Comparison of combination therapy of prednisolone and cyclosporine with corticosteroid pulse therapy in Vogt?Koyanagi?Harada disease
Comparison of combination therapy of prednisolone and cyclosporine with corticosteroid pulse therapy in Vogt?Koyanagi?Harada disease
复制标题
泼尼松龙、环孢素联合治疗与皮质类固醇冲击治疗Vogt·小柳·原田病的比较
DOI：
10.1007/s10384-021-00878-w
复制
发表时间：
2021
影响因子：
2.4
通讯作者：
The Japan VKH Disease Treatment Study Group
中科院分区：
文献类型：
--
作者：
Ono Takashi;Goto Hiroshi;Sakai Tsutomu;(中間省略);Tomita Makoto;The Japan VKH Disease Treatment Study Group
目的比较泼尼松龙和环孢素联合治疗与皮质类固醇冲击治疗Vogt-小柳-原田（VKH）病的疗效和安全性。2014年至2018年期间，日本11个中心的新发急性VKH疾病患者随机接受联合治疗。（口服泼尼松龙60 mg/天，逐渐减量至35 mg/天，环孢菌素3 mg/kg/天）和皮质类固醇（甲基强的松龙1000 mg，持续3天，随后口服强的松龙）组，并随访1 year.Results34例被分配到组合和36例皮质类固醇组。复发/恶化风险为0.15（95%置信区间[CI] 0.03-0.27），联合用药组为0.25（95% CI 0.11-0.39），风险差异为-0.10（90% CI − 0.27至0.06），证明复方制剂组具有非劣效性，非劣效性界值为0.20（P= 0.0013）。联合用药组有3例患者发生严重不良事件（2例低钠血症，1例严重头痛），皮质类固醇组无一例发生。日落辉光眼底等级和白内障率在1年分别为0.57（95%CI 0.42-71）和4.3%，在联合组和0.91（95%CI 0.78-1.04）和34.0%in the corticosteroid group.ConclusionsCombination therapy is noninferior皮质类固醇治疗复发/恶化的风险。值得注意的是，联合用药组的复发/恶化风险、晚霞眼底分级和白内障发生率均低于皮质类固醇组。
PurposeTo compare the efficacy and safety of a combination therapy of prednisolone and cyclosporine and corticosteroid pulse therapy in Vogt–Koyanagi–Harada (VKH) disease.Study designA prospective, multicenter, randomized, non-inferiority trial.MethodsPatients 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.ResultsThirty-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.ConclusionsCombination 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.