Joachim Anja, Altreuther Gertraut, Bangoura Berit, Charles Sam, Daugschies Arwid, Hinney Barbara, Lindsay David S, Mundt Hans-Christian, Ocak Marion, Sotiraki Smaragda
Institute of Parasitology, Department of Pathobiology, University of Veterinary Medicine Vienna, Veterinaerplatz 1, 1210 Vienna, Austria.
Bayer Animal Health GmbH, 51373 Leverkusen, Germany.
Vet Parasitol. 2018 Apr 15;253:102-119. doi: 10.1016/j.vetpar.2018.02.029. Epub 2018 Feb 15.
This guideline is intended as an aid in the design, implementation and interpretation of studies for the assessment of drug efficacy against Eimeria in cattle and sheep, Cystoisospora in pigs and dogs, and Cryptosporidium in cattle. It deals with the most important aspects of how to conduct both experimental and field studies for dose determination, dose confirmation and assessment of field effectiveness. Also, guidance on the selection of animals, diagnostic techniques, statistical evaluation and methods for the preparation, maintenance and use of parasites is provided. The specific management conditions that may influence the course of natural infections and consequently determine treatment schemes are mentioned and suggestions for best practice in sampling and evaluation of data prior to conducting of efficacy studies are given. The guideline is also intended to assist investigators in carrying out specific studies, provide relevant information for registration authorities involved in the decision-making process, assist in the approval of anticoccidial drugs in the target species, and facilitate the world-wide adoption of standard procedures. Although currently not implemented, issues of drug resistance testing and alternative methods for drug testing are also discussed as future issues in drug testing against mammalian coccidia.
本指南旨在协助设计、实施和解读用于评估牛和羊抗艾美耳球虫、猪和犬抗等孢球虫以及牛抗隐孢子虫药物疗效的研究。它涉及如何开展实验研究和现场研究以确定剂量、确认剂量以及评估现场效果等最重要的方面。此外,还提供了关于动物选择、诊断技术、统计评估以及寄生虫制备、保存和使用方法的指导。文中提及了可能影响自然感染进程并因此决定治疗方案的具体管理条件,并给出了在开展疗效研究之前进行数据采样和评估的最佳实践建议。本指南还旨在协助研究人员开展特定研究,为参与决策过程的注册机构提供相关信息,协助批准目标物种的抗球虫药物,并促进全球采用标准程序。尽管目前尚未实施,但也讨论了耐药性检测问题以及药物检测的替代方法,作为未来针对哺乳动物球虫进行药物检测的议题。