Jauch A, Fsadni M, Gamba G
CIBA Vision AG, Central Medical Affairs, Grenzstrasse 10, CH-8180 Bülach, Switzerland.
Graefes Arch Clin Exp Ophthalmol. 1999 Sep;237(9):705-13. doi: 10.1007/s004170050300.
Lomefloxacin 0.3% ophthalmic solution twice daily has been compared in patients with bacterial conjunctivitis in six randomized double-blind or investigator-masked phase III studies with either chloramphenicol 0.5% 5x/day, gentamicin 0.3% 4x/day, fusidic acid 1% 2x/day, tobramycin 0.3% 4x/day or norfloxacin 0.3% 4x/day.
A meta-analysis of all individual data of these six studies was performed. A total of 582 patients with clinically diagnosed bacterial conjunctivitis were evaluated by slit-lamp examination with grading of eight key signs and symptoms and by conjunctival swab cultures at baseline, on day 3-5 and on day 7-9. Success of therapy, local tolerance and safety were evaluated at termination. In vitro sensitivity of the ocular isolates to 6-10 antibiotics was evaluated by disk diffusion tests.
Two hundred and ninety patients treated with lomefloxacin 0.3% (LF) and 292 patients treated by one of the control antibiotics (combined control group, CCG) were enrolled in the studies. Two hundred and seventy-eight LF and 283 CCG patients were evaluable for the intent-to-treat (ITT) analysis, while 85 LF and 95 CCG patients had bacteria above the pathological threshold and formed the core subpopulation. The mean cumulative sum score in the LF group was 9. 47 on day 1, and decreased by 5.70 on day 3-5 and by 8.10 on day 7-9. In the CCG it decreased significantly less: it was 9.19 at baseline, decreased by 5.15 on day 3-5 and by 7.33 on day 7-9. Swab counts decreased in the LF and CCG group similarly, with the major decrease observed between day 1 and day 3-5. Most of the organisms considered resistant in vitro were still eradicated with the regimen used. Of the few surviving organisms also isolated on the next follow-up visit, one isolate in the LF group and seven in the CCG showed decreased in vitro sensitivity towards the treatment antibiotic used. Local tolerance was good or excellent, without any significant differences except for burning sensation, which lasted significantly longer in the CCG group than in the LF group. Adverse events were observed in 18 LF and 23 CCG patients; four LF and three CCG patients had to be withdrawn. All adverse events were non-serious.
Lomefloxacin eye drops used with a loading dosage followed by a twice daily regimen proved as effective, safe and well tolerated as five established standard treatments used at a 2, 4 or 5 times daily regimen, caused less discomfort upon instillation, and showed a lower risk to generate or select new resistant strains.
在六项随机双盲或研究者设盲的III期研究中，对每日两次使用0.3%洛美沙星滴眼液治疗细菌性结膜炎的患者，与每日5次使用0.5%氯霉素、每日4次使用0.3%庆大霉素、每日2次使用1%夫西地酸、每日4次使用0.3%妥布霉素或每日4次使用0.3%诺氟沙星的患者进行了比较。
对这六项研究的所有个体数据进行荟萃分析。共有582例临床诊断为细菌性结膜炎的患者在基线、第3 - 5天和第7 - 9天接受裂隙灯检查，对八项关键体征和症状进行分级，并进行结膜拭子培养。在治疗结束时评估治疗成功率、局部耐受性和安全性。通过纸片扩散试验评估眼部分离株对6 - 10种抗生素的体外敏感性。
290例接受0.3%洛美沙星（LF）治疗的患者和292例接受一种对照抗生素治疗的患者（联合对照组，CCG）纳入研究。278例LF患者和283例CCG患者可进行意向性治疗（ITT）分析，而85例LF患者和95例CCG患者的细菌数量高于病理阈值，构成核心亚组。LF组第1天的平均累积总分是9.47，在第3 - 5天下降了5.70，在第7 - 9天下降了8.10。在CCG组下降明显较少：基线时为9.19，在第3 - 5天下降了5.15，在第7 - 9天下降了7.33。LF组和CCG组的拭子菌数下降情况相似，主要下降发生在第1天至第3 - 5天之间。大多数体外被认为耐药的微生物仍被所用治疗方案根除。在下次随访中也分离出的少数存活微生物中，LF组有1株，CCG组有7株对所用治疗抗生素的体外敏感性降低。局部耐受性良好或极佳，除烧灼感外无任何显著差异，烧灼感在CCG组持续的时间明显长于LF组。18例LF患者和23例CCG患者观察到不良事件；4例LF患者和3例CCG患者不得不退出研究。所有不良事件均不严重。
采用负荷剂量后每日两次给药方案的洛美沙星滴眼液，与每日2次、4次或5次给药的五种既定标准治疗方法一样有效、安全且耐受性良好，滴眼时引起的不适较少，产生或选择新耐药菌株的风险较低。
