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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。
Objective To observe the effectiveness of Rongxin pills in the treatment of children with viral myocarditis (Qi-Yin Deficiency or Cardiac Stasis Syndrome) and the safety of clinical application. Methods A randomized, double-blind, double-dummy trial was conducted. Two hundred and eighty children with viral myocarditis (Qi-Yin Deficiency or Heart-Stasis Syndrome) were selected from 6 centers. 210 patients were divided into experimental group Group of 70 cases. The trial group was given Rongxin Pill orally 4.5 ~ 9 g, 3 times / d, while the control group was orally administered with CoQ10 10 ~ 20 mg twice daily. Treatment were 28 d. Observed before and after treatment of myocarditis symptom score and, electrocardiogram, echocardiography, myocardial enzymes, as well as the efficacy of traditional Chinese medicine syndrome, the improvement of disease efficacy. Results The results of FAS (PPS) analysis on the 28th day after treatment showed that the mean and the mean scores of symptoms of myocarditis in the experimental group and the control group were 5.975 (6.000) and 4.721 (4.788), respectively. The total effective rates of syndromes were 91.62% 90.59%) and 70.59% (71.21%) respectively. The total effective rate of the curative effect of the disease was 90.14% (92.08%) and 72.06% (72.73%), respectively. The experimental group was higher than the control group 0.05). The researchers reported a total of 3 cases of clinical adverse events, the researchers judged, and the test drugs are impossible, are not part of the adverse drug reactions. Conclusion Rongxin pills in children with viral myocarditis (Qi and Yin Deficiency or Heart Failure Syndrome) efficacy is better than coenzyme Q10, and did not prompt a higher risk of clinical application.