Nielsen Steven A, McDonald Marguerite B, Majmudar Parag A
Nielsen Eye Center, Quincy, MA, USA.
Clin Ophthalmol. 2013;7:149-56. doi: 10.2147/OPTH.S38279. Epub 2013 Jan 17.
To evaluate the safety of besifloxacin ophthalmic suspension 0.6% when used in laser-assisted in situ keratomileusis (LASIK) prophylactic antibiotic regimens.
Retrospective surveillance of LASIK surgery cases where besifloxacin ophthalmic suspension 0.6% or moxifloxacin ophthalmic solution 0.5% were prescribed as prophylactic medications. Surgeons from nine US surgical centers provided retrospective case information on surgical outcomes from consecutive cases and reported any adverse events related to the antibacterial used. The primary endpoint was the incidence of adverse drug reactions.
A total of 801 case reports (801 eyes; 534 besifloxacin, 267 moxifloxacin) were obtained. The mean (standard deviation [SD]) age at time of surgery was 36.1 (10.6) years. The mean (SD) duration of antibiotic treatment was 8.6 (2.2) days in the besifloxacin group and 8.0 (2.3) in the moxifloxacin group; daily dosing frequency was higher in the moxifloxacin group preoperatively, on the day of surgery, and postoperatively. There were no reports of adverse drug reactions for the 801 eyes in this surveillance. There were no differences between the besifloxacin and moxifloxacin treatment groups in rates of unexpected corneal findings (2.1% vs 1.5%, P = 0.949). The distribution of final visual acuity for the besifloxacin and moxifloxacin groups were similar (P = 0.793). Most cases had a final visual acuity of 20/20 or better.
In this retrospective surveillance study, the prophylactic use of besifloxacin ophthalmic suspension 0.6% and moxifloxacin ophthalmic solution 0.5% in patients undergoing LASIK surgery was not associated with any adverse drug reactions.
评估0.6%贝西沙星眼用混悬液用于准分子原位角膜磨镶术（LASIK）预防性抗生素方案时的安全性。
对将0.6%贝西沙星眼用混悬液或0.5%莫西沙星滴眼液作为预防性用药的LASIK手术病例进行回顾性监测。来自美国9个手术中心的外科医生提供了连续病例手术结果的回顾性病例信息，并报告了与所用抗菌药物相关的任何不良事件。主要终点是药物不良反应的发生率。
共获得801例报告（801只眼；534只使用贝西沙星，267只使用莫西沙星）。手术时的平均（标准差[SD]）年龄为36.1（10.6）岁。贝西沙星组抗生素治疗的平均（SD）持续时间为8.6（2.2）天，莫西沙星组为8.0（2.3）天；莫西沙星组术前、手术当天和术后的每日给药频率更高。在该监测中，801只眼中没有药物不良反应的报告。贝西沙星和莫西沙星治疗组在意外角膜检查结果发生率方面没有差异（2.1%对1.5%，P = 0.949）。贝西沙星组和莫西沙星组的最终视力分布相似（P = 0.793）。大多数病例的最终视力为20/20或更好。
在这项回顾性监测研究中，LASIK手术患者预防性使用0.6%贝西沙星眼用混悬液和0.5%莫西沙星滴眼液与任何药物不良反应均无关联。
