Department of General Practice, University Hospital Zurich, Zurich, Switzerland.
Eur J Clin Pharmacol. 2013 Mar;69(3):357-9. doi: 10.1007/s00228-012-1371-x. Epub 2012 Aug 16.
Existing drug safety systems with phase II and III studies and post-marketing surveillance by principle do not allow for the recognition of an important class of adverse drug reactions (ADRs). ADRs that are resistant to being detected reliably may a) appear as if they are age-related chronic diseases, which also manifest themselves in a high degree without drug treatment, b) arise in "old" drugs, c) arise during long-term application, and d) arise with the administration to frail and aged populations.
"Silent" and multi-factorial health problems evolving from long-term drug treatment must therefore be addressed with a systematic search strategy, as a third track along with the phase II and III studies and spontaneous reporting systems which still exist.
现有的药物安全系统，包括 II 期和 III 期研究以及上市后监测，原则上无法识别一类重要的药物不良反应（ADR）。ADR 不易被可靠检测到，可能是 a）表现为似乎与年龄相关的慢性疾病，这些疾病在没有药物治疗的情况下也会高度表现出来，b）出现在“旧”药物中，c）在长期应用中出现，d）在给予体弱和老年人群时出现。
因此，必须采用系统的搜索策略来解决长期药物治疗引起的“沉默”和多因素健康问题，作为与现有的 II 期和 III 期研究以及自发报告系统并行的第三条途径。
