Veuillez lire l’article suivant : Hoffman JJ, Yadav R, Sanyam SD, et al. Topical Chlorhexidine 0.2% versus Topical Natamycin 5% for the Treatment of Fungal Keratitis in Nepal. Ophtalmol 2022;129(5):530-41.
Question 1 - Cochez la ou les réponse(s) correcte(s) concernant les traitements de la kératite fongique (FK) selon l’article :
"The preferred treatment for FK is topical natamycin 5% based on the results of the Mycotic Ulcer Treatment Trials (MUTT)".
La chlorhexidine est considérée comme une alternative potentiellement non inférieure mais pas comme traitement de première intention.
"Natamycin is not available in most countries in sub-Saharan Africa".
"Approximately one quarter of patients continue to progress to corneal perforation and ultimately blindness or evisceration/enucleation".
"It is relatively expensive and difficult to formulate".
Question 2 - Cochez la ou les réponse(s) correcte(s) concernant l’utilisation de la chlorhexidine dans le traitement de la kératite fongique :
"Chlorhexidine is a broad-spectrum, antiseptic biocidal agent... used in various forms in ophthalmology for > 30 years".
"A nonsignificant trend favoring chlorhexidine over natamycin in “curing” by 21 days".
"Chlorhexidine has the additional advantages of being inexpensive, easy to formulate, and generally well tolerated".
"A nonsignificant trend favoring chlorhexidine" indique que les résultats ne sont pas concluants.
"In the early 1990s, chlorhexidine 0.2% was reported effective in vitro".
Question 3 - Cochez la ou les réponse(s) correcte(s) concernant le design de l’étude décrite dans l’article :
"We performed a randomized controlled, single-masked, non-inferiority clinical trial".
"The trial was conducted at Sagarmatha Choudhary Eye Hospital (SCEH), Lahan, Nepal".
"Approximately half of patients are Indian nationals".
"Ethical and regulatory approval was obtained from... the London School of Hygiene and Tropical Medicine Ethics Committee, United Kingdom".
"The trial was registered with ISRCTN, number ISRCTN14332621".
Question 4 - Cochez la ou les réponse(s) correcte(s) concernant les critères d’inclusion et d’exclusion des participants dans l’étude :
"Eligible patients were adults with acute MK (corneal epithelial ulceration > 1 mm in diameter)".
"Participants had to have evidence of filamentous fungal infection, not bacterial infections".
"Exclusion criteria included prior topical antifungal use".
"Exclusion criteria included no perception of light visual acuity in the affected eye".
"Exclusion criteria included very severe ulcers warranting immediate surgical intervention".
Question 5 - Cochez la ou les réponse(s) correcte(s) concernant la procédure de randomisation et de masquage dans l’étude :
"Participants were randomly assigned (1:1) to chlorhexidine 0.2 % or natamycin 5 %".
"Given that chlorhexidine and natamycin have different appearances, it was not possible to mask participants".
"A computer-generated randomization list was prepared by an independent statistician using Stata 16".
"Clinicians were masked to treatment allocation".
"Bottle labels were replaced with standardized labels with “A” or “B” replacing the drug name".
Question 6 - Cochez la ou les réponse(s) correcte(s) concernant le suivi et l’évaluation des participants dans l’étude :
"Compliance was checked through self-reporting and weighing of study medication bottles".
"BSCVA at 3 months was assessed by an optometrist masked to treatment allocation".
"The statistician performing the primary analysis was masked to allocation and only received the allocation sequence after the analysis code was prepared and pretested".
"Patients were not told which treatment they were allocated to, but masking was not possible due to treatment appearance".
"Corneal scrapes were performed for microbiological cultures for fungal organism identification and to diagnose any mixed bacterial-fungal infections".
Question 7 - Cochez la ou les réponse(s) correcte(s) concernant les schémas posologiques et la gestion du traitement dans l’étude :
"Dosing schedules were identical between arms".
"Dosing schedules consisted of 1 drop every 1 hour per day and night for 48 hours, then hourly while awake for 5 days, then every 2 hours while awake until 3 weeks from enrollment".
"All antifungal medications were kept in a dark place at < 25 °C".
"Dosing schedules consisted of 1 drop every 1 hour per day and night for 48 hours, then hourly while awake for 5 days, then every 2 hours while awake until 3 weeks from enrollment".
"Topical medications were replenished as needed at follow-up".
Question 8 - Cochez la ou les réponse(s) correcte(s) concernant les critères de continuation ou de modification du traitement :
"If the ulcer had healed (epithelial defect [ED] < 1 mm), then the treatment was stopped".
"If there was resolving stromal infiltration or ED > 1 mm but < 5 mm, treatment was reduced to 4 times daily".
