一个简短的,全口服治疗方案,用于预先广泛的耐药结核病:一个多中心的开放标签单臂研究
Yang Li1,2, Yilin Zhang1,2, Lingyun Song1,2
1National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China.
概括
包括贝达基林在内的新口服疗法显示,在前广泛耐药结核病 (前XDR-TB) 治疗中,成功率为77.5%. 这种全口服选择为治疗选择有限的患者提供了可行的替代方案.
科学领域:
- 传染性疾病 传染性疾病
- 微生物学 微生物学
- 药理学 药理学是指药理学的学科.
背景情况:
- 前广泛耐药结核病 (XDR-TB前) 由于治疗干预有限,对全球健康构成了重大挑战.
- 当前的治疗方案虽然有效,但在全球范围内面临着可访问性问题,突出了需要替代策略的需要.
研究的目的:
- 评估一种新的6至9个月全口服治疗方案的疗效和安全性,用于治疗XDR前肺结核.
- 在中国患者群体中评估基于贝达基林的治疗方案的结果.
主要方法:
- 一项开放的,多中心的,单臂研究招募了89名年龄在18-70岁的肺前XDR-TB患者.
- 参与者接受了一种口服疗法,包括贝达基林,线索利德,环素,胺和/或克洛法西明,根据分子敏感性进行调整.
- 主要终点是治疗开始后84周在修改后的治疗意向人群中获得有利结果的百分比.
主要成果:
- 在84周,在77.5% (62/80) 的参与者中观察到有利的结果.
- 不利的结果包括停药,细菌学失败,退出,死亡和对随访的损失.
- 3级或更高的不良事件发生在59.1%的参与者中,最常见的是QTc延长.
结论:
- 完全口服的,基于贝达基林的治疗方案是前XDR-TB的可行的治疗选择.
- 该疗法在研究群体中显示出可接受的疗效和可管理的安全性.
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