动物实验研究报告(Animal Research: Reporting of In Vivo Experiments, ARRIVE)指南——概述

发布于 2023年8月3日 星期四 19:48:34 浏览:683
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动物实验是重要的生物医学研究类型,常用于新药研发、疾病研究、教研教学等领域,在生命科学和现代医学中发挥着重要作用。动物实验研究报告不完整或不细致很可能限制读者了解研究的真实性和实用性,影响研究结果向临床的转化。动物实验研究报告(Animal Research: Reporting of In Vivo Experiments, ARRIVE)指南是目前广泛使用的动物实验报告规范之一,本文概述其背景、条目清单和使用注意事项。

关键词:动物实验; 动物研究; 动物实验报告规范; 体内实验报告; ARRIVE指南

一、动物实验研究报告指南背景

动物实验是指用动物模型进行实验,并对所施加因素的反应、表现及发生的变化进行监测,从而获取生物学、医学科学数据的研究方法。动物实验是重要的生物医学研究类型,也是医学研究常用方法之一,在生命科学和现代医学中发挥着重要作用。动物实验设计的合理性及其报告的规范性直接影响其成果向临床研究的进一步转化。

2009年,英国国际实验动物3Rs中心(National Centre for the Replacement, Refinement and Reduction of Animals in Research, NC3Rs)调查评估了271篇动物实验报告的质量,发现很多动物实验报告信息不完整,缺乏对实验设计、实施和分析等一些重要信息的报告。为了提高动物实验报告质量、促进动物研究规范化和透明化、确保动物实验资料被充分评估和利用、避免实验动物不必要的浪费,NC3Rs于2009年6月通过会议讨论形成了基于CONSORT声明的动物实验研究报告(Animal Research: Reporting of In Vivo Experiments, ARRIVE)指南清单,并于2010年正式发表,即ARRIVE 2010版。该指南包括题目、摘要、前言、方法、结果和讨论6部分,共20个条目39个亚条目。2019年工作组对ARRIVE 2010版进行了修订,发布了ARRIVE 2.0版。ARRIVE 2.0版共涉及21个条目和39个亚条目。ARRIVE 2.0版根据德尔菲法确定各条目的优先顺序,并根据条目的重要性将其分成ARRIVE Essential 10 (10个关键条目)和Recommended Set (11个推荐条目)两个部分。每个部分的条目根据文章的逻辑顺序进行排序,并非重要性的先后顺序。

