Analysis on registration schemes for domestic clinical studies combining TCM with targeted drug therapy for lung cancer treatment
10.3760/cma.j.cn115398-20240806-00052
- VernacularTitle:中医药联合靶向药治疗肺癌的国内临床研究注册方案分析
- Author:
Jingyi ZENG
1
;
Bo LIN
;
Tiancheng ZHAO
;
Juying JIAO
;
Hegen LI
;
Weijie XU
Author Information
1. 上海中医药大学附属龙华医院2022级硕士研究生，上海 200032
- Keywords:
Clinical protocols;
TCM;
Lung cancer;
Clinical research;
Molecular targeted therapy
- From:
International Journal of Traditional Chinese Medicine
2025;47(1):108-113
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To systematically review the current registered clinical study schemes in China regarding the combination of TCM and targeted drug therapy for lung cancer; To analyze their strengths and weaknesses; To provide reference for future study.Methods:Chinese Clinical Trial Registry for clinical study schemes combining TCM with targeted drug therapy for lung cancer treatment was retrieved from the inception to July 10, 2024. The general characteristics, study types, intervention measures, and outcome indicators of existing schemes were systematically summarized and analyzed.Results:A total of 15 studies were included, with the earliest study registered in 2013. Registration locations were concentrated in Shanghai, Guangdong, Tianjin, and Zhejiang. Among them, 9 studies received funding from local, national finance, or hospitals; 13 studies passed ethical review, and 12 included informed consent. The design schemes included 10 randomized controlled studies, 1 cohort study, 1 interventional single-arm study, and 3 observational studies. 6 studies had a sample size smaller than 100 cases, and most were single-center trials. Intervention measures primarily involved the combination of Chinese patent medicine or TCM with targeted drugs, with evaluation indicators mainly focusing on clinical symptoms and laboratory indicators. The setting of outcome indicators lacked a unified standard.Conclusions:Since 2013, clinical studies combining TCM with targeted drug therapy for lung cancer have been relatively methodologically sound but face challenges such as small sample sizes and a certain degree of regional concentration, leading to relatively insufficient representativeness. The future direction for improvement lies in multi-center, large-sample, and well-designed clinical trials. It is also necessary to establish a standardized and normalized system for evaluating outcomes. Integrating basic research to clarify the mechanisms of TCM can provide a theoretical basis for the combination of TCM and targeted drugs, which is conducive to enhancing the rigor and scientific nature of clinical trial design and promoting the formation of high-level evidence-based medicine.
