Current Situation on Clinical Comprehensive Evaluation of Chinese Patent Medicines in China
10.13422/j.cnki.syfjx.20232197
- VernacularTitle:我国中成药临床综合评价发展及方法研究现状
- Author:
Wenshuang LI
1
;
Zeqi DAI
2
;
Qingran SUN
1
;
Chuchuan WAN
1
;
Xing LIAO
2
;
Xiaoyu XI
1
Author Information
1. The research center of national drug policy & ecosystem，China pharmaceutical university， Nanjing 211198，China
2. Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences，Beijing 100700，China
- Publication Type:Journal Article
- Keywords:
Chinese patent medicine;
clinical comprehensive evaluation;
literature studies;
policy analysis;
current research status
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2023;29(24):155-162
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo clarify the development and methodological research status of clinical comprehensive evaluation of Chinese patent medicines in China and identify the problems and difficulties in the evaluation， so as to provide a reference for promoting the subsequent evaluation. MethodFirstly， we analyzed the current situation of clinical comprehensive evaluation in China by reviewing the articles about the process of clinical comprehensive evaluation of drugs and the process of clinical comprehensive evaluation of Chinese patent medicines. Secondly， we comprehensively summarized the formulation background and key points of policies related to clinical comprehensive evaluation of Chinese patent medicines and then show the development status in this field at the national and provincial levels. ResultThe comprehensive clinical evaluation of Chinese patent medicines is still in its infancy in China， and 32 articles of specific evaluation of Chinese patent medicines were included in the study. The dosage forms were mainly capsules （15 articles， 46.88%） and injections （28.13%）. The evaluation mainly involved diseases such as the nervous system （10 articles， 31.25%）， digestive system （5 articles， 15.63%）， and respiratory system （5 articles， 15.63%）. The research results of clinical comprehensive evaluation of Chinese patent medicines were mainly from relevant societies and research institutions. Different research teams have developed technical guidelines or specifications for the evaluation， while the government-leading evaluation guidelines remained to be formulated at the national and provincial levels. In addition， the research articles in this field mainly concentrated on the application of evaluation methods， the building of evaluation index systems， and completed evaluation reports. ConclusionTo reflect the unique value and advantages of Chinese patent medicines， the government needs to build technical guidelines for the clinical comprehensive evaluation of Chinese patent medicines on the basis of the clinical comprehensive evaluation of drugs and create a favorable policy environment for the evaluation work.
