,发生不良事件的严重程度明显轻于盐酸普罗帕酮,差异有统计学意义.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,发生的不良事件较盐酸普罗帕酮为轻,今后应对其抗心律失常作用进行进一步的研究.

Effect of Guanfu Base A in patients with ventricular arrhythmias

OBJECTIVE: To investigate the effect and safety of intravenous Guanfu Base A hydrochloride (GFA) in the treatment of ventricular arrhythmias. 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 in drug-free holter monitoring were recruited in this double blind randomized active-controlled study. Eligible patients were randomly assigned to receive GFA or propafenone intravenously by a proportion of 1:1 in a double-blind manner. Intravenous bolus of the study medicine was given, followed by maintenance infusion for 6 hours. 24 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 201 patients came from eight centres were randomized to GFA or propafenone group. The demographic characteristics, the extent of ventricular arrhythmias and baseline clinical findings were comparable between the two groups. There were no significant differences in the percentage of reducing premature ventricular contractions and the accumulated efficacy between two groups. GFA had tendency to be more effective than propafenone in reducing the number of ventricular ectopy (P = 0.0609). There were no significant differences in the onset of action after drug administration between two drugs. The tolerance of GFA was better than propafenone. The adverse events in GFA group were less severe than those in propafenone group. CONCLUSIONS: Intravenous GFA in controlling the premature ventricular contraction has comparable effect to IV propafenone. Tolerance of GFA was better than propafenone.