Current Status and Optimization Strategies for Investigator Initiated Trial on Traditional Chinese Medicine in the Treatment of Malignant Tumors Conducted by Western Medicine Institutions

GENG Xuechen; LIU Yanmei; BU qianqian; ZHANG Qinchang; ZHANG Dong; TAO Yuquan; LI Liu; LI Ling; CHENG Haibo

doi:10.13288/j.11-2166/r.2025.09.002

您当前的位置：

首页 >

文章列表页 >

Current Status and Optimization Strategies for Investigator Initiated Trial on Traditional Chinese Medicine in the Treatment of Malignant Tumors Conducted by Western Medicine Institutions

更新时间：2025-04-30

- Current Status and Optimization Strategies for Investigator Initiated Trial on Traditional Chinese Medicine in the Treatment of Malignant Tumors Conducted by Western Medicine Institutions
- Journal of Traditional Chinese Medicine Vol. 66, Issue 9, Pages: 878-882(2025)
- 作者机构：
  
  1.南京中医药大学第一临床医学院，江苏省南京市栖霞区仙林大道138号，210023
  2.江苏省中医药防治肿瘤协同创新中心
  3.南京中医药大学附属医院
  4.四川大学华西医院中国循证医学中心
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2025.09.002
  CLC：
- Received：31 October 2024，
  
  Revised：2025-02-10，
  
  Published：02 May 2025
- 稿件说明：
移动端阅览
耿雪尘,刘艳梅,卜岍岍等.西医医疗机构开展研究者发起的中医药治疗恶性肿瘤临床研究现状分析及优化实施策略探讨[J].中医杂志,2025,66(09):878-882.

GENG Xuechen,LIU Yanmei,BU qianqian,et al.Current Status and Optimization Strategies for Investigator Initiated Trial on Traditional Chinese Medicine in the Treatment of Malignant Tumors Conducted by Western Medicine Institutions[J].Journal of Traditional Chinese Medicine,2025,66(09):878-882.
耿雪尘,刘艳梅,卜岍岍等.西医医疗机构开展研究者发起的中医药治疗恶性肿瘤临床研究现状分析及优化实施策略探讨[J].中医杂志,2025,66(09):878-882. DOI： 10.13288/j.11-2166/r.2025.09.002.

GENG Xuechen,LIU Yanmei,BU qianqian,et al.Current Status and Optimization Strategies for Investigator Initiated Trial on Traditional Chinese Medicine in the Treatment of Malignant Tumors Conducted by Western Medicine Institutions[J].Journal of Traditional Chinese Medicine,2025,66(09):878-882. DOI： 10.13288/j.11-2166/r.2025.09.002.

摘要

研究者发起的临床研究（IIT）是中医药临床研究的主要形式。作为中医药治疗恶性肿瘤IIT的重要实施地点，西医医疗机构在临床开展中医药临床研究的过程中常存在特殊难点，制约了研究的可行性、规范性。通过梳理西医医疗机构开展中医药治疗恶性肿瘤IIT的注册现状，分析西医医疗机构开展这类研究的难点问题，包括研究立项、过程管理模式相对繁琐，西医医师中医药知识、技能欠缺，患者中医药认可度相对不足。从研究具体实施层面提出优化策略，包括完善西医医疗机构中医药IIT审查、管理模式；建立中西医多学科临床研究团队，中医科协同参与临床研究；加强西医医疗机构研究者方案相关中医药理论、技能培训；实现IIT操作流程标准化、四诊信息采集客观化；优化受试者招募形式，增加患者随访管理中医药参与力度。探索研究者视角下有中医药特点、可操作性强的IIT优化实施策略，以推动中医药治疗恶性肿瘤IIT在西医医疗机构的高质量开展，促进中医药在临床中的推广应用。

Abstract

Investigator initiated trial （IIT） represents a primary format for clinical research in traditional Chinese medicine （TCM）. As key implementation sites for TCM-based IIT targeting malignant tumors， western medicine institutions often face unique challenges in conducting such studies， which limit their feasibility and standardization. This paper reviews the registration status of TCM-based IIT for malignancies conducted in western medical institutions and analyzes key difficulties， including complex project initiation and management processes， limited TCM knowledge and skills among western medicine physicians， and relatively low patient acceptance of TCM. From a practical perspective， the study proposes several optimization strategies. These include improving the review and management mechanisms of TCM-related IIT within western medical institutions， establishing multidisciplinary clinical research teams that integrate TCM and western medicine， and enhancing investigators' training in TCM theory and clinical skills. Additionally， the study suggests standardizing IIT operational procedures， objectifying the collection of TCM diagnostic information， refining subject recruitment methods， and increasing TCM involvement in patient follow-up and management. These investigator-oriented， TCM-featured， and operable strategies aim to promote the high-quality development of TCM-based IIT in western medicine institutions and enhance the clinical application of TCM.

