Haslund-Krog Sissel Sundell, Jørgensen Inger Merete, Dalhoff Kim, Holst Helle
Department of Clinical Pharmacology, Bispebjerg and Frederiksberg University Hospital, 2400 Copenhagen, Denmark.
Faculty of Health and Medical Sciences, Department of Clinical Medicine, University of Copenhagen, 1165 Copenhagen, Denmark.
Children (Basel). 2022 Aug 16;9(8):1236. doi: 10.3390/children9081236.
Developing acceptable medicines for children is a complicated task. Several factors must be considered, including age, physiology, texture preference, formulation, and legal framework among others. In the development of new paediatric medicines, these factors are assessed. However, for older medicines, e.g., prednisolone, acceptability is still a challenge. This study was an open-label randomised three-arm cross-over study investigating different formulations of prednisolone (crushed tablets, whole tablets, and oral solution) in paediatric patients with asthma and asthma-like symptoms. Participants were randomised into two different formulations on two consecutive days. For each formulation, the child or caregiver was asked to evaluate acceptability using a modified five-point Wong Baker Face scale. An analysis of variance (ANOVA) model was used to test for significance. For the 41 children, included mean age was 4.7 years (SD ± 3.6), and mean weight was 21 kg (SD ± 10.8). Sixty-one percent were boys. The participants were divided accordingly into three age groups: 6 to 23 months (N = 11), 2 to 5 years (N = 14), and 6−11 years (N = 16). The overall acceptability was low, with only 23 out of 71 scores rating the treatment either 1 or 2 (32%). The ANOVA test showed a significant difference in acceptability score between crushed tablets and whole tablets (p < 0.003). The mean acceptability score for the crushed tablet was the least favourable at 3.9 compared to oral solution (3.1), oro-dispersible tablet (2.8), and whole tablets (2.4). This is problematic in long-term treatment and for the youngest children who cannot swallow tablets. The improvement of age-appropriate and acceptable formulations is necessary.
开发适合儿童的可接受药物是一项复杂的任务。必须考虑几个因素，包括年龄、生理状况、口感偏好、剂型以及法律框架等。在开发新的儿科药物时，会对这些因素进行评估。然而，对于旧药，例如泼尼松龙，其可接受性仍然是一个挑战。本研究是一项开放标签的随机三臂交叉研究，旨在调查患有哮喘和哮喘样症状的儿科患者中泼尼松龙的不同剂型（碾碎片、整片和口服液）。参与者在连续两天被随机分配到两种不同的剂型。对于每种剂型，要求儿童或照顾者使用改良的五点面部表情疼痛评分量表评估可接受性。使用方差分析（ANOVA）模型进行显著性检验。纳入研究的41名儿童，平均年龄为4.7岁（标准差±3.6），平均体重为21千克（标准差±10.8）。61%为男孩。参与者被相应地分为三个年龄组：6至23个月（N = 11）、2至5岁（N = 14）和6至11岁（N = 16）。总体可接受性较低，71个评分中只有23个将治疗评为1或2（32%）。方差分析检验显示碾碎片和整片之间的可接受性评分存在显著差异（p < 0.003）。碾碎片的平均可接受性评分最不理想，为3.9，而口服液为3.1、口腔崩解片为2.8、整片为2.4。这对于长期治疗以及无法吞咽片剂的最小儿童来说是个问题。改进适合年龄且可接受的剂型是必要的。
