目的 觀察榮心丸治療兒童病毒性心肌炎（氣陰兩虛或兼心脈瘀阻證）的有效性以及臨床應(yīng)用的安全性。方法 采用隨機(jī)、雙盲雙模擬法試驗(yàn)，從6家中心選擇兒童病毒性心肌炎（氣陰兩虛或兼心脈瘀阻證）患者280例，按3∶1比例分為試驗(yàn)組210例、對(duì)照組70例。試驗(yàn)組口服榮心丸每次4.5~9 g，3次/d；對(duì)照組口服輔酶Q10膠囊每次10~20 mg，2次/d。療程均28 d。觀察治療前后心肌炎癥狀積分和、心電圖、超聲心動(dòng)圖、心肌酶，以及中醫(yī)證候療效、疾病療效的改善情況。結(jié)果 療后28 d的FAS（PPS）分析結(jié)果顯示，試驗(yàn)組、對(duì)照組的心肌炎癥狀積分和下降均值分別為5.975（6.000）、4.721（4.788），證候療效的總有效率分別為91.62%（90.59%）、70.59%（71.21%），疾病療效的總有效率分別為90.14%（92.08%）、72.06%（72.73%），試驗(yàn)組高于對(duì)照組，組間差異有統(tǒng)計(jì)學(xué)意義（P<0.05）。研究者共報(bào)道臨床不良事件3例，經(jīng)研究者判斷，與試驗(yàn)藥物均不可能有關(guān)，均不屬于藥物不良反應(yīng)。結(jié)論 榮心丸治療兒童病毒性心肌炎（氣陰兩虛或兼心脈瘀阻證）療效優(yōu)于輔酶Q10，并且未提示更高臨床應(yīng)用風(fēng)險(xiǎn)。

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.

上海市科學(xué)技術(shù)委員會(huì)資助課題（13DZ1970300）