Antiviral and Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) Virus Pneumonia: Multi-centre, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously)
研究概览
简要总结
The purpose of the study is to determine whether the combination treatment of Chinese medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel influenza A (H1N1) pneumonia.
详细描述
The antiviral agent, oseltamivir, is recommended by the World Health Organization (WHO) to treat recent outbreak novel influenza A (H1N1) virus infection around world. But limited stock and resistant strain emergence raised increasing concerns. Chinese medicinal herbs, are derived from plants and usually incorporate one or more herbs as the basic drug(s) to treat the disease. The investigators performed RCT to indicate that a combination treatment of Chinese medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel influenza A (H1N1) pneumonia.
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
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed novel influenza A(H1N1) case with laboratory evidence
- •70 ys ≥ age ≥14ys
- •Within 72hr after the onset of symptoms(body temperature≥37.5℃ with at least one respiratory symptom (cough, sore throat, or nasal symptom)
- •New lung infiltration showed by chest radiology(x-ray or CT)
排除标准
- •Age<14ys or >70ys
- •Pregnancy
- •Severe chronic underlying diseases: severe COPD(FEV1/EVC <70% and FEV1 <30% predicted or respiratory failure or congestive heart failure), severe liver disfunction（ALT or AST ≥3 times normal elevation), renal disfunction（Cr>2mg/dL), chronic heart failure(NYHA Ⅲ-Ⅳ grade）
- •Immunocompromised patients(cancer, organ transplant, AIDS and a history of treatment with immunosuppressive drug and glucocorticoids in the past 3 months)
- •Taken Chinese medicinal herbs, antiviral or antibiotic drug in the past 2 weeks
- •Inoculation influenza vaccination
- •One of the following items appeared at the enrollment
- •respiratory failure：PaO2<60mmHg and/or PCO2>50mmHg or PaO2/FiO2≤300
- •circulation failure: despite adequate fluid resuscitation and cardiac output, systolic <90mmHg or requirement inotropic support
- •renal function failure: despite adequate fluid resuscitation and cardiac output, urine ≤ 0.5ml/kg.h, Cr or BUN≥1 time normal elevation
- •liver function failure: total bilirubin>34μmol/L or ALT/AST ≥3 times normal elevation
- •Other unappropriated enrollment situations considered by investigator
研究组 & 干预措施
oseltamivir
single antiviral treatment
干预措施: oseltamivir (Drug)
oseltimivir and chinese medicinal herbs
combination treatment
干预措施: oseltamivir and chinese medicinal herbs (Drug)
结局指标
主要结局
Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously)
时间窗: two years
次要结局
- Time to resolution of fever(defined as the period from start of study-drug to relief of fever)(two years)
- Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)(two years)
- Virus shedding time(two years)
- Infiltration resolution of chest radiology(two years)
- SaO2 and PaO2/FiO2(arterial blood gas)(two years)