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首页> 外文期刊>The journal of clinical hypertension. >Antihypertensive Drug Use By Children: Are the Drugs Labeled and Indicated?
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Antihypertensive Drug Use By Children: Are the Drugs Labeled and Indicated?

机译：儿童使用降压药：是否已标记和标示药物？

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摘要

As a result of the Food and Drug Administration (FDA) Modernization Act and the Best Pharmaceuticals for Children Act, the number of medications with FDA-approved pediatric labeling has increased. To assess the success of these initiatives, we examined whether antihypertensive drugs used by children with hypertension in 2008 had FDA-approved pediatric labeling and indications. Using a nationwide commercial insurer database, 2915 children with primary (n=2607) and secondary (n=308) hypertension were identified. Drug user rate and days of supply were calculated from pharmacy claims. Drugs were categorized based on pediatric labeling and indication and whether they were recommended for pediatric use. Antihypertensive drugs were used by 889 (34%) children with primary hypertension and 200 children (65%) with secondary hypertension. User rates were 44.3% in hypertensive children younger than 6years, 30.9% in those 6 years to older than 12years, and 38.1% in those 12 years to older than 18years. Seven percent of drugs were neither labeled for pediatric use nor considered recommended for use in children. In children younger than 6years, 29% of drugs used were not indicated for use in that age group. Despite recent legislative initiatives, many drugs used by hypertensive children still lack pediatric labeling. Additional efforts are needed to close the gap between the availability of drugs that are labeled and indicated for pediatric use and actual drug usage in children.
机译：由于《食品药物管理局（FDA）现代化法案》和《儿童最佳药品法案》的实施，带有FDA批准的儿科标签的药物数量有所增加。为了评估这些措施是否成功，我们检查了2008年高血压儿童使用的降压药是否具有FDA批准的儿科标签和适应症。使用全国性商业保险公司数据库，确定了2915名患有原发性（n = 2607）和继发性（n = 308）高血压的儿童。吸毒率和供应天数是根据药房索赔计算得出的。药物根据儿科标签和适应症以及是否推荐用于儿科进行分类。 889名（34％）原发性高血压儿童和200名儿童（65％）继发性高血压使用了降压药。 6岁以下高血压儿童的使用率为44.3％，6岁至12岁以上的儿童为30.9％，12岁至18岁以上的儿童为38.1％。百分之七的药物既未标记儿科用途，也未考虑建议用于儿童。在6岁以下的儿童中，有29％的药物未在该年龄段使用。尽管有最近的立法倡议，高血压儿童使用的许多药物仍缺乏儿科标签。需要付出额外的努力来缩小标记和指示用于儿科用途的药物与儿童实际药物使用之间的差距。

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