Paganelli Fernando, Cardillo José A, Melo Luiz A S, Oliveira Anselmo G, Skaf Mirian, Costa Rogério A
Hospital de Olhos de Araraquara, Araraquara, Brazil.
Ophthalmology. 2004 Nov;111(11):2102-8. doi: 10.1016/j.ophtha.2004.04.026.
To compare a single intraoperative sub-Tenon's capsule triamcinolone acetonide injection with steroid drops in the treatment of ocular inflammation after cataract surgery.
Randomized, double-masked controlled trial.
A total of 100 patients were randomized prospectively into 2 groups: 50 patients treated with 1% prednisolone eyedrops (control group A) and 50 patients treated with sub-Tenon's capsule triamcinolone (treatment group B).
All patients underwent phacoemulsification and intraocular posterior lens implantation. After surgery, patients were randomized to receive either (group B) an intraoperative 40 mg triamcinolone acetonide sub-Tenon's capsule injection or (group A) 1% prednisolone acetate eyedrops, according to the following schedule: 1 drop 4 times daily (week 1), 3 times daily (week 2), 2 times daily (week 3), once daily (week 4). To mask the study, group B received vehicle drops administered on a similar schedule, and group A received an intraoperative sub-Tenon's capsule injection of a 1 ml balanced salt solution.
The main outcome measures included inflammation (cell, flare, ciliary flush), intraocular pressure, and lack of response.
Triamcinolone was shown to have anti-inflammatory efficacy clinically equivalent to conventional 1% prednisolone eyedrops in reducing intraocular inflammation, as measured by clinical methods. Triamcinolone was found to be as safe as the prednisolone in terms of adverse effects, changes in visual acuity, intraocular pressure, and biomicroscopic and ophthalmoscopic variables. On the third, seventh, fourteenth, and twenty-eighth postoperative days, a significantly lower intraocular pressure (P<0.01) was noted in the triamcinolone group than in the prednisolone group.
A single intraoperative 40-mg triamcinolone acetonide sub-Tenon's capsule injection demonstrated a clinically equivalent therapeutic response and ocular tolerance compared with 1% prednisolone drops in controlling postoperative inflammation after uncomplicated cataract surgery and merits further investigation.
比较术中单次球后注射曲安奈德与使用类固醇滴眼液治疗白内障手术后眼部炎症的效果。
随机、双盲对照试验。
共100例患者被前瞻性随机分为2组：50例患者使用1%泼尼松龙滴眼液治疗（A对照组），50例患者接受球后注射曲安奈德治疗（B治疗组）。
所有患者均接受超声乳化白内障吸除术及人工晶状体植入术。术后，根据以下方案，患者被随机分配接受（B组）术中40mg曲安奈德球后注射或（A组）1%醋酸泼尼松龙滴眼液：第1周每日4次，每次1滴；第2周每日3次；第3周每日2次；第4周每日1次。为使研究具有盲法，B组按相似方案给予赋形剂滴眼液，A组术中接受1ml平衡盐溶液球后注射。
主要观察指标包括炎症（细胞、闪光、睫状充血）、眼压及无反应情况。
通过临床方法测量，曲安奈德在减轻眼内炎症方面显示出与传统1%泼尼松龙滴眼液临床等效的抗炎效果。在不良反应、视力变化、眼压以及生物显微镜和检眼镜检查变量方面，曲安奈德与泼尼松龙一样安全。在术后第3、7、14和28天，曲安奈德组的眼压显著低于泼尼松龙组（P<0.01）。
在控制单纯性白内障手术后的炎症方面，术中单次40mg曲安奈德球后注射与1%泼尼松龙滴眼液相比，显示出临床等效的治疗反应和眼耐受性，值得进一步研究。
