Stimulation programs for pediatric drug research - do children really benefit?
Stimulation programs for pediatric drug research - do children really benefit?
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DOI：
10.1007/s00431-006-0381-z
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发表时间：
2007-08-01
影响因子：
3.6
通讯作者：
Burggraaf, Jacobus
中科院分区：
文献类型：
--
作者：
Boots, Isabelle;Sukhai, Ram N.;Burggraaf, Jacobus
目前儿科处方的大多数药物都没有在儿童身上进行测试。在美国，儿科药物研究受到《食品和药物管理局现代化法案》(FDAMA)中儿科专有性条款的刺激，该条款在提供儿科标签时授予专利延期。我们调查了这些项目在刺激儿童药物研究方面的有效性，从而增加了在儿科人群中安全有效使用药物的证据。所有根据FDAMA被授予儿科专营权的药物都是通过研究儿科研究的医学和临床药理学审查的相关摘要进行分析的，如果没有这些摘要，则研究制造商提供的标签信息。对文献进行了系统的搜索，以确定儿童的药物使用模式。从1998年7月到2006年8月，135个药物实体被授予儿科专营权。最常见的药物组是抗抑郁剂和情绪稳定剂，ACE抑制剂，降脂制剂，HIV抗病毒药物，以及非类固醇抗炎和抗风湿药物。不同药物的分布与这些药物在成人市场上的分布密切相关，而不是儿童的药物利用情况。自FDAMA推出以来，已经进行了许多儿童药物研究。然而，儿童很少使用这些被授予儿科专用权的药物。儿科药物研究的重点应该根据患者的需要而不是市场考虑来确定。
Most drugs that are currently prescribed in pediatrics have not been tested in children. Pediatric drug studies are stimulated in the USA by the pediatric exclusivity provision under the Food and Drug Administration Modernization Act (FDAMA) that grants patent extensions when pediatric labeling is provided. We investigated the effectiveness of these programs in stimulating drug research in children, thereby increasing the evidence for safe and effective drug use in the pediatric population. All drugs granted pediatric exclusivity under the FDAMA were analyzed by studying the relevant summaries of medical and clinical pharmacology reviews of the pediatric studies or, if these were unavailable, the labeling information as provided by the manufacturer. A systematic search of the literature was performed to identify drug utilization patterns in children. From July 1998 to August 2006, 135 drug entities were granted pediatric exclusivity. Most frequent drug groups were anti-depressants and mood stabilizers, ACE inhibitors, lipid- lowering preparations, HIV antivirals, and non-steroidal anti-inflammatory and anti-rheumatic drugs. The distribution of the different drugs closely matched the distribution of these drugs over the adult market, and not the drug utilization by children.Many drug studies in children have been performed since the introduction of the FDAMA. However, children infrequently use the drugs granted pediatric exclusivity. The priorities for pediatric drug research should be set by the need of the patients, not by market considerations.