儿童对六种新型莫西沙星和利奈唑胺分散片的偏好。

IJTLD open Pub Date : 2025-04-09 eCollection Date: 2025-04-01 DOI:10.5588/ijtldopen.24.0546
G Hoddinott, H R Draper, N Vanqa, S Myeni, S Staples, T Sachs, M Raffique, N Tshethu, M Palmer, L Viljoen, K Inabathina, R Taneja, A C Hesseling, A J Garcia-Prats
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引用次数: 0

摘要

背景:莫西沙星(MFX)和利奈唑胺(LZD)是耐利福平结核病治疗方案的关键组成部分。目前,这两种药物的可分散片剂在儿童中的适口性较差。我们评估了儿童对来自两家通用制造商的更适合儿童的配方的偏好。方法:这是一项在南非两个地点进行的随机、横断面“刷和吐”味道小组研究。每个制造商都为每种药物创造了三种口味的混合变体。5-17岁的健康儿童志愿者按年龄、性别和种族进行分层,并完成偏好等级排序和5个可接受性5点李克特量表。我们使用总结、比较和排名统计来探索混合的可接受性。结果:97名儿童和96名儿童分别为MFX和LZD混合药物提供了数据。对于两家制造商的MFX混合物,Friedman检验显示,与现有混合物相比,儿童对新选择的偏好在统计上显著(Q(2) = 24,937;P < 0.001, Q(2) = 21.213;P < 0.001)。即使是最受欢迎的MFX混合也有次优的可接受性,特别是对一个制造商来说。儿童对两家制造商的LZD混合物并没有明确的偏好。这些发现不受年龄、性别或种族的影响。结论:广泛年龄段的儿童可以为结核病药物配方的适口性偏好提供有意义的信息。建议开发新的MFX配方混合物,但可接受性仍然不理想。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Children's preferences among six novel moxifloxacin and linezolid-dispersible tablet formulations.

Background: Moxifloxacin (MFX) and linezolid (LZD) are key components of rifampicin-resistant TB treatment regimens. Currently, available dispersible tablet formulations of both drugs have poor palatability in children. We evaluated children's preferences for more child-friendly formulations from two generic manufacturers.

Methods: This was a randomised, cross-sectional 'swish-and-spit' taste panel study at two sites in South Africa. Each manufacturer created three flavour-blend variants for each drug. Healthy child volunteers 5-17 years old were sampled stratified by age, sex, and ethnic group and completed a preference rank-ordering and five acceptability 5-point Likert scales. We explored the blends' acceptability using summary, comparative, and ranking statistics.

Results: Ninety-seven and 96 children contributed data for the MFX and LZD drug blends, respectively. For both manufacturers' MFX blends, the Friedman test showed children had a statistically significant preference for novel options over the Existing blend (Q(2) = 24,937; P < 0.001, and Q(2) = 21.213; P < 0.001, respectively). Even the most preferred MFX blend had sub-optimal acceptability, especially for one manufacturer. Children did not have a clear preference for both manufacturers' LZD blends. These findings were not influenced by age, sex, or ethnic group.

Conclusion: Children across a broad age spectrum can provide meaningful input on the palatability preferences of TB drug formulations. Novel MFX formulation blends were recommended for development, but acceptability remains suboptimal.

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