医疗器械/医用材料动物实验研究
|
摘要
动物实验研究是医疗器械/医用材料临床前安全性有效性评估的重要手段,其独特性在于研究范围广,无通用方法,故而,在该类研究的设计和执行上,需要进行多方面考虑。该文通过介绍医疗器械/医用材料动物实验研究的背景及法规,方案设计的参考原则及考虑因素,结果分析要点,实验期间的质量保证等内容,以期望为行业内研究人员提供参考。
Animal research of medical devices/medical materials is an essential part of preclinical safety and efficacy evaluation. Many questions should be taken in considerations when it comes to design and conduction animal research of medical devices/medical materials because of its uniqueness. This kind of research has widespread studying objects while has no universal standard method, and should be designed case-by-case. This article is aimed at serving as a reference for sponsors and researchers when performing preclinical safety and efficacy evaluation of medical devices/medical materials.
Animal research of medical devices/medical materials is an essential part of preclinical safety and efficacy evaluation. Many questions should be taken in considerations when it comes to design and conduction animal research of medical devices/medical materials because of its uniqueness. This kind of research has widespread studying objects while has no universal standard method, and should be designed case-by-case. This article is aimed at serving as a reference for sponsors and researchers when performing preclinical safety and efficacy evaluation of medical devices/medical materials.
引文
[1]杨国忠.在医疗器械监管中要重视临床前试验这一环节[J].中国医疗器械信息,2010,16(3):59-60.
[2]施新猷,王四旺,顾为望,等.比较医学[M].西安:陕西科学技术出版社,2003.
[3]IQBAL J,CHAMBERLAIN J,FRANCIS S E,et al.Role of animal models in coronary stenting[J].Ann Biomed Eng,2016,44(2):453-465.
[4]European Medicines Agency,London.Guideline on the clinical and non clinical evaluation during the consultation procedure on medicinal substances contained in drugeluting(Medical substanceeluting)coronary stents[Z].(2008-05-30)[2018-07-10].
[5]食品药品监管总局器审中心.冠状动脉药物洗脱支架临床前研究技术审查指导原则征求意见稿[Z].(2017-9-28)[2018-07-10].
[6]路慧彬,韩新巍.气道内支架:动物实验研究的现状与进展[J].介入放射学杂志,2009,18(1):72-75.
[7]韩倩倩,李青,王宝全,等.角膜修复材料有效性评价动物模型的建立和验证[J].中国组织工程研究,2017,21(34):5499-5505.
[8]DIAMOND M P,LINSKY C B,CUNNINGHAM T,et al.A model for sidewall adhesions in the rabbit:reduction by an absorbable barrier[J].Microsurg,1987,8:197-200
[9]NOVOTNY T,JERABEK J,VESELY K,et al.Evaluation of a knitted polytetrafluoroethylene mesh placed intraperitoneally in a New Zealand white rabbit model[J].Surg Endosc,2012,26(7):1884-1891.
[10]朱姝,付越,刘雪梅,等.新型生物陶瓷材料iRoot FM作为乳牙根管填充材料的动物实验研究[J].中国实用口腔科杂志,2017,10(10):626-634.
[11]CARDOSO M,CATR D,NOITES R,et al.Animal models used in furcation perforation studies:a systematic review and comprehensive synthesis of model characteristics[J].Aust Endod J,2017,44:273-280.
[12]NUHOGLU F,ALTIPARMAK U E,HAZIROLAN D O,et al.Comparison of sutures and cyanoacrylate tissue adhesives for wound repair in a rat model of corneal laceration[J].Ophthalmic Res,2013,49(4):199-204.
[13]ISO 10993.6:2016 Biological evaluation of medical devices--Part6:Tests for local effects after implantation[S].Switzerland,IHS,2016.
[14]IQBAL J,CHAMBERLAIN J,FRANCIS S E,et al.Role of animal models in coronary stenting[J].Ann Biomed Eng,2016,44(2):453-465.
[15]陈艺丹,潘一峰,赵天力.可降解室间隔缺损封堵器的安全性与有效性的动物实验研究[J].中国现代医学杂志,2017,27(13):44-49.
[16]张本,徐同毅,李鑫,等.高分子心瓣膜材料的体内评价:一种新型大动物模型[J].中华实验外科杂志,2014,31(10):2335-2337.
[17]VONARX T,COCHRAN D L,HERMANN J S,et al.Lateral ridge augmentation using different bone fillers and barrier membrane application:a histologic and histomorphometric pilot study in the canine mandible[J].Clin Oral Implants Res,2001,12(3):260-269.
[18]HAAS R,BARON M,DONATH K,et al.Porous hydroxyapatite for grafting the maxillary sinus:a comparative histomorphometric study in sheep[J].Int J Oral Maxillofac Implants,2002,17(3):337-346.
[19]ISO 10993.11:2017 Biological evaluation of medical devices--Part 11:Tests for systemic toxicity[S].Switzerland,IHS,2017.
[20]周宗灿.毒理学教程(第三版)[M].北京:北京大学医学出版社,2006.
[21]颜波,施瑞华,冯亚东,等.新型可降解食管支架动物实验研究[J].介入放射学杂志,2016,25(2):155-159.
[22]闵捷,陈熹,唐华,等.可降解镁锌合金肋骨固定器的设计制备与动物实验研究[J].中华胸部外科电子杂志,2015,2(1):63-68.
[23]DE JONG W H,BERGAMA J E,ROBINSON J E,et al.Tissue response to partially in vitro predegraded poly-L-lactide implants[J].Biomaterials,2005,26:1781-1791.
[24]食品药品监管总局器审中心.腹腔内置疝修补补片动物实验技术审查指导原则征求意见稿[Z].(2016-6-22)[2018-07-10].
