Finch R G
Department of Microbial Diseases, City Hospital, Nottingham, UK.
Eur J Clin Microbiol Infect Dis. 1990 Jul;9(7):542-7. doi: 10.1007/BF01964300.
Anti-infective agents differ in several respects from other classes of therapeutic drugs. They are aimed at the treatment or prevention of infection which can occur at several body sites and be caused by a wide range of microorganisms. The infectious process frequently modifies metabolic behaviour which in turn may affect the pharmacology of an agent. In addition, the issue of drug resistance raises concerns in individual patients, hospital units and the broader community. The difficulties in scientifically validating the clinical efficacy and safety of anti-infective drugs led to the Report on the Clinical Evaluation of Antibacterial Drugs of the British Society for Antimicrobial Chemotherapy. The report identifies general principles relevant to the study of these drugs in man and identifies the major microbiological and clinical considerations. Detailed comments on the conduct of pharmacokinetic studies and therapeutic trials are provided with particular emphasis on design, definitions, execution and analysis. Adverse event monitoring, assessment of severity and determination of causality are also reviewed. Pharmaco-economic considerations are identified as a significant issue for the future. The revision of the 1977 FDA guidelines on anti-infective drug development provides the opportunity to harmonise these issues, particularly within the major markets of North America, Europe and Japan.
抗感染药物在几个方面与其他类别的治疗药物有所不同。它们旨在治疗或预防感染，感染可发生在身体的多个部位，由多种微生物引起。感染过程常常会改变代谢行为，而这反过来又可能影响药物的药理学特性。此外，耐药性问题在个体患者、医院科室以及更广泛的社区中引发了关注。科学验证抗感染药物临床疗效和安全性方面存在的困难促使英国抗菌化疗协会发布了《抗菌药物临床评估报告》。该报告确定了与这些药物人体研究相关的一般原则，并明确了主要的微生物学和临床考量因素。报告对药代动力学研究和治疗试验的开展进行了详细评论，特别强调了设计、定义、实施和分析。还审查了不良事件监测、严重程度评估和因果关系判定。药物经济学考量被确定为未来的一个重要问题。1977年美国食品药品监督管理局（FDA）关于抗感染药物研发的指南修订为协调这些问题提供了契机，尤其是在北美、欧洲和日本等主要市场。