关键词

Keywords

references

陶立元，冯玉婷，商洪才 . 近20年中医药临床研究创新发展［J］. 科技导报， 2022 ， 40 （ 23 ）： 24 - 29 .

国家卫生健康委，国家中医药局，国家疾控局 . 关于印发医疗卫生机构开展研究者发起的临床研究管理办法的通知［EB/OL］. （ 2024-09-18 ）［ 2024-09-26 ］. https：// www.gov.cn/zhengce/zhengceku/202409/content_6976872. htm https://www.gov.cn/zhengce/zhengceku/202409/content_6976872.htm .

GENG X ， WANG Z ， FENG L ， et al . Efficacy and safety of Xian-Lian-Jie-Du optimization decoction as an adjuvant treatment for prevention of recurrence in patients with stage IIIB/IIIC colon cancer： study protocol for a multicentre， randomized controlled trial ［J］. BMC Complement Med Ther ， 2023 ， 23 （ 1 ）： 239 .

NI M ， ZHANG Y ， SUN Z ， et al . Efficacy and safety of Shenbai Granules for recurrent colorectal adenoma： a multicenter randomized controlled trial ［J］. Phytomedicine ， 2024 ， 127 ： 155496 . doi： 10.1016/j.phymed.2024. 155496 http://dx.doi.org/10.1016/j.phymed.2024.155496 .

卢芝岑，杨逢柱，罗桂波 . 中医药临床研究伦理审查问题探究［J］. 中国卫生法制， 2022 ， 30 （ 4 ）： 38 - 43 .

吴新宇，沈燕菊，杨庆有，等 . 新时代中医药临床研究伦理审查工作的守正创新：无锡市中医医院伦理审查体系建设实践［J］. 中国医学伦理学， 2023 ， 36 （ 10 ）： 1138 - 1142 .

韦传姑，蔡颖，陈大宾，等 . 临床研究中受试者脱落的影响因素分析［J］. 中国卫生统计， 2021 ， 38 （ 5 ）： 752 - 754 .

叶美香 . 公众对西医院中医药文化建设认知情况的调查［J］. 中医药管理杂志， 2023 ， 31 （ 3 ）： 47 - 49 .

戴婕，吴紫姗，俞婷，等 . 口服抗肿瘤药物临床试验受试者用药依从性的影响因素研究［J］. 中国药物评价， 2023 ， 40 （ 6 ）： 517 - 520 .

王晶 . 中医药临床研究伦理审查的实践与思考［J］. 中国医学伦理学， 2021 ， 34 （ 6 ）： 716 - 719 .

王晶 . 研究者发起的中医药临床研究伦理审查要点［J］. 中国医学伦理学， 2025 ， 38 （ 1 ）： 52 - 57 .

戴国华，张伯礼，郭治昕，等 . 多中心临床试验的研究者培训［J］. 中国新药杂志， 2007 ， 16 （ 11 ）： 825 - 828 .

林宏远，蒋寅，张心怡，等 . 中医临床辅助诊疗平台的研究现状及应用前景分析［J］. 中华中医药杂志， 2024 ， 39 （ 6 ）： 2711 - 2714 .

文玲子，杨宇飞，许云，等 . 基于临床试验的受试者招募过程分析及建议［J］. 中医杂志， 2020 ， 61 （ 21 ）： 1888 - 1893 .

查看原文

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Pathogenesis and Prevention Strategies of Hypercoagulable State in Malignant Tumors Based on the Theory of "Sweet-Flavored Medicinals Retaining and Restoring Body Fluid"

Pathogenesis，Differentiation and Treatment of Pre-Metastatic Niche in Malignant Tumors Based on the Theory of "Toxin Accumulation Damaging Yin"

Analysis of the Distribution of Traditional Chinese Medicine Syndrome Elements and Influencing Factors in Patients with Immune-Related Adverse Events from Malignant Tumors： A Retrospective Study Based on Propensity Score Matching

Discuss the Preventive and Treatment for Immune-Related Adverse Events of Malignant Tumors Based on Simultaneous Treatment of Qi and Fire

Clinical Characteristics and Use of Traditional Chinese Medicine Therapy in 222 Malignant Tumor Cases with COVID-19： A Retrospective Study

Related Author

LIU Zhaidong

QIN Ruyu

SHI Yunxuan

SUN Yuwei

KONG Weiyang

CHENG Zixuan

WANG Yong

XU Ling

Related Institution

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

First Clinical Medical College，Shandong University of Traditional Chinese Medicine

Fudan University Shanghai Cancer Center

Pulmonary Oncology Clinical Medicine Center，Shanghai Chest Hospital，Shanghai Jiao Tong University School of Medicine

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine，Shanghai University of Traditional Chinese Medicine

Address：No.16, Nanxiao street, Dongzhimen, Dongcheng District, Beijing Postal code：100700
Tel：010-64035632 Email：jtcmcn@188.com
Technical support is provided by Beijing Founder electronics co., LTD 京ICP备09064830号-19 京公网安备11010102007558号
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