Abstract: Objective　To evaluate the efficacy，safety and tolerability of recombinanat human interferon α2b（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.

Key words: children with acute upper respiratory tract infection, rhIFNα2b spray（P.putida）, local application, viral , infection

摘要： 目的　评价重组人干扰素（rhIFN）α2b喷雾剂（假单胞菌）治疗儿童非流感急性上呼吸道感染的临床疗效、安全性及耐受性。方法　2019年1月至7月，由首都医科大学附属北京儿童医院和中国医科大学附属盛京医院牵头，在全国开展rhIFNα2b喷雾剂治疗儿童急性上呼吸道感染的多中心、随机对照临床研究。共纳入符合入选标准的急性上呼吸道感染患儿575例，分为rhIFNα2b喷雾剂组291例和利巴韦林组284例，分别给予rhIFNα2b喷雾剂和利巴韦林气雾剂治疗，并对药物疗效和安全性进行评定。结果　完成本研究的符合方案集（per-protocol set，PPS）病例共448例，其中rhIFNα2b喷雾剂组233例，利巴韦林组215例。主要疗效指标完全退热时间rhIFNα2b喷雾剂组为25.0 h，利巴韦林组为33.6 h，差异有统计学意义（P＝0.0001）；上呼吸道感染症状缓解时间比较，rhIFNα2b喷雾剂组在鼻塞、流涕、咽喉痛、咳嗽等症状消退时间均早于利巴韦林组，差异有统计学意义（均P＜0.05），rhIFNα2b喷雾剂组和利巴韦林组的痊愈时间分为92 h、112 h，rhIFNα2b喷雾剂组优于利巴韦林组，差异有统计学意义（P＜0.0001）。两组不良反应发生率差异无统计学意义（P＝0.2461）。结论　rhIFNα2b喷雾剂用于儿童病毒性急性上呼吸道感染治疗起效快、疗效显著，尤其有助于快速缓解发热及减轻鼻咽部症状，缩短病程，且安全和耐受性良好，适合在临床中推广使用。

关键词: 儿童急性上呼吸道感染, 重组人干扰素α2b喷雾剂（假单胞菌）, 局部用药, 病毒, 感染