Zhang Yang, Hu Jiepin, Xu Qiong, Zhang Feng, Sun Chunlei, Liu Kailei
Dr. Yang Zhang, Department of Pharmacy, Zhejiang Putuo Hospital, Zhejiang, China. Branch of Sir Run Run Shaw Hospital, Zhejiang Unversity School of Medicine, Zhejiang, China.
Dr. Jiepin Hu, Department of Pharmacy, Zhejiang Putuo Hospital, Zhejiang, China. Branch of Sir Run Run Shaw Hospital, Zhejiang Unversity School of Medicine, Zhejiang, China.
Pak J Med Sci. 2025 May;41(5):1517-1525. doi: 10.12669/pjms.41.5.9545.
Corticosteroids (CSs) are often administered for coronavirus disease 2019 (COVID-19); however, the advantages and disadvantages of CSs remain controversial. Accordingly, we performed a meta-analysis with trial sequential analysis (TSA) to ascertain the efficacy and safety of CSs in treating COVID-19.
From their inception until April 2023, PubMed, Embase, The Cochrane Library, Web of Science, and China Biology Medicine(CBM) were searched to gather randomized controlled trials on the administration of CSs for COVID-19 treatment. Following the literature screening according to the inclusion criteria, data extraction and quality assessment were conducted by two reviewers, and then we conducted a meta-analysis with trial sequential analysis using RevMan 5.4 and TSA v0.9, respectively. This meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, and the study protocol was registered with PROSPERO (CRD42023458633).
A total of 6,077 literatures were obtained through the search, and 14 studies were finally included for quantitative meta-analysis. The meta-analysis revealed that the all-cause mortality in the group treated with CSs and standard treatment was significantly lower than that in the control group that received only standard treatment (RR 0.89, 95% CI: 0.82-0.96, P=0.002), with a statistically significant difference. However, the TSA analysis revealed that the cumulative Z value exceeded the traditional boundary value yet did not surpass the TSA boundary value, indicating a possibility of false positive outcomes in the meta-analysis. The incidence of adverse reactions in the group receiving CSs treatment was higher than that in the control group, but the distinction was not statistically significant (RR 1.02, 95% CI: 0.64-1.63, P=0.93).
CSs appear to be effective and safe in decreasing the overall mortality of patients who suffer from severe COVID-19; however, further assessment is required to determine adverse reactions and improvements in clinical symptoms associated with CS administration.
2019冠状病毒病（COVID-19）治疗中常使用皮质类固醇（CSs）；然而，CSs的利弊仍存在争议。因此，我们进行了一项采用试验序贯分析（TSA）的荟萃分析，以确定CSs治疗COVID-19的疗效和安全性。
从数据库建库至2023年4月，检索了PubMed、Embase、Cochrane图书馆、Web of Science和中国生物医学文献数据库（CBM），以收集关于使用CSs治疗COVID-19的随机对照试验。按照纳入标准进行文献筛选后，由两名评价员进行数据提取和质量评估，然后分别使用RevMan 5.4和TSA v0.9进行试验序贯分析的荟萃分析。本荟萃分析遵循系统评价和荟萃分析的首选报告项目（PRISMA）指南，研究方案已在国际前瞻性注册系统（PROSPERO）注册（注册号：CRD42023458633）。
通过检索共获得6077篇文献，最终纳入14项研究进行定量荟萃分析。荟萃分析显示，接受CSs和标准治疗组的全因死亡率显著低于仅接受标准治疗的对照组（风险比[RR]0.89，95%置信区间[CI]：0.82 - 0.96，P = 0.002），差异具有统计学意义。然而，TSA分析显示，累积Z值超过传统界值但未超过TSA界值，表明荟萃分析可能存在假阳性结果。接受CSs治疗组的不良反应发生率高于对照组，但差异无统计学意义（RR 1.02，95% CI：0.64 - 1.63，P = 0.93）。
CSs似乎能有效且安全地降低重症COVID-19患者的总体死亡率；然而，需要进一步评估以确定与CSs给药相关的不良反应及临床症状改善情况。
