金贝口服液治疗异常性肺纤维化:一个随机的安慰剂对照试验
Aijun Zhang1,2, Kangkang Han3, Fangfang Chen4
1Shandong Hongji-tang Pharmaceutical Group Co., Ltd., Jinan, People's Republic of China.
Scientific reports
|January 23, 2025
概括
传统中医药的金贝口服液 (JBOL) 在26周内显示出异常性肺纤维化 (IPF) 患者的肺总容量 (TLC) 在统计学上显著减少. JBOL的安全性与安慰剂相提并论,这表明它对治疗IPF的潜在有效性.
科学领域:
- 整合和补充医学是整合和补充医学.
- 肺部病理学 肺部病理学
- 药理学 药理学是指药理学的学科.
背景情况:
- 异形性肺纤维化 (IPF) 是一种进展性和致命的肺病,治疗选择有限.
- 传统中医药 (TCM) 化合物,如金口服液 (JBOL),在治疗肺部疾病方面有着悠久的使用历史.
- 一种12种草药制剂JBOL被研究其对IPF的潜在治疗作用.
研究的目的:
- 评估金贝口服液 (JBOL) 在异形性肺纤维化 (IPF) 患者的疗效和安全性.
- 评估JBOL在26周期间对关键肺功能参数和疾病进展标志物的影响.
- 为了比较JBOL与安慰剂在随机,双盲,多中心临床试验中的作用.
主要方法:
- 这是一项为期26周的双盲多中心随机化,安慰剂对照试验,涉及68名IPF患者 (34名JBOL,34名安慰剂).
- 患者每天接受口服JBOL (40毫升) 或安慰剂三次.
- 效率是通过总肺容量 (TLC),强迫生命容量 (FVC),肺部对一氧化碳的扩散能力 (DLCO),6分钟步行距离 (6MWD),圣乔治呼吸问卷 (SGRQ) 分数和动脉氧气部分压力 (PaO2) 的变化来衡量.
主要成果:
- 与安慰剂相比,在JBOL组观察到总肺容量 (TLC) 的统计学显著减少 (p=0.02).
- 虽然数值差异有利于预测的FVC%,FVC,DLCO%和PaO2的JBOL,但这些差异没有达到统计学意义.
- 两组之间在第一次急性恶化的时间或SGRQ得分方面没有发现显著差异.
- JBOL的安全性与安慰剂相当,治疗引起的不良事件 (TEAE) 没有显著差异.
结论:
- 这项概念验证研究初步表明,JBOL可能对减缓IPF肺功能下降产生有益影响,特别是在TLC方面.
- 在IPF患者中,JBOL证明了可接受的安全性和耐受性.
- 需要进一步的大规模,涉及患者的临床试验来证实JBOL在IPF治疗中的疗效和长期安全性.
更多相关视频
相关概念视频
COPD: Management Using Bronchodilators and Corticosteroids
188
Chronic obstructive pulmonary isease (COPD) involves a group of progressive lung disorders characterized by persistent airflow limitation and chronic respiratory symptoms. Asthma-COPD Overlap Syndrome (ACOS), encompassing features of both asthma and Chronic obstructive pulmonary disease (COPD), is a group of progressive lung disorders that includes chronic bronchitis, emphysema, and refractory (non-reversible) asthma. ACOS leads to complex clinical presentations that combine the inflammatory...
188
Treatment for Pulmonary Arterial Hypertension: Endothelin Receptor Antagonists
142
Endothelins (ETs) are potent vasoactive peptides critical in the human body's various physiological and pathological processes. One of the most promising therapeutic strategies for treating pulmonary arterial hypertension (PAH) involves counteracting the effects of these endothelins using a class of drugs known as endothelin receptor antagonists.
ETs are synthesized through a complex sequence of enzymatic steps, primarily involving an enzyme referred to as endothelin-converting enzyme...
ETs are synthesized through a complex sequence of enzymatic steps, primarily involving an enzyme referred to as endothelin-converting enzyme...
142
Treatment for Pulmonary Arterial Hypertension: Phosphodiesterase Inhibitors
136
Phosphodiesterase 5 (PDE5) inhibitors are potent enzymes that function to hydrolyze cyclic nucleotides to their corresponding 5' monophosphates. Their unique biochemical properties have been applied in treating Pulmonary Arterial Hypertension (PAH).
Among the PDE5 inhibitors, sildenafil (Revatio) stands out as a competitive and selective inhibitor. It operates by elevating cellular levels of cGMP and augmenting signaling through the cGMP-PKG pathway, promoting vasodilation. Upon oral...
Among the PDE5 inhibitors, sildenafil (Revatio) stands out as a competitive and selective inhibitor. It operates by elevating cellular levels of cGMP and augmenting signaling through the cGMP-PKG pathway, promoting vasodilation. Upon oral...
136
Chronic Obstructive Pulmonary Disease-IV: Assessement and Diagnostic Studies
2.5K
Assessing and diagnosing Chronic Obstructive Pulmonary Disease (COPD) involves a detailed approach that includes a comprehensive review of medical history, physical examination, and a variety of diagnostic tests. This thorough evaluation is essential to ensure an accurate diagnosis and guide effective management strategies.
Medical History
Medical History
2.5K
Treatment for Pulmonary Arterial Hypertension: Oxygen Therapy for Respiratory Failure
187
Oxygen therapy has emerged as a significant tool in enhancing the quality of life for patients suffering from pulmonary arterial hypertension (PAH). While this therapy has principally been studied on patients with significant hypoxemia, this therapeutic approach helps prevent potential organ damage and can be administered in the comfort of one's home.
Oxygen therapy is vital in increasing and maintaining blood oxygen levels in PAH patients. As a result, it aids in reducing fatigue,...
Oxygen therapy is vital in increasing and maintaining blood oxygen levels in PAH patients. As a result, it aids in reducing fatigue,...
187
Treatment for Pulmonary Arterial Hypertension: Prostacyclin Receptor Agonists
160
Prostacyclin receptor agonists are a class of therapeutic agents integral to managing pulmonary arterial hypertension (PAH). These drugs operate by mimicking the action of prostaglandin I2, or PGI2, a naturally occurring compound in the body.
These agonists bind to the IPR receptor situated on the plasma membrane of the pulmonary artery smooth muscle cells. This binding triggers a cascade of reactions known as the GS-AC-cAMP-PKA pathway. This pathway results in the relaxation of smooth muscle...
These agonists bind to the IPR receptor situated on the plasma membrane of the pulmonary artery smooth muscle cells. This binding triggers a cascade of reactions known as the GS-AC-cAMP-PKA pathway. This pathway results in the relaxation of smooth muscle...
160


