重组人干扰素α1b治疗儿童病毒性脑炎安全性及有效性研究

摘要

目的 探讨常规治疗辅以重组人干扰素α1b(rhINA-α1b)注射液肌肉注射治疗儿童病毒性脑炎的安全性及有效性.方法 收集2016年1月至2016年12月期间,在河北医科大学第二医院儿科住院并被诊断为病毒性脑炎的患儿164例,按随机数字表随机分为rhINA-α1b组和非rhINA-α1b组各82例.非rhINA-α1b组给予常规治疗(对症支持+炎琥宁),rhINA-α1b组给予常规治疗联合肌肉注射重组人rhINA-α1bα1b.观察对比两组患儿治疗期间临床症状、体征改善与不良反应发生情况.结果 两组患儿治疗后,rhINA-α1b组常见发热、头痛头晕、呕吐症状及脑膜刺激征、巴氏征消失时间短于非rhINA-α1b组(P<0.05),而非rhINA-α1b组与rhINA-α1b组抽搐、嗜睡、意识不清等症缓解时限分别为48(14.25)h vs 48(7.5)h,120(24)hvs 60(48)h,24(24)hvs 48(24)h,对比差异无统计学意义(P>0.05).两组患儿不良反应主要为体温升高(38±0.32℃)、肌注部位疼痛、粒细胞减少等,发生率均较低,分别为8.5％、4.9％、4.9％,差异(均P>0.05),多为一过性,可自行缓解,不影响继续使用.相对危险系数较低,其中应用rhINA-α1b发生体温升高的风险是非rhINA-α1b组的2.333倍,其他不良反应相对危险度更低.结论 肌肉注射重组人rhINA-α1bα1b治疗儿童病毒性脑炎安全有效,可在临床推广使用.%Objective To observe the safety and therapeutic effect of recombinant human interferon alpha 1b(rhINA-α1b) intramuscular injection to children viral encephalitis.Method We selected 164 children who hospitalized and been diagnosed as viral encephalitis in the Second Hospital of Hebei Medical University from January 2016 to December 2016. According to the random number table, they were randomly divided into 82 cases of interferon group and non interferon group. Non interferon group were provided by antiviral and symptomatic treatment. Interferon group were provided by regular treatment combined with rhINA-α1b injection. Observe the adverse reactions and, the common symptoms and pathologic of the two groups during therapy.Results In the interferon group, the common symptoms and pathologic reflex such as fever, headache, dizziness, vomiting disappeared in a shorter time than the non-interferon group. However, the improvement of the convulsions, lethargy, loss of consciousness in the two groups showed no significant difference. The adverse reactions were mainly temperature rising,intramuscular paining and granulocyte reducing which occurred in a few hours after the injection and could self-relieve. There was no significant difference in the incidence of adverse reactions between the two groups, and the relative risk coefficient was low.Conclusion rhINA-α1b intramuscular injection is safe and urative effect is affirmation and can be used in clinical practice.