Notivol R, Martínez M, Bergamini M V
Department of Ophthalmology, Research and Development, Laboratorios Cusí S.A., El Masnou, Spain.
Am J Ophthalmol. 1994 May 15;117(5):651-6. doi: 10.1016/s0002-9394(14)70073-x.
A multicenter, double-masked, parallel-group clinical trial was carried out in 151 patients with moderate to severe chronic conjunctivitis. The study compared the antiinflammatory efficacy and safety of pranoprofen 0.1%, a new cyclo-oxygenase inhibitor, with fluorometholone 0.1%, after topical doses four times a day for 15 days. The basal mean score for the signs and symptoms of inflammation, was significantly reduced (P < .001), with no significant difference between the two groups, at days 8 and 15. There was a statistically significant difference of approximately 1.0 mm Hg (P < .05) in the mean intraocular pressure between treatment, which was a decrease of 0.3 mm Hg with pranoprofen and an increase of 0.8 mm Hg with fluorometholone. One patient in the pranoprofen group had an adverse experience, compared to nine patients in the fluorometholone group (P < .03). Our data suggest that pranoprofen has efficacy equivalent to a moderate-potency corticosteroid with a better safety profile. It should be considered for the treatment of chronic conjunctivitis of presumed nonbacterial origin.
对151例中重度慢性结膜炎患者进行了一项多中心、双盲、平行组临床试验。该研究比较了新型环氧化酶抑制剂0.1%普拉洛芬与0.1%氟米龙在每天局部用药4次、持续15天情况下的抗炎疗效和安全性。在第8天和第15天，炎症体征和症状的基础平均评分显著降低（P <.001），两组之间无显著差异。治疗组之间平均眼压存在约1.0 mmHg的统计学显著差异（P <.05），其中普拉洛芬使眼压降低0.3 mmHg，氟米龙使眼压升高0.8 mmHg。普拉洛芬组有1例患者出现不良事件，而氟米龙组有9例患者出现不良事件（P <.03）。我们的数据表明，普拉洛芬具有与中效皮质类固醇相当的疗效，且安全性更好。对于假定非细菌性起源的慢性结膜炎的治疗，应考虑使用普拉洛芬。
