NCT03266601已完成4 期
Effect and Safety of Recombinant Human Interferon α-2b Spray on Herpangina in Pediatric Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 668
- 试验地点
- 1
- 主要终点
- The defervesce rate during treatment by 72 hours
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Recombinant Human Interferon α-2b Spray
Experimental
干预措施: Recombinant Human Interferon α-2b Spray (Drug)
Ribavirin
Active Comparator
干预措施: Ribavirin (Drug)
结局指标
主要结局
The defervesce rate during treatment by 72 hours
时间窗: 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.
次要结局
- Abnormal blood routine(Before admission and 72th hours after treatment.)
- The effective rate(From starting of treatment to the 72th hour.)
- The ineffective rate(From starting of treatment to the 96th hour.)
- The total effective rate(From starting of treatment to the 96th hour.)
- Appetite improvement(From starting of treatment to the 96th hour.)
- 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.)
- The significant efficiency rate(From starting of treatment to the 48th hour.)
- Total hospital stay(From starting of treatment to the 96th hour.)
- Myocardial enzymes and electrocardiogram(Before admission and 72th hours after treatment.)
研究者
Hui Yu
Professor, Director
Children's Hospital of Fudan University
研究点 (1)
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