法国内克尔儿童医院François Angoulvant团队比较了静脉注射免疫球蛋白加甲基强的松龙与单独注射免疫球蛋白治疗小儿多系统炎症综合征对发热病程的影响。2021年2月1日，该研究发表在《美国医学会杂志》上。

儿童多系统炎症综合征（MIS-C）是与SARS-CoV-2感染相关的最严重的儿科疾病，可能危及生命，但其最佳治疗策略尚不清楚。

为了比较静脉注射免疫球蛋白（IVIG）加甲基强的松龙与单纯IVIG作为MIS-C的初始治疗的效果，2020年4月1日至2021年1月6日，研究组对国家监测系统进行了一项回顾性队列研究，采用倾向评分匹配分析。

所有疑似MIS-C病例均向法国国家公共卫生局报告，包括符合世界卫生组织定义的确诊MIS-C病例。主要结局是首次治疗后2天持续发热或7天内发热复发，即治疗失败。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不全以及在儿科重症监护室的住院时间。

在招募的181例疑似MIS-C患儿中，共有111例符合世界卫生组织定义，其中女童58例，占52%；中位年龄为8.6岁。有5名儿童未接受任何一种治疗。总体来说，IVIG+甲基强的松龙组的34名儿童中有3名（9%），单独IVIG组的72名儿童中有37名（51%）治疗失败。

IVIG+甲基强的松龙组与单独IVIG组相比，治疗失败的风险较低，比值比为0.25。IVIG+甲基强的松龙治疗与IVIG单独治疗相比，二线治疗、血流动力学支持、初始治疗后出现急性左心室功能障碍的风险显著降低，同时儿科重症监护病房的住院时间显著缩短。

研究结果表明，IVIG+甲基强的松龙治疗MIS-C患儿，与单纯IVIG治疗相比，治疗成功率更高。

附：英文原文

Title: Association of Intravenous Immunoglobulins Plus Methylprednisolone vs Immunoglobulins Alone With Course of Fever in Multisystem Inflammatory Syndrome in Children

Author: Nam Ouldali, Julie Toubiana, Denise Antona, Etienne Javouhey, Fouad Madhi, Mathie Lorrot, Pierre-Louis Léger, Caroline Galeotti, Caroline Claude, Arnaud Wiedemann, Noémie Lachaume, Caroline Ovaert, Morgane Dumortier, Jean-Emmanuel Kahn, Alexis Mandelcwajg, Lucas Percheron, Blandine Biot, Jeanne Bordet, Marie-Laure Girardin, David Dawei Yang, Marion Grimaud, Mehdi Oualha, Slimane Allali, Fanny Bajolle, Constance Beyler, Ulrich Meinzer, Michael Levy, Ana-Maria Paulet, Corinne Levy, Robert Cohen, Alexandre Belot, Franois Angoulvant, French Covid- Paediatric Inflammation Consortium

Issue&Volume: 2021-02-01

Abstract:

Importance  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.

Objective  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.

Exposures  IVIG and methylprednisolone vs IVIG alone.

Main Outcomes and Measures  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.

Results  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]).

Conclusions and Relevance  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.

DOI: 10.1001/jama.2021.0694

Source: https://jamanetwork.com/journals/jama/fullarticle/2776054