Clinical efficacy and modeling evaluation of He-wei-zhi-xie capsules in treating diarrhea patients
10.12092/j.issn.1009-2501.2022.01.007
- Author:
Liying XU
1
;
Xiaomin HUANG
1
;
Shuhua WANG
1
;
Gaosong ZHANG
2
;
Jihan HUANG
3
;
Shuhua WANG
4
Author Information
1. The First Affiliated Hospital of Zhejiang Chinese Medical University
2. The People's Hospital of Xinchang
3. Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine
4. Zhejiang Yongning Pharmaceutical Co., LTD
- Publication Type:Journal Article
- Keywords:
Clinical study;
Diarrhea;
He-wei-zhi-xie capsule;
Population pharmacodynamics model;
Post-marketing re-evaluation
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2022;27(1):47-55
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To evaluate the clinical efficacy and safety of He-wei-zhi-xie (HWZX) capsules in diarrhea patients. METHODS: The clinical study was conducted in 35 clinical trials centers from October 2015 to December 2017 by multicenter, prospective, open and uncontrolled design methods. The primary efficacy endpoint is the effective rate of diarrhea, the secondary endpoints include recovery rate of diarrhea, recovery time of diarrhea, number of irregular stools and Leeds dyspepsia questionnaire. The pharmacodynamics model of time course was established by nonlinear mixed effect model, and the effect of covariates on pharmacodynamic parameters was investigated. The safety measures were the incidence of adverse events, adverse reactions and the laboratory test indicators. RESULTS: A total of 2 285 cases were included in full analysis set. The effective rate of diarrhea was 90.8%, and the diarrhea recovery rate was 77.3%. The median time of recovery was 3 days, and the Leeds score was reduced by 3.6 points. It is found that baseline has a significant effect on model parameter E
