Exploratory on Phase 0 Clinical Pharmacodynamics Trial in Chinese Materia Medica
10.11842/wst.2017.05.024
- VernacularTitle:中药0期临床药效学试验探索
- Author:
Lizhe LIANG
;
Guoxin LI
;
Xuefeng YU
- Keywords:
Chinese materia medica;
phase 0 clinical trial;
pharmacodynamics Shu-Xue-Ning injection
- From:
World Science and Technology-Modernization of Traditional Chinese Medicine
2017;19(5):851-857
- CountryChina
- Language:Chinese
-
Abstract:
Shu-Xue-Ning (SXN) injection was used as study subject in order to explore the feasibility of pharmacodynamics experiment of Phase 0 clinical trial in Chinese materia medica (CMM).This paper tried to establish key-technique standards which fit to the evaluation on CMM phase 0 (early) clinical evaluations.According to the established research methods,this research selected volunteers and assured low dose SXN injection inside their body.And then,serum before and after medication were collected for the HAEC in vitro experiment.Blood sample of the clinical dosage was used as control to verify the tendency consistency of pharmacodynamics in low dose and clinical dose.The results showed that in the H2O2 inducing HAEC damage experiment,low dose SXN injection can affect the cell proliferation,protect the shape of cells,reduce the release of ion owing to cell damages and influence the secretion in cells.Complete-sequence RNA gave differential multiterm expression before and after the low dose.It was concluded that compared with the clinical group,low dose medication had similar metabolic tendency.The pharmacodynamics experiment of phase 0 CMM clinical trial is feasible.
