A Retrospective, Real-world Study of Eucalyptol, Limonene and Pinene Enteric Soft Capsules Used in the Expectorant Treatment of Community-acquired Pneumonia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 试验地点
- 7
- 主要终点
- Rate of cough-related symptoms improvement
研究概览
简要总结
Through a series of retrospective analysis, it is hoped that an objective evaluation of the effect and safety of Eucalyptol, Limonene and Pinene Enteric Soft Capsules in the treatment of community-acquired pneumonia can be made.
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
- •Patients with community-acquired pneumonia
- •Inpatients from 2017 to 2019
- •Regardless of age and gender
排除标准
- •Patients diagnosed with hospital-acquired pneumonia
- •Patients who take two or more oral mucolytics
- •Patients with combined use of Chinese and Western expectorants other than mucolytic drugs
研究组 & 干预措施
ELP_ONLY
Patients who were diagnosed with community-acquired pneumonia and were treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules, not treated with other oral mucolytics.
干预措施: Eucalyptol, Limonene and Pinene Enteric Soft Capsule (Drug)
EXP_ONLY
Patients diagnosed with community-acquired pneumonia and treated with an oral mucolytic drug other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules.
干预措施: Other oral mucolytic drugs (Drug)
ELP+AMB
Patients diagnosed with community-acquired pneumonia and treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules and ambroxol injection.
干预措施: Eucalyptol, Limonene and Pinene Enteric Soft Capsule (Drug)
ELP+AMB
Patients diagnosed with community-acquired pneumonia and treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules and ambroxol injection.
干预措施: Ambroxol injection (Drug)
EXP+AMB
Patients diagnosed with community-acquired pneumonia and treated with oral mucolytics and ambroxol injection other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules.
干预措施: Ambroxol injection (Drug)
EXP+AMB
Patients diagnosed with community-acquired pneumonia and treated with oral mucolytics and ambroxol injection other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules.
干预措施: Other oral mucolytic drugs (Drug)
AMB_ONLY
Patients diagnosed with community-acquired pneumonia and treated with ambroxol injection alone.
干预措施: Ambroxol injection (Drug)
结局指标
主要结局
Rate of cough-related symptoms improvement
时间窗: 7 days
Rate of cough-related symptoms improvement in the expectorant treatment of inpatients with community-acquired pneumonia. Compared the differences of the rates of cough improvement between the experiment group and the control group. The cough-related symptoms are evaluated and recorded in the inpatients' medical records. All the descriptions of cough-related symptoms and assessments in every inpatient's medical records will be captured.
次要结局
- Rate of pulmonary imageological improvement(Up to 30 days)
- Rate of normalization of vital signs(7 days)
- Rate of overal cure and improvement in pneumonia treatment(Up to 30 days)
- Cost-effectiveness ratio(Up to 30 days)
- Hospitalization length of stay(Up to 30 days)
- Rate of normalization of inflammatory index of pneumonia(7 days)
- Safety assessment: adverse events(Up to 30 days after first dose)