Assil K K, Massry G, Lehmann R, Fox K, Stewart R
Sinskey Eye Institute, Santa Monica, California 90411-0031, USA.
J Cataract Refract Surg. 1997 Jun;23(5):750-7. doi: 10.1016/s0886-3350(97)80286-6.
To assess the efficacy and safety of rimexolone 1% ophthalmic suspension in controlling intraocular inflammation after cataract extraction.
Twelve independent investigational centers in the United States
This study comprised 197 patients who had cataract extraction. Postoperatively, patients were randomized to a 2 week regimen of rimexolone 1% ophthalmic suspension or a placebo. Efficacy was analyzed by monitoring total anterior chamber cells and flare, other parameters of inflammation, and treatment failures. Safety was evaluated by monitoring treatment-related adverse events and intraocular pressure (IOP).
Rimexolone 1% was clinically and statistically more effective in suppressing cell and flare than the placebo (P < .02). The overall discontinuation rate for treatment-related adverse events was 5.3% in the rimexolone group and 22.2% in the placebo group. There were no between-group differences in IOP.
Rimexolone 1% ophthalmic suspension was safe and significantly more effective than a placebo in controlling intraocular inflammation after cataract extraction when used four times daily and continued for 2 weeks.
评估1%醋酸泼尼松龙眼用混悬液在控制白内障摘除术后眼内炎症方面的疗效和安全性。
美国12个独立的研究中心
本研究纳入了197例接受白内障摘除术的患者。术后，患者被随机分配接受为期2周的1%醋酸泼尼松龙眼用混悬液治疗或安慰剂治疗。通过监测前房细胞总数、闪光感、其他炎症参数以及治疗失败情况来分析疗效。通过监测与治疗相关的不良事件和眼压（IOP）来评估安全性。
1%醋酸泼尼松龙在临床和统计学上抑制细胞和闪光感的效果均优于安慰剂（P < 0.02）。醋酸泼尼松龙组与治疗相关不良事件的总体停药率为5.3%，安慰剂组为22.2%。眼压在两组之间无差异。
1%醋酸泼尼松龙眼用混悬液每日使用4次并持续2周时，在控制白内障摘除术后眼内炎症方面安全且明显优于安慰剂。
