荣心丸治疗儿童病毒性心肌炎(气阴两虚或兼心脉瘀阻证)的多中心临床研究

目的 观察荣心丸治疗儿童病毒性心肌炎（气阴两虚或兼心脉瘀阻证）的有效性以及临床应用的安全性。方法 采用随机、双盲双模拟法试验，从6家中心选择儿童病毒性心肌炎（气阴两虚或兼心脉瘀阻证）患者280例，按3∶1比例分为试验组210例、对照组70例。试验组口服荣心丸每次4.5~9 g，3次/d；对照组口服辅酶Q10胶囊每次10~20 mg，2次/d。疗程均28 d。观察治疗前后心肌炎症状积分和、心电图、超声心动图、心肌酶，以及中医证候疗效、疾病疗效的改善情况。结果 疗后28 d的FAS（PPS）分析结果显示，试验组、对照组的心肌炎症状积分和下降均值分别为5.975（6.000）、4.721（4.788），证候疗效的总有效率分别为91.62%（90.59%）、70.59%（71.21%），疾病疗效的总有效率分别为90.14%（92.08%）、72.06%（72.73%），试验组高于对照组，组间差异有统计学意义（P<0.05）。研究者共报道临床不良事件3例，经研究者判断，与试验药物均不可能有关，均不属于药物不良反应。结论 荣心丸治疗儿童病毒性心肌炎（气阴两虚或兼心脉瘀阻证）疗效优于辅酶Q10，并且未提示更高临床应用风险。

Multi-center clinical trial of Rongxin Pills in treating viral myocarditis in children with deficiency of both qi and yin and heart meridian stasis syndrome

Objective To observe Rongxin Pills in the treatment of viral myocarditis in children (deficiency of both qi and yin and heart meridian stasis syndrome) and the effectiveness and clinical application of safety. Methods Viral myocarditis patients (280 cases, deficiency of both qi and yin and heart meridian stasis syndrome), according to 3:1 ratio as the test group (n=210) and control group (n=70). The test group took orally Rongxin pills each time 4.5~9 g, 3 times daily; the control group oral coenzyme Q10 capsule each time 10~20 mg, twice daily. The course of treatment was 28 d. The experiment was carried out with the random and double blind method. The symptoms of myocarditis, integrated and electrocardiogram, echocardiography, myocardial enzymes, as well as the efficacy of traditional Chinese medicine and improvement of the effect of the disease were observed. Results The results of FAS (PPS) analysis showed that 28 d after treatment, the symptom score and mean of experimental group and control group were 5.975 (6.000) and 4.721 (4.788). The syndromes of the total effective rates were 91.62% (90.59%) and 70.59% (71.21%), curative effect the total effective rates were 90.14% (92.08%) and 72.06% (72.73%). The total effective rate of experimental group was higher than that of the control group, the difference was statistically significant. In this experiment, three cases of clinical adverse events were reported, which were not related to the experimental drug. It also not belongs to adverse drug reactions. Conclusion Rongxin Pill in the treatment of viral myocarditis in children (deficiency of both qi and yin and heart meridian stasis syndrome) is more effective than coenzyme Q10 capsule, and there was no indication of higher risk of clinical application.