Clinical Study On The Efficacy And Safety Of Jin-Chan Oral Liquid In The Treatment Of Infants With Respiratory Syncytial Virus Pneumonia

Background:Respiratory syncytial virus(RSV) is the most common pathogen in infants with acute lower respiratory tract infection. The severe bronchiolitis and pneumonia often occur in 2-6 months’ infants after RSV infection. Its acute onset, and the progression of the disease goes rapidly. Symptoms of wheezing and shortness of breath are commom in children with RSV pneumonia. There is no specific therapy for RSV pneumonia in children.The clinical symptoms and supportive treatment is given priority to, but the treatment effect is still not ideal. Jin-Chan oral liquid is a self-made preparation of Children’s Hospital of Soochow University, with the effect of expelling wind to relieve exterior syndrome and clearing away the heat and toxin. Significant clinical effect in the treatment of children’s wind heat common cold, but its efficacy against respiratory syncytial virus has not been reported.Objective:Through a randomized, double-blind, placebo-controlled clinical study, we evaluate the effectiveness and safety of Jin-Chan oral liquid in the treatment of infants with respiratory syncytial virus pneumonia, which lay a foundation for the clinical application of the drug.Methods:The study used a randomized, double-blind, placebo-controlled clinical trial design.120 patients were planned to enroll in this clinical study,117 cases were enrolled actually, which were randomly divided into the test group(n = 59) and the control group(n= 58). The control group on the basis of regular treatment pluses placebo, while the test group pluses Jin-Chan oral liquid. The improving situation of clinical symptoms and signs in the two groups were observed, then fill in the case report form to evaluate the efficacy and safety.Result:1 A total of 126 cases were included in the trial, 9 cases were dropped out or quittedduring the period, and in the end 117 cases completed the clinical trial.2 The results showed that the general information on two groups of comparison,including sex, age, weight, duration, severity of disease, clinical signs of life on two groups of comparison, there were no statistic significance( P > 0.05).3 The mean hospitalization time, as well as the average recovery time of the main clinical symptoms and signs on two groups of comparison, statistic analysis showed that P< 0.05, clinical curative effect of the test group is better than that of the control group.4 Survival analysis of the main symptoms, include cough, sputum, tachypnea, lung rales were carried out, the test group and the control group in the onset time compared with significant difference(P<0.05).5 Safety observation indicators, two groups of patients during treatment shows no other adverse reactions, besides 3 cases with vomiting(caused by the drug slightly bitter),and 1 case with diarrhea(caused by rotavirus infection).Conclusion:Jin-Chan oral liquid can be used for infants with respiratory syncytial virus pneumonia.It is safe and economic. It is worth clinical application.