Department of Ophthalmology, Queen's University, Hotel Dieu Hospital, Kingston, Ontario, Canada.
J Cataract Refract Surg. 2012 Sep;38(9):1537-43. doi: 10.1016/j.jcrs.2012.04.034. Epub 2012 Jul 15.
To evaluate the efficacy of prophylactic ketorolac 0.5% versus nepafenac 0.1% versus placebo on macular volume 1 month after uneventful phacoemulsification and evaluate the health-related quality-of-life (HRQOL) of topical nonsteroidal antiinflammatory drugs (NSAIDs) in the context of cataract surgery.
Hotel Dieu Hospital, Kingston, Ontario, Canada.
Prospective placebo-controlled parallel-assignment double-masked randomized clinical trial.
In this study, patients 18 years or older scheduled for routine phacoemulsification were randomized to a placebo, ketorolac 0.5%, or nepafenac 0.1% and dosed 4 times a day starting 1 day before surgery and continuing for 4 weeks. Spectral-domain macular cube ocular coherence tomography scans measuring central subfield thickness, macular cube volume, and average macular cube thickness were performed at baseline and 1 month postoperatively. The HRQOL metrics were determined with the Comparison of Ophthalmic Medications for Tolerability (COMTOL) questionnaire.
Each study group comprised 54 patients. One month postoperatively, although a trend toward significance occurred for nepafenac and ketorolac, analysis of the means of differences showed no statistically significant differences between the 3 study groups (P=.2901). The COMTOL analysis found no difference in tolerability, compliance, side-effect frequency and bother, and effects on HRQOL between ketorolac and nepafenac compared with the placebo.
One month after uneventful phacoemulsification, there was no difference in macular volume between the placebo, ketorolac, and nepafenac. Ketorolac and nepafenac were well tolerated with minimal side-effect profiles. Thus, for patients without risk factors having routine surgery, prophylactic topical NSAIDs are not recommended.
评估在无并发症的超声乳化白内障吸除术后 1 个月时预防性使用酮咯酸 0.5%、奈帕芬胺 0.1%和安慰剂对黄斑体积的疗效，并评估局部非甾体抗炎药（NSAIDs）在白内障手术背景下对健康相关生活质量（HRQOL）的影响。
加拿大安大略省金士顿的圣母医院。
前瞻性安慰剂对照平行分组双盲随机临床试验。
本研究纳入了年龄在 18 岁及以上、计划行常规超声乳化白内障吸除术的患者，将其随机分配至安慰剂组、酮咯酸 0.5%组或奈帕芬胺 0.1%组，于术前 1 天开始每天滴药 4 次，持续 4 周。在基线和术后 1 个月时进行频域光相干断层扫描（OCT）黄斑区立方扫描，以测量中央凹下厚度、黄斑区立方体积和平均黄斑区立方厚度。使用眼科药物耐受性比较（COMTOL）问卷来确定 HRQOL 指标。
每组各有 54 例患者。尽管术后 1 个月时奈帕芬胺和酮咯酸有统计学意义的趋势，但差异平均值分析显示 3 个研究组之间无统计学显著差异（P=.2901）。COMTOL 分析发现，与安慰剂相比，酮咯酸和奈帕芬胺在耐受性、依从性、不良反应频率和困扰、以及对 HRQOL 的影响方面无差异。
在无并发症的超声乳化白内障吸除术后 1 个月时，安慰剂、酮咯酸和奈帕芬胺组之间的黄斑体积无差异。酮咯酸和奈帕芬胺的耐受性良好，不良反应发生率低。因此，对于无危险因素的常规手术患者，不建议预防性使用局部 NSAIDs。
