Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China.
Lanzhou University Institute of Health Data Science, Lanzhou, China.
Eur J Pediatr. 2022 May;181(5):2135-2146. doi: 10.1007/s00431-022-04388-w. Epub 2022 Feb 22.
The purpose of this systematic review is to evaluate the efficacy and safety of using potential drugs: remdesivir and glucocorticoid in treating children and adolescents with COVID-19 and intravenous immunoglobulin (IVIG) in treating MIS-C. We searched seven databases, three preprint platform, ClinicalTrials.gov, and Google from December 1, 2019, to August 5, 2021, to collect evidence of remdesivir, glucocorticoid, and IVIG which were used in children and adolescents with COVID-19 or MIS-C. A total of nine cohort studies and one case series study were included in this systematic review. In terms of remdesivir, the meta-analysis of single-arm cohort studies have shown that after the treatment, 54.7% (95%CI, 10.3 to 99.1%) experienced adverse events, 5.6% (95%CI, 1.2 to 10.1%) died, and 27.0% (95%CI, 0 to 73.0%) needed extracorporeal membrane oxygenation or invasive mechanical ventilation. As for glucocorticoids, the results of the meta-analysis showed that the fixed-effect summary odds ratio for the association with mortality was 2.79 (95%CI, 0.13 to 60.87), and the mechanical ventilation rate was 3.12 (95%CI, 0.80 to 12.08) for glucocorticoids compared with the control group. In terms of IVIG, most of the included cohort studies showed that for MIS-C patients with more severe clinical symptoms, IVIG combined with methylprednisolone could achieve better clinical efficacy than IVIG alone.
Overall, the current evidence in the included studies is insignificant and of low quality. It is recommended to conduct high-quality randomized controlled trials of remdesivir, glucocorticoids, and IVIG in children and adolescents with COVID-19 or MIS-C to provide substantial evidence for the development of guidelines.
• The efficacy and safety of using potential drugs such as remdesivir, glucocorticoid, and intravenous immunoglobulin (IVIG) in treating children and adolescents with COVID-19/MIS-C are unclear.
• Overall, the current evidence cannot adequately demonstrate the effectiveness and safety of using remdesivir, glucocorticoids, and IVIG in treating children and adolescents with COVID-19 or MIS-C. • We are calling for the publication of high-quality clinical trials and provide substantial evidence for the development of guidelines.
本系统评价旨在评估使用潜在药物（瑞德西韦、糖皮质激素治疗 COVID-19 患儿和青少年，静脉注射免疫球蛋白（IVIG）治疗 MIS-C）的疗效和安全性。我们从 2019 年 12 月 1 日至 2021 年 8 月 5 日，检索了 7 个数据库、3 个预印本平台、ClinicalTrials.gov 和 Google，以收集瑞德西韦、糖皮质激素和 IVIG 在 COVID-19 或 MIS-C 患儿中的应用证据。本系统评价共纳入 9 项队列研究和 1 项病例系列研究。关于瑞德西韦，单臂队列研究的荟萃分析显示，治疗后 54.7%（95%CI，10.3%至 99.1%）发生不良事件，5.6%（95%CI，1.2%至 10.1%）死亡，27.0%（95%CI，0%至 73.0%）需要体外膜氧合或有创机械通气。至于糖皮质激素，荟萃分析结果显示，与对照组相比，与死亡率相关的固定效应汇总优势比为 2.79（95%CI，0.13 至 60.87），机械通气率为 3.12（95%CI，0.80 至 12.08）。关于 IVIG，纳入的队列研究大多表明，对于症状更严重的 MIS-C 患者，IVIG 联合甲泼尼龙比单独使用 IVIG 能获得更好的临床疗效。
总体而言，目前纳入研究的证据质量低，数量少。建议开展 COVID-19 或 MIS-C 患儿瑞德西韦、糖皮质激素和 IVIG 的高质量随机对照试验，为指南制定提供实质性证据。
• 使用潜在药物（如瑞德西韦、糖皮质激素和静脉注射免疫球蛋白）治疗 COVID-19 患儿和青少年的疗效和安全性尚不清楚。
• 总体而言，目前的证据不能充分证明瑞德西韦、糖皮质激素和 IVIG 治疗 COVID-19 患儿和青少年的有效性和安全性。• 我们呼吁发表高质量的临床试验，并为指南的制定提供实质性证据。
