Efficacy of Xuanfei Baidu granules in patients with acute exacerbation of COPD: a randomized, controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
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
- 40 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Patients aged 40–85 years
- •Confirmed diagnosis of COPD according to GOLD 2026 guidelines, with an acute exacerbation necessitating hospitalization (defined by an acute onset of respiratory symptoms—dyspnea, increased sputum volume, or purulent sputum—exceeding daily variations)
- •GOLD classification 1–4
- •Willingness to provide written informed consent
排除标准
- •Respiratory failure requiring invasive mechanical ventilation
- •Concomitant diagnosis of asthma, bronchiectasis, or active pulmonary tuberculosis
- •Severe comorbidities, including unstable cardiovascular disease, malignancy, or end-stage renal/hepatic failure
- •History of severe allergic reaction to the study drug
- •Inability to comply with the 7-day treatment protocol
研究组 & 干预措施
The Control Group received standardized comprehensive Western medicine treatment, adhering strictly to GOLD 2026 and domestic AECOPD management standards. This protocol included oxygen therapy to maintain SpO2 between 88%–92% (with early non-invasive mechanical ventilation for hypercapnia), scheduled nebulization using short-acting ß2-agonists combined with anticholinergic agents every 2–4 hours, systemic corticosteroids (prednisone 40 mg/day orally or methylprednisolone 40 mg/day intravenously for 5 days), targeted antibiotic therapy based on clinical risk stratification and sputum culture for 5–7 days, and supportive care including mucolytics, postural drainage, nutrition, and venous thromboembolism prophylaxis. The Experimental Group received the identical standardized Western medicine regimen described above, supplemented with Xuanfei Baidu Granules (1 sachet, 3 times daily for 7 days).
干预措施: The Control Group received standardized comprehensive Western medicine treatment, adhering strictly to GOLD 2026 and domestic AECOPD management standards. This protocol included oxygen therapy to maintain SpO2 between 88%–92% (with early non-invasive mechanical ventilation for hypercapnia), scheduled nebulization using short-acting ß2-agonists combined with anticholinergic agents every 2–4 hours, systemic corticosteroids (prednisone 40 mg/day orally or methylprednisolone 40 mg/day intravenously for 5 days), targeted antibiotic therapy based on clinical risk stratification and sputum culture for 5–7 days, and supportive care including mucolytics, postural drainage, nutrition, and venous thromboembolism prophylaxis. The Experimental Group received the identical standardized Western medicine regimen described above, supplemented with Xuanfei Baidu Granules (1 sachet, 3 times daily for 7 days).