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[一项在日本过敏性结膜炎患者中使用结膜过敏原激发模型对0.2%奥洛他定进行的多中心、双盲、随机评估]

[A multicenter, double-masked, randomized evaluation of olopatadine 0.2% using the conjunctival allergen challenge model in Japanese patients with allergic conjunctivitis].

作者信息

Ohno Shigeaki

机构信息

University Graduate School of Medicine, N-15, W-7, Kita-ku, Sapporo 060-8638, Japan.

出版信息

Nippon Ganka Gakkai Zasshi. 2012 Dec;116(12):1123-9.

PMID:23379201
Abstract

PURPOSE

Olopatadine hydrochloride ophthalmic solution, 0.2% (olopatadine 0.2%) is approved for allergic conjunctivitis when instilled twice-daily. The objective of this study was to evaluate the efficacy and safety of olopatadine 0.2% (instilled twice-daily) versus vehicle and olopatadine 0.1% (instilled 4-times daily) in Japanese patients with allergic conjunctivitis.

METHODS

A multicenter, parallel-group, double-masked, randomized, conjunctival allergen challenge (CAC) study. Patients > or = 18 years of age with histories of allergic conjunctivitis were treated with either olopatadine 0.2% or olopatadine 0.1% in a single eye and the vehicle in the contralateral eye at 1 visit.

RESULTS

Overall, 267 patients were enrolled. Olopatadine 0.2% was superior to its vehicle for ocular itching (p < 0.0001 at the time of observation) and marginally superior for total redness (p = 0.0543 at the time of observation). Olopatadine 0.2% was similar to olopatadine 0.1% for ocular itching at the time of observation. No trends were identified through a review of safety parameters.

CONCLUSIONS

Olopatadine 0.2% (instilled twice-daily) is safe, well tolerated, superior to the vehicle, and similar to olopatadine 0.1% in preventing ocular itching. Olopatadine 0.2%, which can be instilled less often than olopatadine 0.1%, is a useful new option for allergic conjunctivitis in Japanese patients that could potentially result in better treatment compliance.

摘要

目的

0.2%盐酸奥洛他定滴眼液(奥洛他定0.2%)被批准用于每日滴眼两次治疗过敏性结膜炎。本研究的目的是评估0.2%奥洛他定(每日滴眼两次)与赋形剂以及0.1%奥洛他定(每日滴眼四次)在日本过敏性结膜炎患者中的疗效和安全性。

方法

一项多中心、平行组、双盲、随机、结膜过敏原激发(CAC)研究。年龄大于或等于18岁且有过敏性结膜炎病史的患者在一次就诊时,单眼使用0.2%奥洛他定或0.1%奥洛他定,对侧眼使用赋形剂。

结果

总共纳入267例患者。0.2%奥洛他定在缓解眼部瘙痒方面优于其赋形剂(观察时p<0.0001),在缓解眼部整体发红方面略优于赋形剂(观察时p = 0.0543)。观察时,0.2%奥洛他定在缓解眼部瘙痒方面与0.1%奥洛他定相似。通过对安全性参数的审查未发现任何趋势。

结论

0.2%奥洛他定(每日滴眼两次)安全、耐受性良好,优于赋形剂,在预防眼部瘙痒方面与0.1%奥洛他定相似。0.2%奥洛他定的滴眼频率低于0.1%奥洛他定,是日本过敏性结膜炎患者的一种有用的新选择,可能会提高治疗依从性。

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