Treatment of Multisystem Inflammatory Syndrome in Children.
Treatment of Multisystem Inflammatory Syndrome in Children.
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DOI：
10.1056/nejmoa2102968
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发表时间：
2021-07-01
期刊：
影响因子：
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通讯作者：
BATS Consortium
中科院分区：
文献类型：
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作者：
McArdle AJ;Vito O;Patel H;Seaby EG;Shah P;Wilson C;Broderick C;Nijman R;Tremoulet AH;Munblit D;Ulloa-Gutierrez R;Carter MJ;De T;Hoggart C;Whittaker E;Herberg JA;Kaforou M;Cunnington AJ;Levin M;BATS Consortium
迫切需要证据来支持与严重急性呼吸综合征冠状病毒2相关的多系统炎症综合征（MIS-C）儿童的治疗决策。我们进行了一项国际观察性队列研究，研究了医生上传到基于网络的数据库中的关于疑似MIS-C的临床和结局数据。我们使用逆概率加权和广义线性模型来评估静脉注射免疫球蛋白（IVIG）作为参考，与IVIG加糖皮质激素和糖皮质激素单独。有两个主要结局：第一个是到第2天或之后的正性肌力支持或机械通气或死亡的复合终点;第二个是到第2天的疾病严重程度的顺序量表降低。次要结局包括治疗升级和器官衰竭和炎症减少的时间。2020年6月至2021年2月，来自32个国家的614名儿童的治疗过程数据可用; 490名符合世界卫生组织MIS-C标准。在614名疑似MIS-C的儿童中，246名接受了IVIG单独治疗，208名接受了IVIG+糖皮质激素治疗，99名接受了糖皮质激素治疗; 22名儿童接受了其他治疗组合，包括生物制剂，39名儿童没有接受免疫调节治疗。56例接受IVIG+糖皮质激素治疗的患者（与单独使用IVIG相比，调整后的比值比为0.77; 95%置信区间[CI]为0.33 - 1.82）和17例单独使用糖皮质激素的患者（调整后的比值比为0.54; 95% CI为0.22 - 1.33）发生了变力性或缓解性支持或死亡。与单独使用IVIG相比，两组中疾病严重程度降低的校正比值比相似（IVIG+糖皮质激素为0.90，糖皮质激素为0.93）。三组中疾病严重程度降低的时间相似。我们没有发现任何证据表明MIS-C的恢复在IVIG单独、IVIG加糖皮质激素或糖皮质激素单独的初级治疗后有差异，尽管随着更多数据的积累可能会出现显著差异。（由欧盟地平线2020计划和其他人资助; BATS ISRCTN编号，ISRCTN 69546370。
Evidence is urgently needed to support treatment decisions for children with multisystem inflammatory syndrome (MIS-C) associated with severe acute respiratory syndrome coronavirus 2. We performed an international observational cohort study of clinical and outcome data regarding suspected MIS-C that had been uploaded by physicians onto a Web-based database. We used inverse-probability weighting and generalized linear models to evaluate intravenous immune globulin (IVIG) as a reference, as compared with IVIG plus glucocorticoids and glucocorticoids alone. There were two primary outcomes: the first was a composite of inotropic support or mechanical ventilation by day 2 or later or death; the second was a reduction in disease severity on an ordinal scale by day 2. Secondary outcomes included treatment escalation and the time until a reduction in organ failure and inflammation. Data were available regarding the course of treatment for 614 children from 32 countries from June 2020 through February 2021; 490 met the World Health Organization criteria for MIS-C. Of the 614 children with suspected MIS-C, 246 received primary treatment with IVIG alone, 208 with IVIG plus glucocorticoids, and 99 with glucocorticoids alone; 22 children received other treatment combinations, including biologic agents, and 39 received no immunomodulatory therapy. Receipt of inotropic or ventilatory support or death occurred in 56 patients who received IVIG plus glucocorticoids (adjusted odds ratio for the comparison with IVIG alone, 0.77; 95% confidence interval [CI], 0.33 to 1.82) and in 17 patients who received glucocorticoids alone (adjusted odds ratio, 0.54; 95% CI, 0.22 to 1.33). The adjusted odds ratios for a reduction in disease severity were similar in the two groups, as compared with IVIG alone (0.90 for IVIG plus glucocorticoids and 0.93 for glucocorticoids alone). The time until a reduction in disease severity was similar in the three groups. We found no evidence that recovery from MIS-C differed after primary treatment with IVIG alone, IVIG plus glucocorticoids, or glucocorticoids alone, although significant differences may emerge as more data accrue. (Funded by the European Union’s Horizon 2020 Program and others; BATS ISRCTN number, ISRCTN69546370.)