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为了在坦桑尼亚监测治疗性抗结核病药物的临床决策支持系统 (TuberXpert项目):算法开发和实施协议

Yann Thoma¹, Annie E Cathignol^1,2, Yuan J Pétermann²

¹School of Engineering and Management Vaud, HES-SO University of Applied Sciences and Arts Western Switzerland, Yverdon-les-Bains, Switzerland.

JMIR research protocols

|October 21, 2024

概括

这项研究开发了一种用于结核病 (TB) 治疗的自动化临床决策支持系统 (CDSS),可实现个性化的利芬素剂量. 该系统旨在通过支持没有专门的药理学培训的从业者来改善资源有限的环境中的药物疗效和可访问性.

科学领域:

药理动力学和药理动力学
临床决策支持系统临床决策支持系统
结核病的治疗方法

背景情况:

全球终结结核病 (TB) 战略需要个性化的患者治疗,超越一种适合所有人的方法,因为影响药物消除的生理变异.
治疗药物监测 (TDM) 对于调整药物剂量至关重要,但在资源有限的环境中,由于训练有素的药理学家稀缺而受到限制.
利芬素是关键的抗结核病药物,具有显著的药理动力学变异性和频繁的低于最佳血度,突出需要精确的剂量调整.

研究的目的:

开发一个自动化的临床决策支持系统 (CDSS),以优化结核病患者的利芬素剂量调整.
在医疗保健从业人员中培养剂量个性化的文化,包括那些没有专门的药理学专业知识的人.
建立坦桑尼亚患者里芬素的群体药理动力学 (popPK) 模型,自动生成药物剂量调整的报告,并验证该系统的现场实施.

主要方法:

通过三支团队的联合努力,开发了一种针对结核病的自动化TDM CDSS.
进行一项横截面研究,以优化临床医生信息显示,并使用现有文献和新数据开发一款利芬素popPK模型.
设计基于决策树的CDSS,自动化报告生成,通过案例研究验证,并在坦桑尼亚实施前性坚持研究.

主要成果:

该TuberXpert项目始于2022年11月,在2024年7月在坦桑尼亚完成了一项临床研究.
这项研究招募了50名患者,以收集数据,以开发利法素popPK模型.
一项定性研究定义了报告设计,并建立了CDSS的一般架构.

结论:

结核病专家项目将为坦桑尼亚提供一个自动化工具,帮助从业人员适应复杂结核病病例 (例如,结核病/艾滋病,结核病/糖尿病,结核病/营养不良) 的药物剂量.
经过验证的自动化系统将在现场部署,并建议其他结核病流行国家采用.
这种方法可以证明CDSS辅助的TDM在资源有限的地区的可行性,用于各种抗结核病药物,包括二线治疗.

关键词:

时间 TDM TDM 坦桑尼亚坦桑尼亚坦桑尼亚坦桑尼亚临床决策支持系统.临床药理学临床药理学手机电话手机电话手机电话基于模型的精确剂量软件.药学指标药学指标药学指标药学指标治疗药物监测治疗药物监测结核病是一种肺结核病.

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