伴侣动物用非细胞毒类抗肿瘤药临床试验设计及评价要点  

Analysis of Clinical Trial Design and Evaluation Points of Non-cytotoxic Antitumor Drugs for Companion Animals

作　　者：邱基程 杨宇欣 李格宾[1,3] 吴聪明 冯华兵[4] 汪霞 梁先明[5] 苏富琴[5] 曹兴元[1,2] QIU Ji-cheng;YANG Yu-xin;LI Ge-bin;WU Cong-ming;FENG Hua-bing;WANG Xia;LIANG Xian-ming;SU Fu-qin;CAO Xing-yuan(College of Veterinary Medicine,China Agricultural University,Beijing,100193,China;National Center for Veterinary Drug Safety Evaluation,Beijing,100193,China;China Agricultural University Veterinary Teaching Hospital,Beijing,100193,China;Husbandry and Veterinary Bureau,Ministry of Agriculture and Rural Affairs of the People's Republic of China Animal,Beijing,100125,China;China Institute of Veterinary Drug Control,Beijing,100081,China)

机构地区：[1]中国农业大学动物医学院,北京100193 [2]中国农业大学国家兽药安全评价中心,北京100193 [3]北京中农大动物医院有限公司,北京100193 [4]中华人民共和国农业农村部畜牧兽医局,北京100125 [5]中国兽医药品监察所,北京100081

出　　处：《中国兽药杂志》2022年第10期82-90,共9页Chinese Journal of Veterinary Drug

摘　　要：肿瘤已经成为影响伴侣动物生存和生活质量的主要疾病之一,伴侣动物临床罹患多种复杂、高异质性肿瘤,然而目前临床却面临无药可用的尴尬局面。相较于人肿瘤治疗目的,伴侣动物肿瘤治疗更关注患肿瘤动物生活质量的改善。非细胞毒类抗肿瘤药的靶向作用在肿瘤治疗过程中可以极大减少药物对伴侣动物自身的伤害,因而,被越来越多的研发者所关注。结合伴侣动物用非细胞毒类抗肿瘤药临床试验文献及技术指南要求对伴侣动物用非细胞毒类抗肿瘤药研发中的临床试验设计、疗效评价及其要点进行分析,旨在为伴侣动物非细胞毒类肿瘤药研发者提供参考。Tumors have become one of the main diseases affecting the survival and quality of life of companion animals. Suffered from a variety of complex and highly heterogeneous tumors, however, it is embarrassing that there is no effective drug available. Compared with the purpose of therapy for human tumor, the therapy of companion animal is more concerned with improving the condition of tumor-bearing animals. Nowadays, a growing number of researchers are paying attention to non-cytotoxic anti-tumor drugs for its’ targeting effects and greatly reducing the damage of drugs during the therapy. Based on literatures and guidelines, this article has briefly described the clinical trial design, efficacy evaluation and key points in the development of non-cytotoxic anti-tumor drugs for companion animals in order to provide reference for developers.

关 键 词：伴侣动物 非细胞毒类 抗肿瘤药 临床试验设计 疗效评价 

分 类 号：S859.79[农业科学—临床兽医学]