Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease
Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease
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DOI：
10.1056/nejmoa061235
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发表时间：
2007-02-15
影响因子：
158.5
通讯作者：
Sundel, Robert P.
中科院分区：
文献类型：
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作者：
Newburger, Jane W.;Sleeper, Lynn A.;Sundel, Robert P.
背景静脉注射免疫球蛋白和阿司匹林治疗急性川崎病可降低冠状动脉异常和全身炎症的风险，但尽管静脉注射免疫球蛋白治疗，一些儿童仍会发生冠状动脉异常。研究表明，主要的皮质类固醇治疗可能是有益的，不良事件是罕见的，短期use.METHODSWe进行了一项多中心，随机，双盲，安慰剂对照试验，以确定是否增加静脉内甲基强的松龙常规初级治疗川崎降低冠状动脉异常的风险。发热≤ 10天的患者被随机分配接受静脉注射甲基强的松龙，30 mg/kg体重（101例患者）或安慰剂（98例患者）。然后所有患者接受常规治疗，静脉注射免疫球蛋白，2g/kg，以及阿司匹林，80 - 100 mg/kg/天，直到他们不发热48小时，此后每天3 - 5 mg/kg。在随机化后第1周和第5周，两个研究组中的患者具有相似的冠状动脉尺寸，表示为针对体表面积调整的z分数，绝对尺寸和尺寸变化。与接受安慰剂的患者相比，接受静脉注射甲泼尼龙的患者的初始住院时间略短（P=0.05），在第1周，红细胞沉降率较低（P=0.02），C反应蛋白水平有降低的趋势（P=0.07）。然而，这两组有类似的天数在医院度过的，发烧的天数，再治疗与静脉注射免疫球蛋白，和不良事件的数量。CONCLUSIONSOUR的数据不提供支持，除了一个单一的脉冲剂量的静脉注射甲泼尼龙常规静脉注射免疫球蛋白治疗的常规初级治疗儿童川崎病。
BACKGROUNDTreatment of acute Kawasaki disease with intravenous immune globulin and aspirin reduces the risk of coronary-artery abnormalities and systemic inflammation, but despite intravenous immune globulin therapy, coronary-artery abnormalities develop in some children. Studies have suggested that primary corticosteroid therapy might be beneficial and that adverse events are infrequent with short-term use.METHODSWe conducted a multicenter, randomized, double-blind, placebo-controlled trial to determine whether the addition of intravenous methylprednisolone to conventional primary therapy for Kawasaki disease reduces the risk of coronary-artery abnormalities. Patients with 10 or fewer days of fever were randomly assigned to receive intravenous methylprednisolone, 30 mg per kilogram of body weight (101 patients), or placebo (98 patients). All patients then received conventional therapy with intravenous immune globulin, 2 g per kilogram, as well as aspirin, 80 to 100 mg per kilogram per day until they were afebrile for 48 hours and 3 to 5 mg per kilogram per day thereafter.RESULTSAt week 1 and week 5 after randomization, patients in the two study groups had similar coronary dimensions, expressed as z scores adjusted for body-surface area, absolute dimensions, and changes in dimensions. As compared with patients receiving placebo, patients receiving intravenous methylprednisolone had a somewhat shorter initial period of hospitalization (P=0.05) and, at week 1, a lower erythrocyte sedimentation rate (P=0.02) and a tendency toward a lower C-reactive protein level (P=0.07). However, the two groups had similar numbers of days spent in the hospital, numbers of days of fever, rates of retreatment with intravenous immune globulin, and numbers of adverse events.CONCLUSIONSOur data do not provide support for the addition of a single pulsed dose of intravenous methylprednisolone to conventional intravenous immune globulin therapy for the routine primary treatment of children with Kawasaki disease.