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Multicenter, randomized, open-label study to compare immunoglobulin to immunoglobulin plus cyclosporin A combination therapy in patients with severe Kawasaki disease
比较免疫球蛋白与免疫球蛋白加环孢素A联合治疗重症川崎病患者的多中心、随机、开放标签研究
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其它 |
INTERVENTION: Intervention type:DRUG. Intervention1:Cyclosporin A(CsA), Dose form:ORAL SOLUTION, Route of administration:ORAL, intended dose regimen:CsA (5 mg/kg/day in two separate oral doses*5days) + IVIG (2 g/kg*1 day] + Aspirin(30 mg/kg/day in 3 two separate doses every day). Control intervention1:Intravenous immunoglobulin(IVIG), Dose form:INJECTION, Intended dose regimen:IVIG 2g/kg*1 day + Aspirin 30 mg/kg/day. CONDITION: Severe Kawasaki disease PRIMARY OUTCOME: Frequency of CAAs during the study period (central review of echocardiography data). Timepoint:Day 3, Day 8, Day15, Day 29, Day 85. |
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