RESUMEN
PURPOSE: To compare the equivalence of moxifloxacin 0.5% with a combination of fortified cefazolin sodium 5% and tobramycin sulfate 1.3% eye drops in the treatment of moderate bacterial corneal ulcers. DESIGN: Randomized, controlled, equivalence clinical trial. PARTICIPANTS AND CONTROLS: Microbiologically proven cases of bacterial corneal ulcers were enrolled in the study and were allocated randomly to 1 of the 2 treatment groups. INTERVENTION: Group A was given combination therapy (fortified cefazolin sodium 5% and tobramycin sulfate) and group B was given monotherapy (moxifloxacin 0.5%). MAIN OUTCOME MEASURES: The primary outcome variable for the study was percentage of the ulcers healed at 3 months. The secondary outcome variables were best-corrected visual acuity and resolution of infiltrates. RESULTS: Of a total of 224 patients with bacterial keratitis, 114 patients were randomized to group A, whereas 110 patients were randomized to group B. The mean ± standard deviation ulcer size in groups A and B were 4.2 ± 2 and 4.41 ± 1.5 mm, respectively. The prevalence of coagulase-negative Staphylococcus (40.9% in group A and 48.2% in group B) was similar in both the study groups. A complete resolution of keratitis and healing of ulcers occurred in 90 patients (81.8%) in group A and 88 patients (81.4%) in group B at 3 months. The observed percentage of healing at 3 months was less than the equivalence margin of 20%. Worsening of ulcer was seen in 18.2% cases in group A and in 18.5% cases in group B. Mean time to epithelialization was similar, and there was no significant difference in the 2 groups (P = 0.065). No serious events attributable to therapy were reported. CONCLUSIONS: Corneal healing using 0.5% moxifloxacin monotherapy is equivalent to that of combination therapy using fortified cefazolin and tobramycin in the treatment of moderate bacterial corneal ulcers. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Asunto(s)
Antibacterianos/uso terapéutico , Compuestos Aza/uso terapéutico , Cefazolina/uso terapéutico , Úlcera de la Córnea/tratamiento farmacológico , Infecciones Bacterianas del Ojo/tratamiento farmacológico , Quinolinas/uso terapéutico , Tobramicina/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Antibacterianos/administración & dosificación , Antibacterianos/efectos adversos , Compuestos Aza/administración & dosificación , Compuestos Aza/efectos adversos , Bacterias/aislamiento & purificación , Cefazolina/administración & dosificación , Cefazolina/efectos adversos , Córnea/efectos de los fármacos , Córnea/fisiopatología , Úlcera de la Córnea/microbiología , Úlcera de la Córnea/fisiopatología , Evaluación de Medicamentos , Quimioterapia Combinada , Infecciones Bacterianas del Ojo/microbiología , Infecciones Bacterianas del Ojo/fisiopatología , Femenino , Fluoroquinolonas , Humanos , Masculino , Persona de Mediana Edad , Moxifloxacino , Soluciones Oftálmicas , Prevalencia , Estudios Prospectivos , Quinolinas/administración & dosificación , Quinolinas/efectos adversos , Equivalencia Terapéutica , Tobramicina/administración & dosificación , Tobramicina/efectos adversos , Resultado del Tratamiento , Agudeza Visual/efectos de los fármacos , Agudeza Visual/fisiologíaRESUMEN
PURPOSE: To report three cases of bilateral microbial keratitis in eyes with Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) induced by highly active antiretroviral therapy (HAART) in patients of acquired immune deficiency syndrome (AIDS). METHODS: A case series. RESULTS: A detailed clinical examination and systemic review of all the three patients on HAART was performed. While one manifested with the more severe variant of TEN, two of these patients presented with SJS with ocular involvement. Despite withdrawal of nevirapine, the ocular surface disorder persisted. The entailing chronic epitheliopathy along with the compromised immune status led to the development of secondary microbial keratitis in all these cases. CONCLUSIONS: The immune reconstitution occurring as a response to the antiretroviral therapy may potentially increase immunologically mediated diseases like SJS and TEN, which in turn may predispose the eye to develop corneal ulcer.