病毒性肺炎患儿雾化吸入重组人干扰素α1b的耐受性及安全性研究

Tolerance and Safety Study of Aerosol Inhalation of Recombinant Human Interferon α1b in Children with Viral Pneumonia

目的:研究病毒性肺炎患儿雾化吸入重组人干扰素α1b的耐受性及安全性。方法:依据其临床前安全资料确定初始剂量及最大剂量,随机选择病毒性肺炎恢复期患儿24例,分别采用单剂量、连续多剂量雾化吸入的方法给药,动态观测用药后的临床症状、各项监测结果并严密观察、记录试验期间发生的不良反应事件。结果:各组患儿给药后生命体征、各项实验室检查指标、尿及大便常规检查结果均在正常范围内,未见有临床意义的改变。结论:病毒性肺炎恢复期患儿雾化吸入重组人干扰素α1b在0.3～2.0μg.kg-1范围内,耐受性良好,无明显毒副作用,该剂量可作为Ⅱ期临床研究剂量。

OBJECTIVE:To study the tolerance and safety of aerosol inhalation of recombinant human interferon α1b(IFN-α1b) in children with viral pneumonia.METHODS:The initial dose and maximum dose of drug were confirmed according to clinical information.24 children with viral pneumonia were randomly selected and treated with single aerosol inhalation of IFN-α1b and multiple aerosol inhalation of IFN-α1b.Clinical symptom and monitoring results were observed dynamically and adverse drug reactions of experiment period we...