Preliminary Discussion on Post-marketing Comprehensive Evaluation Indicator System of Ancient Famous Classical Formula Preparations
10.13422/j.cnki.syfjx.20231047
- VernacularTitle:古代经典名方制剂上市后综合评价指标体系初探
- Author:
Danping ZHENG
1
;
Lin TONG
1
;
Lei ZHANG
1
;
Ziling ZENG
2
;
Bing LI
2
;
Huamin ZHANG
2
Author Information
1. Institute of Information on Traditional Chinese Medicine， China Academy of Chinese Medical Sciences，Beijing 100700，China
2. Institute of Chinese Materia Medica，China Academy of Chinese Medical Sciences，Beijing 100700，China
- Publication Type:Journal Article
- Keywords:
ancient famous classical formulas;
post-marketing evaluation;
indicator system;
bibliometrics;
pharmacovigilance;
quality control;
traditional Chinese medicine preparations
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2023;29(18):175-182
- CountryChina
- Language:Chinese
-
Abstract:
The construction of the comprehensive evaluation index system of the famous classical formula preparations after the marketing has both theoretical and practical significance. In this study， literature related to the post-marketing comprehensive evaluation of traditional Chinese medicine（TCM） compound preparations was retrieved from China National Knowledge Infrastructure（CNKI）， China Science and Technology Journal Database（VIP）， Wanfang Data Knowledge Service Platform（WanFang） and SinoMed from January 1， 2000 to April 30， 2022. CiteSpace 6.1.R2， a scientometrics software， was used to visualize the keywords involved， and to analyze the dynamic evolution trend and research hotspots in this field. Then， the existing comprehensive post-marketing evaluation index system of TCM compound preparations was screened and extracted， and the research status was systematically analyzed by mathematical statistics. It was found that there were problems such as the generalized boundaries between assessment dimensions and assessment elements， the lack of data sources for individual evaluation indexes， unset weight of some index system and insufficient application degree. In addition， according to the characteristics of famous classical formulas， the authors discuss the importance of evidence evaluation based on combination of disease and syndrome， pharmacovigilance of famous classical formulas preparations， and whole-process quality control of famous classical formulas， and put forward the construction strategy of comprehensive post-marketing evaluation of the famous classical formula preparations， which is oriented by clinical value， centered on evidence evaluation， and guaranteed by the whole-process quality control.
