Current Status and Reflections on Key Technologies and Methods for Clinical Research Design and Evaluation of Traditional Chinese Medicine in Spleen and Stomach Diseases

LU Fang; WANG Ping; BIAN Liqun; LYU Lin; XIAO Mengli; ZHANG Tai; TANG Xudong

doi:10.13288/j.11-2166/r.2026.05.007

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Current Status and Reflections on Key Technologies and Methods for Clinical Research Design and Evaluation of Traditional Chinese Medicine in Spleen and Stomach Diseases

更新时间：2026-05-19

- Current Status and Reflections on Key Technologies and Methods for Clinical Research Design and Evaluation of Traditional Chinese Medicine in Spleen and Stomach Diseases
- Journal of Traditional Chinese Medicine Vol. 67, Issue 5, Pages: 498-503(2026)
- 作者机构：
  
  1.中国中医科学院西苑医院中药临床研究与评价重点实验室，北京市海淀区西苑操场1号，100091
  2.中国中医科学院西苑医院脾胃病研究所
  3.广州中医药大学第一附属医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2026.05.007
  CLC：
- Received：20 June 2025，
  
  Revised：2026-01-20，
  
  Published：02 March 2026
- 稿件说明：
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陆芳,王萍,卞立群等.中医脾胃病临床研究设计及评价关键技术的研究现状与思考[J].中医杂志,2026,67(05):498-503.

LU Fang,WANG Ping,BIAN Liqun,et al.Current Status and Reflections on Key Technologies and Methods for Clinical Research Design and Evaluation of Traditional Chinese Medicine in Spleen and Stomach Diseases[J].Journal of Traditional Chinese Medicine,2026,67(05):498-503.
陆芳,王萍,卞立群等.中医脾胃病临床研究设计及评价关键技术的研究现状与思考[J].中医杂志,2026,67(05):498-503. DOI： 10.13288/j.11-2166/r.2026.05.007.

LU Fang,WANG Ping,BIAN Liqun,et al.Current Status and Reflections on Key Technologies and Methods for Clinical Research Design and Evaluation of Traditional Chinese Medicine in Spleen and Stomach Diseases[J].Journal of Traditional Chinese Medicine,2026,67(05):498-503. DOI： 10.13288/j.11-2166/r.2026.05.007.

摘要

临床试验是药物研发的关键环节，由于中药的多靶点作用机制以及中医辨证论治的诊疗特点，全面反映中医药特性、符合中医药特点的临床研究评价技术与方法仍需完善和创新。从临床研究设计、评价技术与平台建设三个方面系统梳理中医药治疗脾胃病临床研究设计及评价的关键技术与方法，对比国内外研究现状，提出未来应当整合现代医学与中医理论的多维度评价体系，进一步创新中药疗效评价研究设计及方法，借助新一代信息技术融合的智能设备和技术促进临床数据转化为高质量的循证证据，并加快构建中医药临床数据标准化与共享平台，为今后中医药治疗脾胃病临床研究设计、实施与评价提供思路。

Abstract

Clinical trials represent a pivotal stage in the development of pharmaceutical drugs. Nevertheless， given the unique characteristics of traditional Chinese medicine （TCM） and the diagnostic and treatment principle of syndrome differentiation and treatment in TCM， the clinical evaluation techniques and methods that can comprehensively reflect the characteristics of TCM and are tailored to its specificities are still in need of refinement and innovation. This paper systematically summarizes the key techniques and methods for designing and evaluating the clinical research on the treatment of the spleen and stomach diseases with TCM from three aspects including clinical research design， evaluation， and platform construction， compares domestic and international research landscapes， and proposes for future directions. It is suggested that a multidimensional evaluation system integrating modern medicine and TCM theory should be established， and further innovation is needed in TCM research design and methodologies， leveraging intelligent devices and technologies powered by next-generation information technology to transform clinical data into high-quality TCM evidence. Moreover， standardized and shared platforms for TCM clinical data should be accelerated， so as to provide references for the design， implementation， and evaluation of future clinical research on the treatment of the spleen and stomach diseases with TCM.

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references

XIAO Y ， LI Y ， SHU J ， et al . The efficacy of oral Zhizhu Kuanzhong， a traditional Chinese medicine， in patients with postprandial distress syndrome ［J］. J Gastroenterol Hepatol ， 2019 ， 34 （ 3 ）： 526 - 531 .

WEN YD ， LU F ， ZHAO YP ， et al . Epigastric pain syndrome： what can traditional Chinese medicine do？ A randomized controlled trial of Biling Weitong Granules ［J］. World J Gastroenterol ， 2020 ， 26 （ 28 ）： 4170 - 4181 .

XIAO M ， ZHONG LLD ， LAM WC ， et al . Zhizhu Kuanzhong Capsule in treating patients with functional dyspepsia postprandial distress syndrome： study protocol for a multicenter， randomized， double-blind， placebo-controlled， parallel-group clinical trial ［J］. Trials ， 2022 ， 23 （ 1 ）： 454 .

