参松养心胶囊治疗阵发性心房颤动的多中心临床研究

Evaluation of shensongyangxin capsules in the treatment of paroxysmal atrial fibrillation： a randomized, double-blind and controlled multicenter trial

目的 评价复方中药参松养心胶囊治疗阵发性心房颤动（房颤）的有效性及安全性。方法自2007年8月至2008年7月，采用随机、双盲、双模拟、平行对照、多中心临床试验方法，在11家临床医院的门诊患者，选择年龄18～75岁，男女不限，阵发性房颤发作频率≥2次／月的受试者，按1：1：1比例随机数字分组分为3组：（1）参松养心组：服用参松养心胶囊4粒＋普罗帕酮模拟剂150mg，1日3次；（2）普罗帕组：服用普罗帕酮片150mg＋参松养心胶囊模拟剂4粒，1日3次；（3）参松养心＋普罗帕酮组：服用参松养心胶囊4粒＋普罗帕酮片150mg，1日3次。门诊随访10：／月，疗程为8周。结果共纳入阵发性房颤患者349例，其中参松养心组和参松养心＋普罗帕酮组各117例，普罗帕酮组115例；3组患者的基线房颤发作频率、24h动态心电图、心脏超声及症状等指标差异均无统计学意义（均P〉0．05）。经8周治疗，房颤发作频率（由平均6次／月降至2次／月，P〈0．01）、房颤发作例数[参松养心组从46（43．8％）降至22（20．8％）例，普罗帕酮组从43（43．4％）例降至25（25．3％）例，参松养心＋普罗帕酮组从40（40．6％）降至31（29．2％）例，P〈0．01]、房颤发作持续时间（参松养心组，普罗帕酮组从4h降至0．5h，参松养心＋普罗帕酮组从4．25h降至0．5h，P〈0．01）均显著下降，房颤总体疗效参松养心组62．3％，普罗帕酮组58．6％，参松养心＋普罗帕酮组58．5％。参松养心组发生不良反应2例（1．8％），普罗帕酮组和参松养心＋普罗帕酮组分别发生不良反应9例（8．2％）和6例（5．4％）。结论参松养心胶囊与普罗帕酮治疗阵发性房颤疗效相当；参松养心胶囊具有良好的安全性。

Objective To evaluate the efficacy and safety of Chinese medicinal shensongyangxin capsules in the treatment of paroxysmal atrial fibrillation. Methods From August 2007 to July 2008, Beijing Chaoyang Hospital coducted a muhicenter study, select the eleven hospital＇s outpatient subjects, aged 18 to 75 years old, male or female, paroxysmal atrial fibrillation （at least one electrocardiogram diagnosis） seizure frequency ≥ ：2 times / month, according to the ratio 1： 1： 1, subjects were randomly divided into three groups： a. shensongyangxin group, taking shensongyangxin capsule 4 ＋ propafenone analogues 150 mg, 3 times a day; b. propafenone group, taking propafenone tablets 150 mg ＋ 4 shensongyangxin analogues, 3 times a day; shensongyangxin capsule ＋ propafenone group, taking shensongyangxin capsule 4 ＋ propafenone 150 mg, 3 times a day. The treatment course is 8 weeks, with 3 times of follow-up. Results Total of 349 cases of paroxysmal atrial fibrillation, which 117 cases in shensongyangxin group, 115 cases in propafenone group; ll7cases in shensongyangxin ＋ propafenone group. The baseline data analysis showed that there were no significantly difference （P 〉 0. 05 ） among the three groups of atrial fibrillation seizure frequency, vital signs, general condition, medical history, 24-hour ambulatory ECG, 12-lead normal electrocardiogram, cardiac ultrasound and symptoms. The comparioson before and after （8 weeks ） treatment showed that the frequency （from 6 times/m to 2 times/m in each group, P 〈 0. 01 ）, number of cases [ from 46 （43.3 % ） to 22 （20. 8 % ）, 43 （43.4%） to 25 （25.3 % ）, and 40（40. 6% ） to 31 （29. 2% ）, respectively P 〈 0. 01 ] and dutaion time of attack of atrial fibrillation （ from 4 h to 0. 5 h,4 h to 0. 5 h, and 4. 25 h to 0. 5 h, respectively P 〈 0. 01 ） all decreased in three groups. No significant difference among the three groups comparing the overall effect （62. 3% ,58.6% , and 58.5% , respectively, P 〉 0. 05 ） , while the efficiacy of TCM symptoms in shensongyangxin group （ 80. 2% ） was better than that of propafenone group（67. 7% ） （ P 〈0. 05）. Safety evaluation showed that adverse reaction rate was 1.8% in shensongyangxin group, and 8.2% and 5.4% in propafenone group and shensongyangxin ＋ propafenone group. Conclusion Shensongyangxin capsules and propafenone have comparable effieacies in the treatment of PAF. The efficacy of TCM symptoms is better than propafenone. Shensongyangxin capsules have an excellent profile of safety.