Abelson Mark B, Berdy Gregg J, Mundorf Thomas, Amdahl Lawrence D, Graves Adrienne L
Schepens Eye Research Institute, Harvard Medical School, Boston, Massachusetts, USA.
J Ocul Pharmacol Ther. 2002 Oct;18(5):475-88. doi: 10.1089/10807680260362759.
Patients with allergic conjunctivitis may experience several debilitating symptoms, particularly ocular itching. The objective of this study was to evaluate the efficacy and safety of pemirolast potassium 0.1% ophthalmic solution (Alamast trade mark ), a novel mast-cell stabilizer, for preventing ocular manifestations of seasonal allergic conjunctivitis. A pooled analysis was performed of data derived from 2 prospective, randomized, double-masked, placebo-controlled, multicenter phase III clinical trials of pemirolast potassium 0.1% in patients with a history of allergic conjunctivitis. Patients having a positive bilateral response to conjunctival allergen challenge (CAC) with ragweed antigen (N = 274) were randomized to receive pemirolast potassium 0.1% or placebo QID, beginning approximately 1-2 weeks before the onset of ragweed season and continuing until after the first killing frost (12-17 weeks duration). Patients recorded their daily evaluations of ocular itching in a diary. After the allergy season, patients underwent a second CAC. Evaluable patients (n = 265) recorded a total of 21,491 patient-days of ocular itching data during allergy season. In every 7-day or 14-day period, patients treated with pemirolast potassium 0.1% reported more days without any ocular itching compared with patients receiving placebo. Differences favoring pemirolast potassium 0.1% were statistically significant in 63% (10/16) of all 7-day periods (p < or = 0.046) and 88% (7/8) of all 14-day periods (p < or = 0.016). After the allergy season, pemirolast potassium 0.1% was significantly superior to placebo in relieving CAC-induced ocular itching, with relief occurring as early as 3 minutes after allergen challenge (p < or = 0.034). Pemirolast potassium 0.1% was well tolerated and had a safety profile similar to that of placebo. In conclusion, pemirolast potassium 0.1% is effective and safe in preventing ocular itching in patients with allergic conjunctivitis during allergy season.
过敏性结膜炎患者可能会出现多种使人衰弱的症状，尤其是眼部瘙痒。本研究的目的是评估新型肥大细胞稳定剂0.1%吡嘧司特钾滴眼液（商品名：Alamast）预防季节性过敏性结膜炎眼部表现的疗效和安全性。对两项前瞻性、随机、双盲、安慰剂对照、多中心III期临床试验的数据进行了汇总分析，这两项试验研究对象为有过敏性结膜炎病史的患者，使用的药物为0.1%吡嘧司特钾。对豚草抗原结膜过敏原激发试验（CAC）呈双侧阳性反应的患者（N = 274）被随机分组，从豚草季节开始前约1 - 2周起，每日4次接受0.1%吡嘧司特钾或安慰剂治疗，持续至首次霜降后（疗程12 - 17周）。患者在日记中记录他们对眼部瘙痒的每日评估。过敏季节过后，患者接受第二次CAC。可评估的患者（n = 265）在过敏季节共记录了21,491个患者日的眼部瘙痒数据。在每7天或14天的时间段内，与接受安慰剂治疗的患者相比，接受0.1%吡嘧司特钾治疗的患者报告无眼部瘙痒的天数更多。在所有7天时间段中，63%（10/16）、在所有14天时间段中88%（7/8），使用0.1%吡嘧司特钾的优势具有统计学意义（p≤0.046和p≤0.016）。过敏季节过后，0.1%吡嘧司特钾在缓解CAC诱发的眼部瘙痒方面显著优于安慰剂，在过敏原激发后3分钟即可出现缓解（p≤0.034）。0.1%吡嘧司特钾耐受性良好，安全性与安慰剂相似。总之，0.1%吡嘧司特钾在预防过敏季节过敏性结膜炎患者的眼部瘙痒方面有效且安全。
