Lichtenstein Steven J, Rinehart Mike
Louisville Children's Eye Specialists, 334 East Broadway, Suite 325, Louisville, KY 40202, USA.
J AAPOS. 2003 Oct;7(5):317-24. doi: 10.1016/s1091-8531(03)00168-x.
To compare the efficacy and safety of 0.5% levofloxacin ophthalmic solution (Quixin; Santen, Napa, CA) with 0.3% ofloxacin (Ocuflox; Allergan Inc., Irvine, CA) and placebo for the treatment of pediatric bacterial conjunctivitis.
This study was a subset analysis of 167 pediatric patients (age range, 1 to 16 years) from two randomized, double-masked, multicenter, parallel group studies. Eye drops were instilled every 2 hours on days 1 and 2 and every 4 hours on days 3 through 5. Ocular signs and symptoms were noted, and conjunctival cultures were obtained on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). Endpoint was defined as the last evaluable observation. Microbial and clinical outcomes were based on culture results and cardinal signs, respectively.
At endpoint (mean of 6.5 days for 118 evaluable patients), 0.5% levofloxacin treatment demonstrated greater microbial eradication rates (percentage of patients with absence of causative organisms cultured at baseline) compared with 0.3% ofloxacin or placebo. In children age 2 to 11 years, this finding was statistically significant in favor of 0.5% levofloxacin (87% vs 62% with 0.3% ofloxacin [P < or =.032] and 88% vs 24% with placebo [P <.001]). No significant differences between treatment groups in microbial eradication rates were noted in other age subgroups.
After 5 days of therapy, 0.5% levofloxacin ophthalmic solution was found to be safe and effective in treating pediatric bacterial conjunctivitis. Treatment with 0.5% levofloxacin achieved microbial eradication rates in children that were statistically superior to those attained with 0.3% ofloxacin or placebo.
比较0.5%左氧氟沙星滴眼液（可乐必妥；参天制药，加利福尼亚州纳帕）与0.3%氧氟沙星（奥复星；爱尔康公司，加利福尼亚州欧文）及安慰剂治疗儿童细菌性结膜炎的疗效和安全性。
本研究是对来自两项随机、双盲、多中心、平行组研究的167例儿科患者（年龄范围1至16岁）的亚组分析。在第1天和第2天每2小时滴注一次眼药水，第3天至第5天每4小时滴注一次。记录眼部体征和症状，并在第1天（基线）、第3至5天（中期）和第6至10天（末期）获取结膜培养物。终点定义为最后一次可评估观察。微生物学和临床结果分别基于培养结果和主要体征。
在终点时（118例可评估患者的平均时间为6.5天），与0.3%氧氟沙星或安慰剂相比，0.5%左氧氟沙星治疗显示出更高的微生物根除率（基线培养时无致病微生物的患者百分比）。在2至11岁的儿童中，这一发现对0.5%左氧氟沙星具有统计学意义（分别为87%和62%，0.3%氧氟沙星组[P≤0.032]；分别为88%和24%，安慰剂组[P＜0.001]）。在其他年龄亚组中未观察到治疗组之间微生物根除率的显著差异。
经过5天治疗，发现0.5%左氧氟沙星滴眼液治疗儿童细菌性结膜炎安全有效。0.5%左氧氟沙星治疗儿童的微生物根除率在统计学上优于0.3%氧氟沙星或安慰剂。
