肺里芬辛耐药结核病 (TB-PRACTECAL) 的简短口服治疗方案:一个开放式,随机,受控的2B-3期,多臂,多中心,非劣势性试验
Bern-Thomas Nyang'wa1, Catherine Berry2, Emil Kazounis2
1Public Health Department OCA, Médecins Sans Frontières, Amsterdam, Netherlands; London School of Hygiene & Tropical Medicine, London, UK; Institute for Global Health, University College London, London, UK.
The Lancet. Respiratory medicine
|November 19, 2023
概括
全口服BPaLM疗法提供了24周的安全有效治疗耐利芬辛结核病. 这种新疗法已纳入世卫组织的指导方针,为患者提供了更好的治疗结果.
科学领域:
- 传染性疾病 传染性疾病
- 肺部病理学 肺部病理学
- 临床药理学 临床药理学
背景情况:
- 全球每年约有50万人患有耐利芬素结核病 (TB),治疗的成功结果有限.
- 迫切需要新的治疗策略来应对这种日益严重的公共卫生挑战.
研究的目的:
- 评估新型口服治疗方案的安全性和有效性,用于治疗肺部耐利芬素结核病.
- 为了比较BPaLM方案与标准护理的结果.
主要方法:
- 一个开放的标签,随机的,受控的,多臂试验,在乌兹别克斯坦,白俄罗斯和南非的七个地点进行.
- 15岁及以上患有肺里芬辛耐药结核病的参与者被随机分配到接受标准护理或24周全口服BPaLM治疗方案.
- 主要结局是随机化后72周的复合不利结局,评估在修改后的治疗意图和每协议人群中.
主要成果:
- BPaLM疗法表现出卓越的疗效,在12%的参与者中出现不良结果,而在标准护理组中为41% (p<0.0001).
- 3级或更高的不良事件在BPaLM组 (23%) 与标准护理 (48%) 相比显著较低.
- 在标准护理组报告了四起与治疗相关的死亡,而在BPaLM组没有任何死亡.
结论:
- 24周的全口服BPaLM疗法是一种安全有效的治疗肺里芬辛耐药结核病.
- 世界卫生组织已经推了BPaLM疗法,并准备成为成人和青少年首选的治疗选择.
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