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Toward an Evidence-Based Nonclinical Road Map for Evaluating the Efficacy of New Tuberculosis (TB) Drug Regimens: Proceedings of a Critical Path to TB Drug Regimens-National Institute of Allergy and Infectious Diseases In Vivo Pharmacology Workshop for TB Drug Development.迈向基于证据的非临床路线图以评估新型结核病药物治疗方案的疗效：结核病药物治疗方案关键路径——美国国立过敏与传染病研究所结核病药物开发体内药理学研讨会会议记录
Antimicrob Agents Chemother. 2016 Jan 11;60(3):1177-82. doi: 10.1128/AAC.02041-15.
2
Preclinical Efficacy Testing of New Drug Candidates.新药候选物的临床前疗效测试。
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Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool.中空纤维结核系统作为一种新型药物研发工具的战略监管评估和认可。
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[Development of antituberculous drugs: current status and future prospects].[抗结核药物的研发：现状与未来前景]
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Comprehensive analysis of methods used for the evaluation of compounds against Mycobacterium tuberculosis.全面分析用于评估抗结核分枝杆菌化合物的方法。
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Preclinical study of new TB drugs and drug combinations in mouse models.新型结核病药物及药物组合在小鼠模型中的临床前研究。
Recent Pat Antiinfect Drug Discov. 2008 Jun;3(2):102-16. doi: 10.2174/157489108784746579.
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Drug therapy of experimental tuberculosis (TB): improved outcome by combining SQ109, a new diamine antibiotic, with existing TB drugs.实验性结核病的药物治疗：新型二胺类抗生素SQ109与现有结核病药物联合使用可改善治疗效果。
Antimicrob Agents Chemother. 2007 Apr;51(4):1563-5. doi: 10.1128/AAC.01326-06. Epub 2007 Jan 22.

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Proc Natl Acad Sci U S A. 2022 Apr 12;119(15):e2201632119. doi: 10.1073/pnas.2201632119. Epub 2022 Apr 5.
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Long-acting formulations for the treatment of latent tuberculous infection: opportunities and challenges.长效制剂治疗潜伏性结核感染：机遇与挑战。
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Assessment of Bactericidal Drug Activity and Treatment Outcome in a Mouse Tuberculosis Model Using a Clinical Beijing Strain.使用临床分离的北京株评估小鼠结核病模型中的杀菌药物活性和治疗效果。
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本文引用的文献

1
Preclinical Evaluations To Identify Optimal Linezolid Regimens for Tuberculosis Therapy.用于确定结核病治疗最佳利奈唑胺方案的临床前评估
mBio. 2015 Nov 3;6(6):e01741-15. doi: 10.1128/mBio.01741-15.
2
Forecasting Accuracy of the Hollow Fiber Model of Tuberculosis for Clinical Therapeutic Outcomes.中空纤维模型预测结核病临床治疗结局的准确性。
Clin Infect Dis. 2015 Aug 15;61 Suppl 1:S25-31. doi: 10.1093/cid/civ427.
3
Correlations Between the Hollow Fiber Model of Tuberculosis and Therapeutic Events in Tuberculosis Patients: Learn and Confirm.结核中空纤维模型与结核患者治疗事件的相关性：学习与确认。
Clin Infect Dis. 2015 Aug 15;61 Suppl 1:S18-24. doi: 10.1093/cid/civ426.
4
Systematic Analysis of Hollow Fiber Model of Tuberculosis Experiments.系统分析结核病实验中空纤维模型。
Clin Infect Dis. 2015 Aug 15;61 Suppl 1:S10-7. doi: 10.1093/cid/civ425.
5
Heterogeneous disease progression and treatment response in a C3HeB/FeJ mouse model of tuberculosis.C3HeB/FeJ小鼠结核病模型中的异质性疾病进展和治疗反应
Dis Model Mech. 2015 Jun;8(6):603-10. doi: 10.1242/dmm.019513. Epub 2015 Mar 30.
6
Pharmacokinetic-pharmacodynamic and dose-response relationships of antituberculosis drugs: recommendations and standards for industry and academia.抗结核药物的药代动力学-药效学及剂量反应关系：行业与学术界的建议和标准
J Infect Dis. 2015 Jun 15;211 Suppl 3:S96-S106. doi: 10.1093/infdis/jiu610.
7
Nonclinical models for antituberculosis drug development: a landscape analysis.抗结核药物研发的非临床模型：一项全景分析。
J Infect Dis. 2015 Jun 15;211 Suppl 3:S83-95. doi: 10.1093/infdis/jiv183.
8
Analysis of combination drug therapy to develop regimens with shortened duration of treatment for tuberculosis.分析联合药物治疗，以制定缩短结核病治疗疗程的方案。
PLoS One. 2014 Jul 8;9(7):e101311. doi: 10.1371/journal.pone.0101311. eCollection 2014.
9
The path of anti-tuberculosis drugs: from blood to lesions to mycobacterial cells.抗结核药物的作用途径：从血液到病灶再到分枝杆菌细胞。
Nat Rev Microbiol. 2014 Mar;12(3):159-67. doi: 10.1038/nrmicro3200. Epub 2014 Feb 3.
10
Differential virulence and disease progression following Mycobacterium tuberculosis complex infection of the common marmoset (Callithrix jacchus).结核分枝杆菌复合体感染普通卷尾猴（Callithrix jacchus）后的差异毒力和疾病进展。
Infect Immun. 2013 Aug;81(8):2909-19. doi: 10.1128/IAI.00632-13. Epub 2013 May 28.

迈向基于证据的非临床路线图以评估新型结核病药物治疗方案的疗效：结核病药物治疗方案关键路径——美国国立过敏与传染病研究所结核病药物开发体内药理学研讨会会议记录

Toward an Evidence-Based Nonclinical Road Map for Evaluating the Efficacy of New Tuberculosis (TB) Drug Regimens: Proceedings of a Critical Path to TB Drug Regimens-National Institute of Allergy and Infectious Diseases In Vivo Pharmacology Workshop for TB Drug Development.

作者信息

Nuermberger Eric, Sizemore Christine, Romero Klaus, Hanna Debra

机构信息

Center for Tuberculosis Research, Johns Hopkins University, Baltimore, Maryland, USA.

National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, Maryland, USA.

出版信息

Antimicrob Agents Chemother. 2016 Jan 11;60(3):1177-82. doi: 10.1128/AAC.02041-15.

DOI:10.1128/AAC.02041-15
PMID:26824941
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4775974/
Abstract

Novel tuberculosis (TB) drug regimens are urgently needed, and their development will be enabled by improved preclinical approaches that more effectively inform and ensure safe selection of clinical candidates and drug combination/regimens. An evidence-based approach for the assessment of nonclinical models supporting TB drug development has been proposed by a joint partnership between the National Institute of Allergy and Infectious Diseases (NIAID) and the Critical Path to TB Drug Regimens (CPTR) Consortium.

摘要

迫切需要新型结核病（TB）药物治疗方案，而改进的临床前方法将推动其研发，这些方法能更有效地为临床候选药物及药物组合/治疗方案的安全选择提供依据并确保其安全性。美国国立过敏与传染病研究所（NIAID）和结核病药物治疗方案关键路径（CPTR）联盟的联合合作伙伴关系提出了一种基于证据的方法，用于评估支持结核病药物研发的非临床模型。