McNeil Consumer Healthcare, Fort Washington, Pennsylvania; Department of Pediatrics, University of Utah College of Medicine, Salt Lake City, Utah.
Clin Ther. 2013 Sep;35(9):1361-75.e1-45. doi: 10.1016/j.clinthera.2013.06.022. Epub 2013 Aug 23.
A standardized approach to dosing acetaminophen in pediatric populations was published in 1983. That review proposed specific weight-related dosing for infants and children weighing 6 through 95 lb and an age-based schedule for children aged <4 months through 11 years. Subsequent clinical studies evaluating these and alternative doses of acetaminophen supported the recommended 10-15-mg/kg dose.
This article reviewed published and unpublished pediatric antipyretic data to provide a critical assessment of the 10-15-mg/kg oral dose and the current pediatric oral dosing schedules for acetaminophen.
Published literature and unpublished clinical trials that evaluated the antipyretic efficacy of acetaminophen in children were reviewed. The PubMed database was searched using the term acetaminophen or paracetamol, with study criteria limited to randomized, controlled trials; oral dosing; patient age <12 years; and publication between 1982 and August 2012. All of the sponsor's unpublished antipyretic clinical studies completed between 1980 and August 2012 and involving at least 1 oral-formulation acetaminophen-only treatment arm were identified. Data from published literature containing sufficient detail to verify doses; dosing frequency; and, when necessary, estimates from figures, and from acetaminophen arms of the unpublished studies were analyzed.
Thirteen unpublished trials enrolled 705 children to receive an oral dose of 10-15 mg/kg of acetaminophen. This dose resulted in a rapid onset of temperature reduction, with a maximum temperature decrement of ~3 hours following administration. Results from 40 published clinical trials in which 2332 children received oral acetaminophen for fever support these findings. The most common adverse events reported in any of the reported studies were gastrointestinal in nature and generally mild in intensity.
Data support the recommended 10-15-mg/kg oral dose and demonstrate that the age and weight schedules for over-the-counter acetaminophen proposed in 1983 remain appropriate.
1983 年发表了一种标准化的儿童人群扑热息痛剂量方法。该综述提出了针对 6 至 95 磅婴儿和儿童的特定体重相关剂量以及 4 个月至 11 岁儿童的年龄计划。随后的临床研究评估了这些和替代剂量的扑热息痛，支持推荐的 10-15mg/kg 剂量。
本文综述了已发表和未发表的儿科退热数据，以对 10-15mg/kg 口服剂量和目前的扑热息痛儿科口服剂量方案进行批判性评估。
综述了评估儿童扑热息痛退热疗效的已发表文献和未发表临床试验。使用术语扑热息痛或对乙酰氨基酚在 PubMed 数据库中进行搜索，研究标准仅限于随机对照试验；口服剂量；患者年龄<12 岁；以及 1982 年至 2012 年 8 月间的出版物。确定了所有赞助商在 1980 年至 2012 年 8 月间完成的至少有 1 个口服制剂扑热息痛单一治疗组的未发表退热临床研究。分析了含有足够详细信息以验证剂量、给药频率的已发表文献数据；以及必要时从图中以及未发表研究的扑热息痛组中进行估计。
13 项未发表的试验共纳入 705 名儿童，给予 10-15mg/kg 的口服扑热息痛剂量。该剂量可迅速降低体温，给药后约 3 小时达到最大体温下降。40 项已发表的临床试验中有 2332 名儿童接受口服扑热息痛退热，支持这些发现。报告的任何研究中最常见的不良事件是胃肠道性质的，通常为轻度。
数据支持推荐的 10-15mg/kg 口服剂量，并表明 1983 年提出的非处方扑热息痛的年龄和体重方案仍然适用。
