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恢复期血浆可能是治疗 COVID-19 的一种方法:系统评价。

Convalescent plasma may be a possible treatment for COVID-19: A systematic review.

机构信息

Department of Pharmacy, China-Japan Union Hospital of Jilin University, Jilin University, Changchun 130033, Jilin, China.

Department of Inter Care Medicine, China-Japan Union Hospital of Jilin University, Jilin University, Changchun 130033, Jilin, China.

出版信息

Int Immunopharmacol. 2021 Feb;91:107262. doi: 10.1016/j.intimp.2020.107262. Epub 2020 Dec 5.

Abstract

INTRODUCTION

The coronavirus disease 2019 (COVID-19) pandemic has spread globally. Therapeutic options including antivirals, anti-inflammatory compounds, and vaccines are still under study. Convalescent plasma(CP) immunotherapy was an effective method for fighting against similar viral infections such as SARS-CoV, and MERS-CoV. In the epidemic of COVID-19, a large number of literatures reported the application of CP. However, there is controversy over the efficacy of CP therapy for COVID-19. This systematic review was designed to evaluate the existing evidence and experience related to CP immunotherapy for COVID-19.

METHODS

A literature search was conducted on Pubmed, Cochrane Library, Clinical Key, Wanfang Database; China National Knowledge Infrastructure(CNKI) were used to search for the proper keywords such as SARS-CoV-2, COVID-19, plasma, serum, immunoglobulins, blood transfusion, convalescent, novel coronavirus, immune and the related words for publications published until 15.10.2020. Other available resources were also used to identify relevant articles. The present systematic review was performed based on PRISMA protocol. Data extraction and risk of bias assessments were performed by two reviewers.

RESULTS

Based on the inclusions and exclusions criteria, 45 articles were included in the final review. First, meta-analysis results of RCTs showed that, there were no statistically significant differences between CP transfusion and the control group in terms of reducing mortality(OR 0.79, 95% CI 0.52-1.19, I = 28%) and improving clinical symptoms(OR 1.21, 95%CI 0.68-2.16; I = 0%). The results of controlled NRSIs showed that CP therapy may reduce mortality in COVID-19 patients(RR 0.59, 95% CI 0.53-0.66, I = 0%). Second, limited safety data suggested that CP is a well-tolerated therapy with a low incidence of adverse events. But, due to lack of safety data for the control group, it is really not easy to determine whether CP transfusion has an impact on moderate to serious AEs. Thirdly, for children, pregnant, elderly, tumor and immunocompromised patients, CP may be a well-tolerated therapy, if the disease cannot be controlled and continues to progress. Studies were commonly of low or very low quality.

CONCLUSIONS

Although the results of limited RCTs showed that CP cannot significantly reduce mortality, some non-RCTs and case report(series) have found that CP may help patients improve clinical symptoms, clear the virus, and reduce mortality, especially for patients with COVID-19 within ten days of illness. We speculate that CP may be a possible treatment option. High-quality studies are needed for establishing stronger quality of evidence and pharmacists should also be actively involved in the CP treatment process and provide close pharmaceutical care.

摘要

简介

2019 年冠状病毒病(COVID-19)大流行已在全球范围内蔓延。抗病毒药物、抗炎化合物和疫苗等治疗选择仍在研究中。恢复期血浆(CP)免疫疗法是对抗 SARS-CoV 和 MERS-CoV 等类似病毒感染的有效方法。在 COVID-19 疫情中,大量文献报道了 CP 的应用。然而,CP 治疗 COVID-19 的疗效存在争议。本系统评价旨在评估与 CP 免疫疗法治疗 COVID-19 相关的现有证据和经验。

方法

通过 Pubmed、Cochrane Library、Clinical Key、万方数据库进行文献检索;使用中国知网(CNKI)等合适的关键词,如 SARS-CoV-2、COVID-19、血浆、血清、免疫球蛋白、输血、恢复期、新型冠状病毒、免疫等,检索截至 2020 年 10 月 15 日的相关出版物。还使用其他可用资源来确定相关文章。本系统评价是基于 PRISMA 方案进行的。由两名评审员进行数据提取和偏倚风险评估。

结果

根据纳入和排除标准,最终有 45 篇文章纳入综述。首先,RCT 的荟萃分析结果表明,CP 输注与对照组在降低死亡率(OR 0.79,95%CI 0.52-1.19,I²=28%)和改善临床症状(OR 1.21,95%CI 0.68-2.16;I²=0%)方面无统计学差异。对照非随机研究的结果表明,CP 治疗可能降低 COVID-19 患者的死亡率(RR 0.59,95%CI 0.53-0.66,I²=0%)。其次,有限的安全性数据表明 CP 是一种耐受良好的治疗方法,不良事件发生率低。但是,由于对照组缺乏安全性数据,真的不容易确定 CP 输注是否会对中重度 AE 产生影响。第三,对于儿童、孕妇、老年人、肿瘤和免疫功能低下患者,如果疾病无法控制并持续进展,CP 可能是一种耐受良好的治疗方法。研究通常质量较低或极低。

结论

尽管有限的 RCT 结果表明 CP 不能显著降低死亡率,但一些非 RCT 和病例报告(系列)发现 CP 可能有助于患者改善临床症状、清除病毒并降低死亡率,尤其是 COVID-19 发病后 10 天内的患者。我们推测 CP 可能是一种可能的治疗选择。需要高质量的研究来建立更强的证据质量,药剂师也应积极参与 CP 治疗过程并提供密切的药学护理。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab6e/7833727/e253ceb74596/gr1_lrg.jpg

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