对药物敏感性肺结核的风险分层治疗
Vincent K Chang1,2, Marjorie Z Imperial1,2, Patrick P J Phillips2,3
1Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, CA, USA.
长达4个月的利法丁-莫西弗洛克萨辛治疗方案对于药物敏感性肺结核是安全有效的. 较低的药物暴露和较高的疾病严重程度预测了不利的结果,使得个性化治疗的风险分层成为可能.
科学领域:
- 传染性疾病 传染性疾病
- 临床药理学 临床药理学
- 肺部医学 肺部医学
背景情况:
- 长达4个月的里法丁-莫西弗洛克萨辛疗法显示出对治疗药物敏感性肺结核的前景.
- 了解影响治疗结果的因素对于优化患者护理至关重要.
研究的目的:
- 分析TBTC研究31/ACTG A5349试验中的人口,临床,微生物,放射和药物动力学数据.
- 为了确定与里法丁-莫西弗洛克萨辛治疗方案相关的不利结果和不良事件的风险因素.
- 开发一个风险分层模型来分类结核病 (TB) 疾病表型.
主要方法:
- 第三期随机对照试验 (TBTC研究31/ACTG A5349).
- 分析疗效 (12个月无病生存期) 和安全性 (3级以上不良事件).
- 对人口,临床,微生物学,放射学和药物动力学数据进行多变量分析,以确定风险因素.
主要成果:
- 较低的利法丁暴露是不良结核病结局的最强预测因素 (HR 0.65每100μg·h/mL增加).
- 较高的基线疾病严重程度 (Xpert MTB/RIF周期值,胸部X射线图上的疾病程度) 也预测了不利的结果.
- 没有安全问题被确定与高Rifapentine暴露.
结论:
- 风险分层模型将结核病分为更容易,中度更难或更难治疗的表型.
- 更容易治疗的结核病患者可能会从治疗缩短中受益.
- 难以治疗的结核病患者可能需要更高的剂量或更长的治疗时间.
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