Objective To systematically assess the safety of recombinant humaninterferon α1b(rhIFNα1b) as therapy for viral diseases in children,so as to provide on evidence-based medicine for the clinical treatment.Methods Randomized controlled trails (RCTs) of rhIFNα1b for viral diseases in children were investigated through PubMedliterature retrieval service system,Science Citation Index,China National KnowledgeInfrastructure,WanFang Database;RCTs were selected according to the inclusion and exclusion criteria.Related data were extracted and the Meta-analysis was performed.Results Nineteen RCTs were involved,including 2 731 patients.In the overall,59/1 437 cases (4.1%) in the rhIFNα1b treatment group and 79/1 294 cases (6.1%) in the control group had adverse reactions.The Meta-analysis revealed that in the overall and in atomization inhalation subgroup,the incidence of adverse reactions was significantly lower in the rhIFNα1b treatment group than that in the control group [Z =2.18 (P =0.03),RR =0.71(95% CI0.52-0.97);Z =2.44(P =0.01),RR =0.53 (95% CI0.32-0.88)].But,there was no significant difference in the incidence of adverse reactions between the rhIFNα1b treatment group and the control group in intramuscular injection subgroup,and the test for overall effect was Z =0.78 (P =0.43),RR =0.86 (95 % CI0.58-1.26).The incidence of adverse reactions of the control group was significantly higher than that of the rhIFNα1b treatment group in gastrointestinal adverse reaction [Z =2.20 (P =0.03),RR =0.60 (95 % CI0.39-0.95)],and the incidence of adverse reactions of the rhIFNα1b treatment group was significantly higher than that of the control group in nervous system symptoms [Z=2.09(P=0.04),RR =4.28(95% CI1.10-16.72)].Conclusion Compared with other antiviral drugs,the treatment of pediatric common viral diseases with rhIFNα1 b has good safety,low incidence of adverse reactions,and the incidence of adverse reactions through atomization inhalation can be lower than that of intramuscular injection.