Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD：a Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Invasive mechanical ventilation rate
研究概览
简要总结
Objective: A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD).
Methods: 254 AECOPD inpatients will be recruited in 6 hospitals in China over 2 years. They will be randomly assigned to Experimental group and Placebo group，Experimental: Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days；Placebo Comparator: Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days. Compare the following index between the two groups: Invasive mechanical ventilation rate, length of hospital stay, Treg cell,Th1,Th2,HLA-DR,CRP,PCT,IL-4,IL-6,IL-10,TNF-α，IFN-γ, APACHEⅡ, CAPS score.
详细描述
A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight≥40kg and ≤100kg
- •Diagnosis of COPD :(following Global initiative for Chronic Obstructive Lung Disease，GOLD2016)
- •Forced Expiratory Volume in 1 second of less than 70% predicted value after bronchodilator
- •Acute exacerbation of COPD: the clinical presentation of the patient complaining of an acute change of symptoms(baseline dyspnea,cough,and/or sputum production)that is beyond normal day-to-day variation.
- •Assessment of COPD Exacerbations: Medical History:severity of COPD based on degree of airflow limitation;Duration of worsening or new symptoms;Number of previous episodes (total/hospitalizations); Comorbidities; Present treatment regimen;Previous use of mechanical ventilation;
- •sign the informed consent
排除标准
- •Pregnant women, lactating women；
- •Be allergic to Xuebijing；
- •Acute exacerbation of COPD onset of more than 72 hours；
- •AECOPD with severe hypoxemia：oxygenation index <150 or received Endotracheal intubation invasive mechanical ventilation；
- •Participation in another experimental protocol within 30 days of study entry
- •Primary diseases：Asthma，Cystic fibrosis，Lung cancer，Tuberculosis，Pulmonary sarcoidosis，Pulmonary interstitial fibrosis，Malignant neoplasms，Blood system diseases，HIV；
- •Complications：Pulmonary embolism，shock，DIC，Unstable cardiovascular disease，Upper gastrointestinal bleeding，pneumothorax，Severe liver and kidney dysfunction；
- •Mental incompetence or active psychiatric illness
- •used the following drugs within 72 hours days of study entry：Ulinastatin，Tanreqing， Reduning，Qingkailing；
- •The investigator judged that the subject could not be completed or should not participate in the trial：Hemodialysis more than 1 mouth，Organ transplant patients with potential medical dispute.
研究组 & 干预措施
Xuebijing
Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days
干预措施: Xuebijing (Drug)
Placebo
Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Invasive mechanical ventilation rate
时间窗: 28 days
Invasive mechanical ventilation rate in %
次要结局
- length of Hospital stay(28 days)
研究者
Lixin Xie
professor
Chinese PLA General Hospital