新药免疫毒性评价研究进展
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摘要
新药免疫系统毒性研究一直是国内外的研究热点。本文参照各国的指导原则,以及国内外免疫毒性研究的相关报道,对免疫毒性研究的技术要求、免疫毒性的评价流程、免疫毒性的评价实验、动物模型的选择、免疫毒性的组合策略及替代实验等进行综述,阐述免疫毒性的研究进展。
Immunotoxicity assessment of new drugs is always a focused area of frontier research at home and abroad. Based on the guidelines from regulatory agencies and findings of immunotoxicity research,this review will mainly discuss the followings: technical requirements,evaluation procedure,experiments for immunotoxicity assessment,selection of animal models,integrated and alternative approaches to immunotoxicity test.
Immunotoxicity assessment of new drugs is always a focused area of frontier research at home and abroad. Based on the guidelines from regulatory agencies and findings of immunotoxicity research,this review will mainly discuss the followings: technical requirements,evaluation procedure,experiments for immunotoxicity assessment,selection of animal models,integrated and alternative approaches to immunotoxicity test.
引文
[1]ONAKPOYA IJ,HENEGHAN CJ,ARONSON JK.Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions:a systematic review of the world literature[J].BMC Med,2016,14(1):1-11.
[2]GERMOLEC DR.Sensitivity and predictivity in immunotoxicity testing:immune endpoints and disease resistance[J].Toxicol Lett,2004,149(1-3):109-114.
[3]EMEA.CPMP/SWP/1042/99 Note for guidance on repeated-dose toxicity[S].2000:1.
[4]CDER(Center for Drug Evaluation and Research).Immunotoxicology evaluation of investigational new drugs[S].US Department of Health and Human Services,Food and Drug,2002:1-38.
[5]国家药品食品监督管理局药品审评中心.中药、天然药物免疫毒性(过敏性、光过敏反应)研究的技术指导原则)[S].指导原则编号:[Z]GPT5-1,2005:1-20.
[6]ICH.Guidance for industry.S8 immunotoxicology studies for human pharmaceuticals[S].Brussels:ICH,2005:1-13.
[7]GIANNAKOU C,PARK MV,DE JONG WH,et al.A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements[J].Int J Nanomedicine,2016,11:2935-2952.
[8]Japan Ministry of Health,Labour and Welfare.Guidance on the immunotoxicity study[S].Tokyo:Japan MHLW,2004:1-6.
[9]LUEBKE R,HOUSE R,KIMBER I.Emanuela corsini animal and in vitro models of immunotoxicity[M].New York:CRC Press,2007:66-68.
[10]ELMORE SA.Enhanced histopathology of the immune system:areview and update[J].Toxicol Pathol,2012,40(2):148-156.
[11]PUTMAN E,VAN DERLAANJW,VAN LOVEREN H.Assessing immunotoxicity:guidelines[J].Fundam Clin Pharmacol,2003,17(5):615-626.
[11]DOBROVOLSKAIA MA,MCNEIL SE.Understanding the correlation between in vitro and in vivo immunotoxicity tests for nanomedicines[J].J Control Release,2013,172(2):456-466.
[12]PICHLER WJ,BEELER A,KELLER M,et al.Pharmacological interaction of drugs with immune receptors:the p-i concept[J].Allergol Int,2006,55(1):17-25.
[13]WHITE KL JR,SHETH CM,PEACHEE VL.Comparison of primary immune responses to SRBC and KLH in rodents[J].J Immunotoxicol,2007,4(2):153-158.
[14]KAWAI R1,ITO S,AIDA T,et al.Evaluation of primary and secondary responses to a T-cell-dependent antigen,keyhole limpet hemocyanin,in rats[J].J Immunotoxicol,2013,10(1):40-48.
[15]GERMOLEC DR.Sensitivity and predictivity in immunotoxicity testing:immune endpoints and disease resistance[J].Toxicol Lett,2004,149(1-3):109-114.
[16]LUSTER MI,PORTIER C,PAIT DG,et al.Risk assessment in immunotoxicology.II.relationships between immune and host resistance tests[J].Fundam Appl Toxicol,1993,21(1):71-82.
[17]LUSTER MI,PORTIER C,PAIT DG,et al.Risk assessment in immunotoxicology.I.sensitivity and predictability of immune tests[J].Fundam Appl Toxicol,1992,18(2):200-210.
[18]SELGRADE MK,DANIELS MJ,DEAN JH.Correlation between chemical suppression of natural killer cell activity in mice and susceptibility to cytomegalovirus:rationale for applying murine cytomegalovirus as a host resistance model and for interpreting immunotoxicity testing in terms of risk of disease[J].J Toxicol Environ Health,1992,37(1):123-137.
[19]BOVERHOF DR,LADICS G,LUEBKE B,et al.Approaches and considerations for the assessment of immunotoxicity for environmental chemicals:a workshop summary[J].Regul Toxicol Pharmacol,2014,68(1):96-107.
[20]HARTUNG T,CORSINI E.Immunotoxicology:challenges in the21st century and in vitro opportunities[J].ALTEX,2013,30(4):411-426.
[21]GALBIATI V,MITJANS M,CORSINI E.Present and future of in vitro immunotoxicology in drug development[J].J Immunotoxicol,2010,7(4):255-267.
