Ophthalmology. 1998 Sep;105(9):1780-6. doi: 10.1016/s0161-6420(98)99054-6.
This study aimed to compare the efficacy and safety of loteprednol etabonate (LE) 0.5% to placebo (vehicle) in controlling the anterior chamber cell and flare reaction in patients undergoing cataract surgery with intraocular lens (IOL) implantation.
Randomized, double-masked, placebo-controlled, parallel group multicenter study.
A total of 203 patients undergoing elective cataract removal and posterior chamber intraocular lens implantation who, on the day after surgery, exhibited a minimum anterior chamber inflammation score (ACI, sum of cell and flare reaction) rating of 3 (0-9 scale).
All patients received either LE 0.5% or placebo (vehicle) four times daily in the eye that was operated on for up to 14 days after surgery.
Resolution of ACI by final, on-treatment visit was measured.
The proportion of patients with ACI resolved by the final visit was 56 (55%) of 102 in the LE group and 28 (28%) of 100 in the placebo group (P < 0.001). For all the individual components of ACI (cell and flare), as well as other signs and symptoms, the resolution rate and mean change from baseline favored LE. Expanding the efficacy criterion to include patients with mild inflammation at final visit, the efficacy of LE was 95 (93%) of 102 in contrast to 65 (65%) of 100 for placebo. Among the 39 patients who did not complete the study, the majority were discontinued for inadequate anti-inflammatory effect: 25 (25%) of 101 placebo patients and 5 (5%) of 102 of LE patients. The difference in the treatment failure rates, as well the difference in the time course of failures, was both clinically meaningful and statistically significant in favor of LE (P < 0.001). Both treatments were well-tolerated. No clinically significant elevations in intraocular pressure (> or = 10 mmHg) were seen in the LE treatment group. One patient in the placebo treatment group met this criterion.
Loteprednol etabonate showed a clinically meaningful reduction in the signs and symptoms of postoperative anterior chamber inflammation when compared with that of placebo and had an acceptable safety profile compared with placebo.
本研究旨在比较0.5%氯替泼诺乙酯（LE）与安慰剂（赋形剂）在控制接受白内障摘除联合人工晶状体（IOL）植入术患者前房细胞和闪光反应方面的疗效和安全性。
随机、双盲、安慰剂对照、平行组多中心研究。
总共203例接受择期白内障摘除和后房型人工晶状体植入术的患者，术后第一天，其前房炎症评分（ACI，细胞和闪光反应总和）最低评分为3分（0 - 9分制）。
所有患者在接受手术的眼内每日4次给予0.5% LE或安慰剂（赋形剂），持续至术后14天。
测量治疗结束时ACI的消退情况。
LE组102例患者中，最终访视时ACI消退的患者比例为56例（55%），安慰剂组100例患者中为28例（28%）（P < 0.001）。对于ACI的所有个体成分（细胞和闪光）以及其他体征和症状，消退率和相对于基线的平均变化均有利于LE。将疗效标准扩大到包括最终访视时有轻度炎症的患者，LE的疗效为102例中的95例（93%），而安慰剂为100例中的65例（65%）。在39例未完成研究的患者中，大多数因抗炎效果不佳而停药：安慰剂组101例患者中有25例（25%），LE组102例患者中有5例（5%）。治疗失败率的差异以及失败时间进程的差异在临床和统计学上均有意义，有利于LE（P < 0.001）。两种治疗耐受性均良好。LE治疗组未观察到具有临床意义的眼压升高（>或 = 10 mmHg）。安慰剂治疗组有1例患者达到该标准。
与安慰剂相比，氯替泼诺乙酯在减轻术后前房炎症的体征和症状方面显示出具有临床意义的降低，并且与安慰剂相比具有可接受的安全性。
