Safety evaluation and risk control measures of Psoralea corylifolia.
10.19540/j.cnki.cjcmm.20170919.011
- Author:
Wen-Yang TIAN
1
;
Shan LAN
2
;
Li ZHANG
1
;
Lu SUN
1
;
Ju-Kai HUANG
1
;
Xiao-Hui YANG
1
;
Gui-Bo SUN
3
;
Xue-Min GAO
4
;
Xiao-Bo SUN
3
Author Information
1. Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100078, China.
2. Sichuan Center for Food and Drug Evaluation, Inspection and Monitorin, Chengdu 610017, China.
3. Institute of Medicinal Plants, Chinese Academy of Medical Sciences, Beijing 100193, China.
4. Beijing University of Chinese Medicine, Beijing 100029, China.
- Publication Type:Journal Article
- Keywords:
Psoralea corylifolia;
adverse drug reaction;
risk control;
safety evaluation
- From:
China Journal of Chinese Materia Medica
2017;42(21):4059-4066
- CountryChina
- Language:Chinese
-
Abstract:
Through a systematic and comprehensive study of domestic and foreign literatures and information, this study aims to trace the herbal origin and the toxicity recorded in ancient and current documents, analyze the safety case reports of Psoralea corylifolia and experimental studies on toxicity in recent years, and make a preliminary summary about the clinical characteristics and potential risk factors of cases related to the safety of P. corylifolia and its preparations. The study involved 84 patients in the safety case reports of P. corylifolia. The adverse events were mainly liver damage (55.95%) and light toxic contact dermatitis (38.10%), sugguesting that P. corylifolia may lead to liver damage and photo toxicity. However, reproductive toxicity and renal damage were only reported in animal studies, but not in clinical reports. Because of its complicated ingredients, the toxic components and mechanisms of P. corylifolia have not been clear at present. Therefore, the authors proposed to strictly apply P. corylifolia in clinic, use it rationally and combine it with other medications. Besides, efforts shall be made to strength the guidance for doctors, the safety monitoring of P. corylifolia and relevant preparations, and actively carry out safety-related basic and clinical studies, so as to give a better guidance to safe medication, full exert the efficacy and avoid the medication risk.
