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确定影响居家儿科人群口服药物可接受性的配方因素。

Determination of formulation factors that affect oral medicines acceptability in a domiciliary paediatric population.

机构信息

School of Pharmacy, Keele University, Keele, Staffordshire ST5 5BG, UK; Pharmacy and Therapeutics Section, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences (CMDS), Medical School Building, University of Birmingham, Edgbaston B15 2TT, UK.

Pharmacy and Therapeutics Section, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences (CMDS), Medical School Building, University of Birmingham, Edgbaston B15 2TT, UK.

出版信息

Int J Pharm. 2015 Mar 1;480(1-2):55-62. doi: 10.1016/j.ijpharm.2015.01.023. Epub 2015 Jan 16.

Abstract

UNLABELLED

Acceptability of medicines for children is a challenge, yet critical to ensure adherence to treatment. There is very little literature on formulation factors that influence acceptability of medicines, particularly in the domiciliary environment. This pragmatic study was conducted at University Hospital Coventry and Warwickshire (UHCW) with the aim of identifying the prevalence and nature of oral formulation-related barriers to medicines administration in children suffering from long-term conditions. This study used semi-structured face-to-face interviews with 221 parents/carers of children (0-18 years) and 57 young people (12-18 years).

RESULT

showed significant medicines refusal and manipulation in the domiciliary environment. Nearly one-third (71/232) of respondents reported medicines refusal. This was associated significantly with the age of child (p=0.016), socioeconomic status (IMD 2010 score) (p=0.002), taste (p<0.001), texture (p=0.017), and volume (of liquid/powder) or quantity (of solid dosage form) (p<0.001). 29% (74/252) of respondents reported manipulating medicines. P-values are based on multivariable statistical analysis models. This study has indicated that formulations prescribed to children with chronic conditions are not meeting the needs of a significant number of patients based on self-report. Age-appropriate medicines are required to provide suitable dose units with an acceptable taste for children. This study should aid pharmaceutical companies to prioritise paediatric formulation work.

摘要

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药品的可接受性是一个挑战,但对于确保治疗依从性至关重要。关于影响药品可接受性的制剂因素的文献很少,特别是在家庭环境中。这项实用研究在考文垂和沃里克郡大学医院(UHCW)进行,目的是确定长期患病儿童在家庭环境中口服制剂相关用药障碍的流行程度和性质。该研究使用半结构式面对面访谈的方法,对 221 名儿童(0-18 岁)和 57 名青少年(12-18 岁)的家长/照顾者进行了调查。

结果

显示出在家庭环境中存在显著的药物拒绝和操作障碍。近三分之一(71/232)的受访者报告了药物拒绝。这与儿童年龄(p=0.016)、社会经济地位(IMD 2010 评分)(p=0.002)、味道(p<0.001)、质地(p=0.017)和体积(液体/粉末)或数量(固体剂型)(p<0.001)显著相关。29%(74/252)的受访者报告说他们在操纵药物。p 值基于多变量统计分析模型。本研究表明,根据自我报告,为患有慢性疾病的儿童开具的处方制剂并不能满足相当一部分患者的需求。需要为儿童提供适合年龄的药物,以提供具有可接受口味的合适剂量单位。本研究应有助于制药公司优先开展儿科制剂工作。

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