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 (XYP-202401)

Qingfeng Pharmaceutical

Status: Not yet enrolling

Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Treatments: Drug: Antibiotic; Drug: Xiyanping injection+ antibiotic

Study type: Observational

Funder types: Industry

Identifiers

NCT06754865

2024XLA207-1

Details and patient eligibility

About

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.

Enrollment: 1,140 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Discharged with chronic obstructive pulmonary disease;
2. Hospitalized patients with COPD or AECOPD combined with lower respiratory tract infection;
3. The treatment course of Xiyanping injection in the exposed group was ≥3 days, and the non-exposed group did not use Xiyanping injection;
4. Study patients with complete medical records.

Exclusion criteria

1. 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;
2. Patients with viral pneumonia or other systemic infection (such as urinary tract infection);
3. Patients who do not use intravenous antibiotics;
4. Refuse the case to be used by researchers.

Trial design

1,140 participants in 2 patient groups

Exposure group

Description:

Xiyanping injection + Antimicrobial agents treatment

Treatment:

Drug: Xiyanping injection+ antibiotic

Non-exposure group

Description:

Antimicrobial agents treatment

Treatment:

Drug: Antibiotic