US Food and Drug Administration . Advancing the use of complex innovative designs in clinical trials： from pilot to practice ［EB/OL］.（ 2024-03-05 ）［ 2025-10-20 ］. https：//www.fda.gov/news-events/advancing-use-complex-innovative-designs-clinical-trials-pilot-practice-03052024 https://www.fda.gov/news-events/advancing-use-complex-innovative-designs-clinical-trials-pilot-practice-03052024 .

邝嘉炜 . 基于真实世界研究方法对胃食管反流病辨证论治的疗效观察［D］. 广州：广州中医药大学， 2019 .

白云峰 . 健脾通络解毒法治疗慢性萎缩性胃炎传承应用真实世界研究［D］. 北京：中国中医科学院， 2023 .

贾福运 . 四磨汤加减治疗便秘型肠易激综合征（肝郁气滞型）的临床疗效观察［D］. 天津：天津中医药大学， 2022 .

杨倩 . 辛开苦降法治疗功能性消化不良重叠腹泻型肠易激综合征的临床疗效观察［D］. 南京：南京中医药大学， 2022 .

唐旭东，王萍，刘保延，等 . 基于慢性胃肠疾病患者报告临床结局测量量表的编制及信度、效度分析［J］. 中医杂志， 2009 ， 50 （ 1 ）： 27 - 29 .

刘凤斌，余纯梓，陈卓群，等 . 胃食管反流病PRO量表的研制和条目筛选［J］. 中国中西医结合消化杂志， 2019 ， 27 （ 2 ）： 92 - 96 .

刘凤斌，梁炳君，陈卓群，等 . 肠易激综合征PRO量表的计量心理学考核［J］. 广州中医药大学学报， 2019 ， 36 （ 5 ）： 607 - 610 .

居凌云，叶小峰，李保良，等 . 百合乌药泻心汤合小六金健胃方对脾胃湿热证慢性萎缩性胃炎癌前病变患者的临床疗效［J］. 中成药， 2025 ， 47 （ 2 ）： 673 - 677 .

郭英辉 . 胃点墨活检法［J］. 日本医学介绍， 1992 （ 3 ）： 132 - 133 .

LUIGIANO C ， FERRARA F ， MORACE C ， et al . Endoscopic tattooing of gastrointestinal and pancreatic lesions ［J］. Adv Ther ， 2012 ， 29 （ 10 ）： 864 - 873 .

石永强，赵向阳，王小平 . 定标活检评价黄连素联合胃复春治疗慢性萎缩性胃炎癌前病变的疗效［J］. 吉林医学， 2016 ， 37 （ 8 ）： 2013 - 2134 .

陈宇基，文安怡 . 以定标活检技术评价胃痞方合黄芪针穴注治疗慢性萎缩性胃炎脾胃虚弱证的疗效［J］. 广州中医药大学学报， 2016 ， 33 （ 3 ）： 317 - 320 .

张泽丹，王斌，陈婷，等 . 我国中医药临床数据存储与共享存在的问题及建议［J］. 中国中医药图书情报杂志， 2023 ， 47 （ 4 ）： 1 - 5 .

张泽丹，王斌，陈婷，等 . 基于区块链的中医消化领域临床科研一体化数据共享平台的研究与设计［J］. 中华中医药学刊， 2024 ， 42 （ 6 ）： 29 - 33，265 .

王斌，庄荟瑛，满志陶，等 . 人工智能赋能中医药脾胃病可信联合循证分析平台构建策略［J］. 中医杂志， 2026 ， 67 （ 1 ）： 95 - 102 .

林媚，唐旭东，王凤云，等 . 肠安Ⅰ号及其低浓度原药安慰剂对腹泻型IBS大鼠血清TNF-α、IL-10的影响［J］. 上海中医药杂志， 2012 ， 46 （ 5 ）： 82 - 84 .

唐旭东，卞立群，高蕊，等 . 中药临床试验安慰剂制作探讨［J］. 中国中西医结合杂志， 2009 ， 29 （ 7 ）： 656 - 658 .

中华中医药学会 . 《中药临床研究质量管理系列标准》发布公告［EB/OL］. （ 2017-11-29 ）［ 2025-06-13 ］. https： //mp.weixin.qq.com/s/YggUqL6xbg0-umcz52Ykfg https://mp.weixin.qq.com/s/YggUqL6xbg0-umcz52Ykfg .

中华中医药学会 . 关于《慢性心力衰竭中医诊疗指南》等3项拟发布团体标准公示的通知［EB/OL］. （ 2022-10-25 ）［ 2025-06-13 ］. https：//www.cacm.org.cn/2022/ 10/25/20251/ https://www.cacm.org.cn/2022/10/25/20251/ .

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