二、ARRIVE 2.0版条目清单的中英文对照

表1 ARRIVE 2.0版10个关键条目的中英文对照

内容条目序号条目内容
Study design
研究设计
1For each experiment, provide brief details of study design including: a. The groups being compared, including control groups. If no control group has been used, the rationale should be stated. b. The experimental unit (e.g., a single animal, litter, or cage of animals).
对于每个实验,提供简要的研究设计细节,包括: a. 比较的组别,含对照组。如果没有对照组,应说明理由 b. 实验单元(如:以只、窝或笼为单元)
Sample size
样本量
2a. Specify the exact number of experimental units allocated to each group, and the total number in each experiment. Also indicate the total number of animals used. b. Explain how the sample size was decided. Provide details of any a priori sample size calculation, if done.
a. 详细说明分配给每个组别的确切实验单元数量,以及每次实验的实验单元总数。同时说明整个实验使用的动物总数 b. 解释样本量是如何确定的。如通过计算所得,需提供计算的细节
Inclusion and exclusion Criteria
纳入和排除标准
3a. Describe any criteria used for including and excluding animals (or experimental units) during the experiment, and data points during the analysis. Specify if these criteria were established a priori. If no criteria were set, state this explicitly. b. For each experimental group, report any animals, experimental units, or data points not included in the analysis and explain why. If there were no exclusions, state so. c. For each analysis, report the exact value of n in each experimental group.
a. 描述实验期间动物(或实验单元)的纳入排除标准,以及分析过程中数据点的纳入排除标准。详细说明这些标准是否为预先设定。如未设定相关标准,应明确声明 b. 对于每个实验组,报告分析中排除的任何动物、实验单元或数据点,并说明原因。如果没有排除的情况,也请说明 c. 对于每次分析,报告每个实验组中被纳入分析的动物、实验单元或数据点的确切数量(n)
Randomisation
随机化
4a. State whether randomisation was used to allocate experimental units to control and treatment groups. If done, provide the method used to generate the randomisation sequence. b. Describe the strategy used to minimise potential confounders such as the order of treatments and measurements, or animal/cage location. If confounders were not controlled, state this explicitly.
a. 说明是否通过随机化方法将实验单元分配给对照组和实验组。如采取了机化分配,需提供产生随机化序列的方法 b. 描述控制潜在混杂因素的策略,如处理和测量的顺序,或者动物/笼具的位置等。如果没有控制混杂因素,应明确声明
Blinding
盲法
5Describe who was aware of the group allocation at the different stages of the experiment (during the allocation, the conduct of the experiment, the outcome assessment, and the data analysis).
描述谁会在实验的不同阶段(动物分配、实验实施、结果评估、数据分析)知晓分组情况
Outcome measures
结果测量(结局变量)
6a. Clearly define all outcome measures assessed (e.g., cell death, molecular markers, or behavioural changes). b. For hypothesis-testing studies, specify the primary outcome measure, i.e., the outcome measure that was used to determine the sample size.
a. 明确定义所有结果测量指标(如细胞死亡、分子标志物或行为改变) b. 对于检验假说的研究,明确主要的结果测量指标,即用于确定样本量的指标
Statistical methods
统计方法
7a. Provide details of the statistical methods used for each analysis, including software used. b. Describe any methods used to assess whether the data met the assumptions of the statistical approach, and what was done if the assumptions were not met.
a. 报告每次数据分析的统计方法的细节,包括所用软件 b. 描述用于评估数据是否能满足统计假设的任何方法,以及当无法满足统计假设时所做的方法变更
Experimental animals
实验动物
8a. Provide species-appropriate details of the animals used, including species, strain and substrain, sex, age or developmental stage, and, if relevant, weight. b. Provide further relevant information on the provenance of animals, health/immune status, genetic modification status, genotype, and any previous procedures.
a. 提供所用动物的详细资料,包括种属、品系和亚品系、性别、年龄或发育阶段,以及体重(如有的话) b. 提供有关动物的更多信息,如动物来源、健康/免疫状况、基因修饰状况、基因型和先前做的处理等
Experimental procedures
实验步骤
9For each experimental group, including controls, describe the procedures in enough detail to allow others to replicate them, including: a. What was done, how it was done, and what was used. b. When and how often. c. Where (including detail of any acclimatisation periods). d. Why (provide rationale for procedures).
对于每个实验组,详细描述实验步骤,以便实验能够被重复,包括: a. 做了什么,怎么做的,用什么做的 b. 什么时候,实验频率 c. 实验场所(包括适应期的任何细节) d. 为什么这么做(提供实验步骤的基本原理)
Results
结果
10For each experiment conducted, including independent replications, report: a. Summary/descriptive statistics for each experimental group, with a measure of variability where applicable (e.g., mean and SD, or median and range). b. If applicable, the effect size with a confidence interval.
对于所进行的每个实验,包括重复实验,需报告: a. 对每个实验组的数据进行总结/描述性统计,如有可能,报告变异程度指标(如,均数和标准差,中位数和四分位数间距或全距) b. 如有可能,报告含置信区间的效应量

