目的 观察荣心丸治疗病毒性心肌炎(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、双盲双模拟法进行试验。选择病毒性心肌炎(气阴两虚或兼心脉瘀阻证)患者160例,按3∶1比例分为试验组和对照组,试验组口服荣心丸每次9 g,对照组口服芪冬颐心颗粒每次5 g,均3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试验组、对照组的心肌炎症状积分和下降的均值分别为6.106、5.026,证候疗效的总有效率分别为92.04%、71.05%,疾病疗效的总有效率分别为92.04%、71.05%,试验组高于对照组,组间差异有统计学意义。研究者未报告临床不良事件与不良反应。结论 荣心丸治疗病毒性心肌炎(气阴两虚或兼心脉瘀阻证)疗效优于上市药物芪冬颐心颗粒,并且未提示更高临床应用风险。
Objective To observe Rongxin Pills in the treatment of viral myocarditis (deficiency of both qi and yin and heart meridian stasis syndrome) and the effectiveness and clinical application of safety. Methods Viral myocarditis patients (160 cases, deficiency of both qi and yin and heart meridian stasis syndrome), divided into experimental group and control group according to ratio of 3:1, the patients in experimental group received Rongxin Pills 9 g each time, and the patients in control group were given Qidong Yixin Granules 5 g each time, three times daily, treatment for 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 After 28 d of treatment, the symptom score and mean of experimental group and control group were 6.106 and 5.026. The syndromes of the total effective rates were 92.04% and 71.05%, curative effect the total effective rates were 92.04% and 71.05%. The total effective rate of experimental group was higher than that of the control group, the difference was statistically significant. In this experiment, the researchers did not report the clinical adverse events and adverse reactions. Conclusion Rongxin Pill in the treatment of viral myocarditis (deficiency of both qi and yin and heart meridian stasis syndrome) is more effective than listed drug Qidong Yixin Granule, and there was no indication of higher risk of clinical application.