a Eastern Virginia Medical School , Norfolk , Virginia , USA.
b Massachusetts Eye Research and Surgery Institution , The Ocular Immunology and Uveitis Foundation , Cambridge , Massachusetts , USA.
Ocul Immunol Inflamm. 2019;27(3):484-496. doi: 10.1080/09273948.2017.1407433. Epub 2017 Dec 20.
: To analyse pooled data from 2 similar phase 3 noninferiority studies comparing difluprednate 0.05% versus prednisolone acetate 1% in patients with endogenous anterior uveitis. : Patients received difluprednate alternating with vehicle or prednisolone acetate for 14 days (8 drops/day in both groups), followed by tapering from day 14 to 28. All patients were observed until day 42. : More patients on difluprednate than on prednisolone acetate were cleared of anterior chamber cells on day twenty one (71.3% vs 54.7%; = 0.02); results were similar at the other time points. Treatment withdrawals were higher with prednisolone acetate than difluprednate (19.8% vs 7.4%; log-rank = 0.02). Study discontinuation due to lack of efficacy was also higher with prednisolone acetate than difluprednate (14.0% vs 0%; = 0.0002 [pre-specified exploratory analysis]). : More difluprednate-treated eyes were quiet following 21 days of treatment, and difluprednate-treated patients were much less likely to be withdrawn from the study because of treatment failure.
：分析 2 项类似的 3 期非劣效性研究的汇总数据，比较二氟泼尼龙 0.05%与醋酸泼尼松龙 1%治疗内源性前葡萄膜炎患者的疗效。：患者接受二氟泼尼龙或赋形剂交替治疗 14 天（两组均每天 8 滴），然后从第 14 天开始逐渐减少至第 28 天。所有患者均观察至第 42 天。：第 21 天，接受二氟泼尼龙治疗的患者前房细胞清除率高于接受醋酸泼尼松龙治疗的患者（71.3%比 54.7%；=0.02）；其他时间点的结果相似。醋酸泼尼松龙治疗组的停药率高于二氟泼尼龙治疗组（19.8%比 7.4%；对数秩检验=0.02）。因疗效不佳而停止研究的患者也多于二氟泼尼龙治疗组（14.0%比 0%；=0.0002[预先指定的探索性分析]）。：治疗 21 天后，更多接受二氟泼尼龙治疗的眼睛恢复安静，且因治疗失败而退出研究的二氟泼尼龙治疗患者更少。
