Dell S J, Shulman D G, Lowry G M, Howes J
Texan Eye Care and Clinicor, Austin, USA.
Am J Ophthalmol. 1997 Jun;123(6):791-7. doi: 10.1016/s0002-9394(14)71128-6.
To evaluate the efficacy and safety of loteprednol etabonate 0.5% as prophylactic treatment for the ocular signs and symptoms of seasonal allergic conjunctivitis.
In this randomized, double-masked, placebo-controlled, parallel study, 293 adults with history of seasonal allergic conjunctivitis were treated with either loteprednol etabonate or vehicle (placebo) four times daily, beginning before the onset of the allergy season and continuing for 6 weeks. The primary efficacy measure was a primary composite score (sum of itching and bulbar conjunctival injection scores). Supportive efficacy measures were the investigator global assessment and a secondary composite score (sum of tearing, erythema, chemosis, and discomfort scores), all calculated during the 21-day peak pollen season.
The proportion of patients who never developed moderate or severe signs and symptoms of allergy during the peak pollen season in the loteprednol etabonate treatment group was greater than that in the placebo group. For the primary composite score, this efficacy criterion was reached by 94% of patients (136/145) in the loteprednol etabonate group and 78% of patients (111/143) in the placebo group (P = .001). The magnitude of effect was similar for the investigator global assessment (86% [118/138] vs 64% [87/137]; P < .001) and, although not statistically significant, the secondary composite score (77% [112/145] vs 68% [97/143]; P = .092). None of the loteprednol etabonate-treated patients had an intraocular pressure increase of 10 mm Hg or more, whereas two placebo patients did.
Loteprednol etabonate is generally effective in prophylaxis of seasonal allergic conjunctivitis and has an acceptable safety profile.
评估0.5%的氯替泼诺依碳酸酯作为季节性过敏性结膜炎眼部体征和症状预防性治疗的有效性和安全性。
在这项随机、双盲、安慰剂对照、平行研究中，293名有季节性过敏性结膜炎病史的成年人在过敏季节开始前每天接受4次氯替泼诺依碳酸酯或赋形剂（安慰剂）治疗，并持续6周。主要疗效指标是主要综合评分（瘙痒和球结膜充血评分之和）。支持性疗效指标是研究者整体评估和次要综合评分（流泪、红斑、结膜水肿和不适评分之和），所有这些指标均在21天的花粉高峰期计算得出。
氯替泼诺依碳酸酯治疗组在花粉高峰期从未出现中度或重度过敏体征和症状的患者比例高于安慰剂组。对于主要综合评分，氯替泼诺依碳酸酯组94%（136/145）的患者达到了这一疗效标准，安慰剂组为78%（111/143）的患者（P = 0.001）。研究者整体评估的效果大小相似（86% [118/138] 对64% [87/137]；P < 0.001），次要综合评分虽然无统计学意义，但也有类似趋势（77% [112/145] 对68% [97/143]；P = 0.092）。氯替泼诺依碳酸酯治疗的患者中没有眼压升高10 mmHg或更高的情况，而两名安慰剂组患者出现了这种情况。
氯替泼诺依碳酸酯通常对季节性过敏性结膜炎的预防有效，且安全性可接受。
