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英夫利昔单抗治疗白塞病难治性葡萄膜视网膜炎的多中心研究。

Multicenter study of infliximab for refractory uveoretinitis in Behçet disease.

作者信息

Okada Annabelle A, Goto Hiroshi, Ohno Shigeaki, Mochizuki Manabu

机构信息

Department of Ophthalmology, Kyorin University School of Medicine, Tokyo, Japan.

出版信息

Arch Ophthalmol. 2012 May;130(5):592-8. doi: 10.1001/archophthalmol.2011.2698.

Abstract

OBJECTIVE

To describe the effects of infliximab on refractory uveoretinitis in patients with Behçet disease during the first year of treatment.

METHODS

Data were collected prospectively at 8 tertiary uveitis centers. Safety was analyzed in 63 patients. Efficacy was analyzed in 50 patients, after exclusion of those who had received infliximab for various reasons before the study.

RESULTS

Eighty-nine percent (56 of 63) of the patients were male, with 70% (44 of 63) of the patients aged 25 to 44 years. The safety analysis demonstrated that 34 episodes of adverse effects occurred in 46% (29 of 63) of patients during 1 year, including 3 episodes of infusion reactions. No adverse effects were deemed serious. The efficacy analysis at 1 year showed that uveoretinitis had improved in 69% (33 of 48), had improved somewhat in 23% (11 of 48), was unchanged in 8% (4 of 48), and had worsened in no patients. The mean number of ocular attacks per 6-month period decreased from 2.66 at baseline to 0.44 during months 1 through 6 of infliximab therapy and to 0.79 during months 7 through 12. Forty-four percent (21 of 48) of patients had no ocular attacks during the 1-year period. Efficacy was best for patients with uveoretinitis duration of less than 5 years. The mean best-corrected visual acuity improved logarithm of the minimum angle of resolution from 0.736 at the first infliximab infusion to 0.616 at the end of 1 year (P = .01).

CONCLUSIONS

Infliximab treatment for Behçet disease uveoretinitis was well tolerated, with nonserious adverse effects occurring in about half of the patients. At the end of 1 year, uveoretinitis had improved or improved somewhat in 92% (44 of 48) of patients, accompanied by improvement in the mean visual acuity.

摘要

目的

描述英夫利昔单抗在治疗白塞病患者难治性葡萄膜炎的第一年中的疗效。

方法

前瞻性收集8个三级葡萄膜炎中心的数据。对63例患者进行安全性分析。排除研究前因各种原因接受过英夫利昔单抗治疗的患者后,对50例患者进行疗效分析。

结果

89%(63例中的56例)患者为男性,70%(63例中的44例)患者年龄在25至44岁之间。安全性分析显示,46%(63例中的29例)患者在1年内发生34次不良反应事件,包括3次输液反应。无不良反应被认为严重。1年时的疗效分析显示,69%(48例中的33例)患者的葡萄膜炎有所改善,23%(48例中的11例)患者有所改善,8%(48例中的4例)患者病情无变化,无患者病情恶化。每6个月的眼部发作平均次数从基线时的2.66次降至英夫利昔单抗治疗第1至6个月时的0.44次,第7至12个月时降至0.79次。44%(48例中的21例)患者在1年期间无眼部发作。葡萄膜炎病程小于5年的患者疗效最佳。平均最佳矫正视力的最小分辨角对数从首次输注英夫利昔单抗时的0.736提高到1年末的0.616(P = 0.01)。

结论

英夫利昔单抗治疗白塞病葡萄膜炎耐受性良好,约半数患者出现非严重不良反应。1年末,92%(48例中的44例)患者的葡萄膜炎有所改善或有所好转,同时平均视力也有所提高。

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