布-费伊伊-申颗粒可减少GOLD 3-4COPD患者的急性恶化:3-4 COPD患者:随机对照试验
Xue-Qing Yu1,2, Jia-Qi Di2, Wei Zhang3
1Department of Respiratory Disease, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan Province, 450000, People's Republic of China.
International journal of chronic obstructive pulmonary disease
|November 13, 2023
概括
布伊申颗粒 (BYG) 减少了重症慢性阻塞性肺病 (COPD) 患者急性恶化和住院治疗. BYG改善了临床症状,生活质量和运动能力,但没有影响死亡率或肺功能.
科学领域:
- 呼吸系统医学 呼吸系统医学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 慢性阻塞性肺病 (COPD) 是一种进展性呼吸道疾病,其特征是频繁的急性恶化 (AEs),特别是在严重阶段.
- 重度COPD (GOLD 3-4) 的管理通常涉及解决AE以改善患者的治疗结果和生活质量.
研究的目的:
- 评估Bu-fei Yi-shen颗粒 (BYG) 在治疗重度至非常重度COPD患者中的疗效和安全性.
- 评估BYG对急性恶化,肺功能,临床症状和生活质量的影响.
主要方法:
- 进行了一项多中心,随机,双盲,安慰剂对照试验,涉及348名GOLD 3-4 COPD患者.
- 参与者接受了BYG或安慰剂口服,每天两次 (5天,休息2天) 持续52周.
- 测量结果包括副作用,肺功能,mMRC呼吸障碍得分,6分钟步行测试 (6MWT),生活质量 (SF-36),以及COPD特定的PROs.
主要成果:
- 共有280名患者完成了这项研究.
- 与安慰剂相比,BYG显著降低了AE和AE相关住院的频率 (P=0.006和P=0.04,分别).
- 在BYG组中,在6MWD (40.93m),mMRC得分 (-0.57),总症状 (-2.18),SF-36得分 (11.60) 和mCOPD-PRO (-0.45) 中观察到显著改善.
结论:
- 布伊申颗粒 (BYG) 在减少GOLD 3-4 COPD患者急性恶化和住院治疗方面表现出显著的有效性.
- 在严重的COPD患者中,BYG可以改善临床症状,生活质量和运动能力.
- 死亡率或肺功能没有显著改善,也没有明显的不良事件.
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