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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 study the safety and tolerability of intramuscular injection of recombinant human interferon α1b in children with viral pneumonia. Methods: According to its pre-clinical safety data, the initial dose and the maximum dose were determined. Twenty-four children were selected randomly during recovery from viral pneumonia. The patients were treated with single or multiple intramuscular injections continuously. The clinical symptoms , Signs and close observation to record the adverse events occurred during the test. Results: The vital signs of all the tested children in the test group and the indexes in the laboratory were within the normal range, and no clinical significance was found. Conclusion: The recovery of children with viral pneumonia in the intramuscular injection of recombinant human interferon α1b in the 0.3 ~ 2.0μg.kg-1 range, well tolerated, no significant side effects, 1.5μg.kg-1 dose can be used as Ⅱ Clinical study dose.