Lode H, Stahlmann R
Medical Department, Freie Universität Berlin, FRG.
Eur J Clin Microbiol Infect Dis. 1990 Jul;9(7):530-3. doi: 10.1007/BF01964297.
In this review the general and specific difficulties encountered in the evaluation of safety and tolerance of antimicrobial agents in clinical trials are discussed. In addition to the usual pharmacological and toxicological effects (adverse drug reactions) occurring in individual patients, microbiologically induced side-effects also have to be considered. The different methods for registration of side-effects and their limitations are discussed. A system is proposed for evaluation of the cause/effect relationships of adverse drug reactions. A system is also discussed for the evaluation of the severity of adverse drug reactions, and different classifications are presented.
在本综述中，讨论了在临床试验中评估抗菌药物安全性和耐受性时遇到的一般和特殊困难。除了个体患者中出现的常见药理和毒理作用（药物不良反应）外，还必须考虑微生物诱导的副作用。讨论了不良反应登记的不同方法及其局限性。提出了一种评估药物不良反应因果关系的系统。还讨论了一种评估药物不良反应严重程度的系统，并给出了不同的分类。
