| Objective:Objective to systematically assess the safety of rhIFNα1b injection as therapy for viral diseases in children,so as to provide reference of evidence-based medicine for the clinical treatment and to investigate the effect of rhIFNα1b injection treatment of infants hospitalized with lower respiratory tract infections on subsequent wheezing and respiratory infections.Methods:1.Randomized controlled trails(RCTS)of rhIFNα1b injection for viral diseases in children were searched through PubMed,SCI,CNKI,WanFang Database;RCTs were selected according to the inclusion and exclusion criteria.Related data were extracted and the meta-analysis was performed;2.The clinical data of infants with viral pneumonia,wheezy bronchitis,bronchiolitis were retrospectively reviewed from June 2009 to June 2015 in 22 hospitals(age,gender,diagnosis,whether to use rhIFNα1b injection when in hospital).Age at follow-up,birth weight,gestation age,child and family history of allergy,feeding history,family environment,wheezing episodes and respiratory infections and hospitalization due to respiratory infections within the last year were obtained by telephone and giving out questionnaires.Based on the condition of whether to use rhIFNα1b injection when in hospital,the subjects were divided into the rhIFNα1b injection treatment group(253cases)and the control group(287cases),the comparisons were respectively made between the two groups in wheezing episodes and respiratory infections and hospitalization due to respiratory infections within the last year.Based on the condition of the wheezing episodes within the last year,the subjects were divided into the wheezing group(95cases)and the non-wheezing group(445cases);Based on the condition of the respiratory infections within the last year,the subjects were divided into the respiratory infections group(390cases)and the non-respiratory infections group(150cases);Based on the condition of the hospitalization due to respiratory infections within the last year,the subjects were divided into the inpatient treatment group(106cases)and the non-inpatient treatment group(434cases),the comparisons were respectively made between the two groups in age,diagnosis,whether to use rhIFNα1b injection when in hospital,gender,age at follow-up,birth weight,gestation age,child and family history of allergy,feeding history,family environment.If the result of single factor comparison showed P<0.05,the indicators were analyzed by the binary logistic regression.The ROC(receiver operator characteristic curve)was drawn to evaluate the predictive ability of logistic regression models.Results:1.The safety analysis of rhIFNa1 b injection in the treatment of viral diseases in children: 19 literatures were involved,including 2731 patients.The meta-analysis revealed that in the overall and in atomization inhalation subgroup,the incidence of adverse reactions was lower in rhIFNα1b injection treatment group than in control group:[respectively: Z=2.18(P=0.03),RR=0.71(95%CI0.52~0.97)and Z=2.44(P=0.01),RR=0.53(95%CI0.32~0.88)].But,there was no statistically significant difference between rhIFNα1b injection treatment group and control group in intramuscular injection subgroup incidence of adverse reactions 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 the control group was higher than that of the rhIFNα1b injection treatment group in the gastrointestinal adverse reaction [Z=2.20(P=0.03),RR=0.60(95%CI0.39~0.95)],but the incidence of adverse reactions of the rhIFNα1b injection treatment group was higher than that of the control group in the nervous system symptoms [Z=2.09(P=0.04),RR=4.28(95%CI1.10~16.72)].2.The effect of rhIFNa1 b injection in the treatment of infants with lower respiratory tract infections on subsequent wheezing and respiratory infections:1)Exclude 62 cases from 602 cases of follow-up data available,because of incomplete questionnaires,the dosage of rhIFNa1 b injection < 1 ug/kg.d or course < 3 days,the date in hospital beyond the scope of follow-up,age when in hospital >3 years old and so on.Finally 540 patients for analysis;2)95cases(17.6%)from 540 cases followed up had wheezing episodes within the last year;respectively 35 cases(13.8%)from 253 cases treated with rhIFNa1 b injection and 60cases(20.9%)from 287 cases without rhIFNa1 b injection treatment had wheezing episodes within the last year,the difference in wheezing episodes within the last year between the rhIFNα1b injection treatment group and the control group was statistically significant(P=0.031);The result of single factor regression indicated that the differences between the two groups of wheezing and non-wheezing in the age,whether to use rhIFNα1b injection when in hospital,child and family history of allergy,housing situation,feeding history were all statistically significant(all P<0.05);The result of binary logistic regression showed that child history of allergy(OR=2.14,P=0.004),rhIFNα1b injection therapy not used(OR=1.70,P=0.028)and house crowding(OR=1.92,P=0.012)were risk factors ofsubsequent wheezing.Breastfeeding(OR=0.44,P=0.008)and age when in hospital≤1year old(OR=0.58,P=0.024)were protective factors;The area under the ROC curve was 0.68,P=0.00.which indicated that the regression models had medium diagnostic accuracy;3)390cases(72.2%)from 540 cases followed up had respiratory infections within the last year;respectively 172 cases(70%)from 253 cases treated with rhIFNa1 b injection and 218 cases(76%)from 287 cases without rhIFNa1 b injection treatment had respiratory infections within the last year,the difference in respiratory infections within the last year between the rhIFNα1b injection treatment group and the control group was statistically significant(P=0.039);The result of single factor regression indicated that the differences between the two groups of respiratory infections group and non-respiratory infections group in the age at follow-up,birth weight,feeding history,whether to use rhIFNα1b injection when in hospital,smoking situation of family,housing situation were all statistically significant(all P<0.05);The result of binary logistic regression showed that rhIFNα1b injection therapy not used(OR=1.59,P=0.02)and house crowding(OR=1.85,P=0.02)were risk factors of subsequent respiratory infections;The area under the ROC curve was 0.65,P=0.00.which indicated that the regression models had medium diagnostic accuracy;4)106 cases(19.6%)from 540 cases followed up had hospitalization due to respiratory infections within the last year;respectively 38 cases(15%)from 253 cases treated with rhIFNa1 b injection and 68 cases(23.7%)from 287 cases without rhIFNa1 b injection treatment had hospitalization due to respiratory infections within the last year,the difference in hospitalization due to respiratory infections within the last year between the rhIFNα1b injection treatment group and the control group was statistically significant(P=0.011);The result of single factor regression indicated that the differences between the two groups of inpatient treatment group and non-inpatient treatment group in the age when in hospital,Whether to keep pets at home,whether to use rhIFNα1b injection when in hospital were all statistically significant(all P<0.05);The result of binary logistic regression showed that rhIFNα1b injection therapy not used(OR=1.65,P=0.03)and pets at home(OR=2.13,P=0.02)were risk factors of subsequent hospitalization due torespiratory infections;The area under the ROC curve was 0.60,P=0.001.which indicated that the regression models had medium diagnostic accuracy.Conclusion:1.Compared with other antiviral drugs,the treatment of pediatric common viral diseases with rhIFNα1b injection has good safety,low incidence of adverse reactions and the incidence of adverse reactions through atomization inhalation was lower than that of intramuscular injection;2.The use of rhIFNα1b injection treatment of infants hospitalized with lower respiratory tract infections could improve the subsequent wheezing and respiratory infections.The atopic constitution and house crowding and pets at home could increase the incidence of respiratory diseases in children. |
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