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.PDFVIP

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 1，2＊ 1 1 1 1# 孙 薇 ，杨 林 ，贾艳艳 ，乔 逸 ，文爱东 （1.第四军医大学第一附属医院药剂科，西安市 710032；兰州 军区兰州总医院药剂科，兰州市 730050） 中图分类号 R969.1；R974 文献标识码 A 文章编号 1001-0408（2011）14-1277-04 摘 要 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。 关键词 病毒性肺炎；患儿；雾化吸入；重组人干扰素α1b ；耐受性 Tolerance and Safety Study of Aerosol Inhalation of Recombinant Human Interferon α1b in Children with Viral Pneumonia SUN Wei ，YANG Lin ，JIA Yan-yan ，QIAO Yi ，WEN Ai-dong （Dept. of Pharmacy ，First Affiliated Hospital of Fourth Military Medical University ，Xi ’an 710032，China ） SUN Wei（Dept. of Pharmacy ，Lanzhou General Hospital of Lanzhou Military Command ，Lanzhou 730050，China ） ABSTRACT OBJECTIVE ：To study the tolerance and safety of aerosol inhalation of recombinant human interferon α1b （IFN-α 1b ）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 reac- tions of experiment period were observed and recorded. RESULTS ：No abnormal outcomes and values were found in vital sign ，lab- oratory index and routine urine and stool test after inhalation. No serious adverse reaction was observed in study. CONCLUSION ： It is safe and tolerable for children with viral pneumonia in recovery stage to inhale IFN-α1b at dose of 0.3～2.0 μg ·kg－1. The rec- ommended dosage of drug can be adopted in phase Ⅱof