RESUMO
OBJECTIVE: To investigate the association between exposure to topical ophthalmic antibiotics during pregnancy and adverse neonatal outcomes. METHODS: In this retrospective cohort study, we identified pregnant women with hordeola, chalazia, blepharitis, or bacterial conjunctivitis from 2005 to 2018 using the Japanese Medical Data Centre Claims Database. From the eligible women, we extracted women who were dispensed no topical antibiotics during the first trimester (non-antibiotic group), women who were dispensed topical fluoroquinolones alone at least once (fluoroquinolone alone group), and women who were dispensed any single type of antibiotic (single-antibiotic group). We compared the frequency of congenital anomalies (CA), preterm birth (PB), low birth weight (LBW), and the composite outcome of these three between the fluoroquinolone and non-antibiotic groups and between the single-antibiotic and non-antibiotic groups, using propensity score adjustment. RESULTS: A total of 891 eligible women were identified. In the fluoroquinolone (n = 409) and non-antibiotic (n = 309) groups, CA occurred in 6.8% and 6.8%, PB in 2.4% and 3.2%, LBW in 2.9% and 3.2%, and the composite outcome in 10.5% and 11.3%, respectively. Analysis using propensity score adjustment showed no significant difference between the groups in the frequency of CA (adjusted odds ratio, 1.15; 95% confidence interval, 0.61-2.18), PB (0.80; 0.30-2.17), LBW (1.08; 0.45-2.63), or the composite outcome (1.12; 0.67-1.87). Comparison of the single-antibiotic and non-antibiotic groups showed similar results. CONCLUSIONS: Topical ophthalmic antibiotics for hordeola, chalazia, blepharitis, or bacterial conjunctivitis during the first trimester were not associated with increased adverse neonatal outcomes.
Assuntos
Blefarite , Calázio , Conjuntivite Bacteriana , Nascimento Prematuro , Antibacterianos/efeitos adversos , Blefarite/induzido quimicamente , Blefarite/tratamento farmacológico , Calázio/induzido quimicamente , Calázio/tratamento farmacológico , Conjuntivite Bacteriana/induzido quimicamente , Conjuntivite Bacteriana/tratamento farmacológico , Conjuntivite Bacteriana/microbiologia , Feminino , Fluoroquinolonas/efeitos adversos , Humanos , Recém-Nascido , Gravidez , Gestantes , Nascimento Prematuro/induzido quimicamente , Nascimento Prematuro/tratamento farmacológico , Pontuação de Propensão , Estudos RetrospectivosRESUMO
The biological treatments for psoriasis, mainly the tumor necrosis factor-alpha inhibitors (TNF-alpha), have demonstrated their efficacy and safety beginning with the clinical trials up to their subsequent marketing. However, pharmacovigilance studies have detected a mild increase in infections. For the management of infectious risk in patients with psoriasis being treated with etanercept or other anti-TNF medications, an evaluation should be made of the adequacy of its use in patients infected by HCV, HBV, HIV, with localized or generalized infections, with risk of sepsis (carriers of intravenous catheter and indwelling urinary catheter) or with underlying disorders that could predispose them to infections (diabetes, hemodialysis). If a patient under treatment with etanercept presents an infection, if the infection is serious, treatment should be discontinued and if it is mild, the patient should be closely monitored and treatment interrupted if decided based on the evolution. Long experience on the use of etanercept in different diseases has made it possible to state that it has a good safety profile in regards to infections, if precautions are taken in regards to tuberculosis and the concomitance of other active infections during the treatment.