Wilson M E, O'Halloran H, VanderVeen D, Roarty J, Plager D A, Markwardt K, Gedif K, Lambert S R
Storm Eye Institute, Medical University of South Carolina, Charleston, SC, USA.
Rady Children's Hospital, San Diego, CA, USA.
Eye (Lond). 2016 Sep;30(9):1187-94. doi: 10.1038/eye.2016.132. Epub 2016 Jul 1.
PurposeTo evaluate safety and efficacy of difluprednate 0.05% ophthalmic emulsion for treatment of postoperative inflammation after cataract surgery in pediatric patients.MethodsThis was a phase 3B, multicentre, randomized, double-masked, active-controlled study of patients aged 0-3 years who underwent uncomplicated cataract surgery in one eye, with/without intraocular lens implantation. Patients were randomized to receive difluprednate 0.05% four times daily or prednisolone acetate 1% for 14 days post surgery, followed by tapering for 14 days. Safety included evaluation of adverse events. Primary efficacy was the proportion of patients with an anterior cell grade of 0 (no cells) at day 14; secondary efficacy was a global inflammation score.ResultsForty patients were randomized to each treatment group. Adverse drug reactions included corneal oedema (difluprednate 0.5%, n=1; prednisolone acetate 1%, n=0) and increased intraocular pressure or ocular hypertension (n=2/group). Mean intraocular pressure values during treatment were 2-3 mm Hg higher with difluprednate 0.05% compared with prednisolone acetate 1%; mean values were similar between groups by the first week after treatment cessation. At 2 weeks post surgery, the incidence of complete clearing of anterior chamber cells was similar between groups (difluprednate 0.05%, n=30 (78.9%); prednisolone acetate 1%, n=31 (77.5%). Compared with prednisolone acetate 1%, approximately twice as many difluprednate 0.05%-treated patients had a global inflammation assessment score indicating no inflammation on day 1 (n=12 (30.8%) vs n=7 (17.5%) and day 8 (n=18 (48.7%) vs n=10 (25.0%).ConclusionsDifluprednate 0.05% four times daily showed safety and efficacy profiles similar to prednisolone acetate 1% four times daily in children 0-3 years undergoing cataract surgery.
评估0.05%地氟泼尼龙眼用乳剂治疗小儿白内障手术后炎症的安全性和有效性。
这是一项3B期、多中心、随机、双盲、活性对照研究，研究对象为年龄在0至3岁、单眼接受无并发症白内障手术（有或无人工晶状体植入）的患者。患者被随机分为两组，一组术后14天每天4次使用0.05%地氟泼尼龙，另一组每天4次使用1%醋酸泼尼松龙，之后逐渐减量使用14天。安全性评估包括不良事件评估。主要疗效指标为术后第14天前房细胞分级为0（无细胞）的患者比例；次要疗效指标为总体炎症评分。
每个治疗组随机分配了40名患者。药物不良反应包括角膜水肿（0.05%地氟泼尼龙组，n = 1；1%醋酸泼尼松龙组，n = 0）和眼压升高或高眼压（每组n = 2）。与1%醋酸泼尼松龙相比，0.05%地氟泼尼龙治疗期间的平均眼压值高2至3 mmHg；停药后第一周两组平均值相似。术后2周，两组前房细胞完全清除的发生率相似（0.05%地氟泼尼龙组，n = 30（78.9%）；1%醋酸泼尼松龙组，n = 31（77.5%）。与1%醋酸泼尼松龙相比，0.05%地氟泼尼龙治疗的患者中，在第1天（n = 12（30.8%）对n = 7（17.5%））和第8天（n = 18（48.7%）对n = 10（25.0%））总体炎症评估评分显示无炎症的患者数量约为两倍。
对于接受白内障手术的0至3岁儿童，每天4次使用0.05%地氟泼尼龙的安全性和有效性与每天4次使用1%醋酸泼尼松龙相似。
