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甘草酸制剂治疗抗 SARS-CoV-2 药物性肝损伤的临床疗效及安全性的系统评价和 Meta 分析方案。

Clinical efficacy and security of glycyrrhizic acid preparation in the treatment of anti-SARS-CoV-2 drug-induced liver injury: a protocol of systematic review and meta-analysis.

机构信息

Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, People's Republic of China.

College of Clinical Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu, People's Republic of China.

出版信息

BMJ Open. 2021 Jul 9;11(7):e051484. doi: 10.1136/bmjopen-2021-051484.

Abstract

INTRODUCTION

COVID-19 is a highly infectious acute pneumonia. Glycyrrhizic acid preparation (GAP) has been found to have hepatoprotective and antiviral effects, but there is no supporting evidence on its efficacy and security for patients with COVID-19.

METHODS AND ANALYSIS

The systematic review methods will be defined by Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. This study will start on 1 July 2021 and end on 31 October 2021. A comprehensive electronic search will be conducted with the search of Web of Science, PubMed, Ovid web, China National Knowledge Infrastructure, Chinese Scientific and Journal Database, Wanfang Database and grey literature, and manual search will be conducted to search literature of randomised controlled trials, single-arm trials and retrospective studies about GAP in the treatment of anti-SARS-CoV-2 drug-induced liver injury from 1 December 2019 to 1 July 2021. There is no time limitations of publication and language will be restricted to Chinese and English. Retrieved studies will be independently screened by two researchers and relevant data will be extracted from studies. Interstudy heterogeneity will be assessed using the I statistic and explored through meta-regressions and subgroup analyses. Depending on data availability, we plan to conduct subgroup analyses by study population, geographical region and other selected clinical variables of interest. Quality assessment of the studies will be performed. Cochrane Handbook for Systematic Reviews of Interventions will be used to assess the risk of bias, and Grading of Recommendations Assessment, Development and Evaluation will be used to access the confidence in cumulative evidence.

ETHICS AND DISSEMINATION

Ethical approval will not be required for no primary data of individual patients will be collected. The final report will be shared with the scientific community through publication in a peer-reviewed journal, as well as with key stakeholders, including patients, healthcare professionals and those working on COVID-19 research.

PROSPERO REGISTRATION NUMBER

CRD42021234647.

摘要

简介

COVID-19 是一种高度传染性的急性肺炎。已发现甘草酸制剂(GAP)具有保肝和抗病毒作用,但尚无其对 COVID-19 患者疗效和安全性的支持证据。

方法和分析

本系统评价将按照系统评价和荟萃分析的首选报告项目(PRISMA)指南定义方法。本研究将于 2021 年 7 月 1 日开始,2021 年 10 月 31 日结束。将全面检索 Web of Science、PubMed、Ovid 网络、中国国家知识基础设施、中国科学与期刊数据库、万方数据库和灰色文献,并通过手动检索,检索 2019 年 12 月 1 日至 2021 年 7 月 1 日期间关于 GAP 治疗抗 SARS-CoV-2 药物性肝损伤的随机对照试验、单臂试验和回顾性研究的文献。本研究没有出版时间限制,语言限制为中文和英文。由两名研究人员独立筛选检索到的研究,并从研究中提取相关数据。采用 I ² 统计量评估研究间异质性,并通过荟萃回归和亚组分析进行探索。根据数据的可用性,我们计划按研究人群、地理区域和其他选定的临床相关变量进行亚组分析。将对研究进行质量评估。将使用 Cochrane 干预措施系统评价手册评估偏倚风险,并使用推荐评估、制定与评价分级法评估累积证据的可信度。

伦理和传播

由于不会收集单个患者的原始数据,因此不需要进行伦理审查。最终报告将通过在同行评议期刊上发表以及与关键利益相关者(包括患者、医疗保健专业人员和从事 COVID-19 研究的人员)共享,在科学界传播。

PROSPERO 注册号:CRD42021234647。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/551e/8275357/682edfe53a77/bmjopen-2021-051484f01.jpg

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