"Topical voriconazole 1 % was added if FK was progressive despite 7 days of trial medication, not antivirals".
"Further continuation and treatment duration of the masked medication depended on the clinical response".
"For infiltrates involving > 75 % of corneal thickness, oral ketoconazole 200 mg twice daily was added".
Question 9 - Cochez la ou les réponse(s) correcte(s) concernant les mesures de résultats dans l’étude :
"The BSCVA was measured at enrollment and at 90 days by a masked trial-certified optometrist".
"Scar/infiltrate size was measured at 7, 21, and 9 days".
"Depth was assessed in 4 categories: > 0 % to 25 %, > 25 % to 50 %, > 50 % to 75 %, and > 75 %".
"Presenting and pinhole visual acuity were also measured at each visit by trial-certified eye health workers using Peek Acuity, a validated smartphone application".
"Patients were monitored at each visit for adverse events or drug reactions".
Question 10 - Cochez la ou les réponse(s) correcte(s) concernant l’analyse statistique et la gestion des données dans l’étude :
"A sample size of 500 patients (250 per arm) was fixed before enrollment".
"One planned interim analysis was conducted after one third of all planned patients (167/500) had completed their 90-day follow-up".
"The random allocation procedure was conducted by an independent randomization administrator with no other involvement in the trial".
"Secondary analyses of the primary outcome included a per-protocol analysis and analysis of the primary outcome (by intention-to-treat) including mixed infections".
"A Data Safety and Monitoring Board (DSMB) was established before enrollment to oversee safety, data quality, and trial conduct".
Question 11 - Cochez la ou les réponse(s) correcte(s) concernant les résultats de l’étude :
La pandémie a provoqué un retard, mais les participants ont été revus et inclus dans l’analyse.
"Follow-up was completed on February 8, 2021".
"There were 25 and 23 patients for whom day 90 outcome data were not available, leading to a total of 141 patients randomized to chlorhexidine and 143 patients randomized to natamycin in the primary analysis".
"There was no evidence to suggest that loss to follow-up was associated with baseline visual acuity, baseline infiltrate size, age, gender, or treatment assignment".
"Recruitment was stopped on November 9, 2020, after the interim analysis and guidance from the DSMB".
Question 12 - Cochez la ou les réponse(s) correcte(s) concernant les caractéristiques des patients et les résultats de l’étude :
"Baseline mean BSCVA was 0.61 logMAR in the chlorhexidine group and 0.55 logMAR in the natamycin group".
"By day 90, BSCVA was 0.64 logMAR in the chlorhexidine arm and 0.26 logMAR in the natamycin arm, indicating that natamycin was superior to chlorhexidine".
"Patients treated with chlorhexidine healed 39% more slowly than those treated with natamycin".
"Mixed bacterial-fungal infections were present in 15 of 178 patients (8.4 %) in the chlorhexidine group and 10 of 176 patients (5.7 %) in the natamycin group".
"At 21 days, estimated mean infiltrate size was 0.42 mm smaller in the natamycin arm than in the chlorhexidine arm".
Question 13 - Cochez la ou le(s) réponse(s) juste(s) :
"We tested the hypothesis that chlorhexidine 0.2 % was noninferior to natamycin 5 % for the treatment of FK; however, we found no evidence to support this".
"Visual acuity was significantly better at day 90 in participants randomized to natamycin than to chlorhexidine".
"Natamycin-treated cases were less likely to develop a perforation or need TPK".
"We also found evidence that natamycin was associated with faster reepithelialization and a slightly smaller scar or infiltrate size from day 7 onwards".
Pour des raisons financières.
Question 14 - Cochez la ou les réponses justes, cochez la ou les réponse(s) juste(s) :
"It was not possible to mask participants to treatment allocation; however, they were not told which medication they had received, and study-team members were masked to allocation".
"The coronavirus disease 2019 pandemic caused significant disruption, with a 3-month period without participant contact because of restrictions".
"Unlike MUTT1, which found natamycin more effective than voriconazole for Fusarium spp. cases, the difference in BSCVA at day 90 did not vary with causative fungal organism in our trial".
L’étude est sans appel.
Des concentrations plus faibles de chlorexidine.
Question 15 - Cochez la ou les réponse(s) juste(s) :
La natamycine contient du chlorure de benzalkonium, un conservateur ayant des propriétés antimicrobiennes, ce qui pourrait augmenter son efficacité.
Les différences de critères d’inclusion et de pathogènes impliqués entre les études limitent les comparaisons directes.
La natamycine a montré une réduction plus importante de la taille des infiltrats et des cicatrices.
Le taux de perforation était plus faible dans le groupe natamycine.
L’article mentionne que la chlorhexidine, à des concentrations élevées et sur des périodes prolongées, pourrait avoir des effets toxiques sur la cornée.
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