药物非临床发育神经毒性研究的神经病理学评价策略
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摘要
神经病理学评价是药物非临床发育神经毒性评价的重要组成部分和金标准,本文从发育神经毒性神经病理学评价的实验动物设计、优选的动物年龄、神经系统解剖和组织处理、以及病理结果的解释方面概述了标准化的发育神经毒性神经病理学评价原则和方法。介绍了药物非临床发育神经毒性研究神经病理学评价相关国际指导原则要求,为减少我国和其它国家及地区间实验程序的差异,为我国从事药物非临床发育神经毒性研究的病理学家提供一定参考。
Neuropathological evaluation is an important part and the gold standard of the evaluation of nonclinical developmental neurotoxicity(DNT) study of drugs. This article summarized standardized neuropathological evaluation principles and methods of DNT from the following aspects: the design of experimental animals, the optimal age of experimental animals, the necropsy and tissue process for nervous system and interpretation of pathological data. The paper also introduced the requirements of relevant international guidelines for neuropathological evaluation of nonclinical DNT of drugs in order to reduce the differences in the experimental procedures between China and other countries and regions and to provide references for pathologists engaging in nonclinical DNT study in China.
Neuropathological evaluation is an important part and the gold standard of the evaluation of nonclinical developmental neurotoxicity(DNT) study of drugs. This article summarized standardized neuropathological evaluation principles and methods of DNT from the following aspects: the design of experimental animals, the optimal age of experimental animals, the necropsy and tissue process for nervous system and interpretation of pathological data. The paper also introduced the requirements of relevant international guidelines for neuropathological evaluation of nonclinical DNT of drugs in order to reduce the differences in the experimental procedures between China and other countries and regions and to provide references for pathologists engaging in nonclinical DNT study in China.
引文
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[7]Anderson BJ.Plasticity of Gray Matter Volume:The Cellular and Synaptic Plasticity that Underlies Volumetric Change[J].Dev Psychobiol,2011,53(5):456–465.
[8]OECD(Organisation for Economic Co-operation and Development).(Test No.426)Developmental Neurotoxicity Study[EB/OL].(2007-01-01)[2017-03-30].http://www.oecd-ilibrary.org/environment/test-no-426-developmental-neurotoxicity-study_9789264067394-en.
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[11]Garman RH,Fix AS,Jortner BS,et al.Methods to Identify and Characterize Developmental Neurotoxicity for Human Health Risk Assessment II:Neuropathology[J].Environ Health Perspect,2001,109(2):93–100.
[12]Alok K,Sharma,James P.et al.Toxicologic Pathology Analysis for Translational Neuroscience:Improving Human Risk Assessment Using Optimized Animal Data[J].International Journal of Toxicology,2016,35(4):410-419.
[13]Garman RH,Li AA,Kaufmann W,et al.Recommended Methods for Brain Processing and Quantitative Analysis in Rodent Developmental Neurotoxicity Studies[J].Toxicol Pathol,2016,44(1):14-42.
[14]Duffell SJ,Soames AR,Gunby S.Morphometric Analysis of the Developing Rat Brain[J].Toxicol Pathol,2000,28(1):157-163.
[15]Powell KA,Wilson D.3-Dimensional Imaging Modalities for Phenotyping Genetically Engineered Mice[J].Vet Pathol,2012,49(1):106-115.
[16]Rao DB,Little PB,Malarkey DE,et al.Histopathological Evaluation of the Nervous System in National Toxicology Program Rodent Studies:A Modified Approach[J].Toxicol Pathol,2011,39(3):463-470.
[17]Morawietz G,Ruehlfehlert C,Kittel B,et al.Revised Guides for Organ Sampling and Trimming in Rats and Mice—Part3.A joint Publication of the RITA and NACAD Groups[J].Exp Toxicol Pathol,2004,55(6):433-449.
[18]Rao DB,Little PB,Sills RC.Subsite Awareness in Neuropathology Evaluation of National Toxicology Program(NTP)Studies:A Review of Select Neuroanatomical Structures with Their Functional Significance in Rodents[J].Toxicol Pathol,2014,42(3):487-509.
