抽象
通过长时间使用bedaquiline的XDR-TB的治疗是适当的某些人http://ow.ly/VmpN30fzReK
致编辑:
我们饶有兴趣地阅读用C文章aminero等。[1]提出一种标准化方法来治疗这两种预广泛耐药结核(预XDR-TB)和广泛耐药结核(XDR-TB)。这个建议是欢迎考虑证据为基础的建议,高度耐药结核病(TB)的最佳管理的缺乏[2]。考虑到与前XDR和XDR-TB相关的患病率,发病率和死亡率的增加识别,以及在治疗结果与使用新的显著改善和改变用途的药物[3],迫切需要对这些形式TB的优化管理的明确政策。
We note that the article emphasises the use of one or both newer TB drugs, bedaquiline or delamanid, and the necessity to include them throughout the treatment or for a minimum of 13–15 months. Global discussion about the prolonged use of bedaquiline beyond 6 months for the treatment of some individuals with multidrug-resistant TB (MDR-TB) has increased [4]。一世ndeed, in 2017 the World Health Organization (WHO) Guidelines Development Group Meeting Report on the use of bedaquiline for the treatment of MDR-TB noted that bedaquiline has been used for longer than 6 months in some populations of limited size with no additional safety concerns being seen [五]。随附的常见问题(FAQ)文件,指出在2013和指南可在认为bedaquiline使用超过24周的建议“...治疗医师的判断...” [6]。尽管有这些陈述,对长时间使用bedaquiline的不确定性已经出现临床医生之间,技术援助伙伴和国家结核病防治规划,他们都依赖于WHO指南更新通知本地做法和建议。直到有更多的临床和规划证据进行收集和分析,长时间使用bedaquiline的支持与MDR-TB选择的个体,原因如下:1)被选定为bedaquiline管理的24周时间,以方便及时的阶段-IIB临床完成试验。另外,延长校正的QT间期(QTc)中,用bedaquiline主要安全性的关注,周8和治疗的12之间的峰。2)通过严格的监管部门批准的临床试验方案还允许长时间使用bedaquiline,即使在患者没有高度耐药的疾病类型[7]。3)从居住与预XDR和XDR人队列证据支持的有效性和长期bedaquiline使用安全,这在谁拥有高度耐药结核病或延迟文化转换的人群受益。Ëxtension of bedaquiline use was associated with culture conversion in most subjects who received the drug for an extended period (median 361 days) with safety parameters comparable to those who received only 24 weeks of bedaquiline [8]。4)有可用于治疗患有高度抗性TB选项的数量有限。因此,停止药物既杀菌,也无需在方案类似的核心药物,实现了非治愈复发的特点杀菌是有风险的。This is especially true in the case of bedaquiline, which has a prolonged terminal elimination half-life of almost 6 months. If this medication is stopped and there are not sufficient active agents left in the regimen, mycobacteria may multiply, which, in the setting of low levels of bedaquiline, could lead to the development of resistance. For patients already at high risk of treatment failure or relapse, this could leave them with few or potentially no efficacious therapeutic options. 5) The “off-label” use of medication to treat MDR-TB is common. Many types of medication, such as fluoroquinolones, linezolid and clofazimine, are recommended for use in MDR-TB without a registered indication for TB [9]。耐多药结核病是公共卫生突发事件,如无标签使用不仅是临床合理的,但是从公共健康和道德的角度至关重要,因此被捐助者的资金支持。这些相同的考虑必须扩展到新的抗结核药物,所提供的经验和关闭标签的方式接收他们的个人成果被认真地记录。
这是与MDR-TB的生活,特别是对疾病的高抗形式的个体人的处理一个激动人心的时刻。虽然从随机临床试验,临床医生,政策制定者和患有结核病等待证据必须做出关于新药的最佳利用的选择。这就需要风险和收益进行仔细分析;however, in the case of bedaquiline use beyond 24 weeks, the potential benefits will outweigh the risks for many. As always, thoughtful discussions between providers and people receiving treatment should guide choices [10]。然而,当务之急是全球和国家政策制定者和捐助者支持对患者的MDR-TB长时间使用bedaquiline的需要,允许约标示外使用的决定,由临床医生和接受治疗进行。这样的使用将通过对MDR-TB治疗的统一而灵活的指导方针来促进。这样的全面准则的实施将通过其捐助者支持创新和周围延长bedaquiline管理业务研究得到进一步加强。
脚注
利益冲突:无申报。
- 收到2017年7月29日。
- 公认2017年8月11日。
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