Effect of Recombinant Human Interferon α-2b Spray on Herpangina

Study Overview
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Brief Summary
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This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness of recombinant human interferon α-2b spray compared with ribavirin treatment on pediatric patients with herpangina.

Official Title
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Effect and Safety of Recombinant Human Interferon α-2b Spray on Herpangina in Pediatric Patients

Conditions
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Herpangina

Intervention / Treatment
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* Drug: Recombinant Human Interferon α-2b Spray
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects should meet all of the following: meet the diagnostic criteria for pediatric herpangina; ages 1-7 years, no limitation for gender; within 72 hours of onset; the main organs (heart, liver, kidney and lung) function normally; follow up according to requirements and be hospitalized for observation; the guardian is fully informed and signed informed consent. Exclusion Criteria: Subjects should be excluded if meet any of the following: have allergy history of interferon; heart failure, respiratory insufficiency,liver and kidney dysfunction or severe malnutrition and other serious disease, or immunodeficient; children with epilepsy or other neurological disorders; other pathogens exist at the same time; the researchers believe that it is not appropriate to participate in this study.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recombinant Human Interferon α-2b Spray<br> | Drug: Recombinant Human Interferon α-2b Spray<br>* Recombinant human interferon α-2b spray (trade name Jeferon, specifications: 1 million U/support, 10mL/support or 2 million U/support, 20mL/support, 2-8 ℃ dark storage and transportation), 1 million U/day, used for 3 days, observed to the 4th day (until the 96th hour).<br>|
| Active Comparator: Ribavirin<br> | Drug: Ribavirin<br>* Ribavirin Spray, spray once every 4-5 hours, 1-2 times a spray, used for 3 days, observed to the 4th day(until the 96th hour ).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The defervesce rate during treatment by 72 hours | Body temperature returned to normal,and remain at least 24 hours. | Measure the body temperature every 4 hours from starting of treatment to the 96th hour. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal blood routine | White blood cell count, absolute neutrophil count, absolute lymphocyte count, platelet count, hemoglobin, the five indicators if one is abnormal, abnormal blood routine is defined as 1, if five indicators all are normal, abnormal blood routine is defined as 0. | Before admission and 72th hours after treatment. | 
| The significant efficiency rate | Within 48 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers significantly improved and no new appeared, appetite significantly improved. | From starting of treatment to the 48th hour. | 
| The effective rate | Within 72 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers improved and no new appeared, appetite improved. | From starting of treatment to the 72th hour. | 
| The ineffective rate | After medication 72 hours still fever, oropharyngeal herpes and ulcer without reducing or even increase, eating difficulty. | From starting of treatment to the 96th hour. | 
| The total effective rate | Total effective rate = efficiency rate + effective rate. | From starting of treatment to the 96th hour. | 
| Total hospital stay |  | From starting of treatment to the 96th hour. | 
| Appetite improvement |  | From starting of treatment to the 96th hour. | 
| Myocardial enzymes and electrocardiogram | Before admission myocardial enzymes and electrocardiogram were checked, then rechecked after 72 hours treatment if abnormal. | Before admission and 72th hours after treatment. | 
| The condition of herpes and ulcers subside | Clinical examination to check herpes subsided, ulcer wounds smaller, with or | Check the oral herpes or ulcers subsided every 24 hours from starting of treatment to the 72th hour. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aged 1-7 years old, within 72 hours of onset patients with herpangina