一项关于新型0.1%环孢素眼药水治疗重度过敏性结膜炎的大型前瞻性观察性研究。

A large prospective observational study of novel cyclosporine 0.1% aqueous ophthalmic solution in the treatment of severe allergic conjunctivitis.

作者信息

Ebihara Nobuyuki, Ohashi Yuichi, Uchio Eiichi, Okamoto Shigeki, Kumagai Naoki, Shoji Jun, Takamura Etsuko, Nakagawa Yayoi, Nanba Kenichi, Fukushima Atsuki, Fujishima Hiroshi

机构信息

Department of Ophthalmology, Juntendo University School of Medicine, 2-1-1 Hongo, Tokyo, Japan.

出版信息

J Ocul Pharmacol Ther. 2009 Aug;25(4):365-72. doi: 10.1089/jop.2008.0103.

DOI:10.1089/jop.2008.0103

PMID:19441889

Abstract

PURPOSE

To evaluate the effectiveness and safety of a novel cyclosporine 0.1% aqueous ophthalmic solution in a large population with vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).

METHODS

A prospective observational postmarketing study was initiated in Japan. A total of 594 patients with VKC or AKC were started on this drug within 1 year after market launch (January 2006) and completed a 6-month follow-up. These patients were observed clinically, and subjective ocular symptoms (itching, discharge, tearing, photophobia, foreign body sensation, and pain), objective signs (hyperemia, swelling, follicle, papillae, and giant papillae for the tarsal conjunctiva; hyperemia and edema for the bulbar conjunctiva; Trantas dots and swelling for the limbus; and corneal involvement), and adverse events were recorded.

RESULTS

All scores for symptoms and signs significantly decreased from Month 1 through Month 6 of treatment in both VKC and AKC. Median total symptom scores at baseline, Month 1, and Month 6 were 6, 2, and 1, respectively, for VKC, and 7, 3, and 2, respectively, for AKC. Similarly, median total sign scores were 12, 7, and 5, respectively, for VKC, and 14, 10, and 7, respectively, for AKC. The percentage of patients able to complete topical cyclosporine 0.1% therapy within 6 months due to alleviation of symptoms was higher for VKC (44.4%) than for AKC (21.9%). In both VKC and AKC, approximately 30% of steroid users were able to discontinue topical steroids. Adverse drug reactions (ADRs) were found in 12.0% of patients, and the most common ADR was eye irritation (4.4%). Infectious corneal complications were observed in five AKC patients, including two cases of bacterial corneal ulcer and three cases of herpetic keratitis; all of these patients were concomitantly using topical steroids.

CONCLUSIONS

Topical cyclosporine 0.1% is an effective and safe treatment for VKC and AKC.

摘要

目的

评估新型0.1%环孢素水性眼用溶液在大量春季角结膜炎（VKC）和特应性角结膜炎（AKC）患者中的有效性和安全性。

方法

在日本开展了一项前瞻性观察性上市后研究。共有594例VKC或AKC患者在该药物上市后1年内（2006年1月）开始使用，并完成了6个月的随访。对这些患者进行临床观察，记录主观眼部症状（瘙痒、分泌物、流泪、畏光、异物感和疼痛）、客观体征（睑结膜充血、肿胀、滤泡、乳头和巨大乳头；球结膜充血和水肿；角膜缘特兰塔氏点和肿胀；以及角膜受累情况）和不良事件。

结果

在VKC和AKC患者中，从治疗第1个月到第6个月，症状和体征的所有评分均显著下降。VKC患者在基线时、第1个月和第6个月的总症状评分中位数分别为6、2和1，AKC患者分别为7、3和2。同样，VKC患者的总体征评分中位数分别为12、7和5，AKC患者分别为14、10和7。由于症状缓解而能够在6个月内完成0.1%环孢素局部治疗的VKC患者百分比（44.4%）高于AKC患者（21.9%）。在VKC和AKC患者中，约30%的类固醇使用者能够停用局部类固醇。12.0%的患者出现药物不良反应（ADR），最常见的ADR是眼部刺激（4.4%）。在5例AKC患者中观察到感染性角膜并发症，包括2例细菌性角膜溃疡和3例疱疹性角膜炎；所有这些患者均同时使用局部类固醇。