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Randomized Controlled Trial Of The Safety And Efficacy Of Recombinant Human Interferon Alpha 1b In The Treatment Of Children Viral Encephalitis

Posted on:2018-05-21Degree:MasterType:Thesis
Country:ChinaCandidate:R R GaoFull Text:PDF
GTID:2334330536463278Subject:Academy of Pediatrics
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Objective: Viral Encephalitis is an acute intracranial inflammatory disease caused by hundreds of viruses [1].Besides symptomatic and immune modulation theropy,effective antiviral treatment is especially important.However compare to the highly specificity of virus,there is no such specific antiviral drugs.Therefore,in order to optimize the treatment of VE,medical scientists had a heated discussion about the drugs.Interferon has been studied all so far since been found the antiviral effect by the British scientist Isaac A [2]in 1957.The inhalation therapy has been widely used at home and abroad for many years,and the curative effect is remarkable,but the application of intramuscular injection therapy is short,and the relevant literature is less.This thesis aims to study the safety and therapeutic effect of recombinant human interferon alpha 1b intramuscular injection to VE,in order to optimize treatment of VE and provide an evidence for clinical application.Methods: We selected 164 children who hospitalized and been diagnosed as viral encephalitis in the Second Hospital of Hebei Medical University from January to December in 2016 as the object.According to the random number table,they were randomly divided into interferon group and non interferon group.We collected 2ml of cerebrospinal fluid and serum within 48 hours and put specimens into cryovials.Then,the specimens were kept in the-80?specimen storeroom,until biological logistics companies deliver the specimens to the CDC under low temperature conditions by dry ice.By run the real-time fluorescence quantitative PCR,we detected 16 kinds of virus nucleic acid in serum and cerebrospinal fluid of children with VE.The virus including intestinal virus(EV),EB virus(EBV),cytomegalovirus(CMV),Japanese encephalitis virus(JEV)and human herpes virus type 6(HHV6),mumps virus(MuV),tick borne encephalitis virus(TBEV),rubella virus(Ruv),measles virus(Mev),adenovirus(Adv)and the West Nile virus(WNV),Jc(JCV)virus,varicella zoster virus(VZV),herpes simplex virus type 1(HSV-1),herpes simplex virus type 2(HSV-2)and human immunodeficiency virus(HIV).Through collected the data of the general information(gender,age,onset season),and the disappeared time of various symptoms and signs,cytological,biochemical and pathogens examination of cerebrospinal fluid and serum,high sensitive C-reactive protein,ECG,EEG and imaging examination.We analyzed the occurrence of adverse reaction and the therapeutic effect between the two groups.Finally,we evaluated the safety and efficacy of Recombinant Human Inteferon Alpha 1b for clinical application.Results: The virus encephalitis of child can onset all through the year.However,the summer and fall seasons have higher incidence-103 children onset at July,August and September.Preschool children have the highest proportion--34.76%.The positive rate of pathogens in serum is 42.74%.EV detection rate is the highest-27.4%.The positive rate of pathogens in cerebrospinal fluid of 124 children is 42.74%.EV detection rate is also the highest-25.81%.Among the 11 cases of severe viral encephalitis,4 cases are caused by infection of herpes simplex virus,the ratio is 36.36%.The abnormal rate of EEG was 82.9%,imaging examination was 9.8%.The adverse reactions of the interferon were mainly temperature rising,intramuscular paining and granulocyte reducing which occurred in a few hours after the injection and could self-relieve.The incidence rates of adverse reactions are 8.5%,4.9%,4.9%,respectively.There was no significant difference in the incidence of adverse reactions between the two groups,and the relative risk coefficient was low.In the interferon group,the disappeared time of fever was 20(12)h,headache was 25(22.5)h,dizziness was 30(24)h,vomiting was 12(6)h,meningeal irritation was 24(20)h,pathological signs was 30(20)h,but in the non interferon group,the time of corresponding symptoms and pathologic reflex were 48(24)h,44(24)h,48(36)h,14(12)h,48(24)h,48(30)h.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.Conclusion:1 Preschool children have the highest risk of incidence.2 Viral Encephalitis of children can onset throughout the year,the highly incidence seasons are summer and autumn.3 The major pathogens of viral encephalitis is intestinal virus followed by JEV,EBV,CMV,HHV6 and so on.Herpes simplex virus is the main pathogen of severe viral encephalitis.4 There is no direct correlation between white blood cell count of cerebrospinal fluid with viral load.5 There is no significant difference in the incidence of adverse reactions between the two groups,and the relative risk coefficient is low.6 The disappeared time of symptoms and pathologic reflex in the interferon group are shorter than the non interferon group.7 Recombinant human interferon alpha-1b intramuscular injection is safe and urative effect is affirmation and can be used in clinical practice.
Keywords/Search Tags:Viral encephalitis, Children, Cerebrospinal fluid, Enterovirus, Safety, Recombinant human interferon alpha-1b
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