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首页> 外文期刊>Pediatrics: Official Publication of the American Academy of Pediatrics >Improving pediatric dosing through pediatric initiatives: what we have learned.
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Improving pediatric dosing through pediatric initiatives: what we have learned.

机译：通过儿科活动改善儿科剂量：我们所学到的。

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摘要

OBJECTIVE: The goal was to review the impact of pediatric drug studies, as measured by the improvement in pediatric dosing and other pertinent information captured in the drug labeling. METHODS: We reviewed the pediatric studies for 108 products submitted (July 1998 through October 2005) in response to a Food and Drug Administration written request for pediatric studies, and the subsequent labeling changes. We analyzed the dosing modifications and focused on drug clearance as an important parameter influencing pediatric dosing. RESULTS: The first 108 drugs with new or revised pediatric labeling changes had dosing changes or pharmacokinetic information (n = 23), new safety information (n = 34), information concerning lack of efficacy (n = 19), new pediatric formulations (n = 12), and extended age limits (n = 77). A product might have had > or = 1 labeling change. We selected specific examples (n = 16) that illustrate significant differences in pediatric pharmacokinetics. CONCLUSIONS: Critical changes indrug labeling for pediatric patients illustrate that unique pediatric dosing often is necessary, reflecting growth and maturational stages of pediatric patients. These changes provide evidence that pediatric dosing should not be determined by simply applying weight-based calculations to the adult dose. Drug clearance is highly variable in the pediatric population and is not readily predictable on the basis of adult information.
机译：目的：目的是回顾儿科药物研究的影响，以儿科剂量的改善和药物标签中捕获的其他相关信息来衡量。方法：我们审查了针对食品药品管理局书面要求进行的儿科研究的1998年7月至2005年10月提交的108种产品的儿科研究，以及随后的标签变更。我们分析了剂量调整，并着眼于药物清除作为影响儿科剂量的重要参数。结果：新的或修订的儿科标签变化的前108种药物具有剂量变化或药代动力学信息（n = 23），新的安全性信息（n = 34），关于功效缺乏的信息（n = 19），新的儿科制剂（n = 12），并延长了年龄限制（n = 77）。产品的标签更改可能大于或等于1。我们选择了具体的例子（n = 16）来说明儿科药代动力学的显着差异。结论：小儿患者药物标签的关键变化说明，通常必须有必要提供小儿药物剂量，这反映了小儿患者的生长和成熟阶段。这些变化提供了证据，表明不应通过简单地将基于体重的计算应用于成人剂量来确定儿科剂量。药物清除率在儿科人群中是高度可变的，并且根据成人信息不容易预测。

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