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0.3%洛美沙星滴眼液每日两次与0.3%妥布霉素滴眼液治疗急性细菌性结膜炎的多中心双盲III期研究。

Topical lomefloxacin 0.3% twice daily versus tobramycin 0.3% in acute bacterial conjunctivitis: A multicenter double-blind phase III study.

作者信息

Gallenga P E, Lobefalo L, Colangelo L, Della Loggia G, Orzalesi N, Velati P, Bujtar E, Ponte F, Damiani S, Bucci M G, Bonini S, Curatola M R, Palma L A, Bonomi L, Tomazzoli Gerosa L, Pagliarusco A, Milan E, Jauch A

机构信息

Institute of Ophthalmology, University 'G. D'Annunzio', Chieti, Italy.

出版信息

Ophthalmologica. 1999;213(4):250-7. doi: 10.1159/000027430.

DOI:10.1159/000027430
PMID:10420109
Abstract

AIMS/BACKGROUND: To evaluate in a double-masked comparative, prospective, randomized multicenter trial the efficacy of lomefloxacin 0.3% eye drops twice daily and of tobramycin eye drops 4 times daily in patients with acute bacterial conjunctivitis.

METHODS

Ninety-nine subjects were enrolled: 50 were treated with lomefloxacin 0.3% eye drops twice daily and 49 with tobramycin 0.3% eye drops 4 times daily. In all patients, conjunctival swabbing and assessment of objective signs and of subjective symptoms were performed.

RESULTS

There was no statistical difference for any individual sign or symptom or for the sum score of either key or other signs and symptoms at any of the examination days. The sum score of both key and other signs and symptoms decreased in both groups at day 3-4 as compared to baseline values (p < 0.0001). The decrease in both these scores continued significantly from day 3-4 to day 7-8 (p < 0.05) and was similar in the two treatment groups (p > 0.4). The lowest resistance rate was seen in lomefloxacin (3.5%) and in neomycin (7.0%), while tobramycin showed resistance in 10 out of 88 resistance strains (11.4%).

CONCLUSION

Both lomefloxacin 0.3% twice daily and tobramycin 0.3% administered 4 times daily were well tolerated and showed a high degree of clinical and microbiological efficacy in the treatment of acute bacterial conjunctivitis. Lomefloxacin caused less resistance than other antibiotics evaluated.

摘要

目的/背景:在一项双盲、比较性、前瞻性、随机多中心试验中,评估每日两次使用0.3%洛美沙星滴眼液和每日四次使用妥布霉素滴眼液治疗急性细菌性结膜炎患者的疗效。

方法

招募了99名受试者:50名患者每日两次使用0.3%洛美沙星滴眼液治疗,49名患者每日四次使用0.3%妥布霉素滴眼液治疗。对所有患者进行结膜拭子采样,并评估客观体征和主观症状。

结果

在任何检查日,任何个体体征或症状以及关键或其他体征和症状的总分均无统计学差异。与基线值相比,两组在第3 - 4天关键和其他体征及症状的总分均下降(p < 0.0001)。从第3 - 4天到第7 - 8天,这两个分数的下降仍有显著差异(p < 0.05),且两个治疗组相似(p > 0.4)。洛美沙星(3.5%)和新霉素(7.0%)的耐药率最低,而妥布霉素在88株耐药菌株中有10株耐药(11.4%)。

结论

每日两次使用0.3%洛美沙星和每日四次使用0.3%妥布霉素耐受性良好,在治疗急性细菌性结膜炎方面显示出高度的临床和微生物学疗效。与评估的其他抗生素相比,洛美沙星引起的耐药性更低。

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