Toyos Melissa M
Toyos Clinic, Nashville, TN, USA.
Ophthalmol Ther. 2019 Jun;8(2):261-270. doi: 10.1007/s40123-019-0174-x. Epub 2019 Mar 13.
Randomized pilot study comparing clinical outcomes with bromfenac ophthalmic solution 0.07% versus nepafenac 0.3% ophthalmic suspension administered as identical dosing regimens in patients undergoing uncomplicated phacoemulsification with intraocular lens implantation.
Forty-nine subjects were treated with bromfenac (n = 25) or nepafenac (n = 24) once daily starting 3 days before cataract surgery, continued on the day of surgery, and for 21 days following surgery, in addition to standard of care. Subjects were followed at 1 day and 7, 21, and 42 days postoperatively. Assessments included best-corrected visual acuity [Early Treatment Diabetic Retinopathy Study (ETDRS)], summed ocular inflammation score (SOIS; anterior chamber cells plus flare grading), macular volume and thickness (spectral domain optical coherence tomography), intraocular pressure, and adverse events.
Treatment groups were similar at baseline. Outcomes for mean letters read (p = 0.20), mean change in macular volume (p = 0.98), and retinal thickness (p = 0.93) were not statistically different between the groups at day 42. Mean SOIS dropped markedly and similarly from post-surgical day 1 to day 7 in both treatment groups and was statistically equivalent to baseline in both groups by day 21. At day 42, 87% of subjects in the bromfenac group and 82% of subjects in the nepafenac group demonstrated stable or improved visual acuity. The proportions of eyes with mean retinal thickness of 10 µm or less at days 7, 21, and 42 were similar for the bromfenac (95.8%, 78.3%, 73.9%, respectively) and nepafenac (91.7%, 87.5%, 66.7%) groups (all p = NS, bromfenac vs. nepafenac).
Both bromfenac 0.07% and nepafenac 0.3% produced positive and similar clinical outcomes with regard to ETDRS visual acuity post-cataract surgery when dosed using identical regimens. Increases in mean retinal thickness and mean macular volume were small and similar between treatments.
NCT01847638.
Bausch & Lomb Incorporated.
进行一项随机试点研究，比较0.07%溴芬酸钠眼药水与0.3%奈帕芬胺眼用混悬液在接受单纯白内障超声乳化联合人工晶状体植入术患者中采用相同给药方案时的临床疗效。
49名受试者在白内障手术前3天开始，每天一次接受溴芬酸钠治疗（n = 25）或奈帕芬胺治疗（n = 24），手术当天继续用药，并在术后持续用药21天，同时给予标准护理。在术后1天、7天、21天和42天对受试者进行随访。评估包括最佳矫正视力[糖尿病视网膜病变早期治疗研究（ETDRS）]、眼部炎症总分（SOIS；前房细胞加闪光分级）、黄斑体积和厚度（频域光学相干断层扫描）、眼压以及不良事件。
治疗组在基线时相似。在第42天，两组之间平均阅读字母数（p = 0.20）、黄斑体积平均变化（p = 0.98）和视网膜厚度（p = 0.93）的结果无统计学差异。在两个治疗组中，平均SOIS从术后第1天到第7天均显著且相似地下降，到第21天时两组均在统计学上等同于基线。在第42天，溴芬酸钠组87%的受试者和奈帕芬胺组82%的受试者视力稳定或改善。在第7天、21天和42天，视网膜平均厚度为10μm或更小的眼睛比例在溴芬酸钠组（分别为95.8%、78.3%、73.9%）和奈帕芬胺组（91.7%、87.5%、66.7%）中相似（所有p = 无显著性差异，溴芬酸钠组与奈帕芬胺组比较）。
当采用相同给药方案时，0.07%溴芬酸钠和0.3%奈帕芬胺在白内障手术后的ETDRS视力方面产生了相似的积极临床疗效。治疗之间视网膜平均厚度和黄斑平均体积的增加较小且相似。
NCT01847638。
博士伦公司。
