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中国药学会团体标准 T/Cpharma×××—2020××× 中国药学会团体标准 T/CPHARMA×××—2020××× 毒性病理学术语集（第一版） Terminology of Toxicologic Pathology（1st Edition） （稿件类型：公开征求意见稿） （本稿完成时间：2020 年 7 月 31 日） 2020-××-××发布 2020-××-××实施 中 国 药 学 会 发布 I T/CPHARMA×××—2020××× 目 次 前言 I 引言 I 1 范围 1 2 规范性引用文件 1 3 术语 1 4 总则 1 参考文献 2 附录 临床前毒性病理标准诊断术语 4 I 前 言 本标准按照 GB/T1.1《标准化工作导则第 1 部分：标准的结构和 编写》给出的规则起草。 本标准由中国药学会归口。 本标准起草单位：中国药学会毒性病理专业委员会 1 引 言 药物安全性是药物三个基本要素的首位，临床前药物安全性评价 是新药进入最终临床试验和上市前的必要程序和重要步骤。因此，临 床前药物安全性评价是新药研发中的关键环节，而毒性病理学是临床 前药物安全性评价的核心和基础，并发挥着不可替代的重要作用。通 过毒性病理学的检查，能够判断药物造成病理损伤的部位、程度、性 质和预后等基本问题，为临床前药物安全性评价提供最重要的依据。 目前我国毒性病理学所用术语不统一、不规范，诊断水平有待提高， 而且实验动物病理学研究较薄弱，与发达国家仍有较大的差距，也是 中国创新药进入国际市场、获得国际认可亟需解决的关键瓶颈和技术 壁垒。 因此，为提高我国临床前药物安全性评价毒性病理学研究水平， 促进毒性病理学术语的专业化、标准化、规范化，并尽快与国际接轨， 更好地发挥毒性病理学在新药研发中的重要作用，促进我国生物医药 产业走向国际主流市场。中国药学会毒性病理专业委员会参考已发表 的《大鼠和小鼠病理变化术语及诊断标准的国际协调》系列文章以及 已出版的国内外权威毒性病理学书籍及译著，采用中英文对照，实用 性强、使用方便的原则，特制订该标准。 1 毒性病理学术语集（第一版） 1 范围 本标准规范了中英对照毒性病理学术语。 本标准适用于高等院校、科研机构、政府监管部门以及从事生物 医药、保健食品、化妆品及医疗器械安全性评价的机构或合同研究组 织，也适用于毒性病理学教学、科研、诊断、出版及翻译等领域。 2 规范性引用文件 下列文件对于本标准的引用是必不可少的。凡是注日期的引用文 件，仅所注日期的版本适用于本标准。凡是不注日期的引用文件，其 最新版本（包括所有的修改单）适用于本标准。 RB/T 193-2015 3 术语 见附录《毒性病理学术语集（第一版）》。 4 总则 毒性病理诊断人员在进行诊断和报告时，应当使用专业、规范和 标准的毒性病理学术语。 1 参 考 文 献 1. Proliferative and Non-Proliferative Lesions of the Rat and Mouse Integument. J Toxicol Pathol 2013; 26 (3 Suppl): 27S - 57S 2. Proliferative and Nonproliferative Lesions of the Rat and Mouse Hepatobiliary System. Toxicologic Pathology, 38: 5S-81S, 2010 3. Nonproliferative and Proliferative Lesions of the Rat and Mouse Skeletal Tissues (Bones, Joints, and Teeth). J Toxicol Pathol 2016; 29 (3 Suppl): 49S - 103S 4. Proliferative and Nonproliferative Lesions of the Rat and Mouse Respiratory Tract. Toxicologic Pathology, 37: 5S - 73S, 2009. 5. Nonproliferative and Proliferative Lesions of the Rat and Mouse Hematolymphoid System. Toxicologic Pathology 2019, Vol. 47(6) 665-783 6. Proliferative and Nonproliferative Lesions of the Rat and Mouse Urinary System. Toxicologic Pathology, 40: 14S-86S, 2012. 7. Nonproliferative and Proliferative Lesions of the Rat and Mouse Endocrine System. J Toxicol Pathol 2018; 31 (3 Suppl): 1S-95S 8. Proliferative and Non-Proliferative Lesions of the Rat and Mouse Soft Tissue, Skeletal Muscle and Mesothelium. J Toxicol Pathol 2013; 26 (3 Suppl): 1S - 26S 9. Proliferative and Nonproliferative Lesions of the Rat and Mouse Central and Peripheral Nervous Systems. Toxicologic Pathology, 40: 87S - 157S, 2012 10. Nonproliferative and Proliferative Lesions of the Rat and Mouse Female Reproductive System. J Toxicol Pathol 2014; 27 (3&4 Suppl): 1S-107S 11. Proliferative and Nonproliferative Lesions of the Rat and Mouse Male Reproductive System. Toxicologic Pathology, 40: 40S-121S, 2012 12. Nonproliferative and Proliferative Lesions of the Rat and Mouse Special Sense Organs (Ocular [eye and glands], Olfactory and Otic). J Toxicol Pathol 2018; 31 (3 Suppl): 97S–214S 13. Proliferative and Nonproliferative Lesions of the Rat and Mouse Mammary, Zymbal’s, Preputial, and Clitoral Glands. Toxicologic Pathology, 40: 7S-39S, 2012 2 14. Nonproliferative and Proliferative Lesions of the Gastrointestinal Tract, Pancreas and Salivary Glands of the Rat and Mouse. J Toxicol Pathol 2016; 29 (1 Suppl): 1S-124S 15. Non-proliferative and Proliferative Lesions of the Cardiovascular System of the Rat and Mouse. J Toxicol Pathol 2016; 29 (3 Suppl): 1S-47S 16. CDISC SEND Controlled Terminology, 2019-09-27 17. 《毒理病理学非临床安全性评价》。北京科学技术出版社，2018 年，Pritam S. Sahota 等著，吕建军等主译。 18. 《临床前毒性试验的组织病理学-药物安全性评价中的解释与相关性-第 4 版》。北京科学技术出版社，2018 年，Peter Greaves 著，王和枚等主译。 19. 《毒理病理学图谱》。北京科技出版社，2017 年，Chirukandath Gopinath 等 著，胡春燕等主译。 20. 《毒理病理学基础（第二版）》。军事医学科学出版社，2014 年，Wanda M. Haschek 等著，刘克俭等主译。 21. 《图解毒性病理学》。云南科学技术出版社，2016 年，任进等著。 22. 《实验动物背景病变彩色图谱》。北京科学技术出版社，2018 年，Elizabeth F. McInnes 著，孔庆喜等主译。 