A multicenter,randomised,controlled clinical study on efficacy and safety of recombinant human interferon α 2b spray (P.putida) in treatment of acute upper respiratory tract infection in children / 中国实用儿科杂志

ABSTRACT

OBJECTIVE: To evaluate the efficacy,safety and tolerability of recombinanat human interferon α2 b(rhIFNα2b)spray in treatment of acute upper respiratory tract infection(except the flu)in children. METHODS: In total,575 children who met the inclusion criteria were enrolled from January,2019 to July,2019. They were divided into rhIFNα2b spray group(291 cases)and ribavirin group(284 cases). The children in rhIFNα2b spray group were given the rhIFNα2b spray(P.putida),and those in ribavirin groups were treated with the ribavirin spray. The curative effect and safety between the two groups were compared. RESULTS: The per-protocol set(PPS) comprised 448 patients(233 in the rhIFNα2b spray group,215 in the ribavirin group). The primary efficacy endpoint was antipyretic time which in rhIFNα2b spray group(25.0 h)was significantly shorter than that in the ribavirin group(33.6 h)(P=0.0001). In the comparison of symptomatic relief time,the relief time of nasal congestion,runny nose,sore throat and cough in rhIFNα2b spray group was shorter than that in ribavirin group(P<0.05). The recovery time in the rhIFNα2b spray group was 92 h,which showed significant decrease compared with the ribavirin group(112 h)(P<0.0001). The incidence of adverse events had no statistical differences between the two groups(P=0.2461). CONCLUSION: The rhIFNα2b spray treatment for acute upper respiratory tract infection in children is proved to be significantly effective;particularly,it can evidently relieve fever symptoms and promote the disappearance of nasal and pharyngeal symptoms. It has good safety and tolerability,so the rhIFNα2b spray is worthy to be promoted in clinical application.