Comparison of Aerosol Inhalation and Intravenous Glucocorticoid in the Treatment of Severe AECOPD-------Multicenter, Prospective, Randomized, Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Relevant indexes after treatment
研究概览
简要总结
Comparison of aerosol inhalation and intravenous glucocorticoid in the treatment of severe AECOPD-------Multicenter, prospective, randomized, controlled clinical study
详细描述
This study aims to compare the efficacy and comprehensive benefits of aerosol inhalation and intravenous injection of glucocorticoids in severe AECOPD patients.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Patients with AECOPD requiring hospitalization or emergency treatment (COPD acute attacks combined with respiratory failure were eligible). (2) 18 years of age ≤80 years of age (3) Patients and their families are willing to participate in clinical research and sign informed consent.
排除标准
- •Combined with tuberculosis.
- •Combined bronchiectasis.
- •complicated with definite infectious diseases.
- •PCT≥0.5ng/ml or CRP≥30mg/L.
- •Serious injury combined with other organ functions
- •Contraindications to other glucocorticoid use.
- •Concomitant bronchial asthma or positive bronchodilation test
研究组 & 干预措施
Nebulized inhalation group
2 mg budesonide suspension for inhalation, nebulized inhalation for minutes,administered 4 times a day for 5 consecutive days.
干预措施: aerosol inhalation of glucocorticoids (Drug)
Intravenous hormone group
40mg sodium methylprednisolone succinate for injection(dissolved in 0.9% saline or5% glucose injection 50ml), intravenous infusion for 30 minutes, once a day for 5 consecutive days.
干预措施: intravenous injection of glucocorticoids (Drug)
结局指标
主要结局
Relevant indexes after treatment
时间窗: The day of admission, day one, day two, day three, day five, day seven, day ten
Changes in blood gas indexes (oxygenation index, arterial partial pressure of carbon dioxide, pH value) of patients with respiratory rate, blood pressure, heart rate changes
次要结局
未报告次要终点
研究者
Dong Yang
Assisted Investigator
Jilin University