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 / 药物评价研究

ABSTRACT

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 31 ratio as the test group (n =21 0) 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 Q 10 capsule,and there was no indication of higher risk of clinical application.