Raizman Michael B, Donnenfeld Eric D, Weinstein Arthur J
Ophthalmic Consultants of Boston, Boston, MA 02114, USA.
Curr Med Res Opin. 2007 Oct;23(10):2325-31. doi: 10.1185/030079907X226195.
To compare the efficacy of two formulations of prednisolone acetate 1% in reducing postoperative inflammation in patients having primary phacoemulsification surgery with IOL implantation.
This multicenter study was conducted in randomized, double-masked fashion with a parallel active control group. Patients undergoing phacoemulsification surgery with IOL implantation were assigned to one of two treatment groups receiving study drug in addition to standard therapy. Study drug was administered four times daily beginning one day before surgery, postoperatively for 14 days, then twice daily until the bottle was empty. Clinical efficacy was compared for differences in corneal surface keratitis, anterior chamber cells and flare, and postoperative pain. Results were compared on day 1, 2 weeks, and 4 weeks postoperatively.
No statistical differences in clinical efficacy or safety were seen between the two formulations tested at any time point evaluated.
In this study of routine cataract patients, both prednisolone acetate 1% formulations are comparably effective and safe when administered for the reduction of inflammation after phacoemulsification surgery with IOL implantation.
比较两种1%醋酸泼尼松龙制剂在降低接受白内障超声乳化吸除联合人工晶状体植入术患者术后炎症反应方面的疗效。
本多中心研究采用随机、双盲方式，设置平行阳性对照组。接受白内障超声乳化吸除联合人工晶状体植入术的患者被分配到两个治疗组之一，除标准治疗外还接受研究药物治疗。研究药物在手术前一天开始每日给药4次，术后给药14天，然后每日给药2次直至药瓶用尽。比较两种制剂在角膜表面角膜炎、前房细胞和闪光以及术后疼痛方面的临床疗效差异。在术后第1天、2周和4周比较结果。
在任何评估的时间点，两种受试制剂在临床疗效和安全性方面均未观察到统计学差异。
在这项针对常规白内障患者的研究中，两种1%醋酸泼尼松龙制剂在白内障超声乳化吸除联合人工晶状体植入术后用于减轻炎症时，疗效和安全性相当。
