Ocular Inflammation Service, The University of Pennsylvania, Philadelphia, Philadelphia, PA 19104, USA.
Ophthalmology. 2011 Oct;118(10):1916-26. doi: 10.1016/j.ophtha.2011.07.027. Epub 2011 Aug 15.
To compare the relative effectiveness of systemic corticosteroids plus immunosuppression when indicated (systemic therapy) versus fluocinolone acetonide implant (implant therapy) for noninfectious intermediate, posterior, or panuveitis (uveitis).
Randomized controlled parallel superiority trial.
Patients with active or recently active uveitis.
Participants were randomized (allocation ratio 1:1) to systemic or implant therapy at 23 centers (3 countries). Implant-assigned participants with bilateral uveitis were assigned to have each eye that warranted study treatment implanted. Treatment-outcome associations were analyzed by assigned treatment for all eyes with uveitis.
Masked examiners measured the primary outcome: change in best-corrected visual acuity from baseline. Secondary outcomes included patient-reported quality of life, ophthalmologist-graded uveitis activity, and local and systemic complications of uveitis or therapy. Reading Center graders and glaucoma specialists assessing ocular complications were masked. Participants, ophthalmologists, and coordinators were unmasked.
On evaluation of changes from baseline to 24 months among 255 patients randomized to implant and systemic therapy (479 eyes with uveitis), the implant and systemic therapy groups had an improvement in visual acuity of +6.0 and +3.2 letters (P = 0.16, 95% confidence interval on difference in improvement between groups, -1.2 to +6.7 letters, positive values favoring implant), an improvement in vision-related quality of life of +11.4 and +6.8 units (P = 0.043), a change in EuroQol-EQ5D health utility of +0.02 and -0.02 (P = 0.060), and residual active uveitis in 12% and 29% (P=0.001), respectively. Over the 24 month period, implant-assigned eyes had a higher risk of cataract surgery (80%, hazard ratio [HR] = 3.3, P < 0.0001), treatment for elevated intraocular pressure (61%, HR=4.2, P < 0.0001), and glaucoma (17%, HR=4.2, P = 0.0008). Patients assigned to systemic therapy had more prescription-requiring infections than patients assigned to implant therapy (0.60 vs 0.36/person-year, P=0.034), without notable long-term consequences; systemic adverse outcomes otherwise were unusual in both groups, with minimal differences between groups.
In each treatment group, mean visual acuity improved over 24 months, with neither approach superior to a degree detectable with the study's power. Therefore, the specific advantages and disadvantages identified should dictate selection between the alternative treatments in consideration of individual patients' particular circumstances. Systemic therapy with aggressive use of corticosteroid-sparing immunosuppression was well tolerated, suggesting that this approach is reasonably safe for local and systemic inflammatory disorders.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
比较在有指征时全身使用皮质类固醇和免疫抑制治疗（全身治疗）与氟轻松醋酸酯植入物（植入物治疗）治疗非感染性中间、后部或全葡萄膜炎（葡萄膜炎）的相对疗效。
随机对照平行优势试验。
患有活动性或近期活动性葡萄膜炎的患者。
参与者在 23 个中心（3 个国家）按（分配比例 1:1）随机分配至全身或植入治疗组。双侧葡萄膜炎的植入物治疗组患者，每只需要治疗的眼睛都接受植入治疗。所有葡萄膜炎患者均按治疗方案评估治疗效果。
由经过盲法评估的研究者评估主要结局：从基线到最佳矫正视力的变化。次要结局包括患者报告的生活质量、眼科医生评估的葡萄膜炎活动度，以及葡萄膜炎或治疗的局部和全身并发症。眼部并发症的评估由阅读中心分级员和青光眼专家进行盲法评估。参与者、眼科医生和协调员不设盲。
在对 255 名随机分配至植入物和全身治疗组（479 只眼患有葡萄膜炎）的患者进行 24 个月的基线评估后，植入物和全身治疗组视力提高了+6.0 和+3.2 个字母（P=0.16，组间改善差异的 95%置信区间为-1.2 至+6.7 个字母，正值表示植入物更有利），视力相关生活质量提高了+11.4 和+6.8 个单位（P=0.043），EuroQol-EQ5D 健康效用提高了+0.02 和-0.02（P=0.060），残余活动性葡萄膜炎分别为 12%和 29%（P=0.001）。在 24 个月期间，植入物治疗组的白内障手术风险较高（80%，风险比[HR]=3.3，P<0.0001），治疗眼压升高的风险较高（61%，HR=4.2，P<0.0001），青光眼风险较高（17%，HR=4.2，P=0.0008）。与接受植入物治疗的患者相比，接受全身治疗的患者需要处方药物治疗的感染更多（0.60 比 0.36/人年，P=0.034），但没有显著的长期后果；两组患者全身不良事件均不常见，两组之间差异极小。
在每个治疗组中，平均视力在 24 个月内均有所改善，且两种方法均未达到可检测到的疗效优势程度。因此，应根据个体患者的具体情况，选择治疗方案，考虑特定治疗方案的具体优缺点。全身性治疗联合积极使用皮质类固醇免疫抑制剂治疗，耐受性良好，提示该方法对局部和全身炎症性疾病是较为安全的。
参考文献后可能存在专有或商业披露。
