A Muulticenter, Open, Non-interventional, Retrospective Cohort Study to Evaluate the Clinical Value and Safety of Xiyanping Injection in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD) Based on Real-world Clinical Data
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,140
- 主要终点
- Course of intravenous antibiotics
研究概览
简要总结
The primary objective is to evaluate the effect of Xiyanping injection on the treatment course of intravenous antibiotics for acute exacerbation of chronic obstructive pulmonary disease based on real-world clinical data, and to provide guidance and basis for the clinical application of Xiyanping injection combined with antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease.The secondary objectives is to evaluate the effect of Xiyanping injection on the indicators of acute exacerbation of inflammation and symptom improvement of chronic obstructive pulmonary disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Discharged with chronic obstructive pulmonary disease;
- •Hospitalized patients with COPD or AECOPD combined with lower respiratory tract infection;
- •The treatment course of Xiyanping injection in the exposed group was ≥3 days, and the non-exposed group did not use Xiyanping injection;
- •Study patients with complete medical records.
排除标准
- •Researchers believe that multiple proprietary Chinese medicines with the same or similar functions (such as Tanreqing injection, Reduning injection, Yanhuning injection, etc.) have been used at the same time during treatment, resulting in no assessment of efficacy or safety;
- •Patients with viral pneumonia or other systemic infection (such as urinary tract infection);
- •Patients who do not use intravenous antibiotics;
- •Refuse the case to be used by researchers.
研究组 & 干预措施
Exposure group
Xiyanping injection + Antimicrobial agents treatment
干预措施: Xiyanping injection+ antibiotic (Drug)
Non-exposure group
Antimicrobial agents treatment
干预措施: Antibiotic (Drug)
结局指标
主要结局
Course of intravenous antibiotics
时间窗: baseline, at 3(±1), 7(±1), and 10 days during medication
Duration of intravenous antibiotic use
次要结局
未报告次要终点