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阿达木单抗治疗难治性葡萄膜炎:一项初步研究。

Adalimumab therapy for refractory uveitis: a pilot study.

作者信息

Diaz-Llopis Manuel, García-Delpech Salvador, Salom David, Udaondo Patricia, Hernández-Garfella Marisa, Bosch-Morell Francisco, Quijada Arturo, Romero Francisco J

机构信息

Uveitis and Retina Unit, Department of Ophthalmology, University General Hospital of Valencia, Valencia, Spain.

出版信息

J Ocul Pharmacol Ther. 2008 Jun;24(3):351-61. doi: 10.1089/jop.2007.0104.

Abstract

PURPOSE

The aim of this study was to assess the efficacy and safety of adalimumab in treating refractory autoimmune uveitis.

METHODS

This work was a prospective, noncomparative, nonrandomized, clinical trial. Nineteen (19) patients meeting eligibility criteria received a 40-mg subcutaneous (s.c.) injection of adalimumab every other week during 1 year.

RESULTS

All patients underwent an outcome assessment at month 12. Visual acuity improved by -0.3 logMar in 12 (31%) eyes of 38, and worsened by +0.3 logMar in 1 (2.6%) eye. All patients had an active intraocular inflammation at baseline, and 12 patients (63%) achieved control of their inflammation with adalimumab at the end of follow-up. After optic coherence tomography, 33 eyes (86%) had cystoid macular edema (CME) at baseline, and at the end of follow-up there was a complete resolution of CME in 18 of these 33 eyes (54.54%). All patients were able to reduce at least 50% of the dose of the concomitant immunosuppressive drugs at the end of follow-up. Adalimumab was well tolerated in all patients, and only local minor side effects at the s.c. injection site were observed. Nevertheless, 8 patients (42.10%) had relapses during the follow-up period that were controlled with 1 periocular steroid injection.

CONCLUSIONS

Adalimumab seems to be an effective, safe therapy for the management of refractory uveitis and may provide the possibility to reduce the concomitant immunosuppressive drugs in these patients. Further long-term studies are warranted to determine the safety and efficacy of adalimumab in treating intraocular inflammation.

摘要

目的

本研究旨在评估阿达木单抗治疗难治性自身免疫性葡萄膜炎的疗效和安全性。

方法

本研究为一项前瞻性、非对照、非随机临床试验。19例符合入选标准的患者在1年时间内每隔一周接受一次40mg皮下注射阿达木单抗。

结果

所有患者在第12个月时接受了疗效评估。38只眼中有12只眼(31%)的视力改善了-0.3 logMar,1只眼(2.6%)的视力恶化了+0.3 logMar。所有患者在基线时均有活动性眼内炎症,12例患者(63%)在随访结束时通过阿达木单抗实现了炎症控制。光学相干断层扫描显示,33只眼(86%)在基线时有黄斑囊样水肿(CME),在随访结束时,这33只眼中有18只眼(54.54%)的CME完全消退。所有患者在随访结束时都能够将伴随使用的免疫抑制药物剂量至少减少50%。所有患者对阿达木单抗耐受性良好,仅观察到皮下注射部位有局部轻微副作用。然而,8例患者(42.10%)在随访期间复发,通过1次眼周注射类固醇得到控制。

结论

阿达木单抗似乎是治疗难治性葡萄膜炎的一种有效、安全的疗法,并且可能为这些患者减少伴随使用的免疫抑制药物提供可能。有必要进行进一步的长期研究以确定阿达木单抗治疗眼内炎症的安全性和疗效。

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