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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6h。用药前一天和用药日均进行24hHolter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。
Objective To evaluate the efficacy and safety of a national class of new drug, Guan Fu Guan Su A Injection (GFA) in the treatment of ventricular arrhythmia. Methods Randomized double-blind multicenter positive drug control trial was completed by 8 clinical pharmacology bases nationwide. Patients with frequent premature ventricular contractions (premature ventricular contractions) without severe organic heart disease had an average morning ≥150 beats per hour (as assessed by Holter) with or without paroxysmal ventricular tachycardia. A 1: 1 randomized control was used with GFA or propafenone hydrochloride. The use of intravenous load and maintenance methods to maintain 6h. The day before treatment and medication day were 24hHolter and ECG monitoring efficacy evaluation. Vital signs, ECGs and adverse events were monitored. Results A total of 201 patients were enrolled in this study. Before the treatment, there was no significant difference in the history, physical examination, laboratory tests, number of ventricular premature ventricular tachycardia and short-tailed ventricular tachycardia. There was no significant difference in the percentage of early reduction and total effective rate between GFA group and propafenone hydrochloride group. The stratification analysis showed that GFA was better than propafenone hydrochloride and reached the threshold of statistical difference (P = 0.0609). There was no significant difference in the extent of GFA inhibition as well as the effect of control room as early as propafenone hydrochloride. GFA intravenous use is better tolerated, the severity of adverse events was significantly lighter than propafenone hydrochloride, the difference was statistically significant. Conclusions GFA is safe and effective in controlling ventricular arrhythmia. Its efficacy is equivalent to that of propafenone hydrochloride. The incidence of adverse events is less than that of propafenone hydrochloride, and its antiarrhythmic effect should be further studied in the future.