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急性细菌性结膜炎的治疗:1%夫西地酸粘性滴眼液与0.3%妥布霉素滴眼液的对比

Treatment of acute bacterial conjunctivitis: 1% fusidic acid viscous drops vs. 0.3% tobramycin drops.

作者信息

Jackson W Bruce, Low Donald E, Dattani Dan, Whitsitt Paul F, Leeder Randall G, MacDougall Rosemary

机构信息

University of Ottawa Eye Institute, Ottawa Hospital, Ont.

出版信息

Can J Ophthalmol. 2002 Jun;37(4):228-37; discussion 237. doi: 10.1016/s0008-4182(02)80114-4.

Abstract

BACKGROUND

A frequent cause of conjunctivitis is an acute bacterial infection, presenting with mucopurulent discharge and conjunctival hyperemia. The authors compared the clinical and microbiologic efficacy, safety and acceptability of 1% fusidic acid viscous drops (Fucithalmic) with 0.3% tobramycin ophthalmic solution (Tobrex) in the treatment of suspected bacterial conjunctivitis.

METHODS

Patients were recruited at 20 sites in Ontario, Saskatchewan and Alberta from October 1995 to December 1998. Patients who presented to their primary care physician with suspected bacterial conjunctivitis, as identified by conjunctival hyperemia and purulent or mucopurulent discharge, were eligible for the study. Patients were randomly assigned to receive 7 days of treatment with either 1% fusidic acid (one drop applied twice daily) or 0.3% tobramycin (one to two drops applied four to six times daily). The investigators were blinded as to treatment status. Bacteriologic samples were taken from the inferior conjunctival cul-de-sac on day 0 and at the end of treatment. Signs and symptoms of conjunctivitis were assessed at baseline and after 3 and 7 days of treatment. The acceptability of treatment was assessed by having the patient or the parent or guardian complete a questionnaire on degree of compliance and ease of use after 3 and 7 days of treatment.

RESULTS

Conjunctival swabs were obtained from 484 patients (410 over 9 years of age and 74 aged 2 to 9 years) to determine baseline bacteriology. Of the 484, 319 (65.9%) (63% of the older patients and 80% of those aged 2 to 9 years) had positive results of culture for bacteria. Ninety-four patients (19%) (63 [15%] of the older patients and 31 [42%] of those aged 2 to 9 years) had per-protocol pathogens as defined by quantitative bacteriology criteria. There was a direct correlation between the presence of mucopurulent discharge and the presence of per-protocol pathogens. There were no significant differences in clinical or bacteriologic efficacy between the treatment groups. Treatment compliance was similar between the treatment groups for the older patients; however, for those aged 2 to 9 years, compliance was significantly better in the fusidic acid group than in the tobramycin group (85% vs. 47%) (p < 0.001). Significantly more patients in the fusidic acid group than in the tobramycin group rated treatment as convenient or very convenient, particularly among younger patients (97% vs. 54%) (p < 0.001).

INTERPRETATION

The clinical and bacteriologic efficacy of fusidic acid viscous drops combined with the convenience of a twice-daily dosage regimen establishes this antibiotic as first-line treatment for suspected acute bacterial conjunctivitis and a favourable alternative to other broad-spectrum antibiotics.

摘要

背景

结膜炎的常见病因是急性细菌感染,表现为黏液脓性分泌物和结膜充血。作者比较了1%夫西地酸粘性滴眼液(Fucithalmic)与0.3%妥布霉素滴眼液(Tobrex)在治疗疑似细菌性结膜炎时的临床和微生物学疗效、安全性及可接受性。

方法

1995年10月至1998年12月期间,在安大略省、萨斯喀彻温省和艾伯塔省的20个地点招募患者。因结膜充血以及脓性或黏液脓性分泌物而被基层医疗医生诊断为疑似细菌性结膜炎的患者符合研究条件。患者被随机分配接受为期7天的治疗,其中一组使用1%夫西地酸(每日滴眼两次,每次一滴),另一组使用0.3%妥布霉素(每日滴眼四至六次,每次一至两滴)。研究人员对治疗情况不知情。在第0天和治疗结束时,从下结膜囊采集细菌学样本。在基线以及治疗3天和7天后评估结膜炎的体征和症状。通过让患者或其父母或监护人在治疗3天和7天后完成一份关于依从程度和使用便利性的问卷来评估治疗的可接受性。

结果

从484例患者(410例年龄超过9岁,74例年龄在2至9岁之间)获取结膜拭子以确定基线细菌学情况。在这484例患者中,319例(65.9%)(年龄较大患者中的63%以及2至9岁患者中的80%)细菌培养结果呈阳性。94例患者(19%)(年龄较大患者中的63例 [占15%]以及2至9岁患者中的31例 [占42%])根据定量细菌学标准属于符合方案规定的病原体。黏液脓性分泌物的存在与符合方案规定的病原体的存在之间存在直接关联。治疗组之间在临床或细菌学疗效方面无显著差异。年龄较大患者的治疗组之间治疗依从性相似;然而,对于2至9岁的患者,夫西地酸组的依从性显著优于妥布霉素组(85%对47%)(p<0.001)。与妥布霉素组相比,夫西地酸组中认为治疗方便或非常方便的患者明显更多,尤其是在年轻患者中(97%对54%)(p<0.001)。

解读

夫西地酸粘性滴眼液的临床和细菌学疗效以及每日滴眼两次给药方案的便利性,使其成为疑似急性细菌性结膜炎的一线治疗药物,也是其他广谱抗生素的良好替代药物。

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