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评价英夫利昔单抗治疗 Behçet 病葡萄膜炎的长期疗效和安全性:一项多中心研究。

Evaluation of the long-term efficacy and safety of infliximab treatment for uveitis in Behçet's disease: a multicenter study.

机构信息

Department of Ophthalmology, National Defense Medical College, Tokorozawa, Japan.

Department of Ophthalmology, Tokyo Medical University, Tokyo, Japan.

出版信息

Ophthalmology. 2014 Oct;121(10):1877-84. doi: 10.1016/j.ophtha.2014.04.042. Epub 2014 Jun 18.

Abstract

PURPOSE

To evaluate the long-term efficacy and safety of infliximab for the treatment of uveitis in Behçet's disease (BD).

DESIGN

Retrospective multicenter study using a questionnaire.

PARTICIPANTS

A total of 164 consecutive patients with BD treated with infliximab for more than 1 year were studied. The mean age at initiation of infliximab treatment was 42.6±11.7 years, and the mean treatment duration was 32.9±14.4 months.

METHODS

Data before and at the last visit during infliximab treatment were analyzed in 4 groups divided by duration of treatment: group A (n = 43, 12-<24 months), group B (n = 62, 24-<36 months), group C (n = 42, 36-<48 months), and group D (n = 17, ≥48 months).

MAIN OUTCOME MEASURES

Best-corrected visual acuity (BCVA), relapse of ocular inflammation, numbers of ocular inflammatory attacks per year, and adverse effects of infliximab therapy.

RESULTS

The frequency of ocular attacks decreased in all groups (from 5.3±3.0 to 1.0±0.3 in group A, 4.8±4.6 to 1.4±0.3 in group B, 4.1±2.9 to 0.9±0.3 in group C, and 9.5±5.8 to 1.6±0.5 in group D; all P < 0.05). The BCVA was improved in approximately 55% of the eyes after treatment. Mean BCVA converted to logarithm of the minimum angle of resolution was improved after treatment with infliximab in groups A to C (from 0.79±1.04 to 0.59±0.94 in group A, 0.59±1.07 to 0.41±1.04 in group B, and 1.15±1.77 to 0.92±1.73 in group C; all P < 0.05) but not in group D. Uveitis relapsed in 59.1% of all patients after infliximab treatment, and no difference in duration until relapse was observed between individual groups. Approximately 80% of relapses occurred within 1 year after the initiation of infliximab treatment in all groups, 90% of which were controlled by increasing doses of topical corticosteroids and shortening the interval of infliximab infusion. Adverse effects were observed in 65 cases or 35% of all subjects. Infliximab treatment was continued in 85% of the patients, but 15% of the patients discontinued infliximab treatment because of adverse effects or insufficient efficacy.

CONCLUSIONS

Infliximab reduced the frequency of ocular attacks and improved visual acuity in patients with BD-related uveitis and was generally well tolerated with few serious adverse events.

摘要

目的

评估英夫利昔单抗治疗贝赫切特病(BD)葡萄膜炎的长期疗效和安全性。

设计

使用问卷进行的回顾性多中心研究。

参与者

共研究了 164 例接受英夫利昔单抗治疗超过 1 年的 BD 连续患者。英夫利昔单抗治疗开始时的平均年龄为 42.6±11.7 岁,平均治疗时间为 32.9±14.4 个月。

方法

根据治疗时间分为 4 组,分析治疗前和治疗期间最后一次就诊的数据:A 组(n = 43,12-<24 个月)、B 组(n = 62,24-<36 个月)、C 组(n = 42,36-<48 个月)和 D 组(n = 17,≥48 个月)。

主要观察指标

最佳矫正视力(BCVA)、眼部炎症复发、每年眼部炎症发作次数以及英夫利昔单抗治疗的不良反应。

结果

所有组别的眼部攻击频率均降低(A 组从 5.3±3.0 降至 1.0±0.3,B 组从 4.8±4.6 降至 1.4±0.3,C 组从 4.1±2.9 降至 0.9±0.3,D 组从 9.5±5.8 降至 1.6±0.5;均 P<0.05)。治疗后约 55%的眼睛视力得到改善。A 组至 C 组治疗后平均 BCVA 对数最小角分辨率提高(从 0.79±1.04 至 0.59±0.94,从 0.59±1.07 至 0.41±1.04,从 1.15±1.77 至 0.92±1.73;均 P<0.05),但 D 组未改善。英夫利昔单抗治疗后 59.1%的患者葡萄膜炎复发,各组间复发持续时间无差异。所有组中,约 80%的复发病例发生在英夫利昔单抗治疗开始后 1 年内,所有病例均通过增加局部皮质类固醇剂量和缩短英夫利昔单抗输注间隔得到控制。65 例(35%)或所有受试者中观察到不良反应。85%的患者继续接受英夫利昔单抗治疗,但 15%的患者因不良反应或疗效不足而停止英夫利昔单抗治疗。

结论

英夫利昔单抗降低了 BD 相关葡萄膜炎患者的眼部攻击频率并改善了视力,总体耐受性良好,严重不良事件少见。

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