Campos Mauro, Muccioli Cristina, Malta João Bns, Gerade Rafael A, LA Salame André, Belfort Rubens
Department of Ophthalmology, Hospital São Paulo, Universidade Federal de São Paulo, Brazil.
Clin Ophthalmol. 2011;5:209-14. doi: 10.2147/OPTH.S17059. Epub 2011 Feb 15.
To compare the efficacy and tolerability of a fixed-dose combination of 0.3% gatifloxacin and 1% prednisolone formulation versus the same agents administered separately for prophylaxis in a laser-assisted in situ keratomileusis (LASIK) population.
In a prospective, randomized, double-masked, parallel-group study, 97 patients were evaluated for signs and symptoms of ocular infection or inflammation after bilateral LASIK. Group 1 (50 patients, 100 eyes) received a combined formulation of 0.3% gatifloxacin + 1% prednisolone acetate (Zypred(®)) plus placebo. Group 2 (47 patients, 94 eyes) received conventional treatment with the same agents from separate vials. The cohorts were similar in age, sex, race, and refractive error. Baseline and postoperative assessments were made on surgery days -2, 1, 3, and 15 and consisted of visual acuity; intraocular pressure; severity of inflammation of eyelids, conjunctiva, and cornea; tearing; ocular discomfort (foreign-body sensation, itching, or photophobia); and ocular pain. The posterior segment was evaluated at the screening and exit visits.
No ocular infection or persistent inflammation was detected in either group at any time. All objective and subjective criteria of efficacy were similar regardless of treatment, with no significant differences between the groups. More patients who were dosed with the combined agent complained of mild ocular discomfort on day 3, but this difference had disappeared by day 15.
Post-LASIK topical prophylaxis with combined gatifloxacin + prednisolone eye drops (Zypred(®)) was well tolerated. This formulation appears to be therapeutically equivalent to conventional dosing with gatifloxacin and prednisolone from individual bottles for topical prophylaxis after laser refractive surgery.
比较0.3%加替沙星与1%泼尼松龙固定剂量复方制剂与单独使用相同药物对激光原位角膜磨镶术（LASIK）患者进行预防的疗效和耐受性。
在一项前瞻性、随机、双盲、平行组研究中，对97例双侧LASIK术后患者的眼部感染或炎症体征和症状进行评估。第1组（50例患者，100只眼）接受0.3%加替沙星+1%醋酸泼尼松龙复方制剂（Zypred®）加安慰剂。第2组（47例患者，94只眼）接受来自不同药瓶的相同药物的常规治疗。两组在年龄、性别、种族和屈光不正方面相似。在手术前2天、1天、3天和15天进行基线和术后评估，包括视力、眼压、眼睑、结膜和角膜的炎症严重程度、流泪、眼部不适（异物感、瘙痒或畏光）和眼痛。在筛查和随访时评估眼后段。
两组在任何时候均未检测到眼部感染或持续性炎症。无论治疗方式如何，所有疗效的客观和主观标准均相似，两组之间无显著差异。更多服用复方制剂的患者在第3天抱怨有轻度眼部不适，但这种差异在第15天时消失。
LASIK术后局部预防性使用加替沙星+泼尼松龙复方滴眼液（Zypred®）耐受性良好。该制剂在治疗上似乎等同于激光屈光手术后局部预防性使用加替沙星和泼尼松龙单独瓶装常规给药。
