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干细胞疗法的安全性与有效性:已发表的荟萃分析及证据图谱概述方案

Safety and efficacy of stem cell therapy: an overview protocol on published meta-analyses and evidence mapping.

作者信息

Chen Jiahui, Wang Haibo, Lu Xiaojing, Yang Kehu, Lu Cuncun

机构信息

First Clinical Medical College, The First Hospital of Lanzhou University, Lanzhou, China.

Institute of Integrated Chinese and Western Medicine, Gansu University of Chinese Medicine, Lanzhou, China.

出版信息

Ann Transl Med. 2021 Feb;9(3):270. doi: 10.21037/atm-20-6892.

DOI:10.21037/atm-20-6892
PMID:33708897
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7940926/
Abstract

BACKGROUND

Stem cell therapy (SCT) is an emerging and promising treatment measure for many conditions (e.g., chronic liver disease, diabetes mellitus, and knee osteoarthritis). Although there are numerous meta-analyses (MAs) concerning SCT, the quality of these MAs and the efficacy and safety data for SCT reported in these MAs remain unknown. Therefore, it is of utmost importance to conduct an overview of existing MAs concerning SCT for evaluating these parameters.

METHODS

We will systematically search PubMed and EMBASE databases from inception to October 2020 for identifying MAs of SCT published in English. Two independent reviewers will select appropriate MAs against the predefined eligibility criteria. The efficacy and safety data of SCT reported in MAs will be descriptively summarized. Following this, the reporting quality and methodological quality of included MAs will be appraised using Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) and A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR-2) tools by two reviewers, respectively. Further, the evidence mapping method will be used to present assessment results. The key information will also be extracted by two independent reviewers. The Spearman's correlation coefficient will be used to explore the association between reporting quality and methodological quality. The factors influencing the quality will be assessed through linear regression analyses. The sensitivity analysis will also be conducted. Data analyses will be performed using Stata 16.0 and Excel 2016. P<0.05 will be considered statistically significant.

DISCUSSION

This overview of MAs concerning SCTs will provide comprehensive evidence on the quality of MAs and data of interest reported in MAs. Further, these data can be used to guide clinical practice and future research.

OVERVIEW REGISTRATION

International Prospective Register of Systematic Reviews (PROSPERO): CRD42020206642.

摘要

背景

干细胞疗法(SCT)是针对多种病症(如慢性肝病、糖尿病和膝关节骨关节炎)的一种新兴且有前景的治疗措施。尽管有大量关于SCT的荟萃分析(MA),但这些MA的质量以及这些MA中报道的SCT的疗效和安全性数据仍不明确。因此,对现有的关于SCT的MA进行概述以评估这些参数至关重要。

方法

我们将系统检索PubMed和EMBASE数据库,从建库至2020年10月,以识别用英文发表的SCT的MA。两名独立的评审员将根据预先确定的纳入标准选择合适的MA。将对MA中报道的SCT的疗效和安全性数据进行描述性总结。在此之后,分别由两名评审员使用系统评价和荟萃分析的首选报告项目(PRISMA)和评估系统评价的测量工具2(AMSTAR - 2)工具对纳入的MA的报告质量和方法学质量进行评估。此外,将使用证据映射方法呈现评估结果。关键信息也将由两名独立的评审员提取。将使用Spearman相关系数探索报告质量与方法学质量之间的关联。将通过线性回归分析评估影响质量的因素。还将进行敏感性分析。使用Stata 16.0和Excel 2016进行数据分析。P<0.05将被视为具有统计学意义。

讨论

关于SCT的MA的这一概述将提供关于MA的质量以及MA中报道的相关数据的全面证据。此外,这些数据可用于指导临床实践和未来研究。

概述注册

国际系统评价前瞻性注册库(PROSPERO):CRD42020206642。

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本文引用的文献

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