2  ARRIVE 2.011个推荐条目的中英文对照

内容条目序号条目内容
Abstract
摘要
11Provide an accurate summary of the research objectives, animal species, strain and sex, key methods, principal findings, and study conclusions.
准确总结研究目的、动物种属、品系和性别、关键方法、主要结果和研究结论
Background
背景
12a. Include sufficient scientific background to understand the rationale and context for the study, and explain the experimental approach. b. Explain how the animal species and model used address the scientific objectives and, where appropriate, the relevance to human biology.
a. 包括充分的科学背景,以了解研究的基本原理和背景,并解释实验方法 b. 说明使用的动物种属和模型的选择依据,即如何解决研究目的,以及该研究与人体生物学的相关性
Objectives
目的
13Clearly describe the research question, research objectives and, where appropriate, specific hypotheses being tested.
清楚地描述研究问题、研究目标或将被验证的具体研究假设
Ethical statement
伦理声明
14Provide the name of the ethical review committee or equivalent that has approved the use of animals in this study, and any relevant licence or protocol numbers (if applicable). If ethical approval was not sought or granted, provide a justification.
提供批准使用动物的伦理审查委员会或同等机构的名称,以及任何相关的许可证或协议编号。如果没有申请或通过伦理审批,需说明理由
Housing and husbandry
饲养场所和饲养
15Provide details of housing and husbandry conditions, including any environmental enrichment.
提供包括环境条件在内的饲养场所和条件的详细信息
Animal care and monitoring
动物护理和监测
16a. Describe any interventions or steps taken in the experimental protocols to reduce pain, suffering, and distress. b. Report any expected or unexpected adverse events. c. Describe the humane endpoints established for the study, the signs that were monitored, and the frequency of monitoring. If the study did not have humane endpoints, state this.
a. 描述实验方案中为减少动物疼痛和折磨而采取的措施 b. 报告任何预期或意外的不良事件 c. 描述为研究建立的人道终点和监测的频率,如果没有人道终点,需说明理由
Interpretation/scientific Implications
诠释/科学内涵
17a. Interpret the results, taking into account the study objectives and hypotheses, current theory, and other relevant studies in the literature. b. Comment on the study limitations, including potential sources of bias, limitations of the animal model, and imprecision associated with the results.
a. 综合考虑研究目的、研究假设以及文献报道的解释原理和其他相关研究对结果进行解释 b. 讨论研究的局限性,包括潜在的偏倚来源,动物模型的局限性及与结果相关的不精确性
Generalisability/translation
推广性/转换
18Comment on whether, and how, the findings of this study are likely to generalise to other species or experimental conditions, including any relevance to human biology (where appropriate).
讨论本研究结果如何用到其他物种,或在其他实验条件下开展,包括与人体生物学的相关性
Protocol registration
方案注册
19Provide a statement indicating whether a protocol (including the research question, key design features, and analysis plan) was prepared before the study, and if and where this protocol was registered.
声明在研究开展之前是否制定研究方案(包括研究问题、关键设计特征和分析计划),方案是否注册以及注册的信息
Data access
数据共享
20Provide a statement describing if and where study data are  available.
说明研究数据是否可获得,以及在何处可获得
Declaration of interests
利益声明
21a. Declare any potential conflicts of interest, including financial and nonfinancial. If none exist, this should be stated. b. List all funding sources (including grant identifier) and the role of the funder(s) in the design, analysis, and reporting of the study.
a. 报告潜在的利益冲突,包括资金和非资金方面的利益冲突。如果不存在,也要予以说明 b. 列出所有资金来源(包括基金编号)以及资助者在研究设计、分析和报告中的作用

三、ARRIVE 2.0版使用注意事项

ARRIVE2.0版在提供动物实验如何规范报告的同时,也可作为动物实验设计、实施和研究报告的审稿参考清单。ARRIVE 2.0版中,每个部分并无重要性的先后顺序,使用者根据研究所需对各条目按逻辑排序。ARRIVE 2.0版中的“10个关键条目”构成了动物实验研究报告的最低要求,“11个推荐条目”则为所述研究提供了更多的背景内容。诚然,研究报告最好能同时包含这两部分条目的全部信息,但应先关注关键问题,推动作者、编辑以及审稿人切实使用该指南。

注:本文内容是参考相关文献后对ARRIVE2.0版报告规范原文的概述,仅代表本网站观点。关于ARRIVE指南的更多内容详见网站(https://www.equator-network.org/)或Nathalie Percie du Sert等发表的论文“The ARRIVE guidelines 2.0: Updated guidelines for reporting animal research (https://pubmed.ncbi.nlm.nih.gov/32663219/)”、Nathalie Percie du Sert等发表的论文“Reporting animal research: Explanation and elaboration for the ARRIVE guidelines 2.0(https://pubmed.ncbi.nlm.nih.gov/32663221/)”。

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