Department of Paediatrics, University of Western Ontario, London, Ontario, Canada.
J Clin Pharmacol. 2018 Oct;58 Suppl 10:S36-S47. doi: 10.1002/jcph.1115.
Adverse drug reactions (ADRs) are common and important complications of drug therapy for children. The risk for ADRs changes over childhood, as do the nature and types of ADRs. Importantly, the risk and nature of ADRs in children are markedly different from those of adults, and adult data cannot be relied on to guide safe drug therapy in children. There are groups of children, notably those with complex and chronic diseases, who are at substantial risk for ADRs. The evaluation of an undesired effect during therapy is ideally accomplished by an organized approach that is a skill that clinicians who care for children-especially those children at high risk for ADRs must have. Additionally, clinicians as well as drug regulatory agencies and industry need to be both vigilant and astute as well as aware that ADRs in children are often different in nature and frequency from those in adults. The increasing use of pharmacogenomics to guide drug dosing and the increasing number of biological agents will provide new sets of challenges to clinicians over the next decade.
药物不良反应(ADRs)是儿童药物治疗中常见且重要的并发症。ADRs 的风险随着儿童年龄的变化而变化,ADRs 的性质和类型也随之变化。重要的是,儿童的 ADR 风险和性质与成人明显不同,不能依赖成人数据来指导儿童的安全药物治疗。有一些儿童群体,特别是患有复杂和慢性疾病的儿童,面临着较大的 ADR 风险。在治疗过程中评估不良影响的理想方法是采用一种有组织的方法,这是照顾儿童的临床医生(尤其是那些有较高 ADR 风险的儿童)必须具备的技能。此外,临床医生以及药物监管机构和行业都需要保持警惕和敏锐,并意识到儿童的 ADR 在性质和频率上通常与成人不同。未来十年,药物基因组学指导药物剂量和越来越多的生物制剂的使用将给临床医生带来新的挑战。