Holmes C J
Renal Division, Baxter Healthcare Corporation, McGaw Park, Illinois 60085, USA.
Perit Dial Int. 2000;20 Suppl 5:S5-9.
Pre-clinical biocompatibility testing of peritoneal dialysis (PD) solutions has become an integral part of new solution development. The construction of a pre-clinical screening program for solution biocompatibility should take a hierarchical approach, starting with in vitro cell viability and function assays. The selection of cell types and assay systems for the in vitro studies should be broad enough to permit a balanced interpretation. Whenever possible, animal models are recommended for the next hierarchical level of testing, followed by human ex vivo study designs. Designs of the latter sort provide evidence that a new solution formulation is exerting an altered biological response in vivo; the response is not purely an in vitro artifact or restricted to a given animal species. This article discusses the various approaches available for biocompatibility testing during the pre-clinical phase of solution development, with an emphasis on the advantages and drawbacks of each method.
腹膜透析（PD）溶液的临床前生物相容性测试已成为新溶液开发不可或缺的一部分。溶液生物相容性临床前筛选方案的构建应采用分层方法，从体外细胞活力和功能测定开始。体外研究中细胞类型和测定系统的选择应足够广泛，以便进行平衡的解释。只要有可能，建议在测试的下一个分层水平使用动物模型，然后是人体离体研究设计。后一种类型的设计提供了证据，表明新的溶液配方在体内正在产生改变的生物学反应；该反应并非纯粹的体外假象或仅限于特定动物物种。本文讨论了在溶液开发临床前阶段进行生物相容性测试的各种可用方法，重点介绍了每种方法的优缺点。
