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0.03%他克莫司软膏治疗顽固性过敏性结膜炎:一项开放标签的试点研究。

Topical tacrolimus 0.03% ointment for intractable allergic conjunctivitis: an open-label pilot study.

作者信息

Attas-Fox Liat, Barkana Yaniv, Iskhakov Vladimir, Rayvich Svetlana, Gerber Yariv, Morad Yair, Avni Isaac, Zadok David

机构信息

Department of Ophthalmology, Assaf Harofeh Medical Center, Zerifin, Israel.

出版信息

Curr Eye Res. 2008 Jul;33(7):545-9. doi: 10.1080/02713680802149115.

DOI:10.1080/02713680802149115
PMID:18600486
Abstract

PURPOSE

To evaluate the feasibility of tacrolimus 0.03% dermatological ointment (Protopic) in the treatment of intractable allergic conjunctivitis.

METHODS

Twenty patients (mean age 10.8 years, range 6-26) with intractable allergic conjunctivitis were enrolled in an open-label study. Tacrolimus 0.03% ointment was applied into the conjunctival sac of both eyes twice daily for 8 weeks, followed by a 2-week washout period. Other ocular medications were discontinued. Conjunctivitis severity was recorded with a composite subjective/objective score (chemosis, tarsal papillary size, corneal staining, tearing, itching, and photophobia) at baseline, week 8, and after washout. Tacrolimus blood levels were measured at 2 weeks.

RESULTS

Statistically significant improvement in all categories of the conjunctivitis score was observed between baseline and the week 8 examination (p < 0.001). Adverse events were limited to local burning in one patient who discontinued treatment. Blood tacrolimus levels were mostly undetectable.

CONCLUSIONS

Application of tacrolimus 0.03% dermatological ointment into the conjunctival sac appears to be effective, well tolerated, and safe in the treatment of allergic conjunctivitis refractory to traditional treatment.

摘要

目的

评估0.03%他克莫司皮肤科软膏(普特彼)治疗难治性过敏性结膜炎的可行性。

方法

20例难治性过敏性结膜炎患者(平均年龄10.8岁,范围6 - 26岁)纳入一项开放标签研究。0.03%他克莫司软膏每天两次涂于双眼结膜囊,持续8周,随后有2周的洗脱期。停用其他眼部药物。在基线、第8周和洗脱期后,用综合主观/客观评分(球结膜水肿、睑结膜乳头大小、角膜染色、流泪、瘙痒和畏光)记录结膜炎严重程度。在第2周测量他克莫司血药浓度。

结果

在基线和第8周检查之间,结膜炎评分的所有类别均有统计学显著改善(p < 0.001)。不良事件仅限于1例因局部烧灼感而停药的患者。血他克莫司水平大多无法检测到。

结论

将0.03%他克莫司皮肤科软膏应用于结膜囊在治疗对传统治疗难治的过敏性结膜炎方面似乎有效、耐受性良好且安全。

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