[19]Morgan DL,Little PB,Herr DW,et al.Neurotoxicity of Carbonyl Sulfide in F344 Rats Following Inhalation Exposure for up to 12 Weeks[J].Toxicol Appl Pharmacol,2004,200(2):131-145.
[20]Pardo ID,Garman RH,Weber K,et al.Technical Guide for Nervous System Sampling of the Cynomolgus Monkey for General Toxicity Studies[J].Toxicol Pathol,2012,40(4):624-636.
[21]Bolon B,Garman RH,Pardo ID,et al.STP Position Paper:Recommended Practices for Sampling and Processing the Nervous System(Brain,Spinal Cord,Nerve,and Eye)during Nonclinical General Toxicity Studies[J].Toxicol Pathol,2013,41(7):1028-1048.
[22]Summers BA,Cummings JF,De Lahunta A.Principles of Neuropathology:Veterinary Neuropathology[M].St Louis,MO:Mosby,1995:3-50.
[23]Bolon B,Bradley A,Garman R,et al.Useful Toxicologic Neuropathology References for Pathologists and Toxicologists[J].Toxicol Pathol,2011,39(1):234-239.
[24]Bolon B,Butt M.Fundamental Neuropathology for Pathologists and Toxicologists:Principles and Techniques[M].Hoboken,NJ:John Wiley&Sons,2011:513-514.
[25]Maurissen,J.Practical Considerations on the Design,Execution and Analysis of Developmental Neurotoxicity Studies to be Published in Neurotoxicology and Teratology[J].Neurotoxicol Teratol,2010,32(2):121-123.
[26]Kaufmann W,and Groters S.Developmental Neuropathology in DNT-Studies—A Sensitive Tool for the Detection and Characterization of Developmental Neurotoxicants[J].Reprod Toxicol,2006,22(2):196–213.
[2]Makris SL,Raffaele K,Allen S,et al.A retrospective Performance Assessment of the Developmental Neurotoxicity Study in Support of OECD Test Guideline426[J].Environ Health Perspect,2009,117(1):17-25.
[3]Raffaele KC,Rowland J,May B,et al.The Use of Developmental Neurotoxicity Data in Pesticide Risk Assessments[J].Neurotoxicol Teratol,2010,32(5):563-572.
[4]Tsuji R,and Crofton KM.Developmental Neurotoxicity Guideline Study:Issues With Methodology,Evaluation and Regulation[J].Congenit Anom(Kyoto),2012,52(3):122-128.
[5]Bolon B,Bradley A,Butt M,et al.Compilation of International Regulatory Guidance Documents for Neuropathology Assessment During Nonclinical General Toxicity and Specialized Neurotoxicity Studies[J].Toxicol Pathol,2011,39(1):92-96.
[6]Kaufmann W.Pathology Methods in Nonclinical Neurotoxicity Studies:The Developing Nervous System.In Fundamental Neuropathology for Pathologists and Toxicologists:Principles and Techniques(B.Bolon and M.Butt,eds.)[M].Hoboken,NJ:John Wiley&Sons,2011:339-363.
[7]Anderson BJ.Plasticity of Gray Matter Volume:The Cellular and Synaptic Plasticity that Underlies Volumetric Change[J].Dev Psychobiol,2011,53(5):456–465.
[8]OECD(Organisation for Economic Co-operation and Development).(Test No.426)Developmental Neurotoxicity Study[EB/OL].(2007-01-01)[2017-03-30].http://www.oecd-ilibrary.org/environment/test-no-426-developmental-neurotoxicity-study_9789264067394-en.
[9]OECD(Organisation for Economic Co-operation and Development).(Test No.443)Extended One-generation Reproductive Toxicity Study[EB/OL].(2012-01-01)[2017-03-30].http://www.oecd-ilibrary.org/environment/testno-443-extended-one-generationreproductive-toxicity-study_9789264185371-en;jsessionid?2flknsxwv043m.x-oecd-live-02.
