A SINGLE INTRAVENOUS-INFUSION OF GAMMA-GLOBULIN AS COMPARED WITH 4 INFUSIONS IN THE TREATMENT OF ACUTE KAWASAKI SYNDROME
A SINGLE INTRAVENOUS-INFUSION OF GAMMA-GLOBULIN AS COMPARED WITH 4 INFUSIONS IN THE TREATMENT OF ACUTE KAWASAKI SYNDROME
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DOI：
10.1056/nejm199106063242305
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发表时间：
1991-06-06
影响因子：
158.5
通讯作者：
ROSEN, FS
中科院分区：
文献类型：
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作者：
NEWBURGER, JW;TAKAHASHI, M;ROSEN, FS
背景 静脉注射丙种球蛋白联合阿司匹林治疗急性川崎综合征4天，已被证明在预防冠状动脉病变和减轻全身炎症方面是安全有效的。 我们假设单次使用高剂量丙种球蛋白治疗至少与标准方案一样有效。 我们对549例急性川崎综合征患儿进行了一项多中心、随机、对照试验。 这些儿童被分配接受丙种球蛋白，单次输注2 g/kg体重，持续10小时，或连续4天每天输注400 mg/kg。 两个治疗组均接受阿司匹林（100 mg/kg/天，直到患病的第14天，然后3至5 mg/kg/天）。 与单次输注方案治疗的患者相比，经年龄和性别调整后，接受4天方案治疗的患者中冠状动脉异常的相对患病率在入组后2周为1.94（95%置信限，1.01和3.71），在入组后7周为1.84（95%置信限，0.89和3.82）。 接受单次输注方案治疗的儿童住院时平均体温较低（第2天，P < 0.001;第3天，P = 0.004），平均发热持续时间较短（P = 0.028）。 此外，在单次输注组中，急性炎症的实验室指标更快地向正常方向移动，包括校正的血清白蛋白水平（P = 0.004）、α-1-抗胰蛋白酶水平（P = 0.007）和C-反应蛋白水平（P = 0.017）。 第4天较低的IgG水平与冠状动脉病变的患病率较高（P = 0.005）和全身炎症程度较高相关。 两组不良反应的发生率相似（包括9名儿童新发或恶化的充血性心力衰竭），总体发生率为2.7%。 所有不良反应均为一过性。 在患有急性川崎病的儿童中，单次大剂量静脉注射丙种球蛋白比常规的每日四次小剂量注射更有效，并且同样安全。
Background. Treatment of acute Kawasaki syndrome with a four-day course of intravenous gamma globulin, together with aspirin, has been demonstrated to be safe and effective in preventing coronary-artery lesions and reducing systemic inflammation. We hypothesized that therapy with a single, very high dose of gamma globulin would be at least as effective as the standard regimen.Methods. We conducted a multicenter, randomized, controlled trial involving 549 children with acute Kawasaki syndrome. The children were assigned to receive gamma globulin either as a single infusion of 2 g per kilogram of body weight over 10 hours or as daily infusions of 400 mg per kilogram for four consecutive days. Both treatment groups received aspirin (100 mg per kilogram per day through the 14th day of illness, then 3 to 5 mg per kilogram per day).Results. The relative prevalence of coronary abnormalities, adjusted for age and sex, among patients treated with the four-day regimen, as compared with those treated with the single-infusion regimen, was 1.94 (95 percent confidence limits, 1.01 and 3.71) two weeks after enrollment and 1.84 (95 percent confidence limits, 0.89 and 3.82) seven weeks after enrollment. Children treated with the single-infusion regimen had lower mean temperatures while hospitalized (day 2, P < 0.001; day 3, P = 0.004), as well as a shorter mean duration of fever (P = 0.028). Furthermore, in the single-infusion group the laboratory indexes of acute inflammation moved more rapidly toward normal, including the adjusted serum albumin level (P = 0.004), alpha-1-antitrypsin level (P = 0.007), and C-reactive protein level (P = 0.017). Lower IgG levels on day 4 were associated with a higher prevalence of coronary lesions (P = 0.005) and with a greater degree of systemic inflammation. The two groups had a similar incidence of adverse effects (including new or worsening congestive heart failure in nine children), which occurred in 2.7 percent of the children overall. All the adverse effects were transient.Conclusions. In children with acute Kawasaki disease, a single large dose of intravenous gamma globulin is more effective than the conventional regimen of four smaller daily doses and is equally safe.