Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, MI, USA.
Horm Res Paediatr. 2013;79(1):4-8. doi: 10.1159/000346381. Epub 2013 Jan 23.
In 2010, new data about the safety of recombinant human growth hormone (rhGH) resulted in warnings and subsequent pronouncements by the US Food and Drug Administration (FDA) and its European counterpart [the European Medicines Agency (EMA)] regarding its use in children and adolescents as an elective treatment for short stature. However, opinions about these new data are divergent: the FDA did not change the label of the drug and experts have argued for further research on the safety of rhGH. In this situation of an evolving scientific controversy, it is unclear how questions about benefit and risk are communicated to patients and their parents. Social biases and misperceptions about the deleterious effects of short stature and the benefits of added height influence decisions to prescribe rhGH and may affect discussions of the warnings by regulators. Fully supporting a model of shared decision-making involving children and adolescents requires sharing risk-benefit information, including evolving information from drug regulators, with patients and parents.
2010 年，有关重组人生长激素（rhGH）安全性的新数据，导致美国食品药品监督管理局（FDA）及其欧洲对应机构[欧洲药品管理局（EMA）]发出警告，并随后宣布rhGH 可被用于儿童和青少年作为矮小症的一种选择性治疗方法。然而，对于这些新数据的意见存在分歧：FDA 并未改变该药物的标签，且专家们主张对 rhGH 的安全性进行进一步研究。在这种科学争议不断发展的情况下，尚不清楚关于获益和风险的问题是如何向患者及其父母传达的。关于矮小症的有害影响和增加身高的益处的社会偏见和误解，影响了 rhGH 的处方决策，并可能影响监管机构对警告的讨论。充分支持涉及儿童和青少年的共同决策模式，需要与患者和家长分享风险获益信息，包括来自药物监管机构的不断发展的信息。