[10]Bolon B,Garman R,Jensen K,et al.A"Best Practices"Approach to Neuropathologic Assessment in Developmental Neurotoxicity Testing—for today[J].Toxicol Pathol,2006,34(3):296-313.
[11]Garman RH,Fix AS,Jortner BS,et al.Methods to Identify and Characterize Developmental Neurotoxicity for Human Health Risk Assessment II:Neuropathology[J].Environ Health Perspect,2001,109(2):93–100.
[12]Alok K,Sharma,James P.et al.Toxicologic Pathology Analysis for Translational Neuroscience:Improving Human Risk Assessment Using Optimized Animal Data[J].International Journal of Toxicology,2016,35(4):410-419.
[13]Garman RH,Li AA,Kaufmann W,et al.Recommended Methods for Brain Processing and Quantitative Analysis in Rodent Developmental Neurotoxicity Studies[J].Toxicol Pathol,2016,44(1):14-42.
[14]Duffell SJ,Soames AR,Gunby S.Morphometric Analysis of the Developing Rat Brain[J].Toxicol Pathol,2000,28(1):157-163.
[15]Powell KA,Wilson D.3-Dimensional Imaging Modalities for Phenotyping Genetically Engineered Mice[J].Vet Pathol,2012,49(1):106-115.
[16]Rao DB,Little PB,Malarkey DE,et al.Histopathological Evaluation of the Nervous System in National Toxicology Program Rodent Studies:A Modified Approach[J].Toxicol Pathol,2011,39(3):463-470.
[17]Morawietz G,Ruehlfehlert C,Kittel B,et al.Revised Guides for Organ Sampling and Trimming in Rats and Mice—Part3.A joint Publication of the RITA and NACAD Groups[J].Exp Toxicol Pathol,2004,55(6):433-449.
[18]Rao DB,Little PB,Sills RC.Subsite Awareness in Neuropathology Evaluation of National Toxicology Program(NTP)Studies:A Review of Select Neuroanatomical Structures with Their Functional Significance in Rodents[J].Toxicol Pathol,2014,42(3):487-509.
[19]Morgan DL,Little PB,Herr DW,et al.Neurotoxicity of Carbonyl Sulfide in F344 Rats Following Inhalation Exposure for up to 12 Weeks[J].Toxicol Appl Pharmacol,2004,200(2):131-145.
[20]Pardo ID,Garman RH,Weber K,et al.Technical Guide for Nervous System Sampling of the Cynomolgus Monkey for General Toxicity Studies[J].Toxicol Pathol,2012,40(4):624-636.
[21]Bolon B,Garman RH,Pardo ID,et al.STP Position Paper:Recommended Practices for Sampling and Processing the Nervous System(Brain,Spinal Cord,Nerve,and Eye)during Nonclinical General Toxicity Studies[J].Toxicol Pathol,2013,41(7):1028-1048.
[22]Summers BA,Cummings JF,De Lahunta A.Principles of Neuropathology:Veterinary Neuropathology[M].St Louis,MO:Mosby,1995:3-50.
[23]Bolon B,Bradley A,Garman R,et al.Useful Toxicologic Neuropathology References for Pathologists and Toxicologists[J].Toxicol Pathol,2011,39(1):234-239.
[24]Bolon B,Butt M.Fundamental Neuropathology for Pathologists and Toxicologists:Principles and Techniques[M].Hoboken,NJ:John Wiley&Sons,2011:513-514.
[25]Maurissen,J.Practical Considerations on the Design,Execution and Analysis of Developmental Neurotoxicity Studies to be Published in Neurotoxicology and Teratology[J].Neurotoxicol Teratol,2010,32(2):121-123.
[26]Kaufmann W,and Groters S.Developmental Neuropathology in DNT-Studies—A Sensitive Tool for the Detection and Characterization of Developmental Neurotoxicants[J].Reprod Toxicol,2006,22(2):196–213.