[22]TULINSKA J,KAZIMIROVA A,KURICOVA M,et al.Immunotoxicity and genotoxicity testing of PLGA-PEO nanoparticles in human blood cell model[J].Nanotoxicology,2015,9(1):33-43.
[23]MARKOVICˇT,GOBEC M,GURWITZ D,et al.Characterization of human lymphoblastoid cell lines as a novel in vitro test system to predict the immunotoxicity of xenobiotics[J].Toxicol Lett,2015,233(1):8-15.
[24]MORAG A,OVED K,GURWITZ D.Sex differences in human lymphoblastoid cells sensitivities to antipsychotic drugs[J].J Mol Neurosci,2013,49(3):554-558.
[2]GERMOLEC DR.Sensitivity and predictivity in immunotoxicity testing:immune endpoints and disease resistance[J].Toxicol Lett,2004,149(1-3):109-114.
[3]EMEA.CPMP/SWP/1042/99 Note for guidance on repeated-dose toxicity[S].2000:1.
[4]CDER(Center for Drug Evaluation and Research).Immunotoxicology evaluation of investigational new drugs[S].US Department of Health and Human Services,Food and Drug,2002:1-38.
[5]国家药品食品监督管理局药品审评中心.中药、天然药物免疫毒性(过敏性、光过敏反应)研究的技术指导原则)[S].指导原则编号:[Z]GPT5-1,2005:1-20.
[6]ICH.Guidance for industry.S8 immunotoxicology studies for human pharmaceuticals[S].Brussels:ICH,2005:1-13.
[7]GIANNAKOU C,PARK MV,DE JONG WH,et al.A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements[J].Int J Nanomedicine,2016,11:2935-2952.
[8]Japan Ministry of Health,Labour and Welfare.Guidance on the immunotoxicity study[S].Tokyo:Japan MHLW,2004:1-6.
[9]LUEBKE R,HOUSE R,KIMBER I.Emanuela corsini animal and in vitro models of immunotoxicity[M].New York:CRC Press,2007:66-68.
[10]ELMORE SA.Enhanced histopathology of the immune system:areview and update[J].Toxicol Pathol,2012,40(2):148-156.
[11]PUTMAN E,VAN DERLAANJW,VAN LOVEREN H.Assessing immunotoxicity:guidelines[J].Fundam Clin Pharmacol,2003,17(5):615-626.
[11]DOBROVOLSKAIA MA,MCNEIL SE.Understanding the correlation between in vitro and in vivo immunotoxicity tests for nanomedicines[J].J Control Release,2013,172(2):456-466.
[12]PICHLER WJ,BEELER A,KELLER M,et al.Pharmacological interaction of drugs with immune receptors:the p-i concept[J].Allergol Int,2006,55(1):17-25.
[13]WHITE KL JR,SHETH CM,PEACHEE VL.Comparison of primary immune responses to SRBC and KLH in rodents[J].J Immunotoxicol,2007,4(2):153-158.
[14]KAWAI R1,ITO S,AIDA T,et al.Evaluation of primary and secondary responses to a T-cell-dependent antigen,keyhole limpet hemocyanin,in rats[J].J Immunotoxicol,2013,10(1):40-48.
[15]GERMOLEC DR.Sensitivity and predictivity in immunotoxicity testing:immune endpoints and disease resistance[J].Toxicol Lett,2004,149(1-3):109-114.
[16]LUSTER MI,PORTIER C,PAIT DG,et al.Risk assessment in immunotoxicology.II.relationships between immune and host resistance tests[J].Fundam Appl Toxicol,1993,21(1):71-82.
[17]LUSTER MI,PORTIER C,PAIT DG,et al.Risk assessment in immunotoxicology.I.sensitivity and predictability of immune tests[J].Fundam Appl Toxicol,1992,18(2):200-210.
[18]SELGRADE MK,DANIELS MJ,DEAN JH.Correlation between chemical suppression of natural killer cell activity in mice and susceptibility to cytomegalovirus:rationale for applying murine cytomegalovirus as a host resistance model and for interpreting immunotoxicity testing in terms of risk of disease[J].J Toxicol Environ Health,1992,37(1):123-137.
[19]BOVERHOF DR,LADICS G,LUEBKE B,et al.Approaches and considerations for the assessment of immunotoxicity for environmental chemicals:a workshop summary[J].Regul Toxicol Pharmacol,2014,68(1):96-107.
[20]HARTUNG T,CORSINI E.Immunotoxicology:challenges in the21st century and in vitro opportunities[J].ALTEX,2013,30(4):411-426.
[21]GALBIATI V,MITJANS M,CORSINI E.Present and future of in vitro immunotoxicology in drug development[J].J Immunotoxicol,2010,7(4):255-267.
[22]TULINSKA J,KAZIMIROVA A,KURICOVA M,et al.Immunotoxicity and genotoxicity testing of PLGA-PEO nanoparticles in human blood cell model[J].Nanotoxicology,2015,9(1):33-43.
[23]MARKOVICˇT,GOBEC M,GURWITZ D,et al.Characterization of human lymphoblastoid cell lines as a novel in vitro test system to predict the immunotoxicity of xenobiotics[J].Toxicol Lett,2015,233(1):8-15.
[24]MORAG A,OVED K,GURWITZ D.Sex differences in human lymphoblastoid cells sensitivities to antipsychotic drugs[J].J Mol Neurosci,2013,49(3):554-558.