Hofman S, Segers M M, Ghimire S, Bolhuis M S, Sturkenboom M G G, Van Soolingen D, Alffenaar J W C
a University of Groningen , University Medical Center Groningen, Department of Clinical Pharmacy and Pharmacology , Groningen , the Netherlands.
b Departments of Pulmonary Diseases and Medical Microbiology , Nijmegen Medical Center, Radboud University , Nijmegen , The Netherlands.
Expert Opin Emerg Drugs. 2016;21(1):103-16. doi: 10.1517/14728214.2016.1151000. Epub 2016 Feb 20.
Tuberculosis (TB) remains a global health problem. Drug resistance, treatment duration, complexity, and adverse drug reactions associated with anti-TB regimens are associated with treatment failure, prolonged infectiousness and relapse. With the current set of anti-TB drugs the goal to end TB has not been met. New drugs and new treatment regimens are needed to eradicate TB.
Literature was explored to select publications on drugs currently in phase II and phase III trials. These include new chemical entities, immunotherapy, established drugs in new treatment regimens and vaccines for the prophylaxis of TB.
Well designed trials, with detailed pharmacokinetic/pharmacodynamic analysis, in which information on drug exposure and drug susceptibility of the entire anti-TB regimen is included, in combination with long-term follow-up will provide relevant data to optimize TB treatment. The new multi arm multistage trial design could be used to test new combinations of compounds, immunotherapy and therapeutic vaccines. This new approach will both reduce the number of patients exposed to inferior treatment and the financial burden. Moreover, it will speed up drug evaluation. Considering the investments involved in development of new drugs it is worthwhile to thoroughly investigate existing, non-TB drugs in new regimens.
结核病仍然是一个全球性的健康问题。耐药性、治疗持续时间、复杂性以及与抗结核治疗方案相关的药物不良反应与治疗失败、传染性延长和复发有关。使用现有的抗结核药物，终结结核病的目标尚未实现。需要新药和新的治疗方案来根除结核病。
对文献进行了检索，以挑选出关于目前处于II期和III期试验的药物的出版物。这些包括新的化学实体、免疫疗法、新治疗方案中的现有药物以及预防结核病的疫苗。
精心设计的试验，结合详细的药代动力学/药效学分析，其中纳入整个抗结核治疗方案的药物暴露和药物敏感性信息，并进行长期随访，将提供相关数据以优化结核病治疗。新的多臂多阶段试验设计可用于测试化合物、免疫疗法和治疗性疫苗的新组合。这种新方法将减少接受劣质治疗的患者数量和经济负担。此外，它将加快药物评估。考虑到新药研发的投入，在新方案中彻底研究现有的非结核药物是值得的。
