Multicenter and random clinical study on efficacy and safety of atomization inhalation recombinant human interferon α2b in treatment of children with bronchiolitis

Abstract

Objective To explore the optimum dose, effectiveness and safety of atomization inhalation recombinant human interferon α2b (rhIFNα2b) in the treatment of children with bronchiolitis. Methods A total of 122 cases of bronchiolitis children treated in 4 hospitals from December 2014 to May 2015 were selected, according to admission time sequence based on random Numbers DAS 3.0 software produced by various centers, all children were randomly divided into a control group (41 cases), the low-dose group (40 cases) and the high-dose group (41 cases). The control group was given conventional treatment; the low-dose group received atomization inhalation rhIFNα2b, 1×105 IU/(kg·time), 2 times/d, based on the conventional treatment; the high-dose group received inhalation rhIFNα2b, 2×105 IU/(kg·time), 2 times/d, based on the conventional atomization treatment.All children were observed for 1 week.The statistical data were analyzed by SPSS 19.0 software.The score of clinical symptoms and signs, improvement rate of symptoms and signs, effective rate, and duration of clinical symptoms and signs among 3 groups were compared.The safety of atomization inhalation rhIFNα2b was evaluated during treatment. Results In this study, 1 case was dropped out on its own, 2 cases of children were excluded, 119 cases were effective, including 40 cases in the high-dose group, 39 cases in the low-dose group and 40 cases in the control group.From the 4th to the 5th day, the three depression signs' score, from the 5th to the 7th day the wheezing rale score and total scores, and in 7th day the cough and wheezing scores in the high-dose group were significantly lower than those of the control group (all P 0.05). No adverse drug reaction was observed during treatment of atomization inhalation rhIFNα2b by detecting the vital signs, routine blood test, routine urine test, liver and kidney function, electrocardiogram and Chest X-ray. Conclusions Atomization inhalation rhIFNα2b in treatment of children's bronchiolitis can significantly improve the cure rate and efficiency rate, relieve the symptoms, shorten the duration of symptoms and signs, without any adverse reactions, and the total efficacy of the high-dose group is superior to that of the low-dose group. Key words: Recombinant human interferon α2b; Bronchiolitis; Atomization inhalation; Clinical symptom score; Multi center study