[Expert consensus on human use experience research of traditional Chinese medicine].
Zhongguo Zhong Yao Za Zhi
; 47(18): 4829-4834, 2022 Sep.
Article
in Zh
| MEDLINE
| ID: mdl-36164892
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.
Key words
Full text:
1
Database:
MEDLINE
Traditional Medicines:
Medicinas_tradicionales_de_asia
/
Medicina_china
Therapeutic Methods and Therapies TCIM:
Terapias_biologicas
Main subject:
Drugs, Chinese Herbal
/
Medicine, Chinese Traditional
Type of study:
Diagnostic_studies
/
Guideline
Language:
Zh
Journal:
Zhongguo Zhong Yao Za Zhi
Year:
2022
Type:
Article
Affiliation country:
China