目的 觀察榮心丸治療病毒性心肌炎(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、雙盲雙模擬法進(jìn)行試驗。選擇病毒性心肌炎(氣陰兩虛或兼心脈瘀阻證)患者160例,按3∶1比例分為試驗組和對照組,試驗組口服榮心丸每次9 g,對照組口服芪冬頤心顆粒每次5 g,均3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試驗組、對照組的心肌炎癥狀積分和下降的均值分別為6.106、5.026,證候療效的總有效率分別為92.04%、71.05%,疾病療效的總有效率分別為92.04%、71.05%,試驗組高于對照組,組間差異有統(tǒng)計學(xué)意義。研究者未報告臨床不良事件與不良反應(yīng)。結(jié)論 榮心丸治療病毒性心肌炎(氣陰兩虛或兼心脈瘀阻證)療效優(yōu)于上市藥物芪冬頤心顆粒,并且未提示更高臨床應(yīng)用風(fēng)險。

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.

上海市科學(xué)技術(shù)委員會資助課題(13DZ1970300)