新生儿临床试验：治疗的迫切需求。

Clinical trials in neonates: a therapeutic imperative.

作者信息

Ward R M, Kern S E

机构信息

Pediatric Pharmacology Program, Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA.

出版信息

Clin Pharmacol Ther. 2009 Dec;86(6):585-7. doi: 10.1038/clpt.2009.207.

DOI:10.1038/clpt.2009.207

PMID:19915600

Abstract

The lack of study of medications in pediatric patients has been recognized since the 1960s, when Shirkey described children as "therapeutic orphans." In 1968, only 25% of approved drugs included adequate pediatric prescribing information on the label. This did not begin to improve until the 1990s, with the 1997 US Food and Drug Administration (FDA) Modernization Act, the Best Pharmaceuticals for Children Acts, and the Pediatric Research Equity Acts. By 2009, more than 300 labeling changes improved pediatric prescribing information, but newborns were seldom included.

摘要

自20世纪60年代以来，儿科患者用药研究的匮乏就已为人所知，当时 Shirkey 将儿童描述为“治疗孤儿”。1968年，只有25%的获批药物在标签上包含足够的儿科处方信息。直到20世纪90年代，随着1997年美国食品药品监督管理局（FDA）的《现代化法案》、《儿童最佳药品法案》以及《儿科研究公平法案》的出台，情况才开始有所改善。到2009年，超过300项标签变更改善了儿科处方信息，但新生儿很少被纳入其中。