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

Children's Hospital of Fudan University668 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

668

Conditions

Herpangina

Interventions

Recombinant Human Interferon α-2b SprayDRUG

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).

RibavirinDRUG

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 ).

Eligibility

Sex: ALLMin age: 1 YearMax age: 7 Years

Medical Language ↔ Plain English

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.

Locations (1)

Children's Hospital of Fudan University

Shanghai, China

Outcomes

Primary Outcomes

The defervesce rate during treatment by 72 hours

Body temperature returned to normal,and remain at least 24 hours.

Time frame: Measure the body temperature every 4 hours from starting of treatment to the 96th hour.

Secondary Outcomes

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".

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: From starting of treatment to the 96th hour.

The total effective rate

Total effective rate = efficiency rate + effective rate.

Time frame: From starting of treatment to the 96th hour.

Total hospital stay

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.