Division for Healthcare Technology Assessment Research, National Evidence-based Healthcare Collaborating Agency, Seoul, Republic of Korea.
Division of Infectious Diseases, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Emerg Microbes Infect. 2022 Dec;11(1):1154-1165. doi: 10.1080/22221751.2022.2059405.
This study investigated the efficacy and safety of interleukin-6 (IL-6) receptor antagonists with standard care treatment in patients with coronavirus disease 2019 (COVID-19). The randomized controlled trials were identified through systematic searches of electronic databases through February 10, 2022. In total, 17 trials comprising 8,614 patients were included. Compared with exclusive standard care or placebo, IL-6 receptor antagonists with standard of care treatment were associated with a significantly reduced all-cause mortality at 28 days (pooled risk ratios [RR], 0.88; 95% confidence interval (CI), 0.82-0.95; 17 studies) and progression to invasive mechanical ventilation (RR, 0.79; 95% CI, 0.71-0.88; nine studies). Particularly, the subgroup of patients with moderate-to-severe COVID-19 showed a significant mortality benefit (RR, 0.89; 95% CI, 0.81-0.96; four studies) and a reduced risk for mechanical ventilation (RR, 0.80; 95% CI, 0.70-0.91; three studies) with tocilizumab treatment. The frequency of serious adverse events was lower in the tocilizumab treatment group than in the standard of care treatment group (RR, 0.83; 95% CI, 0.71-0.97; 11 studies), with no significant difference in the sarilumab treatment group (RR, 1.12; 95% CI, 0.89-1.40; four studies). Our meta-analysis demonstrated that tocilizumab treatment showed promising results in reducing 28-day mortality and progression to mechanical ventilation in patients with moderate-to-severe COVID-19, without the burden of serious adverse events. Clinical Trials Registry India identifier: CTRI/2020/05/025369.The proper registration is PROSPERO: registration number CRD42021294120.
这项研究调查了白细胞介素 6(IL-6)受体拮抗剂联合标准治疗在 2019 年冠状病毒病(COVID-19)患者中的疗效和安全性。通过系统检索电子数据库,我们于 2022 年 2 月 10 日确定了随机对照试验。共有 17 项试验,包括 8614 名患者。与单独的标准治疗或安慰剂相比,IL-6 受体拮抗剂联合标准治疗在 28 天内全因死亡率显著降低(汇总风险比 [RR],0.88;95%置信区间 [CI],0.82-0.95;17 项研究),进展为有创机械通气的风险降低(RR,0.79;95%CI,0.71-0.88;9 项研究)。特别是,亚组中中度至重度 COVID-19 患者的死亡率有显著获益(RR,0.89;95%CI,0.81-0.96;4 项研究),机械通气的风险降低(RR,0.80;95%CI,0.70-0.91;3 项研究)。托珠单抗治疗组的严重不良事件发生率低于标准治疗组(RR,0.83;95%CI,0.71-0.97;11 项研究),而在沙利鲁单抗治疗组则无显著差异(RR,1.12;95%CI,0.89-1.40;4 项研究)。我们的荟萃分析表明,托珠单抗治疗在降低中度至重度 COVID-19 患者 28 天死亡率和进展为机械通气方面显示出良好的效果,且无严重不良事件的负担。印度临床试验注册中心标识符:CTRI/2020/05/025369。恰当的注册是 PROSPERO:注册号 CRD42021294120。