Fardeau Christine, Simon Anne, Rodde Benoît, Viscogliosi Fabiana, Labalette Pierre, Looten Vincent, Tézenas du Montcel Sophie, LeHoang Phuc
Ophthalmology Department, Reference Centre for Rare Diseases, Pitié-Salpétrière Hospital, University Paris VI, DHU Sight Restore, Paris, France.
Internal Medicine Department, Pr S. Herson, Pitié-Salpétrière Hospital, University Paris VI, Paris, France.
Am J Ophthalmol. 2017 May;177:182-194. doi: 10.1016/j.ajo.2017.03.001. Epub 2017 Mar 14.
Macular edema is the leading cause of vision loss in bilateral chronic noninfectious posterior uveitis, and is currently being treated using corticosteroids, immunosuppressive agents, and biotherapies. The aim of this trial was to assess and compare the efficacy and safety of corticosteroids and interferon-α (IFN-α) in adults with such conditions.
Randomized controlled trial.
Subjects: Adult patients with bilateral posterior autoimmune noninfectious and nontumoral uveitis complicated by macular edema in at least 1 eye.
Patients received either subcutaneous IFN-α2a, systemic corticosteroids, or no treatment for 4 months. The efficacy and safety were assessed for up to 4 months.
The main endpoint was the change of the central foveal thickness (CFT) obtained by optical coherence tomography.
Forty-eight patients were included. In intention-to-treat analysis, the median CFT change showed no significant difference. However, the per-protocol analysis showed a significant difference between groups for both eyes (OD and OS), and for the worse and better eyes. Statistically significant difference was found between the control and corticosteroid groups for the OD (P = .0285), and between the control and IFN-α groups for the OD (P = .0424) and worse eye (P = .0354). Serious adverse events occurred in 2 patients in the IFN group, in 1 patient in the corticosteroid group, and in 2 patients in the control group and were completely resolved after switch.
IFN-α and systemic corticosteroids, compared with no treatment, were associated with significant anatomic and visual improvement shown in the per-protocol study.
黄斑水肿是双侧慢性非感染性后葡萄膜炎导致视力丧失的主要原因，目前采用皮质类固醇、免疫抑制剂和生物疗法进行治疗。本试验的目的是评估和比较皮质类固醇与干扰素-α（IFN-α）在患有此类疾病的成人中的疗效和安全性。
随机对照试验。
受试者：患有双侧后部自身免疫性非感染性和非肿瘤性葡萄膜炎且至少一只眼睛并发黄斑水肿的成年患者。
患者接受皮下注射IFN-α2a、全身皮质类固醇治疗或4个月不治疗。对疗效和安全性进行长达4个月的评估。
主要终点是通过光学相干断层扫描获得的中心凹厚度（CFT）的变化。
纳入48例患者。在意向性分析中，CFT变化中位数无显著差异。然而，符合方案分析显示，双眼（右眼和左眼）以及较差和较好眼睛的组间存在显著差异。右眼对照组和皮质类固醇组之间（P = 0.0285）、右眼对照组和IFN-α组之间（P = 0.0424）以及较差眼睛的对照组和IFN-α组之间（P = 0.0354）存在统计学显著差异。IFN组有2例患者、皮质类固醇组有1例患者、对照组有2例患者发生严重不良事件，在换药后完全缓解。
与不治疗相比，IFN-α和全身皮质类固醇在符合方案研究中显示出显著的解剖学和视力改善。
