Norrby S R
Rev Infect Dis. 1986 Jul-Aug;8 Suppl 3:S358-70. doi: 10.1093/clinids/8.supplement_3.s358.
Despite their high degree of safety, beta-lactam agents cause adverse reactions. This article deals with the types of adverse reactions to various beta-lactam agents that have been reported and, especially, with the difficulties involved in monitoring and evaluating these reactions. Comparisons of the results of studies of the same drug carried out in various countries show striking differences in the incidence of adverse effects reported. A reason for this variation is the lack of strict definitions of the events that should be regarded as adverse effects. Only rarely are all the unexpected events occurring in patients in clinical studies reported, but the investigators are allowed to make subjective judgments about which reactions are related to the drug tested and are thus reportable. With such procedures there is an inherent risk of overlooking unexpected adverse effects. Also, in the analysis of laboratory adverse reactions the rule that "one finds what one looks for" applies. It seems obvious that if stricter rules for registration of adverse effects had been applied, the toxic effects of various beta-lactams, such as the nephrotoxicity of cephaloridine and the coagulopathies associated with moxalactam, would have been detected much earlier.
尽管β-内酰胺类药物具有高度安全性，但仍会引起不良反应。本文探讨了已报道的各类β-内酰胺类药物的不良反应类型，尤其是监测和评估这些反应所涉及的困难。在不同国家对同一药物进行的研究结果比较显示，所报告的不良反应发生率存在显著差异。这种差异的一个原因是缺乏对应被视为不良反应的事件的严格定义。临床研究中患者发生的所有意外事件很少全部报告，但研究人员被允许对哪些反应与所测试药物相关从而应报告做出主观判断。采用这样的程序存在忽视意外不良反应的固有风险。此外，在分析实验室不良反应时，“你找到你所寻找的东西”这一规则适用。显然，如果应用更严格的不良反应登记规则，各种β-内酰胺类药物的毒性作用，如头孢利定的肾毒性和与拉氧头孢相关的凝血病，会被更早发现。
