Assistance Publique-Hôpitaux de Paris, Department of General Paediatrics, Paediatric Infectious Disease and Internal Medicine, Robert Debré University Hospital, Université de Paris, Paris, France.
ACTIV, Association Clinique et Thérapeutique Infantile du Val-de-Marne, Créteil, France.
JAMA. 2021 Mar 2;325(9):855-864. doi: 10.1001/jama.2021.0694.
Multisystem inflammatory syndrome in children (MIS-C) is the most severe pediatric disease associated with severe acute respiratory syndrome coronavirus 2 infection, potentially life-threatening, but the optimal therapeutic strategy remains unknown.
To compare intravenous immunoglobulins (IVIG) plus methylprednisolone vs IVIG alone as initial therapy in MIS-C.
DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study drawn from a national surveillance system with propensity score-matched analysis. All cases with suspected MIS-C were reported to the French National Public Health Agency. Confirmed MIS-C cases fulfilling the World Health Organization definition were included. The study started on April 1, 2020, and follow-up ended on January 6, 2021.
IVIG and methylprednisolone vs IVIG alone.
The primary outcome was persistence of fever 2 days after the introduction of initial therapy or recrudescence of fever within 7 days, which defined treatment failure. Secondary outcomes included a second-line therapy, hemodynamic support, acute left ventricular dysfunction after first-line therapy, and length of stay in the pediatric intensive care unit. The primary analysis involved propensity score matching with a minimum caliper of 0.1.
Among 181 children with suspected MIS-C, 111 fulfilled the World Health Organization definition (58 females [52%]; median age, 8.6 years [interquartile range, 4.7 to 12.1]). Five children did not receive either treatment. Overall, 3 of 34 children (9%) in the IVIG and methylprednisolone group and 37 of 72 (51%) in the IVIG alone group did not respond to treatment. Treatment with IVIG and methylprednisolone vs IVIG alone was associated with lower risk of treatment failure (absolute risk difference, -0.28 [95% CI, -0.48 to -0.08]; odds ratio [OR], 0.25 [95% CI, 0.09 to 0.70]; P = .008). IVIG and methylprednisolone therapy vs IVIG alone was also significantly associated with lower risk of use of second-line therapy (absolute risk difference, -0.22 [95% CI, -0.40 to -0.04]; OR, 0.19 [95% CI, 0.06 to 0.61]; P = .004), hemodynamic support (absolute risk difference, -0.17 [95% CI, -0.34 to -0.004]; OR, 0.21 [95% CI, 0.06 to 0.76]), acute left ventricular dysfunction occurring after initial therapy (absolute risk difference, -0.18 [95% CI, -0.35 to -0.01]; OR, 0.20 [95% CI, 0.06 to 0.66]), and duration of stay in the pediatric intensive care unit (median, 4 vs 6 days; difference in days, -2.4 [95% CI, -4.0 to -0.7]).
Among children with MIS-C, treatment with IVIG and methylprednisolone vs IVIG alone was associated with a more favorable fever course. Study interpretation is limited by the observational design.
儿童多系统炎症综合征（MIS-C）是与严重急性呼吸综合征冠状病毒 2 感染相关的最严重儿科疾病，可能危及生命，但最佳治疗策略仍不清楚。
比较静脉注射免疫球蛋白（IVIG）加甲泼尼龙与单独使用 IVIG 作为 MIS-C 的初始治疗。
设计、地点和参与者：回顾性队列研究，来自一个全国性监测系统，采用倾向评分匹配分析。所有疑似 MIS-C 的病例均向法国国家公共卫生机构报告。符合世界卫生组织定义的确诊 MIS-C 病例被纳入研究。研究于 2020 年 4 月 1 日开始，随访于 2021 年 1 月 6 日结束。
IVIG 和甲泼尼龙与 IVIG 单独治疗。
主要结局是初始治疗后 2 天仍发热或 7 天内发热复发，定义为治疗失败。次要结局包括二线治疗、血流动力学支持、一线治疗后急性左心室功能障碍以及儿科重症监护病房的住院时间。主要分析涉及倾向评分匹配，最小卡尺为 0.1。
在 181 名疑似 MIS-C 的儿童中，有 111 名符合世界卫生组织的定义（58 名女性[52%]；中位年龄 8.6 岁[四分位距，4.7 至 12.1]）。有 5 名儿童未接受任何治疗。总体而言，34 名儿童（9%）接受 IVIG 和甲泼尼龙治疗组中有 3 名，72 名儿童（51%）接受 IVIG 单独治疗组中有 37 名未对治疗产生反应。与 IVIG 单独治疗相比，IVIG 和甲泼尼龙治疗与治疗失败风险降低相关（绝对风险差异，-0.28[95%CI，-0.48 至-0.08]；比值比[OR]，0.25[95%CI，0.09 至 0.70]；P=0.008）。与 IVIG 单独治疗相比，IVIG 和甲泼尼龙治疗也显著降低了二线治疗的风险（绝对风险差异，-0.22[95%CI，-0.40 至-0.04]；OR，0.19[95%CI，0.06 至 0.61]；P=0.004）、血流动力学支持（绝对风险差异，-0.17[95%CI，-0.34 至-0.004]；OR，0.21[95%CI，0.06 至 0.76]）、一线治疗后出现急性左心室功能障碍（绝对风险差异，-0.18[95%CI，-0.35 至-0.01]；OR，0.20[95%CI，0.06 至 0.66]）和儿科重症监护病房的住院时间（中位数，4 天与 6 天；差异天数，-2.4[95%CI，-4.0 至-0.7]）。
在 MIS-C 患儿中，与单独使用 IVIG 相比，IVIG 和甲泼尼龙联合治疗可改善发热病程。研究解释受到观察性设计的限制。
