Efficacy and safety of pazufloxacin mesylate eye drops for bacterial conjunctivitis:a multicenter randomized, double-masked, parallel controlled clinical trial / 中华实验眼科杂志

Objective To compare the clinical efficacy and safety following the topical application of pazufloxacin mesylate eye drops with levofloxacin eye drops (LOFX) for bacterial conjunctivitis.Methods A multicenter,randomized,investigator-masked,parallel-controlled clinical trial was performed.Five hundred and twenty eyes of 520 patients with bacterial conjunctivitis were enrolled from March to October 2008 in seven ophthalmic centers in China.The patients were randomized into trial group and control group in 3 ∶ 1 ratio with the 390 eyes in the trial group and 130 eyes in the control group.Pazufloxacin mesylate eye drops was topically used 4 times per day for consecutively 7-14 days in the trial group,and levofloxacin eye drops was used in the same way in the control group.Microbiological cultures for conjunctiva sac secretions and drug sensitive test were carried out before and at the end of the administration of eye drops.The signs and symptoms were observed and scored before treatment and 0,3,7 and 14days after treatment.The adverse events following the administration of the eye drops were evaluated and compared.Results The intention to treat analysis (ITT) showed that the cure rate was 59.38％ in the trial group and 60.47％ in the control group,with the effective rate 88.80％ and 86.05％,respectively,with an insignificant difference between the two groups (x2 =0.12,P =0.72).The clinically evaluable analysis (CE) exhibited that the cure rates were 63.48％ in the trial group and 63.87％ in the control group,with the effective rate 92.46％ and 88.24％,whichwas not significantly different between them (x2 =0.54,P=0.46).The modified-ITT analysis (mITT) showed that the cure rates were 60.57％ in the trial group and 62.07％ in the control group,with the effective rate 90.32％ and 88.51％,without significant difference between the two groups (P＞0.05).Based on microbiologically evaluable analysis (ME),the clinical cure rates were 63.71％ and 63.41％ in the trial group and control group,and the effective rates were 93.44％ and 90.24％,respectively.There was no significantly difference between the both groups (P＞0.05).In the trial group and control group,the bacterial eradication rate was 89.42％ and 90.80％ based on ITT,90.11％ and 92.77％ based on CE,respectively.There was no significant difference in incidences of adverse events following the administration of the drug between the trial group and control group,including ocular tolerance,burning sensation,pricking and itching (P =0.34).Conclusions The effectiveness and adverse response were resemble between Pazufloxacin mesylate eye drops and LOFV following the topical application for bacterial conjunctivitis,which indicate that Pazufloxacin mesylate eye drops is effective and safe.

Investigação oftalmológica pré-clínica do óleo essencial de Origanum vulgare L. Lamiaceae / Ophthalmological pre-clinical research about essential oil from the Origanum vulgare L. Lamiaceae

RESUMO Objetivo: Avaliar a irritação ocular aguda em coelhos, após a administração tópica de óleo essencial. Métodos: Para tanto, os animais foram divididos em três grupos, cada um com três coelhos, totalizando 6 olhos por grupo, e a diferença entre eles foi a concentração utilizada ( 1, 3 e 9%). Aplicou-se no saco conjuntival, de um dos olhos do animal, uma dose única de 0,1 ml do produto e o olho contralateral foi usado como controle. Analisou-se os efeitos causados pelo óleo essencial na conjuntiva, íris e córnea após 1, 24, 48, 72 horas e no final do sétimo dia após a aplicação tópica. As avaliações oftalmológicas foram feitas com o auxílio de um oftalmoscópio binocular indireto com e sem fluoresceína. As reações observadas foram graduadas segundo a escala de Draize. Foram realizados exames anatomopatológicos em todos os olhos estudados no final do experimento. Resultados: No grupo de animais submetidos à instilação ocular do óleo essencial a 1%, não se observou alterações. O tratamento com o óleo a 3% provocou alteração conjuntival no exame feito em 1 hora, o que foi reduzindo. A administração do óleo essencial a 9% induziu hiperemia conjuntival, não havendo qualquer alteração nos outros tempos de avaliação oftalmológica. Conclusão: A avaliação contribuiu para conhecer as alterações clínicas na superfície ocular. Desta forma, foi possível classificar o óleo a 1% como não irritante e nas concentrações de 3 e 9% como pouco irritante, tornando possível estudos clínicos, a fim de estabelecer o óleo como alternativa terapêutica em conjuntivites bacterianas.

ABSTRACT Objective: To evaluate acute eye irritation in rabbits following topical administration of essential oil. Methods: animals were divided into three groups, each containing three rabbits, with a total of 6 eyes per group. The difference between them was the concentration used (1, 3 and 9%). A single dose of 0.1 ml of the product was applied into the conjunctival sac of one eye of the animal, and the contralateral eye was used as control. The effects caused by the essential oil in the conjunctiva, iris and cornea were analyzed after 1, 24, 48 and 72 hours and at the end of the seventh day after topical application. Ophthalmologic evaluations were performed with the aid of a binocular indirect ophthalmoscope fluorescein and with and without the observed responses, before being graded according to the Draize scale. Pathological examinations were performed on all eyes studied at the end of the experiment. Results: in the group of animals subjected to the ocular instillation of 1% essential oil, there was no change. For treatment with 3% oil, conjunctival changes were found to be decreasing during the examination after 1 hour. Administration of the 9%essential oil induced conjunctival injection, without any change in the other ophthalmologic evaluation times. Conclusion: the evaluation contributed to meet the clinical changes in the ocular surface. Thus, it was possible to classify the oil at 1% as non-irritating and the concentration of 3% and 9 as mildly irritating, making it possible for clinical studies to establish the oil as an alternative therapy in bacterial conjunctivitis.

Síndrome oculoglandular de Parinaud causada por esporotricose / Parinaud's oculoglandular syndrome caused by Sporotrichosis

A síndrome oculoglandular de Parinaud é uma doença ocular rara causada por diferentes agentes etiológicos, entre eles bactérias, vírus e fungos. É caracterizada por uma conjuntivite granulomatosa, acompanhada de linfadenopatia pré-auricular adjacente e pode trazer sequelas caso não seja prontamente tratada. Neste artigo é relatado o caso de uma jovem técnica de enfermagem e estudante de medicina veterinária apresentando a síndrome oculoglandular de Parinaud causada pelo fungo Sporothrix schenkii após contaminação com gatos infectados. Sua apresentação clínica e evolução desfavorável até o correto diagnóstico etiológico e instituição do tratamento específico, ressaltam a importância da investigação laboratorial em casos de evolução atípica da doença.

Parinaud's oculoglandular syndrome is a rare eye disease caused by different pathogens, including bacteria, viruses and fungi. It is characterized by a granulomatous conjunctivitis with adjacent preauricular lympha-denopathy and can cause sequelae if not promptly treated. We report a case of a young nurse assistant and veterinary student showing Parinaud's oculoglandular syndrome caused by the fungus Sporothrix schenkii after contamination with infected cats. Its clinical presentation and negative outcome until the correct ethiological diagnosis, in addition to specific treatment, emphasize the importance of laboratory investigations in cases of atypical development of the disease.

A clinical investigation of 0.3% ciprofloxacin eyedrops in the treatment of bacterial conjunctivitis and keratitis / 眼科

A clinical investigation on the treatment of 163 cases of acute bacterial conjunctivitis and bacterial keratitis with 0.3% ciprofloxacin and norfloxacin eyedrops was carried out from May to December, 1993. It showed that the cure and effective rate of the former was 90% and 98.9%. There was no significant difference between the two drugs. No serious side effects occurred.