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伏格特-小柳-原田病的治疗结果:抗代谢物疗法随机临床试验的亚组分析

Outcomes of Vogt-Koyanagi-Harada Disease: A Subanalysis From a Randomized Clinical Trial of Antimetabolite Therapies.

作者信息

Shen Elizabeth, Rathinam Sivakumar R, Babu Manohar, Kanakath Anuradha, Thundikandy Radhika, Lee Salena M, Browne Erica N, Porco Travis C, Acharya Nisha R

机构信息

F.I. Proctor Foundation, University of California San Francisco, San Francisco, California.

Aravind Eye Care System, Madurai, India.

出版信息

Am J Ophthalmol. 2016 Aug;168:279-286. doi: 10.1016/j.ajo.2016.06.004. Epub 2016 Jun 10.

DOI:10.1016/j.ajo.2016.06.004
PMID:27296490
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4969141/
Abstract

PURPOSE

To report outcomes of Vogt-Koyanagi-Harada (VKH) disease from a clinical trial of antimetabolite therapies.

DESIGN

Subanalysis from an observer-masked randomized clinical trial for noninfectious intermediate, posterior, and panuveitis.

METHODS

setting: Clinical practice at Aravind Eye Hospitals, India.

PATIENT POPULATION

Forty-three of 80 patients enrolled (54%) diagnosed with VKH.

INTERVENTION

Patients were randomized to either 25 mg oral methotrexate weekly or 1 g mycophenolate mofetil twice daily, with a corticosteroid taper.

MAIN OUTCOME MEASURES

Primary outcome was corticosteroid-sparing control of inflammation at 5 and 6 months. Secondary outcomes included visual acuity, central subfield thickness, and adverse events. Patients were categorized as acute (diagnosis ≤3 months prior to enrollment) or chronic (diagnosis >3 months prior to enrollment).

RESULTS

Twenty-seven patients were randomized to methotrexate and 16 to mycophenolate mofetil; 30 had acute VKH. The odds of achieving corticosteroid-sparing control of inflammation with methotrexate were 2.5 times (95% CI: 0.6, 9.8; P = .20) the odds with mycophenolate mofetil, a difference that was not statistically significant. The average improvement in visual acuity was 12.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. On average, visual acuity for patients with acute VKH improved by 14 more ETDRS letters than those with chronic VKH (P < .001), but there was no difference in corticosteroid-sparing control of inflammation (P = .99). All 26 eyes with a serous retinal detachment at baseline resolved, and 88% achieved corticosteroid-sparing control of inflammation.

CONCLUSIONS

The majority of patients treated with antimetabolites and corticosteroids were able to achieve corticosteroid-sparing control of inflammation by 6 months. Although patients with acute VKH gained more visual improvement than those with chronic VKH, this did not correspond with a higher rate of controlled inflammation.

摘要

目的

报告抗代谢物疗法临床试验中葡萄膜炎-小柳-原田(VKH)病的治疗结果。

设计

一项针对非感染性中间葡萄膜炎、后葡萄膜炎和全葡萄膜炎的观察者盲法随机临床试验的亚分析。

方法

地点:印度阿拉文眼科医院的临床实践。

患者人群

80名入组患者中有43名(54%)被诊断为VKH。

干预措施

患者被随机分为两组,一组每周口服25毫克甲氨蝶呤,另一组每天两次口服1克霉酚酸酯,并逐渐减少皮质类固醇的用量。

主要观察指标

主要观察指标是在5个月和6个月时皮质类固醇节省效应的炎症控制情况。次要观察指标包括视力、中心子野厚度和不良事件。患者被分为急性(入组前诊断≤3个月)或慢性(入组前诊断>3个月)。

结果

27名患者被随机分配至甲氨蝶呤组,16名患者被随机分配至霉酚酸酯组;30名患有急性VKH。甲氨蝶呤实现皮质类固醇节省效应炎症控制的几率是霉酚酸酯的2.5倍(95%置信区间:0.6,9.8;P = 0.20),差异无统计学意义。视力平均改善12.5个早期糖尿病视网膜病变研究(ETDRS)字母。急性VKH患者的视力平均比慢性VKH患者多改善14个ETDRS字母(P < 0.001),但在皮质类固醇节省效应的炎症控制方面无差异(P = 0.99)。所有26只基线时有浆液性视网膜脱离的眼睛均恢复,88%实现了皮质类固醇节省效应的炎症控制。

结论

大多数接受抗代谢物和皮质类固醇治疗的患者在6个月时能够实现皮质类固醇节省效应的炎症控制。尽管急性VKH患者比慢性VKH患者视力改善更多,但这与更高的炎症控制率并不相符。

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