小儿注射重组人干扰素α1b治疗病毒性肺炎的耐受性及安全性  

Tolerance and safety of recombinant human interferon α1b injection in children with viral pneumonia

作　　者：孙薇[1,2] 乔逸[1] 郭丽[3] 曹玉红[4] 杨林[1] 张国成[4] 文爱东[1] 

机构地区：[1]第四军医大学西京医院药剂科 [2]兰州军区总医院药材科,兰州730050 [3]解放军第323医院神经内科,西安710054 [4]第四军医大学西京医院儿科,西安710032

出　　处：《中国新药杂志》2011年第23期2340-2344,共5页Chinese Journal of New Drugs

摘　　要：目的:研究小儿病毒性肺炎患儿肌内注射重组人干扰素α1b的安全性和耐受性。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,分别采用单次、连续多次肌内注射的方法给药,动态观测用药后的临床症状、体征并严密观察记录试验期间发生的不良事件。结果:各组受试儿给药后生命体征和实验室各项检查指标均在正常范围,未见有临床意义的改变。结论:小儿病毒性肺炎恢复期患儿肌内注射重组人干扰素α1b在0.3～2.0μg.kg-1范围内,耐受性良好,无明显毒副作用,1.5μg.kg-1剂量可作为Ⅱ期临床研究剂量。Objective： To evaluate the tolerance and safety of recombinant human interferon α1b injection in children with viral pneumonia. Methods： The initial dose and maximal tolerance dose were determined according to preclinical safety data. Children （n = 24） in recovery from viral pneumonia were randomly chosen, and intramuscularly injected with single dose and muhidoses of the recombinant human interferon α1b injection. During the study, the safety was assessed based on clinical symptoms and laboratory tests. Results： No abnormal outcomes and indicators were found in the physical examination and laboratory blood tests after inhalation, and no serious adverse reactions were observed. Conclusion： The application of recombinant human interferon α1b injection at single doses of 0.3 - 2.0 μg·kg^-1 is safe and tolerable for children in recovery from viral pneumonia. The recommended dosage for phase Ⅱ clinical trial is 1.5 μg·kg^-1

关 键 词：小儿肌内注射 重组人干扰素Α1B 病毒性肺炎 耐受性 

分 类 号：R725[医药卫生—儿科]