Ophthalmology and therapy · 2026
A Multicenter, Real-World Experience with Polyhexamethylene Biguanide (PHMB) 0.08% Monotherapy for Treating Acanthamoeba Keratitis: A Retrospective Review of 39 Cases.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Knutsson Karl Anders, Di Zazzo Antonio, Pedrotti Emilio, Rama Paolo, Romano Vito, Roszkowska Anna Maria, Triolo Giacinto, Aiello Francesco, De Angelis Stefano, Mencucci Rita, Aragona Pasquale, Birattari Federica, Bonacci Erika, Buzzi Matilde, Coassin Marco, Fasolo Adriano, Gari Mariangela, Leon Pia, Nucci Carlo, Paganoni Giorgio, Pederzolli Matteo, Secchi Fabiana, Vaccaro Sabrina, Papa Vincenzo, Franch Antonella
Аннотация
INTRODUCTION: Topical polyhexamethylene biguanide (PHMB) 0.08% (AKANTIOR®, SIFI Italy) is the only licensed medicinal product for the treatment of Acanthamoeba keratitis (AK), demonstrating an 84.9% cure rate in a pivotal clinical trial. This study aimed to evaluate its effectiveness and safety in a routine clinical practice.
METHODS: We retrospectively reviewed patient charts from ten Italian centers for the treatment of AK with PHMB 0.08% monotherapy. The treatment protocol followed that used in the pivotal trial. The primary outcome was medical cure, defined as a healed epithelium without inflammation and treatment for at least four weeks. Treatment failure was defined as the need for surgery or the use of alternative or additional anti-amoebic treatments (AAT). Secondary outcomes included best-corrected visual acuity (BCVA), time to cure, pain, and corneal scarring.
RESULTS: Thirty-nine patients (M/F = 14/25) were evaluated. AK was confirmed by confocal microscopy ± polymerase chain reaction or culture in all cases. Sixteen (41%) had stage 3 AK. Thirty-five (89.7%; 95% confidence intervals 80.2-99.3) achieved medical cure. Four failures occurred: three required corneal surgery and one additional AAT. At the end of treatment, mean (SD) LogMAR BCVA was 0.7 (0.8); the median time to cure was 95 days (Q1-Q3: 63-140 days). Two patients (5.6%) reported residual pain, and 27 (73.0%) had corneal scarring. Four serious adverse events (three hypopyon, one corneal perforation) were reported and considered unlikely to be treatment-related.
CONCLUSIONS: AKANTIOR cured approximately 90% of patients with AK, indicating that the efficacy observed in the clinical trial can be replicated in clinical practice.
TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT06641882.
METHODS: We retrospectively reviewed patient charts from ten Italian centers for the treatment of AK with PHMB 0.08% monotherapy. The treatment protocol followed that used in the pivotal trial. The primary outcome was medical cure, defined as a healed epithelium without inflammation and treatment for at least four weeks. Treatment failure was defined as the need for surgery or the use of alternative or additional anti-amoebic treatments (AAT). Secondary outcomes included best-corrected visual acuity (BCVA), time to cure, pain, and corneal scarring.
RESULTS: Thirty-nine patients (M/F = 14/25) were evaluated. AK was confirmed by confocal microscopy ± polymerase chain reaction or culture in all cases. Sixteen (41%) had stage 3 AK. Thirty-five (89.7%; 95% confidence intervals 80.2-99.3) achieved medical cure. Four failures occurred: three required corneal surgery and one additional AAT. At the end of treatment, mean (SD) LogMAR BCVA was 0.7 (0.8); the median time to cure was 95 days (Q1-Q3: 63-140 days). Two patients (5.6%) reported residual pain, and 27 (73.0%) had corneal scarring. Four serious adverse events (three hypopyon, one corneal perforation) were reported and considered unlikely to be treatment-related.
CONCLUSIONS: AKANTIOR cured approximately 90% of patients with AK, indicating that the efficacy observed in the clinical trial can be replicated in clinical practice.
TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT06641882.