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[中药治疗神经根型颈椎病动物实验研究的质量评价]

[Quality assessment of animal experimental studies on traditional Chinese medicine treatment of cervical radiculopathy].

作者信息

Feng Tian-Xiao, Wang Xu, Bu Han-Mei, Qin Xiao-Kuan, Sun Chuan-Rui, Zhu Li-Guo, Wei Xu

机构信息

Graduate School, Beijing University of Chinese Medicine Beijing 100029, China Wangjing Hospital, China Academy of Chinese Medical Sciences Beijing 100102, China.

Wangjing Hospital, China Academy of Chinese Medical Sciences Beijing 100102, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2024 Nov;49(21):5686-5694. doi: 10.19540/j.cnki.cjcmm.20240620.402.

Abstract

This study aims to assess the methodological and reporting quality of animal experimental studies on the treatment of cervical radiculopathy(CR) with traditional Chinese medicine(TCM), analyze the deficiencies during the experimental process, and develop the methods to enhance the quality of such studies. The related articles were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science. The methodological quality and reporting quality of the included studies were evaluated according to the risk of bias tool of the Systematic Review Centre for Laboratory Animal Experimentation(SYRCLE) and the Animal Research: Reporting of in vivo Experiments(ARRIVE) 2.0 guidelines, respectively. A total of 4 086 articles were initially screened, in which 71 articles met the inclusion criteria. The SYRCLE's risk of bias tool revealed selection bias, performance bias, detection bias, and attrition bias of the included studies. The aspects for improvement were identified in the randomization of animal grouping, experimental implementation and outcome assessment, blinding, reporting baseline characteristics, and handling incomplete data. The essential item assessment of the ARRIVE 2.0 guidelines showed high risks in sample size determination, inclusion and exclusion criteria, randomization, blinding, outcome assessment, statistical methods, experimental procedures, and results reporting. Additionally, there were high risks in items recommended by ARRIVE 2.0 guidelines, including study background, ethical statements, animal care, interpretation/scientific implications, generalizability/translation, experimental protocol registration, data availability, and conflict of interest declaration. The existing animal experimental studies about the TCM treatment of CR exhibited methodological and reporting deficiencies. We recommend that researchers refer to the SYRCLE's risk of bias tool and the ARRIVE 2.0 guidelines to rigorously design, implement, and report experiments in a standardized manner, thereby enhancing the scientific, authentic, and reproducible properties of the experiments.

摘要

本研究旨在评估中医药治疗神经根型颈椎病(CR)动物实验研究的方法学和报告质量,分析实验过程中的不足之处,并提出提高此类研究质量的方法。相关文章从中国知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase、Cochrane图书馆和Web of Science中检索。分别根据实验动物系统评价中心(SYRCLE)的偏倚风险工具和《动物研究:体内实验报告规范》(ARRIVE)2.0指南评估纳入研究的方法学质量和报告质量。初步筛选出4086篇文章,其中71篇符合纳入标准。SYRCLE的偏倚风险工具揭示了纳入研究存在选择偏倚、实施偏倚、检测偏倚和失访偏倚。在动物分组随机化、实验实施与结果评估、盲法、报告基线特征以及处理不完整数据等方面确定了改进方向。ARRIVE 2.0指南的基本项目评估显示,在样本量确定、纳入和排除标准、随机化、盲法、结果评估、统计方法、实验程序和结果报告等方面存在高风险。此外,ARRIVE 2.0指南推荐的项目,包括研究背景、伦理声明、动物护理、解释/科学意义、可推广性/转化、实验方案注册、数据可用性和利益冲突声明等方面也存在高风险。现有的关于中医药治疗CR的动物实验研究存在方法学和报告方面的不足。我们建议研究人员参考SYRCLE的偏倚风险工具和ARRIVE 2.0指南,严格规范地设计、实施和报告实验,从而提高实验的科学性、真实性和可重复性。

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