Dart John K G, Papa Vincenzo, Rama Paolo, Knutsson Karl Anders, Ahmad Saj, Hau Scott, Sanchez Sara, Franch Antonella, Birattari Federica, Leon Pia, Fasolo Adriano, Mrukwa-Kominek Ewa, Jadczyk-Sorek Katarzyna, Carley Fiona, Parwez Hossain, Minassian Darwin C
Moorfields Eye Hospital NHS Foundation Trust, London, UK; National Institute of Health Research (NIHR) Moorfields Biomedical Research Centre, London, UK.
SIFI S.p.A., 36, Via Ercole Patti, Aci S. Antonio (Catania), 95025, Italy.
Ocul Surf. 2025 Apr 7;38:132-141. doi: 10.1016/j.jtos.2025.03.008.
To compare Acanthamoeba keratitis (AK) outcomes for treatment delivered using a detailed protocol versus physician's individualised treatment.
This double cohort study compared the outcomes of these different delivery methods for PHMB 0.02 % and diamidine 0.1 % dual therapy. The primary outcome was the medical cure rate without surgery within 12 months (MCR_12) and the secondary was visual acuity. Any change of treatment, any surgery, or treatment for >12 months was a failure. Outcomes were both unadjusted and adjusted, using multivariable analysis, for baseline differences affecting outcomes. Patients were from two centres in Milan and London treated at different times; the individualised cohort (1991-2012) and per-protocol cohort (2017-2021).
The individualised cohort included 96 and the per-protocol 47 patients. Both unadjusted and adjusted results were similar. The unadjusted outcomes for both centres combined showed significantly improved outcomes for per-protocol treatment with a 1.59-fold improvement in MCR_12 (95 % CI 1.40-1.80, p < 0.001) and a 2.1-fold increase in visual acuity ≥20/25 (95 % CI 1.34-3.29, p < 0.001). Amongst potential confounding factors examined, neither baseline AK disease stage, treatment centre nor the type of diamidine significantly influenced outcomes.
This study shows significant advantages for the use of protocol delivered versus individualised treatment for AK. The use of evidence-based treatment delivery protocols, like the one used here for AK, might improve outcomes for all causes of microbial keratitis and could offer practitioners and patients the benefit of having an easy-to-follow drug delivery protocol, with known outcomes.
比较采用详细方案进行治疗与医生个体化治疗的棘阿米巴角膜炎(AK)的治疗效果。
这项双队列研究比较了0.02%聚六亚甲基双胍(PHMB)和0.1%双脒联合治疗的这两种不同给药方式的治疗效果。主要结局是12个月内无需手术的医学治愈率(MCR_12),次要结局是视力。任何治疗改变、任何手术或超过12个月的治疗均视为失败。结局采用多变量分析进行未调整和调整,以考虑影响结局的基线差异。患者来自米兰和伦敦的两个中心,在不同时间接受治疗;个体化队列(1991 - 2012年)和按方案队列(2017 - 2021年)。
个体化队列包括96例患者,按方案队列包括47例患者。未调整和调整后的结果相似。两个中心合并的未调整结局显示,按方案治疗的结局显著改善,MCR_12提高了1.59倍(95%CI 1.40 - 1.80,p < 0.001),视力≥20/25提高了2.1倍(95%CI 1.34 - 3.29,p < 0.001)。在所检查的潜在混杂因素中,基线AK疾病分期、治疗中心和双脒类型均未显著影响结局。
本研究表明,对于AK,采用方案给药治疗比个体化治疗具有显著优势。使用基于证据的治疗给药方案,如此处用于AK的方案,可能会改善所有微生物性角膜炎病因的治疗效果,并可为从业者和患者提供易于遵循的给药方案以及已知结局的益处。