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首页> 外文期刊>Ophthalmology >A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis.
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A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis.

机译：0.5％左氧氟沙星滴眼液与0.3％氧氟沙星滴眼液治疗细菌性结膜炎的III期临床试验。

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OBJECTIVE: To compare the efficacy and safety of 0.5% levofloxacin ophthalmic solution (QUIXIN) with 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. DESIGN: Prospective, randomized, active-controlled, double-masked, multicenter study. PARTICIPANTS: Four hundred twenty-three patients with a clinical diagnosis of bacterial conjunctivitis were enrolled. METHODS: Patients were randomly assigned to receive either 0.5% levofloxacin (n = 211) or 0.3% ofloxacin (n = 212) for 5 days (every 2 hours on days 1 and 2 and every 4 hours on days 3-5). Conjunctival cultures were obtained, and ocular signs and symptoms were evaluated on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). End point was defined as the last evaluable observation. MAIN OUTCOME MEASURES: Primary microbial and clinical outcomes were based on culture results and resolution of cardinal signs, respectively. Secondary efficacy assessments included evaluations of ocular signs and symptoms. RESULTS: Two hundred eight patients (levofloxacin, n = 109; ofloxacin, n = 99) were evaluated for efficacy. Microbial eradication rates were significantly greater in the 0.5% levofloxacin treatment group compared with the 0.3% ofloxacin group at both the final visit (89% vs. 80%, P = 0.034) and at end point (90% vs. 81%; P = 0.038). Treatment with 0.5% levofloxacin was significantly more effective in resolving photophobia than was 0.3% ofloxacin treatment (94% vs. 73%, P = 0.006). Both study medications were well tolerated, with a low incidence of adverse events. CONCLUSIONS: Although clinical cure rates in the 0.5% levofloxacin and 0.3% ofloxacin treatment groups were similar, a 5-day treatment regimen with 0.5% levofloxacin achieved microbial eradication rates that were statistically superior to those attained with 0.3% ofloxacin. Despite the higher concentration of active drug in 0.5% levofloxacin versus 0.3% ofloxacin, there was no difference between treatment groups in the incidence of treatment-related adverse events.
机译：目的：比较0.5％左氧氟沙星滴眼液（QUIXIN）与0.3％氧氟沙星滴眼液治疗细菌性结膜炎的疗效和安全性。设计：前瞻性，随机，主动控制，双掩蔽，多中心研究。参与者：243例临床诊断为细菌性结膜炎的患者入选。方法：患者被随机分配接受0.5％左氧氟沙星（n = 211）或0.3％氧氟沙星（n = 212），为期5天（第1天和第2天每2小时一次，第3-5天每4小时一次）。获得结膜培养物，并在第1天（基线），第3天至第5天（中期）和第6天至第10天（最终）评估眼部症状和体征。终点定义为最后可评估的观察值。主要观察指标：主要的微生物和临床结果分别基于培养结果和基本症状的解决。次要疗效评估包括眼部症状和体征的评估。结果：对208例患者（左氧氟沙星，n = 109;氧氟沙星，n = 99）进行了疗效评估。在最终访视时（89％vs. 80％，P = 0.034）和终点时（0.5％左氧氟沙星治疗组）的微生物根除率显着高于0.3％氧氟沙星组（90％vs. 81％; P = 0.038）。与0.3％的氧氟沙星治疗相比，用0.5％的左氧氟沙星治疗更有效地解决了恐惧症（94％比73％，P = 0.006）。两种研究药物均耐受良好，不良事件发生率低。结论：尽管0.5％左氧氟沙星和0.3％氧氟沙星治疗组的临床治愈率相似，但使用0.5％左氧氟沙星的5天治疗方案的微生物根除率在统计学上优于0.3％的氧氟沙星。尽管活性药物在0.5％左氧氟沙星中的浓度高于0.3％氧氟沙星，但治疗相关不良事件的发生率在治疗组之间没有差异。

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