Data collection, quality and evidence formation for human use experience of traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20210122.501
- Author:
Zhong-Qi YANG
1
;
Ya-Qin TANG
1
;
Hui-Min TANG
1
;
Yan-Ping DU
1
;
Bo LI
2
;
Jian-Yuan TANG
3
;
Chong ZOU
4
;
Wei-An YUAN
5
;
Lei ZHANG
6
;
Hong DING
3
;
Yan-Ling ZHAO
7
Author Information
1. the First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou 510407, China.
2. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Institute of Traditional Chinese Medicine Beijing 100010,China.
3. Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Chengdu 610075, China.
4. Jiangsu Province Hospital of Chinese Medicine Nanjing 210029, China.
5. Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
6. Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
7. the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine Changsha 410007, China.
- Publication Type:Journal Article
- Keywords:
data;
data collection;
evidence;
human use experience(HUE)
- MeSH:
Data Collection;
Drugs, Chinese Herbal;
Humans;
Medicine, Chinese Traditional;
Prescriptions;
Quality Control
- From:
China Journal of Chinese Materia Medica
2021;46(7):1681-1685
- CountryChina
- Language:Chinese
-
Abstract:
Collecting and summarizing human use experience(HUE) data, forming high-quality data and evidences that can be used for evaluation are the key links of HUE research on traditional Chinese medicine(TCM). The collection, collation and summary of human experience data were discussed in this paper. It is pointed out that the collection of HUE should be focus on the source of prescription of new traditional Chinese medicines, and be summarized based on dialectical thinking, experience in medication, characte-ristics of prescription and clinical application. The collected contents include prescription, process, clinical location and applicable population, efficacy data and safety data, etc. The methods include interview, clinical data summary and data mining. When the data formed based on HUE information is used as drug registration information, it is necessary to ensure that the data source is legal and compliant, and the ownership of intellectual property is clear.Data sources should meet the requirements of medical ethics. To avoid conflict of interest, data analysis should be conducted by an independent third party. It is necessary to develop the quality control measures of HUE data to ensure the data traceability, integrity, consistency and accuracy, and avoid data bias.The data of HUE should include the key data such as accurate clinical location and applicable population, recognized clinical efficacy and safety.After the formation of HUE, the statistical analysis plan of empirical data of human use should be formulated. Through strict data processing, statistical analysis and clinical interpretation, HUE can be produced for evaluation.
