Viljoen L, Draper H R, Castillo-Carandang N T, Suryavanshi N, Marthinus A, Cheong A M A, Ocampo J D D, Dhumal G, Bagchi S, Wademan D T, Kinikar A, Paradkar M, Frias M V G, Casalme D J O, Hesseling A C, Garcia-Prats A J, Palmer M, Hoddinott G
Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Department of Clinical Epidemiology, College of Medicine, University of the Philippines Manila, Philippines.
IJTLD Open. 2025 Aug 13;2(8):478-485. doi: 10.5588/ijtldopen.25.0309. eCollection 2025 Aug.
Rifampicin-resistant TB (RR-TB) in children is frequently treated with clofazimine (CFZ), widely available as a 100mg gel capsule. This formulation is challenging to administer and is poorly acceptable to children and caregivers. Poor acceptability may negatively impact adherence and treatment outcomes. We describe the acceptability of a novel 50mg CFZ tablet formulation among children in South Africa, India, and the Philippines.
Mixed methods assessments were completed in a moxifloxacin and CFZ safety and pharmacokinetics trial in children with RR-TB. Quantitative data were collected from 36 participants at 4 timepoints. A sub-sample of 26 child/caregiver dyads participated in ∼4 qualitative interviews. Descriptive statistics and thematic analysis were employed.
The median age of n=36 participants (South Africa n=20; India n=6; the Philippines n=10) was 4.9 years. The majority (29/36) received a CFZ gel capsule prior to switching to the tablet formulation. The 50mg tablet had better acceptability scores for taste (p=0.035), smell (p=0.035), and ease of swallowing (p=0.02) compared to gel capsules. Participants described the tablet formulation as easier to administer/take without a lingering smell or taste. Limited concerns were noted on staining.
The novel 50mg CFZ tablet has better acceptability and should be prioritised for children wherever possible.
儿童耐利福平结核病（RR-TB）通常采用氯法齐明（CFZ）治疗，市面上广泛供应的是100mg的凝胶胶囊剂型。这种剂型给药具有挑战性，儿童及其护理人员的接受度较差。接受度差可能会对依从性和治疗结果产生负面影响。我们描述了一种新型50mg CFZ片剂剂型在南非、印度和菲律宾儿童中的接受度。
在一项针对RR-TB儿童的莫西沙星和CFZ安全性及药代动力学试验中完成了混合方法评估。在4个时间点从36名参与者中收集定量数据。26对儿童/护理人员的子样本参与了约4次定性访谈。采用描述性统计和主题分析。
36名参与者（南非20名；印度6名；菲律宾10名）的中位年龄为4.9岁。大多数人（29/36）在改用片剂剂型之前服用过CFZ凝胶胶囊。与凝胶胶囊相比，50mg片剂在味道（p=0.035）、气味（p=0.035）和吞咽 ease（p=0.02）方面的接受度得分更高。参与者将片剂剂型描述为更容易给药/服用，没有残留的气味或味道。关于染色的担忧有限。
新型50mg CFZ片剂具有更好的接受度，应尽可能优先用于儿童。 （原文中“ease of swallowing”这里的“ease”可能有误，推测可能是“easiness”，但按照要求未修改直接翻译）
