Miyata Eye Hospital, 6-3 Kurahara, Miyakonojo, Miyazaki, 885-0051, Japan.
Department of Ophthalmology, Tokyo Medical University, Tokyo, Japan.
Jpn J Ophthalmol. 2022 Mar;66(2):119-129. doi: 10.1007/s10384-021-00878-w. Epub 2021 Oct 24.
To compare the efficacy and safety of a combination therapy of prednisolone and cyclosporine and corticosteroid pulse therapy in Vogt-Koyanagi-Harada (VKH) disease.
A prospective, multicenter, randomized, non-inferiority trial.
Patients of new-onset acute VKH disease at 11 centers in Japan between 2014 and 2018 were randomized to a combination (oral prednisolone 60 mg daily with gradual taper-off to 35 mg/day and cyclosporine 3 mg/kg/day) and corticosteroid (methylprednisolone 1000 mg for 3 days followed by oral prednisolone) groups, and were followed for 1 year.
Thirty-four were assigned to the combination and thirty-six patients to the corticosteroid group. Recurrence/worsening risk was 0.15 (95% confidence-interval [CI] 0.03-0.27) in the combination group and 0.25 (95% CI 0.11-0.39) in the corticosteroid group, with a risk difference of - 0.10 (90% CI - 0.27 to 0.06), demonstrating non-inferiority of the combination group with a non-inferiority margin of 0.20 (P = 0.0013). Serious adverse events occurred in three patients (two with hyponatremia and one with severe headaches) in the combination group and none in the corticosteroid group. Sunset glow fundus grades and cataract rates at 1 year were 0.57 (95% CI 0.42-71) and 4.3% in the combination group and 0.91 (95% CI 0.78-1.04) and 34.0% in the corticosteroid group, respectively.
Combination therapy was noninferior to corticosteroid therapy with respect to recurrence/worsening risk. Notably, the recurrence/worsening risk, sunset glow fundus grade, and cataract rate were lower in the combination group than in the corticosteroid group.
比较泼尼松龙和环孢素联合治疗与皮质类固醇脉冲疗法在 Vogt-Koyanagi-Harada（VKH）病中的疗效和安全性。
前瞻性、多中心、随机、非劣效性试验。
2014 年至 2018 年期间，日本 11 个中心的新发急性 VKH 病患者被随机分为联合组（口服泼尼松龙 60mg/天，逐渐减量至 35mg/天，环孢素 3mg/kg/天）和皮质类固醇组（甲泼尼龙 1000mg 治疗 3 天，随后口服泼尼松龙），随访 1 年。
34 例患者被分配至联合组，36 例患者被分配至皮质类固醇组。联合组的复发/加重风险为 0.15（95%置信区间 [CI] 0.03-0.27），皮质类固醇组为 0.25（95%CI 0.11-0.39），风险差为 -0.10（90%CI -0.27 至 0.06），联合组具有非劣效性，非劣效性边界为 0.20（P=0.0013）。联合组有 3 例患者（2 例低钠血症，1 例严重头痛）发生严重不良事件，皮质类固醇组无患者发生严重不良事件。联合组 1 年后晚霞状眼底分级和白内障发生率分别为 0.57（95%CI 0.42-71）和 4.3%，皮质类固醇组分别为 0.91（95%CI 0.78-1.04）和 34.0%。
联合治疗在复发/加重风险方面不劣于皮质类固醇治疗。值得注意的是，联合组的复发/加重风险、晚霞状眼底分级和白内障发生率均低于皮质类固醇组。
