Service d'Ophtalmologie, Centre Saint Victor, CHU d'Amiens, Bd de Beauvillé, Amiens, Université Picardie Jules Verne, France.
Pediatr Infect Dis J. 2010 Mar;29(3):222-6. doi: 10.1097/INF.0b013e3181b99fa2.
Purulent bacterial conjunctivitis affects all ages with high frequency in newborns and children. In a subset of 150 children included in a large study having enrolled 1043 patients, our aim was to analyze in children, the efficacy and safety of azithromycin 1.5% eye-drops in the treatment of this disease.
This multicenter, randomized, investigator-masked, parallel-group study, included 150 children and adolescents to study safety and compare azithromycin 1.5% eye drops twice daily for 3 days and tobramycin 0.3% 1 drop every 2 hours for 2 days then 4 times daily for 5 days. Out of 150 patients included, 58 had positive cultures and were studied for efficacy. Signs and symptoms were evaluated and cultures obtained at baseline, Days 3 and 9. Primary efficacy variable was the clinical cure (score 0 for bulbar conjunctival injection and purulent discharge) at the test of cure visit (day 9).
Both treatments were effective with a clinical and microbiologic cure of more than 80% of children on day 9. Azithromycin therapy provided a greater bacteriologic cure on day 3 than did tobramycin (P < 0.001) and eradicated bacteria that were defined as resistant, using classical antibiogram. No adverse effects were noted on the ocular surface.
Azithromycin 1.5% eye drops leads to a rapid clinical and microbiological cure.
化脓性细菌性结膜炎在新生儿和儿童中高频发生，影响所有年龄段。在一项纳入 1043 例患者的大型研究中，我们对 150 例儿童进行了亚组分析，旨在分析阿奇霉素 1.5%滴眼剂治疗该病的疗效和安全性。
这是一项多中心、随机、研究者设盲、平行组研究，纳入了 150 名儿童和青少年，以评估安全性，并比较阿奇霉素 1.5%滴眼剂每日 2 次，连用 3 天，与妥布霉素 0.3% 1 滴，每 2 小时 1 次，连用 2 天，然后每天 4 次，连用 5 天。在纳入的 150 例患者中，58 例有阳性培养物，用于评估疗效。在基线、第 3 天和第 9 天评估体征和症状并进行培养。主要疗效变量是治愈时的临床疗效（第 9 天的治愈访视时评分 0，即球结膜充血和脓性分泌物）。
两种治疗方法均有效，第 9 天时，超过 80%的儿童获得临床和微生物学治愈。阿奇霉素治疗在第 3 天的细菌学治愈率高于妥布霉素（P<0.001），并消除了经典抗生素药敏试验定义的耐药菌。眼部表面未见不良反应。
阿奇霉素 1.5%滴眼剂可迅速达到临床和微生物学治愈。
