Herpangina
Conditions
Keywords
Aged 1-7 years old, within 72 hours of onset patients with herpangina
Brief summary
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.
Interventions
DRUGRecombinant Human Interferon α-2b Spray
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).
DRUGRibavirin
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 ).
Sponsors
Tianjin Sinobioway Biomedicine Co.Ltd.
Hunan Children's Hospital
Children's Hospital of Chongqing Medical University
Yuying Children's Hospital of Wenzhou Medical University
Qilu Children's Hospital of Shandong University
Children's Hospital of Kaifeng City
Shenzhen Children's Hospital
Zunyi Medical College
Changhai Hospital
Anhui Provincial Children's Hospital
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
Subjects should meet all of the following: 1. meet the diagnostic criteria for pediatric herpangina; 2. ages 1-7 years, no limitation for gender; 3. within 72 hours of onset; 4. the main organs (heart, liver, kidney and lung) function normally; 5. follow up according to requirements and be hospitalized for observation; 6. the guardian is fully informed and signed informed consent.
Exclusion criteria
Subjects should be excluded if meet any of the following: 1. have allergy history of interferon; 2. heart failure, respiratory insufficiency,liver and kidney dysfunction or severe malnutrition and other serious disease, or immunodeficient; 3. children with epilepsy or other neurological disorders; 4. other pathogens exist at the same time; 5. the researchers believe that it is not appropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The defervesce rate during treatment by 72 hours | Measure the body temperature every 4 hours from starting of treatment to the 96th hour. | Body temperature returned to normal,and remain at least 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The significant efficiency rate | From starting of treatment to the 48th hour. | Within 48 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers significantly improved and no new appeared, appetite significantly improved. |
| The effective rate | From starting of treatment to the 72th hour. | Within 72 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers improved and no new appeared, appetite improved. |
| The ineffective rate | From starting of treatment to the 96th hour. | After medication 72 hours still fever, oropharyngeal herpes and ulcer without reducing or even increase, eating difficulty. |
| The total effective rate | From starting of treatment to the 96th hour. | Total effective rate = efficiency rate + effective rate. |
| Abnormal blood routine | Before admission and 72th hours after treatment. | 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. |
| Appetite improvement | From starting of treatment to the 96th hour. | — |
| Myocardial enzymes and electrocardiogram | Before admission and 72th hours after treatment. | Before admission myocardial enzymes and electrocardiogram were checked, then rechecked after 72 hours treatment if abnormal. |
| The condition of herpes and ulcers subside | Check the oral herpes or ulcers subsided every 24 hours from starting of treatment to the 72th hour. | Clinical examination to check herpes subsided, ulcer wounds smaller, with or |
| Total hospital stay | From starting of treatment to the 96th hour. | — |
Countries
China
Outcome results
None listed