世界中医药2024,Vol.19Issue(7) :927-930.DOI:10.3969/j.issn.1673-7202.2024.07.003

基于儿童孤独症的针灸真实世界研究方法探索

Exploration of Real-world Research Methods for Acupuncture and Moxibustion Based on Childhood Autism

龙政莉 孙铭磷 邓辉 孙睿婕 赵宁侠 刘佳
世界中医药2024,Vol.19Issue(7) :927-930.DOI:10.3969/j.issn.1673-7202.2024.07.003

基于儿童孤独症的针灸真实世界研究方法探索

Exploration of Real-world Research Methods for Acupuncture and Moxibustion Based on Childhood Autism

龙政莉 1孙铭磷 2邓辉 1孙睿婕 1赵宁侠 3刘佳4
扫码查看

作者信息

  • 1. 陕西中医药大学针灸推拿学院,咸阳,712046
  • 2. 中国中医科学院中医临床基础医学研究所,北京,100700
  • 3. 西安中医脑病医院,西安,710032
  • 4. 陕西中医药大学针灸推拿学院,咸阳,712046;中国中医科学院中医临床基础医学研究所,北京,100700
  • 折叠

摘要

真实世界研究(RWS)是一种基于对真实临床医疗数据进行收集、处理、分析并从多角度解读的研究,因其研究结果具有内在有效性和外部可推性的特点,越来越受到针灸学界的重视.通过分析RWS与儿童孤独症谱系障碍(ASD)针灸临床研究的相适性,认为RWS在儿童ASD研究中价值医疗显著,提出了儿童ASD针灸真实世界研究可能存在的问题:1)缺乏高质量针灸临床研究证据;2)没有形成临床评价体系;3)临床研究成果转化脱节.针对存在的问题,探讨了儿童ASD针灸RWS方法相应的解决办法:1)实施场景、研究时间、样本量应根据真实数据来确定;2)因纳入排除标准较为宽泛,受试者具有广泛代表性,无需对其依从性进行密切监视;3)根据患儿病情及家长意愿进行非随机干预,随访周期可较长,以利于观察患儿的个体化治疗情况;4)数据分析应从基线可比性、主要结局指标、亚组分析等方面对RWS结果进行合理的解读;5)在伦理学方面,慎重选择知情同意方式,严格审查风险受益、隐私保护,将更好地保护儿童ASD受试者.同时对真实医疗环境中儿童ASD针灸RWS进行了展望.

Abstract

Real-world study(RWS)is a study that collects,processes,analyzes,and interprets real clinical medical data from mul-tiple perspectives.Because its results have inherent validity and external generalizability,it is increasingly valued in the field of ac-upuncture and moxibustion.By analyzing the suitability of RWS for acupuncture and moxibustion clinical research on Autism Spec-trum Disorder(ASD)in children,it is believed that RWS holds significant value in medical research on children with ASD.Howev-er,several potential problems in conducting RWS on acupuncture and moxibustion for children with ASD were identified:1)Lack of high-quality acupuncture and moxibustion clinical research evidence;2)Absence of a clinical evaluation system;3)Disconnect between clinical research outcomes and translation.In response to these problems,potential solutions for conducting RWS on acu-puncture and moxibustion for children with ASD were discussed:l)Research scenarios,study duration,and sample size should be determined based on real data;2)Due to broad inclusion and exclusion criteria,subjects had broad representativeness,and close monitoring of compliance was unnecessary;3)Non-randomized interventions should be conducted based on the child's condition and parental preferences,with longer follow-up periods to observe individualized treatment outcomes;4)RWS results should be an-alyzed reasonably from aspects such as baseline comparability,primary outcome indicators,and subgroup analysis;5)Ethically,in-formed consent methods should be selected cautiously,risk-benefit considerations and privacy protection should be rigorously re-viewed to better safeguard child ASD participants.Additionally,the future prospects of conducting RWS on acupuncture and moxi-bustion for children with ASD in real medical environments were outlined.

关键词

针灸/真实世界研究/儿童孤独症/研究方法/成果转化/疗效评价/效应优势/综述

Key words

Acupuncture and moxibustion/Real-world study/Childhood autism/Research methods/Achievement transformation/Efficacy evaluation/Effect advantage/Review

引用本文复制引用

基金项目

国家重点研发计划(2019YFC1712200)

国际针灸临床研究服务标准研制课题(2019YFC1712205)

中国中医科学院创新工程课题(CI2021A00702-02)

中国中医科学院结余经费再立项项目(2023014-212090)

出版年

2024
世界中医药
世界中医药学会联合会

世界中医药

CSTPCDCHSSCD北大核心
影响因子:1.266
ISSN:1673-7202
段落导航相关论文