中医药信息2025,Vol.42Issue(2):21-29,9.DOI:10.19656/j.cnki.1002-2406.20250204
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
Analysis of Outcome Measures and Tools in Randomized Controlled Trials on Acupuncture for Chemotherapy-Induced Peripheral Neuropathy
摘要
Abstract
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.关键词
针刺/化疗/周围神经病变/随机对照试验/核心结局指标Key words
Acupuncture/Chemotherapy/Peripheral neuropathy/Randomized controlled trial/Core outcome measures引用本文复制引用
于丽嘉,邓云,傅海扬..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[J].中医药信息,2025,42(2):21-29,9.基金项目
江苏省中医药科技发展计划面上项目(MS2023027) (MS2023027)
江苏省中医院院内项目(Y2020CX22) (Y2020CX22)