3 附录：毒性病理学术语集（第一版） 目 录 ( 英中对照，以英文首字母 A-Z 的顺序排列 ) ( 中英对照，以汉语拼音首字母 A-Z 的顺序排列 ) A ....................................................................... 1-14 a ........................................................................ 170 B ..................................................................... 15-19 b ............................................................... 171-177 C ..................................................................... 20-35 c ................................................................. 178-182 D ..................................................................... 36-43 d ................................................................. 183-189 E ..................................................................... 44-50 e ................................................................. 190-196 F ..................................................................... 51-56 f ................................................................ 197-202 G ..................................................................... 57-62 g ................................................................. 203-208 H ..................................................................... 63-74 h ................................................................. 209-214 I ..................................................................... 75-83 j ................................................................. 215-227 J .......................................................................... 84 k ................................................................. 228-230 K .......................................................................... 85 l ................................................................. 231-241 L ..................................................................... 86-91 m ................................................................. 242-246 M ................................................................... 92-103 n ................................................................. 247-251 N ................................................................. 104-110 o ........................................................................ 252 O .................................................................. 111-114 p ................................................................ 253-257 P ................................................................. 115-126 q ................................................................ 258-260 Q ........................................................................ 127 r ................................................................ 261-263 R ................................................................. 128-131 s ................................................................. 264-278 S ................................................................. 132-141 t ................................................................. 279-281 T ................................................................. 142-148 w ................................................................. 282-285 U ................................................................. 149-150 x ................................................................. 286-300 V ................................................................. 151-154 y ................................................................. 301-310 W ........................................................................ 155 z ................................................................. 311-328 X ........................................................................ 156 Y ........................................................................ 157 Z ........................................................................ 158 英文常规缩写词 ( 以英文首字母 A-Z 的顺序排列 ) A-Z ..............................................................
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