基于 SYRCLE 风险评价工具及实验研究报告规范评价电针干预脊髓损伤后神经源性膀胱动物实验报告质量
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1.江西中医药大学研究生院,南昌 330006;2.江西中医药大学附属医院,南昌 330006

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R-33

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Evaluation of the quality of animal experiment report electroacupuncture intervention for neurogenic bladder after spinal cord injury based on SYRCLE risk assessment tool and experimental research report specification
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1.Graduate School of Jiangxi University of TCM, Nanchang 330006, China. 2. Affiliated Hospital of Jiangxi University of TCM, Nanchang 330006

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    摘要:

    目的 通过 SYRCLE 动物实验风险评估工具、ARRIVE 2019 指南和 GSPC 清单评价电针干预脊髓损伤后神经源性膀胱的动物实验的报告质量,寻找提高电针干预脊髓损伤后神经源性膀胱动物实验报告质量的方法。 方法 计算机检索 CNKI、WANFANG、VIP、SinoMed、PubMed、Web of science 和 Cochrane library 等数据库, 寻找电针干预治疗神经源性膀胱的动物实验,按照 SYRCLE 动物实验风险评估工具、ARRIVE 2019 指南和 GSPC 清单的各个条目提取数据,通过 Excel 2019 进行统计分析,STATA 软件进行系统评价分析。 结果 最终纳入了 26 项研究,SYRCLE 动物实验风险评估工具中所有研究的总评分普遍偏低,均在 10 ~ 14 分,偏倚风险偏高,仅有 18 项研究使用了“随机数字表法” ,有 21 项研究在实验过程中有动物数量的缺失但均未采取措施或描述对实验结果的影响。 ARRIVE 2019 指南中必备条目的低风险率为 43. 14%,而推荐条目的低风险率仅有 23. 56%,GSPC 清单的低风险率为 20. 45%。 主要情况有 21 项研究报道了剔除动物,大多是因死亡、其他并发症或者造模失败; 18 项研究采用随机数字表法,8 项研究仅提及随机而未指明方法;8 项研究详细描述了动物品种、年龄、性别和重量等;2 项研究既提供了动物许可证号又表明通过伦理审查;3 项研究描述了实验过程中为减少疼痛和折磨而采取的措施;6 项研究讨论了研究的局限性。 9 项研究讲述了当前 SCI 后 NGB 的研究进展并提供相关参考文献,指出当前治疗中存在的不足并确立明确的研究目标;2 项研究对实验工作人员描述了具体结局指标及测量方法; 26 项研究均对主要发现进行了讨论并对结果带给临床意义和整个科学的意义进行阐述。对研究结果进行系统 评价发现电针较模型组可以提高膀胱最大容量和膀胱顺应性,降低膀胱漏尿点压力。 结论 当前公开发表的有关电针干预脊髓损伤后神经源性膀胱的动物实验报告质量普遍偏低,对多个条目的描述不完整,导致读者无法客观、准确得评估该动物实验可能产生的偏倚风险的高低,甚至会影响读者对动物研究是否可以进一步向临床研究的转化的判断。建议采取针对性的措施进一步推广和使用 SYRCLE 动物实验偏倚风险评价工具及实验研究报告规范(ARRIVE2019 指南和 GSPC 清单) ,能够进一步改进动物实验的设计、实施和报告,提高动物实验研究的可重复性和实验结果的再现性。

    Abstract:

    Objective To use the SYRCLE animal experiment risk assessment tool, ARRIVE 2019 guidelines and GSPC checklist to evaluate the report quality of animal experiments of electroacupuncture in the neurogenic bladder after spinal cord injury and determine method to improve the quality of animal experiment reports. Methods CNKI, WANFANG, VIP, SinoMed, PubMed, Web of science and Cochrane library databases were searched to find animal experiments of electroacupuncture in the neurogenic bladder in accordance with the SYRCLE animal experiment risk assessment tool, ARRIVE 2019 guidelines and GSPC list. These data were extracted from each database and statistical analysis was performed using Excel 2019. Stata software was used for systematic evaluation and analysis. Results Twenty- six studies were finally included. The total scores of all studies in the SYRCLE animal experiment risk assessment tool were generally low, which ranged from 10 to 14 points and the risk of bias was high. Only 18 studies used the “random number table method ”. No studies used blinded method in animal allocation or result measurement. There were 21 studies in which the number of animals was missing during the experiment, but none of them took measures or described the effect on experimental result. The low-risk rate of essential items in the ARRIVE 2019 guideline is 43. 14%, while the low-risk rate of recommended items is only 23. 56% and the low-risk rate of the GSPC list is 20. 45%. There were 21 studies that reported animal exclusion mostly due to death, other complications, or model failure. Eighteen studies used the random number table method and eight studies only mentioned randomness without specifying the method. Eight studies described the animal species, age, sex and weight in detail. Two studies both provided animal license numbers and indicated that they had passed ethical review. Three studies described measures to reduce pain and suffering during the experiments. Six studies discussed the limitations of the research. Nine studies described the current research progress of NGB after SCI and provided relevant references, indicated the deficiencies in current treatments and established clear research goals. Two studies blindly described specific outcome indicators and measurement method to experimental staff. The 26 studies discussed the main findings and explained the clinical significance of the result and the significance of the entire science. Systematic evaluation of the study result showed that electroacupuncture improved the maximum bladder volume and bladder compliance and reduced the bladder leakage point pressure compared with the model group. Conclusions The current publicly published animal studies on electroacupuncture of the neurogenic bladder after spinal cord injury are generally of low quality and descriptions of multiple items are incomplete, which prevents readers from Objectively and accurately assessing the level of risk of bias that the animal experiment may produce and even affects the reader’ s understanding of animal research. Judgments can be further translated into clinical research. It is recommended to take targeted measures to further promote and use SYRCLE animal experiment bias risk assessment tools and experimental research report specifications (ARRIVE 2019 guidelines and GSPC list),which can further improve the design, implementation, and reporting of animal experiments and improve the reproducibility of animal experimental research and result.

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王瑞奇,黄春华,吴清忠,刘浪辉,官磊瑶,徐 添.基于 SYRCLE 风险评价工具及实验研究报告规范评价电针干预脊髓损伤后神经源性膀胱动物实验报告质量[J].中国比较医学杂志,2021,31(11):76~87.

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  • 收稿日期:2020-12-03
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  • 在线发布日期: 2021-12-17
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自2024年1期开始,杂志参考文献改为中英文对照,具体格式要求可置下载中心查看!
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