安福尔胶囊治疗心络瘀阻、心神不宁型室性早搏的临床观察

Effect of Anfuer Capsule on Ventricular Premature Beats

目的观察安福尔胶囊治疗心络瘀阻、心神不宁型室性早搏的临床疗效和安全性。方法采用随机单盲平行对照的临床试验。安福尔组(治疗组)30例,口服安福尔胶囊,每次3粒,每日3次;两个对照组分别为安福尔联用普罗帕酮(心律平)组(对照1组)30例和心律平组(对照2组)30例,治疗4周。采用安全性指标与疗效性指标观察。结果3组24h动态心电图疗效比较,安福尔组与对照组差异无统计学意义(P>0.05)。中医证候疗效有效率和心率变异SDNN、SDANN、SDNNIndex、PNN50变化值比较,治疗组与两个对照组比较差异均有统计学意义P<0.05或P<0.01)。结论安福尔胶囊对心络瘀阻、心神不宁型室性早搏病人安全有效,能明显改善中医证候。

Objective To observe the clinical effect and safety of Anfuer capsule on ventricular premature beats （VPB）. Methods Patients were randomly assigned into three groups： Anfuer group （ n = 30） treated Anfuer; Control groups 1 （ n = 30） treated with Anfuer and propafenone; Control group 2 treated with propafenone. Results The clinical effect was no difference between the Anfuer group and the control groups （P〉0.05）. The clinical efficiency on ameliorating traditional Chinese medicine syndrome was better in Anfuer capsule than that in the control groups obviously （P 〈 0.01）. The SDNN,SDANN,SDNN Index and PNN50 in the three groups were different significantly （P〈0.01 or P〈0.05）. The effect in Anfuer group was superior to that in the control groups. Conclusion Anfuer capsule was effective and safe for VPB.