针刺治疗化疗所致周围神经病变随机对照试验结局指标及测量工具现状分析OA
Analysis of Outcome Measures and Tools in Randomized Controlled Trials on Acupuncture for Chemotherapy-Induced Peripheral Neuropathy
目的:通过分析针刺治疗化疗所致周围神经病变(CIPN)的随机对照试验(RCT),以及相关的结局指标和测量工具报告情况,为未来临床试验的设计和核心结局指标的建立提供参考依据.方法:全面检索 2013年12月1日—2024年1月1日中国知网数据库(CNKI)、万方数据知识服务平台(Wanfang)、维普中文科技期刊数据库(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Embase、Web of Science中收录的关于针刺治疗CIPN的随机对照试验(RCT)类文献.由2名研究人员对文献进行筛选,提取文献特征,随后对针刺治疗化疗所致CIPN的RCT中涉及的结局指标、测量工具、测量时点进行分析归纳.结果:共纳入33篇文献,样本量2 025例,共使用70个结局指标;将70个结局指标分类为临床疗效指标、临床症状指标、中医病症指标、神经学研究指标、其他检查指标、生化指标、生活质量及满意度指标、安全性指标8类.结论:针刺治疗化疗所致周围神经病变RCT文献结局指标的选用存在结局指标报告名称不规范、结局指标主次不明、结局指标引用无明确来源、结局指标测量时点表述不清、中医特色呈现不足等问题.未来的研究中应结合中医药辨证特色,明确指标引用来源,开展研究前选定合理的测量时间点,采用科学而严谨的结局指标来评价针刺治疗CIPN的临床疗效,以推动构建规范、统一的中医药治疗CIPN的核心指标集.
Objective:To analyze randomized controlled trials(RCTs)on acupuncture for chemotherapy-induced peripheral neuropathy(CIPN),focusing on reported outcome measures and tools,to provide references for future clinical trial designs and the establishment of core outcome sets.Methods:A comprehensive search was conducted from December 1,2013,to January 1,2024,across CNKI,Wanfang Data,VIP,SinoMed,PubMed,Embase,and Web of Science for RCTs on acupuncture for CIPN.Two researchers independently screened the literature,extracted study characteristics,and analyzed outcome measures,measurement tools,and time points reported in RCTs.Results:A total of 33 studies involving 2,025 participants were included,with 70 outcome measures identified.These were categorized into eight domains:clinical efficacy indicators,clinical symptom indicators,traditional Chinese medicine(TCM)syndrome indicators,neurological research indicators,other examination indicators,biochemical indicators,quality of life and satisfaction indicators,and safety indicators.Conclusion:There are issues in the selection and reporting of outcome measures in RCTs of acupuncture for CIPN,including inconsistent naming of outcomes,unclear prioritization,lack of source citation,ambiguous timing of measurements,and insufficient representation of TCM characteristics.Future research should incorporate TCM diagnostic features,clearly cite sources for outcome measures,determine appropriate measurement time points before study initiation,and adopt scientifically rigorous outcome measures to evaluate the clinical efficacy of acupuncture for CIPN.This will help establish a standardized and unified core outcome set for TCM-based treatments of CIPN.
于丽嘉;邓云;傅海扬
南京中医药大学附属医院,江苏 南京 210029南京中医药大学附属医院,江苏 南京 210029南京中医药大学附属医院,江苏 南京 210029
针刺化疗周围神经病变随机对照试验核心结局指标
AcupunctureChemotherapyPeripheral neuropathyRandomized controlled trialCore outcome measures
《中医药信息》 2025 (2)
21-29,9
江苏省中医药科技发展计划面上项目(MS2023027)江苏省中医院院内项目(Y2020CX22)
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