[25]牛军强,王亚楠,朱芊各,等.动物实验方法学和报告质量评估工具的横断面研究[J].中国循证医学杂志,2015,15(2):223-229.
[26]U.S.Department of Health and Human Services.Considerations for animal studies for medical device-draft guidance for industry and food and drug administration staff[Z].(2010-7-29)[2018-07-10].
[27]KILKENNY C,BROWNE W J,CUTHILL I C,et al.The ARRIVE(animal research:reporting of in vivo experiments)guidelines[Z].PLOS Biology,(2017-07)[2018-07-10].
[2]施新猷,王四旺,顾为望,等.比较医学[M].西安:陕西科学技术出版社,2003.
[3]IQBAL J,CHAMBERLAIN J,FRANCIS S E,et al.Role of animal models in coronary stenting[J].Ann Biomed Eng,2016,44(2):453-465.
[4]European Medicines Agency,London.Guideline on the clinical and non clinical evaluation during the consultation procedure on medicinal substances contained in drugeluting(Medical substanceeluting)coronary stents[Z].(2008-05-30)[2018-07-10].
[5]食品药品监管总局器审中心.冠状动脉药物洗脱支架临床前研究技术审查指导原则征求意见稿[Z].(2017-9-28)[2018-07-10].
[6]路慧彬,韩新巍.气道内支架:动物实验研究的现状与进展[J].介入放射学杂志,2009,18(1):72-75.
[7]韩倩倩,李青,王宝全,等.角膜修复材料有效性评价动物模型的建立和验证[J].中国组织工程研究,2017,21(34):5499-5505.
[8]DIAMOND M P,LINSKY C B,CUNNINGHAM T,et al.A model for sidewall adhesions in the rabbit:reduction by an absorbable barrier[J].Microsurg,1987,8:197-200
[9]NOVOTNY T,JERABEK J,VESELY K,et al.Evaluation of a knitted polytetrafluoroethylene mesh placed intraperitoneally in a New Zealand white rabbit model[J].Surg Endosc,2012,26(7):1884-1891.
[10]朱姝,付越,刘雪梅,等.新型生物陶瓷材料iRoot FM作为乳牙根管填充材料的动物实验研究[J].中国实用口腔科杂志,2017,10(10):626-634.
[11]CARDOSO M,CATR D,NOITES R,et al.Animal models used in furcation perforation studies:a systematic review and comprehensive synthesis of model characteristics[J].Aust Endod J,2017,44:273-280.
[12]NUHOGLU F,ALTIPARMAK U E,HAZIROLAN D O,et al.Comparison of sutures and cyanoacrylate tissue adhesives for wound repair in a rat model of corneal laceration[J].Ophthalmic Res,2013,49(4):199-204.
[13]ISO 10993.6:2016 Biological evaluation of medical devices--Part6:Tests for local effects after implantation[S].Switzerland,IHS,2016.
[14]IQBAL J,CHAMBERLAIN J,FRANCIS S E,et al.Role of animal models in coronary stenting[J].Ann Biomed Eng,2016,44(2):453-465.
[15]陈艺丹,潘一峰,赵天力.可降解室间隔缺损封堵器的安全性与有效性的动物实验研究[J].中国现代医学杂志,2017,27(13):44-49.
[16]张本,徐同毅,李鑫,等.高分子心瓣膜材料的体内评价:一种新型大动物模型[J].中华实验外科杂志,2014,31(10):2335-2337.
[17]VONARX T,COCHRAN D L,HERMANN J S,et al.Lateral ridge augmentation using different bone fillers and barrier membrane application:a histologic and histomorphometric pilot study in the canine mandible[J].Clin Oral Implants Res,2001,12(3):260-269.
[18]HAAS R,BARON M,DONATH K,et al.Porous hydroxyapatite for grafting the maxillary sinus:a comparative histomorphometric study in sheep[J].Int J Oral Maxillofac Implants,2002,17(3):337-346.
[19]ISO 10993.11:2017 Biological evaluation of medical devices--Part 11:Tests for systemic toxicity[S].Switzerland,IHS,2017.
[20]周宗灿.毒理学教程(第三版)[M].北京:北京大学医学出版社,2006.
[21]颜波,施瑞华,冯亚东,等.新型可降解食管支架动物实验研究[J].介入放射学杂志,2016,25(2):155-159.
[22]闵捷,陈熹,唐华,等.可降解镁锌合金肋骨固定器的设计制备与动物实验研究[J].中华胸部外科电子杂志,2015,2(1):63-68.
[23]DE JONG W H,BERGAMA J E,ROBINSON J E,et al.Tissue response to partially in vitro predegraded poly-L-lactide implants[J].Biomaterials,2005,26:1781-1791.
[24]食品药品监管总局器审中心.腹腔内置疝修补补片动物实验技术审查指导原则征求意见稿[Z].(2016-6-22)[2018-07-10].
[25]牛军强,王亚楠,朱芊各,等.动物实验方法学和报告质量评估工具的横断面研究[J].中国循证医学杂志,2015,15(2):223-229.
[26]U.S.Department of Health and Human Services.Considerations for animal studies for medical device-draft guidance for industry and food and drug administration staff[Z].(2010-7-29)[2018-07-10].
[27]KILKENNY C,BROWNE W J,CUTHILL I C,et al.The ARRIVE(animal research:reporting of in vivo experiments)guidelines[Z].PLOS Biology,(2017-07)[2018-07-10].
© 2004-2018 中国地质图书馆版权所有 京ICP备05064691号 京公网安备11010802017129号 地址：北京市海淀区学院路29号 邮编：100083 电话：办公室：(+86 10)66554848；文献借阅、咨询服务、科技查新：66554700 |