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对川崎病患儿重复服用乙酰水杨酸迷你片的可行性:一项试点研究。

The Feasibility of the Repeated Administration of Acetylsalicylic Acid Mini-Tablets to Children with Kawasaki Disease: A Pilot Study.

作者信息

Hida Noriko, Serizawa Fuka, Sambe Takehiko, Nakamura Akihiro, Harada Tsutomu

机构信息

Department of Clinical Research and Development, Graduate School of Pharmacy, Showa University, Tokyo 157-8577, Japan.

Department of Pharmaceutics, Graduate School of Pharmacy, Showa University, Tokyo 157-8577, Japan.

出版信息

Pharmaceutics. 2025 Mar 5;17(3):333. doi: 10.3390/pharmaceutics17030333.

DOI:10.3390/pharmaceutics17030333
PMID:40142997
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11945137/
Abstract

: Mini-tablets are a novel pediatric dosage form designed to mask drug taste and facilitate easier administration. This study aimed to assess the feasibility and acceptability of uncoated acetylsalicylic acid (ASA) mini-tablets in Japanese children with Kawasaki disease (KD) aged 1 to 4 years. : A retrospective case series study of three pediatric patients with KD treated with ASA mini-tablets (3 mm diameter, 10 mg) was conducted at Showa University Hospital. ASA mini-tablets were administered for up to 68 days. Caregivers recorded daily medication intake and any issues in medication logbooks. : All three patients successfully took 100% of the prescribed doses. No adverse events related to mini-tablet ingestion were reported. Patients could take the mini-tablets for extended periods (63-68 days) as part of their KD treatment. : ASA mini-tablets showed potential acceptability in this small cohort of pediatric patients with KD. This study represents the first investigation into the acceptability of mini-tablets containing active ingredients in Japanese pediatric patients. Larger studies are needed to confirm these findings and evaluate long-term safety and efficacy.

摘要

迷你片是一种新型儿科剂型,旨在掩盖药物味道并便于给药。本研究旨在评估未包衣的乙酰水杨酸(ASA)迷你片在1至4岁日本川崎病(KD)患儿中的可行性和可接受性。

在昭和大学医院对3例接受ASA迷你片(直径3毫米,10毫克)治疗的KD儿科患者进行了一项回顾性病例系列研究。ASA迷你片给药长达68天。护理人员在用药日志中记录每日用药情况和任何问题。

所有3例患者均成功服用了100%的规定剂量。未报告与服用迷你片相关的不良事件。作为KD治疗的一部分,患者能够长时间(63 - 68天)服用迷你片。

ASA迷你片在这一小群KD儿科患者中显示出潜在的可接受性。本研究是对日本儿科患者中含有活性成分的迷你片可接受性的首次调查。需要开展更大规模的研究来证实这些发现并评估长期安全性和有效性。

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Pharmaceutics. 2025 Mar 5;17(3):333. doi: 10.3390/pharmaceutics17030333.
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本文引用的文献

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A Study on Pharmacokinetics of Acetylsalicylic Acid Mini-Tablets in Healthy Adult Males-Comparison with the Powder Formulation.乙酰水杨酸微型片在健康成年男性中的药代动力学研究——与粉末制剂的比较。
Pharmaceutics. 2023 Aug 3;15(8):2079. doi: 10.3390/pharmaceutics15082079.
2
Meeting Challenges of Pediatric Drug Delivery: The Potential of Orally Fast Disintegrating Tablets for Infants and Children.应对儿科给药挑战:口腔速崩片对婴幼儿的潜力
Pharmaceutics. 2023 Mar 23;15(4):1033. doi: 10.3390/pharmaceutics15041033.
3
Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2-<7 Years: Results of an Open-Label Randomised Study.≥2至<7岁儿童使用多层薄膜包衣迷你片的可接受性、吞咽性、适口性和安全性:一项开放标签随机研究的结果
Pharmaceutics. 2023 Feb 20;15(2):701. doi: 10.3390/pharmaceutics15020701.
4
A Survey to Understand Parent/Caregiver and Children's Views on Devices Used for the Administration of Oral Pediatric Medicines in Japan.一项旨在了解日本家长/照顾者及儿童对口服儿科药物给药设备看法的调查。
Children (Basel). 2022 Feb 3;9(2):196. doi: 10.3390/children9020196.
5
Swallowability of Minitablets among Children Aged 6-23 Months: An Exploratory, Randomized Crossover Study.6至23个月儿童的迷你片吞咽性:一项探索性随机交叉研究
Pharmaceutics. 2022 Jan 15;14(1):198. doi: 10.3390/pharmaceutics14010198.
6
Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety in Pediatrics.迷你片剂:儿科中兼顾疗效与安全性的有效策略。
Pharmaceuticals (Basel). 2022 Jan 17;15(1):108. doi: 10.3390/ph15010108.
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8
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Diagnosis, Treatment, and Long-Term Management of Kawasaki Disease: A Scientific Statement for Health Professionals From the American Heart Association.川崎病的诊断、治疗和长期管理:美国心脏协会发布的一份面向医疗保健专业人员的科学声明。
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