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

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

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

Key words:  Companion animals  Non-cytotoxic  Anti-tumor drugs  Clinical trial design  Efficacy evaluation

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。本文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、疗效评价及其要点浅述，旨在为伴侣动物非细胞毒类肿瘤药研发者提供参考。

Abstract:

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.