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儿童多系统炎症综合征的现有几种治疗方案疗效无显著差异
2021-06-20 21:05

英国帝国理工大学伦敦医学院Michael Levin团队研究了儿童多系统炎症综合征的治疗方案。这一研究成果于2021年6月16日发表在《新英格兰医学杂志》上。

目前迫切需要证据来支持与新冠病毒相关的儿童多系统炎症综合征(MIS-C)的治疗决策。

研究组进行了一项国际观察队列研究,对医生上传到网络数据库的疑似MIS-C的临床和预后数据进行分析。研究组使用逆概率加权和广义线性模型来比较评价静脉注射免疫球蛋白(IVIG)、IVIG加糖皮质激素与单纯糖皮质激素治疗的效果。有两个主要结局:第一个是在第2天及以后使用肌力支持或机械通气或死亡的综合结局;第二个是第2天疾病的严重程度降低。次要结局包括治疗升级和器官衰竭和炎症缓解的时间。

2020年6月至2021年2月,研究组共收集来自32个国家的614名儿童的疗程数据,其中490名符合世界卫生组织的MIS-C标准。在614例疑似MIS-C患儿中,246例接受单纯IVIG治疗,208例接受IVIG加糖皮质激素治疗,99例接受单纯糖皮质激素治疗;22名儿童接受包括生物制剂在内的其他联合治疗,39名儿童未接受免疫调节治疗。

与单纯IVIG组相比,IVIG加糖皮质激素治疗组中有56例患儿接受了肌力支持或通气支持或死亡,校正优势比为0.77;单纯糖皮质激素治疗组中有17例,校正优势比为0.54。两组疾病严重程度降低与单纯IVIG组的校正优势比相差不大。三组患者疾病严重程度降低的时间相似。

研究结果表明,对于MIS-C儿童,单纯IVIG、IVIG加糖皮质激素或单纯糖皮质激素治疗对预后的影响没有显著差异。

附:英文原文

Title: Treatment of Multisystem Inflammatory Syndrome in Children

Author: Andrew J. McArdle, M.B., B.Chir.,, Ortensia Vito, M.Sc.,, Harsita Patel, M.B., B.S.,, Eleanor G. Seaby, B.M., B.S.,, Priyen Shah, M.B., B.S.,, Clare Wilson, M.B., B.Chir.,, Claire Broderick, M.B., B.S.,, Ruud Nijman, M.D., Ph.D.,, Adriana H. Tremoulet, M.D.,, Daniel Munblit, M.D., Ph.D.,, Rolando Ulloa-Gutierrez, M.D.,, Michael J. Carter, B.M., B.Ch., D.Phil.,, Tisham De, Ph.D.,, Clive Hoggart, Ph.D.,, Elizabeth Whittaker, M.B., B.A.O., B.Ch., Ph.D.,, Jethro A. Herberg, Ph.D.,, Myrsini Kaforou, Ph.D.,, Aubrey J. Cunnington, B.M., B.Ch., Ph.D.,, and Michael Levin, F.Med.Sci.

Issue&Volume: 2021-06-16

Abstract:

BACKGROUND

Evidence is urgently needed to support treatment decisions for children with multisystem inflammatory syndrome (MIS-C) associated with severe acute respiratory syndrome coronavirus 2.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

DOI: 10.1056/NEJMoa2102968

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2102968

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home


本期文章:《新英格兰医学杂志》:Online/在线发表

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