Russo P, Papa V, Russo S, Di Bella A, Pabst G, Milazzo G, Balestrazzi A, Caporossi A
Medical Department SIFI SpA, Catania, Italy.
Eur J Ophthalmol. 2005 Sep-Oct;15(5):598-606.
To investigate whether topical nonsteroidal antiinflammatory drugs (NSAIDs) are useful, in the absence of concomitant corticosteroid therapy, in limiting postoperative inflammation after uncomplicated cataract surgery.
A total of 328 patients were enrolled in a prospective, randomized, double-masked, parallel-group, active-controlled study. Anterior chamber inflammation (ACI) was evaluated as the primary efficacy parameter. Only patients with moderate inflammation (ACI score of < or =4) the day after surgery were randomized and treated with NSAIDs. A novel topical formulation containing 0.2% sodium naproxen was compared with 0.1% diclofenac. Both were administered three times a day for 14 consecutive days. Ocular inflammation was measured after 7 and 14 days by using slit-lamp biomicroscopy. Safety parameters were also evaluated at the same time.
Both treatments were equally effective in controlling postsurgical inflammation. No statistically significant differences between treatment groups were observed for the safety variables. No serious adverse events (AEs) occurred during the course of the study. The most frequent AE reported with naproxen was eye redness.
NSAIDs can effectively be used without concurrent administration of corticosteroids to control postoperative inflammation after uncomplicated cataract surgery. In addition, naproxen ophthalmic solution may be considered a suitable alternative to the currently available NSAIDs.
探讨在不联合使用皮质类固醇治疗的情况下，局部使用非甾体抗炎药（NSAIDs）是否有助于限制单纯性白内障手术后的炎症反应。
共有328例患者纳入一项前瞻性、随机、双盲、平行组、活性药物对照研究。将前房炎症（ACI）作为主要疗效参数进行评估。仅对术后第一天有中度炎症（ACI评分为≤4）的患者进行随机分组并给予NSAIDs治疗。将一种含0.2%萘普生的新型局部制剂与0.1%双氯芬酸进行比较。两者均每日给药3次，连续给药14天。在第7天和第14天时使用裂隙灯生物显微镜测量眼部炎症。同时还评估了安全性参数。
两种治疗在控制术后炎症方面同样有效。治疗组之间的安全性变量未观察到统计学上的显著差异。在研究过程中未发生严重不良事件（AE）。使用萘普生报告的最常见AE是眼红。
在单纯性白内障手术后，NSAIDs可在不联合使用皮质类固醇的情况下有效控制术后炎症。此外，萘普生滴眼液可被视为目前可用NSAIDs的合适替代品。
