Abstract:

Abstract： Objective To evaluate effectiveness and safety of treatment for children’s acute bronchiolitis by nebulized recombinant human interferon α 1b in a multicenter clinical study，and to recommend a reasonable clinical dosage for children. Methods With the design of a randomized, controlled, multi-center study, totally 330 children who were hospitalized from December 2012 to May 2013 for acute bronchiolitis were randomly divided into three groups. The control group had routine and symptomatic treatment. Therapy groups inhaled human recombinant interferon α1b 2 μg/kg and 4 μg/kg respectively, twice a day plus routine treatment, for 5 to 7 days. We used four-level-scoring method to evaluate disease conditions and performed pathogen detections. Results （1）The total improvement rates of low and high dose group were 92.3% and 95.0%, respectively, which were significantly higher than control group （85.3%, P<0.05）. High dose group had obviously improved primary index （wheezing, wheezing rale and three depression sign） compared with low dose group. The disappearance time of symptoms was shortened significantly （P<0.05）, and the improvement of three depression signs was obvious （P<0.01）.（2）Treatments within and after 72 h were both effective, but the total improvement rate within 72 h was better.（3）The effectiveness of interferon α1b in RSV positive children was significantly better than in RSV negative children. Effectiveness of treatment group was superior to that of control group.（4）All children did not show irritation symptoms in local respiratory tracts, and no serious adverse reactions was observed. Conclusion The treatment for acute bronchiolitis in young children by nebulized human recombinant interferon α1b is effective, which shortened the duration of symptoms, with no safety problem. The effect is better when used in the early stage.

Key words: inhalation； human recombinant interferon &alpha, 1b； acute bronchiolitis ； child

摘要：

目的 评价雾化吸入重组人干扰素α1b治疗小儿急性毛细支气管炎的安全性和疗效，为临床推荐合理的用法用量。方法 采用随机、对照、多中心的设计方法，2012年12月至2013年5月期间，将国内11家医院收集的330例细支气管炎患儿按启动顺序随机分配各中心的中心号，按病例入组的时间进行顺序随机入选分为3组。对照组采用常规对症治疗，观察组在此基础上分别加用每次剂量2 μg/kg（低剂量组）和 每次剂量4 μg/kg（高剂量组）的重组人干扰素α1b，雾化吸入，每日2次，疗程5～7 d，采用四级评分法分度评价病情，并进行病原学检测。结果 （1）低剂量组和高剂量组的总改善率分别为（92.3±4.5）%和（95.0±4.9）%，显著优于对照组［（85.3±6.4）%，P＜0.05）］，高剂量组的主要疗效指标（喘息、喘鸣音、三凹征）的改善率优于低剂量组， 症状消失时间显著缩短（P＜0.05）， 对三凹征的改善最为明显（P＜0.05）；（2）发病72 h内和发病72 h后干扰素α1b治疗均有效，发病72 h内干扰素α1b治疗的所有疗效指标的总改善率更高； （3）呼吸道合胞病毒（RSV）阳性的患儿主要疗效指标的改善率显著高于RSV阴性患儿，观察组的改善率均优于对照组； （4）所有患儿干扰素α1b治疗后均未见呼吸道局部刺激症状，无严重不良反应发生。结论 重组人干扰素α1b雾化吸入治疗小儿急性毛细支气管炎症状减轻，病程缩短，安全性良好，早期对因治疗效果更佳。

关键词: 雾化吸入, 重组人干扰素&alpha, 1b, 急性毛细支气管炎, 儿童