Expert consensus on human use experience research of traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20220601.501
- Author:
Zhong-Qi YANG
1
;
Rui GAO
2
;
Si-Yuan HU
3
;
Wei-An YUAN
4
;
Lei ZHANG
5
;
Jian-Yuan TANG
6
;
Chong ZOU
7
;
Bo LI
8
;
Xiao-Hui LI
9
;
Ya-Qin TANG
1
;
Lu LU
1
;
Shi-Hao NI
1
Author Information
1. the First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou 510405, China.
2. Xiyuan Hospital, China Academy of Chinese Medical Sciences Beijing 100091, China.
3. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300193, China.
4. Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Shanghai 200021, China.
5. Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
6. Hospital of Chengdu University of Traditional Chinese Medicine Chengdu 610032, China.
7. Jiangsu Province Hospital of Traditional Chinese Medicine Nanjing 210029, China.
8. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University/Beijing Institute of Chinese Medicine/Beijing Evidence-based Chinese Medicine Center Beijing 100010, China.
9. Xiamen Hospital of Traditional Chinese Medicine Xiamen 361001, China.
- Publication Type:Journal Article
- Keywords:
expert consensus;
human use experience(HUE);
new drug of traditional Chinese medicine
- MeSH:
Consensus;
Drug Prescriptions;
Drugs, Chinese Herbal/therapeutic use*;
Humans;
Medicine, Chinese Traditional;
Reproducibility of Results
- From:
China Journal of Chinese Materia Medica
2022;47(18):4829-4834
- CountryChina
- Language:Chinese
-
Abstract:
Human use experience(HUE) is important for the research and development of Chinese medicine. For the sake of more reliable data, the Professional Committee for Clinical Evaluation of Chinese Medicine of Chinese Pharmaceutical Association drafted the Expert Consensus on Human Use Experience Research of Traditional Chinese Medicine. It highlights that the research on HUE should have clear purposes, describe the theoretical basis of traditional Chinese medicine(TCM) for the clinical indications and prescriptions and the clinical value of prescriptions, especially the advantages or characteristics in clinical orientation and target population, evaluate the dosages and number of medicinals of prescriptions, verify the accordance with the preparation process of new Chinese medicine, analyze feasibility of the process for large-scale production and the rationality of the dosage form, and assess the medicinal material resources. Moreover, such research should have reasonable protocol and the collection of clinical data on HUE must comply with medical ethics and avoid conflicts of interest. The collection method should be selected depending on the characteristics of clinical data. Quality control measures should be formulated to ensure the authenticity, accuracy, completeness, reliability, and traceability of clinical data. The definitions on the clinical data should be uniform and clear, and methods should be adopted to avoid bias. The data can be statistically analyzed after the processing. Through the study of HUE, the clinical orientation, target population, commonly used dosage, course of treatment, preliminary efficacy and safety of Chinese medicine prescriptions will be clarified. On this basis, the data on the HUE should be discussed and conclusions will be drawn. Finally, a standardized report will be formed.
