PAN-TB治疗策略的实施对结核病防控的意义及挑战

doi:10.19982/j.issn.1000-6621.20240316

摘要/Abstract

摘要：

全球耐药结核病的防控仍面临巨大挑战,PAN-TB方案是适用于所有结核病的一线方案,即确诊活动性结核病后即启动该方案,而不需要获得患者的耐药情况。推行PAN-TB方案的目的是旨在尽快启动有效治疗,降低传播,并可以大幅度减轻结核病规划管理的复杂性。它不仅是临床治疗方法,更是公共卫生手段。本文就PAN-TB策略的定义、方案的要求、全球的研究进展,以及对于结核病防控的意义和目前面临的挑战进行阐述,以期为中国结核病的防控提供新的思路。

关键词: 结核, 抗结核药, 治疗应用, 方案评价

Abstract:

The control of drug-resistant tuberculosis (TB) globally still faces huge challenges. The PAN-TB regimen is a first-line regimen suitable for all forms of TB, which means that it should be initiated immediately upon confirmation of active TB disease, without waiting for the patient’s drug resistance status. The goal of implementing the PAN-TB regimen is to initiate effective treatment as soon as possible, reduce transmission, and significantly simplify the complexity of TB program management. It is not only a clinical treatment method, but also a public health measure. This article defines the definition, requirements, global research progress, and significance for TB control of the PAN-TB strategy, with the aim of providing new ideas for the prevention and control of TB in China.

Key words: Tuberculosis, Antitubercular agents, Therapeutic uses, Program evaluation

中图分类号:

沙巍. PAN-TB治疗策略的实施对结核病防控的意义及挑战[J]. 中国防痨杂志, 2024, 46(10): 1188-1192. doi: 10.19982/j.issn.1000-6621.20240316

Sha Wei. Significance and challenges of the implementation of PAN-TB treatment strategy for tuberculosis prevention and control[J]. Chinese Journal of Antituberculosis, 2024, 46(10): 1188-1192. doi: 10.19982/j.issn.1000-6621.20240316

图/表 1

表1

世界卫生组织指南对于PAN-TB方案的配置要求

参数	最低配置		最高配置
参数	2016年	2023年	2016年	2023年
指征	一线治疗方案,不需要确定利福平是否耐药	包括利福平敏感结核病和利福平耐药结核病在内的活动性结核病患者的一线治疗	一线治疗方案,不需要确定利福平是否耐药	包括利福平敏感结核病和利福平耐药结核病在内的活动性结核病患者的一线治疗
疗效	不劣于利福平敏感结核病,疗程6个月	疗效与利福平敏感结核病标准治疗相当的方案,疗程3~4个月	不劣于利福平敏感结核病,疗程4个月	疗效优于利福平敏感结核病标准治疗方案,疗程≤2个月
安全性和耐受性	不良事件的发生率和严重程度不高于标准方案。除特殊人群(已患肝病和糖尿病等)外,每月对不良反应进行实验室监测不超过1次	不良事件的发生率和严重程度低于利福平敏感结核病的标准治疗。除特定人群(已患肝肾疾病和糖尿病等)外,每月不超过1次对药物毒性的临床和实验室监测。耐受性应优于利福平敏感结核病的标准治疗方案	不良事件的发生率和严重程度优于标准方案。除特殊人群(已患肝病和糖尿病等)外,无需进行主动的不良反应监测。无需监测QT间期	不良事件的发生率和严重程度应低于利福平敏感结核病的标准治疗方案。除特定人群(已患肝、肾疾病和糖尿病等)外,无需对药物毒性进行积极的临床监测和实验室监测。耐受性应优于利福平敏感结核病的标准治疗方案
药物相互作用与代谢	需要针对药物相互作用进行剂量调整或安全性监测,包括:至少1种一线抗逆转录病毒治疗药物、诱导或抑制细胞色素P450肝酶的药物、致QT延长药物	无	其他药物无需调整剂量,同时无需对以下药物主动进行药物相互作用监测:抗逆转录病毒治疗药物与复方新诺明、诱导或抑制细胞色素P450肝酶的药物、致QT延长药物	无
发生耐药性的可能(产生耐药性的倾向或存在交叉耐药性)	方案中每种药物的突变率(在未选择的细菌群体中)每种细菌每代不应大于1/10⁷;治疗时对方案中的1种或多种药物的新耐药率低于2%,并且治疗前对药物不存在耐药性	在1种或多种药物的治疗过程中或治疗后获得或扩大耐药性的可能不高于标准治疗方案	方案中每种药物的突变率(在未选择的细菌群体中)每种细菌每代不应大于1/10⁹;治疗后,基本上没有获得性耐药(耐药率<0.1%),并且治疗前对方案中的药物不存在耐药性	在1种或多种药物的治疗过程中或治疗后获得或扩大耐药性的可能低于标准治疗方案
服药负荷	无	不大于当前的利福平敏感结核病标准治疗方案	无	成人剂量1片/d

表1

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