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中医非药物疗法临床研究年度证据分析(2023年)
林静怡1,2, 孟鸿腾3, 王昱3, 郭芯瑜3, 彭甜甜3, 姜涛1,2, 庞博4,5, 陈波2,3, 屠建锋6
1.天津中医药大学第一附属医院, 天津 300381;2.国家中医针灸临床医学研究中心, 天津 300381;3.天津中医药大学针灸推拿学院, 天津 301617;4.天津中医药大学循证医学中心, 天津 301617;5.国家药品监督管理局中医药循证评价重点实验室, 天津 301617;6.北京中医药大学针灸推拿学院, 北京 100029
摘要:
[目的] 通过对2023年发表于中英文医学期刊的中医非药物疗法随机对照试验(RCT)进行系统性分析和质量评估,对临床研究证据进行阶段性总结,为未来相关研究的开展及证据转化提供参考。[方法] 基于针灸临床证据库(ACU-CED)系统,并补充检索中国知网(CNKI)、万方数据知识服务平台(WANFANG DATA)、维普数据库(VIP)、中国生物医学文献服务系统(SinoMed)、Cochrane Library、PubMed、Embase数据库,全面获取2023年度中医非药物疗法RCT文献,对检索结果进行数据提取及计量学分析。[结果] 共纳入1 718篇文献,其中中文文献1 681篇、英文文献37篇,总样本量13万余例,涉及中英文期刊308种。研究涉及20类疾病系统及症状体征,主要以神经系统、肌肉骨骼系统以及结缔组织疾病为主。干预措施中采用较多的方法为针灸复合疗法、单纯针刺、针刺联合常规治疗等。方法学方面,随机化、盲法等方法学较2022年有所提升,但总体方法学质量仍偏低。[结论] 2023年度中医非药物疗法RCT研究数量与2022年基本持平,研究平均样本量及整体研究质量较2022年有所提升,但在治疗和影响力方面仍需要进一步加强。研究者应重视试验注册与试验过程管理规范,提升临床证据质量及影响力。
关键词:  中医非药物疗法  随机对照试验  临床研究  循证医学
DOI:10.11656/j.issn.1673-9043.2025.01.09
分类号:R244
基金项目:国家中医药多学科交叉创新团队项目(ZYYCXTD-D-202204);国家自然科学基金项目(82405613);天津市教委科研计划项目(2022KJ150)。
Annual evidence analysis of clinical research on traditional Chinese medicine non-pharmacological therapy(2023)
LIN Jingyi1,2, MENG Hongteng3, WANG Yu3, GUO Xinyu3, PENG Tiantian3, JIANG Tao1,2, PANG Bo4,5, CHEN Bo2,3, TU Jianfeng6
1.First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China;2.National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China;3.School of Acupuncture-Moxibustion and Tuina, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;4.Evidence-Based Medicine Center of Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;5.Key Laboratory of Evidence-Based Evaluation of Traditional Chinese Medicine, National Medical Products Administration, Tianjin 301617, China;6.College of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China
Abstract:
[Objective] Through systematic analysis and quality evaluation of randomized controlled trials(RCT) of traditional Chinese medicine(TCM) non-pharmacological therapies published in Chinese and English medical journals in 2023,this study summarizes the clinical research evidence in stages. It provides a reference for future related research and evidence transformation. [Methods] Based on the acupuncture and moxibustion clinical evidence database(ACU-CED) system,and supplemented with CNKI,WANFANG DATD,VIP,SinoMed,Cochrane Library,PubMed and Embase databases,the RCT literature of TCM non-pharmacological therapy in 2023 was comprehensively obtained,and the retrieval results were extracted and quantitatively analyzed. [Results] A total of 1 718 articles were included,including 1 681 Chinese articles and 37 English articles,with a total sample size of over 130 thousand and involving 308 Chinese and English journals. The research involves 20 types of disease systems and symptoms,mainly focusing on neurological diseases,musculoskeletal system diseases,and connective tissue diseases. The intervention measures include acupuncture and moxibustion combined therapy,simple acupuncture,acupuncture combined with conventional treatment,etc. In terms of methodology,methods such as randomization and blinding have improved compared to 2022,but the overall quality of the methodology is still relatively low. [Conclusion] The number of RCT studies on TCM non-pharmacological therapies in 2023 is basically the same as that in 2022,and the average sample size and overall research quality have improved compared to last year. However,further strengthening is still needed in terms of treatment and influence. Researchers need to pay attention to the standardization of trial registration and trial process management to improve clinical evidence quality and influence.
Key words:  traditional Chinese medicine non-pharmacological therapy  randomized controlled trial  clinical research  evidence-based medicine
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