Efficacy and safety of azithromycin 1.5% eye drops in paediatric population with purulent bacterial conjunctivitis

被引：13

作者：

Bremond-Gignac, Dominique ^{[1
,2
]}

Nezzar, Hachemi ^{[3
,4
]}

Bianchi, Paolo Emilio ^{[5
]}

Messaoud, Riadh ^{[6
]}

Lazreg, Sihem ^{[7
]}

Voinea, Liliana ^{[8
]}

Speeg-Schatz, Claude ^{[9
]}

Hartani, Dahbia ^{[10
]}

Kaercher, Thomas ^{[11
]}

Kocyla-Karczmarewicz, Beata ^{[12
]}

Murta, Joaquim ^{[13
]}

Delval, Laurent ^{[14
]}

Renault, Didier ^{[14
]}

Chiambaretta, Frederic ^{[3
,15
]}

机构：

[1] Univ Picardie Jules Verne, Ctr St Victor, CHU Amiens, Serv Ophtalmol, Amiens, France

[2] Univ Paris 06, INSERM, UMRS968, Inst Vis, Paris, France

[3] CHU Clermont Ferrand, Hop Gabriel Montpied, Serv Ophtalmol, Clermont Ferrand, France

[4] Univ Clermont Ferrand, Univ Auvergne, UFR Med, IGCNC ISIT EA7282 UMR6284, Clermont Ferrand, France

[5] IRCCS Policlin San Matteo Fdn, Univ Eye Clin, Pavia, Italy

[6] CHU Tahar Sfar Mahdia, Hop Reg Madhia, Serv Ophtalmol, Mahdia, Tunisia

[7] Cabinet Ophtalmol, Blida, Algeria

[8] Univ Emergency Hosp, Dept Ophthalmol, Bucharest, Romania

[9] CHU Strasbourg, Serv Ophtalmol, F-67000 Strasbourg, France

[10] CHU Mustapha, Serv Ophtalmol, Algiers, Algeria

[11] Augenarztpraxis, Heidelberg, Germany

[12] Childrens Mem Hlth Inst, Dept Ophthalmol, Warsaw, Poland

[13] Univ Coimbra, Dept Ophthalmol, Ctr Hosp Univ Coimbra, Fac Med, Coimbra, Portugal

[14] Lab THEA, Clermont Ferrand, France

[15] Univ Auvergne, Fac Med, Lab Biochim Med, EA 7281 R2D2, Clermont Ferrand, France

来源：

BRITISH JOURNAL OF OPHTHALMOLOGY | 2014年 / 98卷 / 06期

关键词：

LEVOFLOXACIN OPHTHALMIC SOLUTION; CLINICAL-TRIAL; 3-DAY TREATMENT; OTITIS SYNDROME; PHASE-III; CHILDREN; 0.5-PERCENT; 0.3-PERCENT; MULTICENTER; TOBRAMYCIN;

D O I：

10.1136/bjophthalmol-2013-303888

中图分类号：

R77 [眼科学];

学科分类号：

100212 ;

摘要：

Objective To determine the efficacy and safety of azithromycin 1.5% eye drops in a paediatric population with purulent bacterial conjunctivitis. Patients and methods This was a multicentre, international, randomised, investigator-masked study in 286 children with purulent discharge and bulbar conjunctival injection. Patients received either azithromycin 1.5% eye drops (twice daily for 3 days) or tobramycin 0.3% eye drops (every 2 h for 2 days, then four times daily for 5 days). Clinical signs were evaluated on day (D) 0, 3 and 7, and cultures on D0 and D7. The primary variable was the clinical cure (absence of bulbar conjunctival injection and discharge) on D3 in the worse eye for patients with positive cultures on D0. Results 286 patients (mean age 3.2 years; range 1 day-17 years) were included; 203 had positive cultures on D0. Azithromycin was superior to tobramycin in clinical cure rate on D3 (47.1% vs 28.7%, p=0.013) and was non-inferior to tobramycin on D7 (89.2% vs 78.2%, respectively). Azithromycin treatment eradicated causative pathogens, including resistant species, with a similar resolution rate to tobramycin (89.8% vs 87.2%, respectively). These results were confirmed in a subgroup of patients younger than 24 months old. Conclusions Azithromycin 1.5% eye drops provided a more rapid clinical cure than tobramycin 0.3% eye drops in the treatment of purulent bacterial conjunctivitis in children, with a more convenient twice-a-day dosing regimen.

引用

页码：739 / 745

页数：7