Wang Ai-hu, Pu Jie-lin, Qi Xiao-yong, Miao Wen-lin, Hou Zi-shan, Cong Hong-liang, Zhou Jian-zhong, Liu Xiao-fang, Li Shu-mei, Han Qing-hua, Liu Yong-Jia, Yang Xin-chun
Department of Cardiology, Capital Medical University, Beijing 100020, China.
Zhonghua Yi Xue Za Zhi. 2011 Jun 28;91(24):1677-81.
To evaluate the efficacy and safety of Chinese medicinal shensongyangxin capsules in the treatment of paroxysmal atrial fibrillation.
From August 2007 to July 2008, Beijing Chaoyang Hospital conducted a multicenter 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.
Total of 349 cases of paroxysmal atrial fibrillation, which 117 cases in shensongyangxin group, 115 cases in propafenone group; 117 cases 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 comparison 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 duration 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 efficacy 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.
Shensongyangxin capsules and propafenone have comparable efficacies in the treatment of PAF. The efficacy of TCM symptoms is better than propafenone. Shensongyangxin capsules have an excellent profile of safety.
评价中药参松养心胶囊治疗阵发性心房颤动的有效性和安全性。
2007年8月至2008年7月，北京朝阳医院开展一项多中心研究，选取11家医院门诊符合条件的患者，年龄18至75岁，男女不限，阵发性心房颤动（至少有一次心电图诊断）发作频率≥2次/月，按照1:1:1的比例，将受试者随机分为三组：a. 参松养心组，服用参松养心胶囊4粒+普罗帕酮片150mg，每日3次；b. 普罗帕酮组，服用普罗帕酮片150mg+参松养心模拟剂4粒，每日3次；参松养心胶囊+普罗帕酮组，服用参松养心胶囊4粒+普罗帕酮150mg，每日3次。疗程为8周，随访3次。
共纳入349例阵发性心房颤动患者，其中参松养心组117例，普罗帕酮组115例；参松养心+普罗帕酮组117例。基线数据分析显示，三组在心房颤动发作频率、生命体征、一般状况、病史、24小时动态心电图、12导联正常心电图、心脏超声及症状等方面差异均无统计学意义（P>0.05）。治疗前后（8周）比较显示，三组心房颤动发作频率（每组均从6次/月降至2次/月，P<0.01）、发作例数[分别从46例（43.3%）降至22例（20.8%）、43例（43.4%）降至25例（25.3%）、40例（40.6%）降至31例（29.2%），P<0.01]及发作持续时间（分别从4小时降至0.5小时、4小时降至0.5小时、4.25小时降至0.5小时，P<0.01）均降低。三组总体疗效比较差异无统计学意义（分别为62.3%、58.6%、58.5%，P>0.05），而参松养心组中医症状疗效（80.2%）优于普罗帕酮组（67.7%）（P<0.05）。安全性评价显示，参松养心组不良反应发生率为1.8%，普罗帕酮组和参松养心+普罗帕酮组分别为8.2%和5.4%。
参松养心胶囊与普罗帕酮治疗阵发性心房颤动疗效相当。参松养心胶囊中医症状疗效优于普罗帕酮。参松养心胶囊安全性良好。
