...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Clinical drug investigation >Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children
【24h】

Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children

机译：每日两次给予贝西沙星眼用混悬液0.6％，连续3天，用于治疗成人和儿童细菌性结膜炎

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Background and Objective: Besifloxacin ophthalmic suspension 0.6% given thrice daily for 5 days is safe and effective in the treatment of patients with bacterial conjunctivitis. This study evaluated the safety and efficacy of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days compared with vehicle in the treatment of bacterial conjunctivitis. Study Design: This was a multicenter, double-masked, randomized, vehiclecontrolled, parallel-group study. Methods: A total of 474 patients aged ≥1 year with bacterial conjunctivitis were randomized in a 1 : 1 ratio to receive either besifloxacin ophthalmic suspension 0.6% or vehicle administered twice daily for 3 days. There were three study visits: day 1 (the baseline visit), day 4/5 (visit 2), and day 7 ± 1 (visit 3). The co-primary efficacy endpoints were bacterial eradication and clinical resolution at day 4/5 in designated study eyes of patients with cultureconfirmed bacterial conjunctivitis. Secondary efficacy endpoints were bacterial eradication and clinical resolution at day 7 ± 1, individual clinical outcomes of ocular discharge and bulbar conjunctival injection at all visits; and microbial and clinical outcomes for overall bacterial species and individual Grampositive and Gram-negative bacterial species at each follow-up visit. Safety endpoints included adverse events (AEs), changes in visual acuity and biomicroscopy findings at each visit, and changes in ophthalmoscopy findings at day 7 ± 1. Results: Bacterial eradication and clinical resolution rates were significantly higher in the besifloxacin group than in the vehicle group (115/135 [85.2%] vs 77/141 [54.6%], p<0.001, and 89/135 [65.9%] vs 62/141 [44.0%], p<0.001, respectively) at day 4/5. Rates of bacterial eradication continued to be significantly greater in the besifloxacin group (115/135 [85.2%] vs 91/141 [64.5%], respectively; p<0.001) at day 7 ± 1; however, the rates of clinical resolution did not differ significantly between the groups (103/135 [76.3%] and 94/141 [66.7%], p = 0.209) at this visit. Ocular discharge and bulbar conjunctival injection at each visit were consistent with the primary outcomes. Clinical resolution and bacterial eradication with Gram-positive or Gram-negative organisms were consistent with the overall findings. All AEs in both groups were of mild or moderate severity and were considered unrelated to the treatment. Conclusion: Treatment with besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days was effective and safe in adults and children with bacterial conjunctivitis.
机译：背景与目的：每天三次给予0.6％的贝西沙星眼用混悬液，连续5天，是治疗细菌性结膜炎安全有效的方法。这项研究评估了与媒介物相比，每日两次，连续3天，每天施用0.6％的贝西沙星眼用混悬液治疗细菌性结膜炎的安全性和有效性。研究设计：这是一个多中心，双掩蔽，随机，车辆控制，平行组研究。方法：将总共474例≥1岁的细菌性结膜炎患者按1：1的比例随机分配，接受0.6％的贝西沙星眼用混悬剂或每天2次的媒介物，连续3天。共进行了3次研究访问：第1天（基线访问），第4/5天（访问2）和第7±1天（访问3）。共同主要疗效终点是在培养证实为细菌性结膜炎的患者的指定研究眼中，在第4/5天进行细菌根除和临床消退。次要疗效终点是在第7±1天进行细菌根除和临床治疗，所有访视时眼球排出和球结膜注射的个别临床结局;每次随访时，总体细菌种类以及单个革兰氏阳性和革兰氏阴性细菌种类的微生物和临床结局。安全终点包括不良事件（AEs），每次就诊时的视力和生物显微镜检查结果变化以及第7±1天的检眼镜检查结果变化。结果：贝西沙星组的细菌根除和临床解决率显着高于媒介物组（第4/5天）（分别为115/135 [85.2％] vs 77/141 [54.6％]，p <0.001和89/135 [65.9％] vs 62/141 [44.0％]，p <0.001） 。在第7±1天，贝西沙星组的细菌根除率继续显着更高（分别为115/135 [85.2％]和91/141 [64.5％]; p <0.001）。然而，在这次访问中，两组之间的临床解决率没有显着差异（103/135 [76.3％]和94/141 [66.7％]，p = 0.209）。每次就诊眼球排出和球结膜注射均与主要结局一致。临床分辨率和革兰氏阳性或革兰氏阴性菌的细菌根除与总体发现一致。两组中的所有AE均为轻度或中度，被认为与治疗无关。结论：成人和儿童细菌性结膜炎，每日两次给予0.6％的贝西沙星眼用混悬液治疗3天是安全有效的。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号