Sinha Yashwant, Cranswick Noel E
Prince of Wales Hospital, Randwick, Victoria, Australia.
J Paediatr Child Health. 2007 Mar;43(3):107-11. doi: 10.1111/j.1440-1754.2007.00970.x.
Knowledge of drug administration in children and infants has significantly lagged behind that of adults. Despite several paediatric therapeutic mishaps that have been a catalyst for major regulatory reform, the majority of registered medicines do not have indications or dosing for children. This paper will briefly summarise key issues in paediatric pharmacology, including differences in prescribing for children, off-label and unlicensed prescribing and conduct of paediatric clinical trials. A particular emphasis will placed on the situation in Australia.
儿童和婴儿用药知识的发展明显滞后于成人。尽管发生了几起儿科治疗事故，这些事故成为了重大监管改革的催化剂，但大多数注册药品都没有针对儿童的适应症或剂量说明。本文将简要总结儿科药理学的关键问题，包括儿童用药处方的差异、超说明书用药和未获许可用药以及儿科临床试验的开展情况。将特别强调澳大利亚的情况。
