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China Journal of Chinese Materia Medica ; (24): 6062-6067, 2021.
Article in Chinese | WPRIM | ID: wpr-921764

ABSTRACT

The clinical comprehensive evaluation of drugs is an important basis for the return of clinical value, decision-making of medical and health authorities, and allocation of medical resources. In July 2021, the National Health Commission issued the Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), which required the evaluation to be implemented from the six dimensions(safety, effectiveness, economy, innovation, suitability, and accessibility), and made detailed arrangements for the clinical comprehensive evaluation of drugs. As Chinese patent medicine differs from chemical medicines in terms of effective components and action modes, the clinical comprehensive evaluation of Chinese patent medicine should highlight the characteristics and advantages of traditional Chinese medicine(TCM) on the basis of general requirements of comprehensive clinical evaluation of drugs. At present, in the clinical comprehensive evaluation of Chinese patent medicine, unified report standards have not yet been generated, resulting in the uneven quality of existing reports. To standardize the clinical comprehensive evaluation report of Chinese patent medicine and improve its quality, the editorial team, based on the relevant policy documents of clinical comprehensive evaluation of drugs, formulated the clinical comprehensive evaluation report standards for Chinese patent medicine in combination with the previous practice and expert opinions. The report standards, containing seven sections with 15 items determined, focus on data source, evaluation content, evidence synthesis, quality control, and evaluation results supported with detailed interpretations to help researchers better understand and apply the report standards for clinical comprehensive evaluation of Chinese patent medicine, improve the report quality, and provide references for the decision-making by the national medical management authorities.


Subject(s)
China , Drugs, Chinese Herbal , Information Storage and Retrieval , Medicine, Chinese Traditional , Nonprescription Drugs , Quality Control
2.
China Journal of Chinese Materia Medica ; (24): 5130-5136, 2021.
Article in Chinese | WPRIM | ID: wpr-921654

ABSTRACT

Due to the profound theoretical rationale, perfect diagnosis and treatment system, and characteristic medicinal resources, Tibetan medicine has been passed down to the present day as one of the four traditional medicine systems all over the world. With the development of modern society and the change in people's concept of seeking medical services, Tibetan medicine has gradually attracted wide attention by virtue of its natural, green and safe diagnosis and treatment characteristics, which enables it to be vigo-rously developed and inherited. There are numerous ancient books on Tibetan medicine, covering a large number of ancient prescriptions, which has laid a solid foundation for later scholars to thoroughly investigate the diagnosis and treatment rules in Tibetan medicine and apply them to modern clinical practice. Screening the classic prescriptions that meet modern clinical needs from those numerous ancient books is a new direction in the inheritance and development of Tibetan medicine. On the basis of historical origin and current application status of ancient prescriptions in Tibetan medicine, this paper preliminarily elaborated the definition of classic prescriptions of Tibetan medicine and their general screening principles and precautions, and also discussed the modern inheritance paths of classic prescriptions in Tibetan medicine from basic research, post-marketing evaluation, and the development of novel preparations. Considering the shortcomings in the present study, the key technical issues mentioned need to be more deeply explored and analyzed in future studies.


Subject(s)
Humans , Medicine, Tibetan Traditional , Medicine, Traditional , Prescriptions
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