RESUMEN
PURPOSE: To investigate the potential effects of chronic exposure to a nasal decongestant and its excipients on ocular tissues using an experimental rat model. METHODS: Sixty adult male Wistar rats were randomized into six groups. The first two groups were control (serum physiologic) and Otrivine® groups. The remaining four groups received the Otrivine excipients xylometazoline, benzalkonium chloride, sorbitol, and ethylene diamine tetra acetic acid. Medications were applied into both nostrils twice a day for 8 weeks. Before the rats were sacrificed, epithelial staining, the Schirmer test, and intraocular pressure measurements were performed under ketamine/xylasine anesthesia (50 and 5 mg/kg, respectively). RESULTS: Epithelial defects and dry eye were common findings in all study groups. Cataracts developed in two cases clinically. Histopathological evaluation revealed many different pathological alterations in all parts of the ocular tissues such as corneal edema, polypoid proliferation and hyalinization of the vessel wall, cystic formation of the lens, retinal nerve fiber layer degeneration, and corpora amylacea formation of the lacrimal gland. CONCLUSIONS: Prolonged usage of the nasal decongestant xylometazoline and its excipients may cause ophthalmic problems such as dry eyes, corneal edema, cataracts, retinal nerve fiber layer, and vascular damage in rats. Although these results were obtained from experimental animals, ophthalmologists should keep in mind the potential ophthalmic adverse effects of this medicine and/or its excipients and exercise caution with drugs containing xylometazoline, ethylene diamine tetra acetic acid, benzalkonium chloride and sorbitol for patients with underlying ocular problems.
Asunto(s)
Oftalmopatías/inducido químicamente , Ojo/efectos de los fármacos , Imidazoles/efectos adversos , Descongestionantes Nasales/efectos adversos , Mucosa Nasal/efectos de los fármacos , Animales , Compuestos de Benzalconio/efectos adversos , Modelos Animales de Enfermedad , Ácido Edético/efectos adversos , Ojo/patología , Oftalmopatías/patología , Presión Intraocular , Masculino , Mucosa Nasal/patología , Distribución Aleatoria , Ratas Wistar , Índice de Severidad de la EnfermedadRESUMEN
ABSTRACT Purpose: To investigate the potential effects of chronic exposure to a nasal decongestant and its excipients on ocular tissues using an experimental rat model. Methods: Sixty adult male Wistar rats were randomized into six groups. The first two groups were control (serum physiologic) and Otrivine® groups. The remaining four groups received the Otrivine excipients xylometazoline, benzalkonium chloride, sorbitol, and ethylene diamine tetra acetic acid. Medications were applied into both nostrils twice a day for 8 weeks. Before the rats were sacrificed, epithelial staining, the Schirmer test, and intraocular pressure measurements were performed under ketamine/xylasine anesthesia (50 and 5 mg/kg, respectively). Results: Epithelial defects and dry eye were common findings in all study groups. Cataracts developed in two cases clinically. Histopathological evaluation revealed many different pathological alterations in all parts of the ocular tissues such as corneal edema, polypoid proliferation and hyalinization of the vessel wall, cystic formation of the lens, retinal nerve fiber layer degeneration, and corpora amylacea formation of the lacrimal gland. Conclusions: Prolonged usage of the nasal decongestant xylometazoline and its excipients may cause ophthalmic problems such as dry eyes, corneal edema, cataracts, retinal nerve fiber layer, and vascular damage in rats. Although these results were obtained from experimental animals, ophthalmologists should keep in mind the potential ophthalmic adverse effects of this medicine and/or its excipients and exercise caution with drugs containing xylometazoline, ethylene diamine tetra acetic acid, benzalkonium chloride and sorbitol for patients with underlying ocular problems.
RESUMO Objetivo: Investigar os possíveis efeitos da exposição crônica de descongestionante nasal e seus excipientes em tecidos oculares, utilizando um modelo experimental com ratos. Métodos: Sessenta ratos Wistar adultos machos foram divididos aleatoriamente em seis grupos. Os primeiros dois grupos foram controle (soro fisiológico) e Otrivina®. Os quatro grupos restantes receberam os excipientes de Otrivina, tais como Xilometazolina, Benzalcônio, Sorbitol e Ácido Etilenodiamino Tetracético (EDTA). Os medicamentos foram aplicados em ambas as narinas dos ratos, duas vezes ao dia, durante 8 semanas. Antes que os ratos fossem sacrificados, a coloração epitelial, o teste de Schirmer e a medida da pressão intraocular foram realizados sob anestesia com Ketamina/Xilasina (50 e 5 mg/kg, respectivamente). Resultados: Defeitos epiteliais e olho seco foram achados comuns nos grupos de estudo. A catarata desenvolveu-se clinicamente em dois casos. A avaliação histopatológica revelou a existência de alterações em todas as partes dos tecidos oculares, tais como edema de córnea, proliferação polipoide e hialinização da parede vascular, formação cística da lente, degeneração da camada de fibra nervosa da retina (RNFL) e formação de corpos amiláceos da glândula lacrimal. Conclusões: O uso prolongado do descongestionante nasal Xilometazolina e seus excipientes pode causar vários problemas oftalmológicos, como olho seco, edema de córnea, catarata, RNFL e dano vascular em ratos. Embora esses resultados tenham sido obtidos a partir de animais experimentais, os oftalmologistas devem ter em mente os potenciais efeitos oftalmológicos adversos desse medicamento e/ou de seus excipientes.