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| 真实世界研究方法在针灸临床研究中的应用进展 |
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李俊龙1,2, 李桂平1,2,3, 李礼1,2,3, 沈燕1,2,3, 杨沙1,2,3, 王婧4, 徐志杰1,2, 徐帆1, 路梦楠1,2, 王晓梅1,2, 张洁瑛1,2, 王舒5,6
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1.天津中医药大学第一附属医院, 天津 300381;2.中医国家临床医学研究中心, 天津 300381;3.天津市针灸学重点实验室, 天津 300381;4.天津中医药大学第二附属医院, 天津 300250;5.天津市中医药研究院附属医院, 天津 300120;6.国家中医药管理局脑病针刺疗法重点研究室, 天津 300381
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| 摘要: |
| 文章探讨真实世界研究(RWS)在针灸领域的应用现状及其对临床疗效评估的意义。检索中国期刊全文数据库(CNKI)、万方数据知识服务平台(Wanfang)、维普中文期刊全文数据库(VIP)、PubMed、EMbase、Web of Science等中英文数据库自2020年1月—2024年12月发表的针灸领域RWS文献,基于RECORD清单及STaRT-RWE工具框架,从研究设计、数据来源、统计方法及临床应用等方面进行总结分析。最终,检索并筛选出57篇针灸相关RWS文献,研究领域涉及神经系统疾病、心血管疾病、疼痛管理及围手术期护理等领域,结果显示针灸疗法在真实临床环境下具有显著疗效与良好安全性。RWS通过多源数据整合和多因素分析方法提高了研究的外部效度与实践价值。RWS为针灸疗效评估提供了更加贴近于临床实践的新路径,未来可以结合人工智能与大数据技术,进一步推动针灸疗法的规范化与国际化发展。 |
| 关键词: 针灸临床研究 真实世界研究 队列研究 疗效评估 安全性 |
| DOI:10.11656/j.issn.1673-9043.2026.01.14 |
| 分类号:R245 |
| 基金项目:天津市科技计划项目(18PTLCSY00040,20ZYJDSY00020);国家中医针灸临床医学研究中心开放课题项目(NCRCOP2023002);长江学者和创新团队发展计划项目(IRT1167)。 |
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| Application progress of real-world study methodology in acupuncture clinical research |
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LI Junlong1,2, LI Guiping1,2,3, LI Li1,2,3, SHEN Yan1,2,3, YANG Sha1,2,3, WANG Jing4, XU Zhijie1,2, XU Fan1, LU Mengnan1,2, WANG Xiaomei1,2, ZHANG Jieying1,2, WANG Shu5,6
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1.First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China;2.National Clinical Research Center for Chinese Medicine, Tianjin 300381, China;3.Tianjin Key Laboratory of Acupuncture and Moxibustion, Tianjin 300381, China;4.Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300250, China;5.Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin 300120, China;6.Key Laboratory of Acupuncture Therapy for Encephalopathy, National Administration of Traditional Chinese Medicine, Tianjin 300381, China
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| Abstract: |
| The article discusses the application status of real-world study(RWS) in the field of acupuncture and its significance for clinical efficacy evaluation. Chinese and English databases,including CNKI,Wanfang,VIP,PubMed,EMbase,and Web of Science,were searched for RWS literature in acupuncture published from January 2020 to December 2024. Based on the RECORD checklist and the STaRT-RWE tool framework,a summary analysis was conducted from the perspectives of study design,data sources,statistical methods,and clinical applications. Finally,57 RWS articles related to acupuncture were retrieved and screened. The research areas involved neurological diseases,cardiovascular diseases,pain management,perioperative care,and others. The results show that acupuncture therapy has significant efficacy and good safety in real-world clinical settings. RWS enhances the external validity and practical value of research through the integration of multi-source data and multi-factor analysis methods. RWS provides a new pathway for evaluating acupuncture efficacy that is closer to clinical practice. In the future,combining artificial intelligence and big data technologies can further promote the standardization and international development of acupuncture therapy. |
| Key words: acupuncture clinical research real-world study cohort study efficacy evaluation safety |
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