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不同口服剂型在医院环境中儿科患者的可接受性。

Acceptability of different oral dosage forms in paediatric patients in hospital setting.

机构信息

Department of Pharmaceutics, Bharati Vidyapeeth Deemed University Poona College of Pharmacy, Pune, India.

Clinsearch, Malakoff, France.

出版信息

Arch Dis Child. 2022 Sep;107(9):796-801. doi: 10.1136/archdischild-2021-322604. Epub 2021 Nov 19.

DOI:10.1136/archdischild-2021-322604
PMID:34799375
Abstract

OBJECTIVE

The understanding of acceptability of existing dosage forms is limited in most of the world and hinders the development of acceptable, age-appropriate medicines. The attributes of paediatric medicine acceptability may differ from country to country based on culture, healthcare infrastructure and health policies. This study was designed to map the acceptability of oral medicines in paediatric patients treated in hospital in India.

METHODS

An observational, cross-sectional study was conducted in patients aged below 18 years and taking any form of oral medication. Acceptability scores were obtained using CAST-ClinSearch Acceptability Score Test tool.

FINDINGS

490 patients were recruited and 193 evaluations of different pharmaceutical products available in 20 dosage forms and 7 routes of administration were studied. Oral liquids (50%) and tablets (35%) were the most commonly prescribed and administered forms. Regardless of the therapeutic class and age, the oral liquids were 'positively accepted' in infants and toddlers. Acceptability of tablets improved with age and appeared to be generally good from the age of 6.

CONCLUSION

This study indicates the limited progress towards adoption of age-appropriate dosage forms in India and thus impact on the acceptability of existing oral dosage forms. The key challenges posed by the adoption of age-appropriate formulations in India are (1) awareness of importance of appropriate administration and acceptability of medicines to children in India, (2) availability of age-appropriate dosage forms and (3) lack of child-appropriate medicine policies.

摘要

目的

在世界大多数地区,对现有剂型的可接受性的理解有限,这阻碍了可接受的、适合年龄的药物的发展。儿科药物可接受性的属性可能因国家的文化、医疗基础设施和卫生政策而异。本研究旨在绘制在印度医院接受治疗的儿科患者对口服药物的可接受性图谱。

方法

在年龄在 18 岁以下并服用任何形式口服药物的患者中进行了一项观察性、横断面研究。使用 CAST-ClinSearch 可接受性评分测试工具获得可接受性评分。

结果

共招募了 490 名患者,研究了 20 种剂型和 7 种给药途径的 193 种不同药物产品的评估。口服液体(50%)和片剂(35%)是最常开的和给予的剂型。无论治疗类别和年龄如何,口服液体在婴儿和幼儿中都是“被积极接受”的。片剂的可接受性随着年龄的增长而提高,从 6 岁起似乎普遍良好。

结论

本研究表明,印度在采用适合年龄的剂型方面进展有限,从而影响了现有口服剂型的可接受性。在印度采用适合年龄的配方所带来的主要挑战是(1)印度对儿童适当给药和接受药物的重要性的认识,(2)适合年龄的剂型的可用性,以及(3)缺乏儿童适用的药物政策。

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