体外膜氧合(extracorporeal membrane oxygenation,ECMO)作为体外生命支持(extracorporeal life support,ECLS)技术的一种,用于部分或完全替代患者心肺功能,目前已得到广泛应用.在该产品的研发过程中,由于血液保存时间限制等原因,需要通过动物试验进行必要的产品性能验证和安全性评估,为临床试验设计提供参考,也可进一步降低临床试验受试者及使用者的风险.为此本文参考相关监管机构发布的体外膜氧合产品动物试验研究的指南性文件、临床及非临床文献、临床操作共识等资料,给出针对ECMO产品进行动物试验研究的要点,以期为相关产品的开发、研制等提供参考.在对ECMO产品性能进行动物试验研究时,要考虑动物种类及模型、对照产品的选择、评价指标的选择、观察时间、样本量、操作要求等.对ECMO产品进行规范、科学、合理的动物试验验证可以通过尽可能少的成本获得更高质量的证据,更好地促进相关产品研制.
Considerations for animal testing of extracorporeal membrane oxygenation products
Extracorporeal membrane oxygenation(ECMO),as one of extracorporeal life support(ECLS)technologies,widely used to partially or completely replace patients'cardiopulmonary function.In the process of research and development of this product,due to the limited time of blood storage and other reasons,it is necessary to conduct performance verification and safety evaluation through animal tests,so as to provide references for clinical trial design and further reduce the risks of clinical trial subjects and users.Therefore,this paper gives the key points of animal test research on risk assessment of ECMO products,in order to provide reference for the development of related products.The guidelines,clinical and non-clinical literature,clinical operation consensus and other documents of animal experimental studies of extracorporeal membrane oxygenation products issued by relevant regulatory agencies were referred.The animal species and model,the selection of control products,the selection of evaluation indexes,the observation time,the sample size and the operation requirements should be considered in the study of the performance of ECMO products.The standard,scientific and reasonable animal test of ECMO products can obtain higher quality evidence with as little cost as possible,and better promote the development of related products.
extracorporeal membrane oxygenationanimal testingsecuritykey point
万方数据
维普
