Denis F, Chaumeil C, Goldschmidt P, Delval L, Pouliquen P, Cochereau I, Chainier D, De Barbeyrac B
Service de Bactériologie-Virologie-Hygiène, CHU de Limoges, Limoges Cedex - France.
Eur J Ophthalmol. 2008 Nov-Dec;18(6):858-68. doi: 10.1177/112067210801800602.
Antibacterial efficacy of topically applied azithromycin 1.5% was compared with tobramycin 0.3% in a multicenter, randomized, investigator-masked study for the treatment of purulent bacterial conjunctivitis.
A total of 1043 adults and children received either azithromycin twice daily for 3 days (n=524) or tobramycin every 2 hours while awake for 2 days, then four times daily for 5 days (n=519). Conjunctival swabbing was taken at days 0, 3, and 9, using alginate swabs resuspended in a dissolution-transport medium, providing rapid and reproducible results. Cagle's criteria were used to define the pathogenicity level for each isolated bacterium.
In the per-protocol set, the rate of bacteriologic resolution was 85.2% for azithromycin versus 83.8% for tobramycin on day 3, and 92.8% for azithromycin versus 94.6% for tobramycin on day 9. Azithromycin was demonstrated to be noninferior to tobramycin according to the 10% noninferiority margin. Although some bacteria were categorized as resistant to tested antibiotics, eradication was observed (for azithromycin: Acinetobacter, Enterobacteriaceae, Pseudomonas), highlighting the specific pharmacokinetics/pharmacodynamics of the ocular route.
In total, topical therapy with azithromycin 1.5% administered only twice daily for 3 days effectively eradicates most pathogenic bacteria associated with bacterial conjunctivitis. These microbiologic results are in accordance with the observed clinical outcome. This new anti-infective product has the advantage of a short treatment course which could lead to an improvement in patient compliance.
在一项多中心、随机、研究者设盲的研究中，比较局部应用1.5%阿奇霉素与0.3%妥布霉素治疗脓性细菌性结膜炎的抗菌疗效。
共有1043名成人和儿童参与研究，其中524人每日两次使用阿奇霉素，持续3天；519人清醒时每2小时使用一次妥布霉素，持续2天，之后每日4次，持续5天。在第0、3和9天采集结膜拭子，使用悬浮于溶解转运介质中的藻酸盐拭子，可提供快速且可重复的结果。采用卡格尔标准定义每种分离细菌的致病性水平。
在符合方案集里，第3天阿奇霉素的细菌学清除率为85.2%，妥布霉素为83.8%；第9天阿奇霉素为92.8%，妥布霉素为94.6%。根据10%的非劣效性界值，阿奇霉素被证明不劣于妥布霉素。尽管有些细菌被归类为对受试抗生素耐药，但仍观察到清除情况（阿奇霉素：不动杆菌属、肠杆菌科、假单胞菌属），突出了眼部给药途径特定的药代动力学/药效学特点。
总体而言，每日仅两次、持续3天局部应用1.5%阿奇霉素能有效根除与细菌性结膜炎相关的大多数病原菌。这些微生物学结果与观察到的临床结果一致。这种新型抗感染产品具有疗程短的优势，可能会提高患者的依从性。
