Journal of Clinical & Experimental Pharmacology

A retrospective study on detecting signals about traditional Chinese medicine adverse drug reaction with pharmacovigilance analyzing methods

International Conference and Exhibition on Pharmacovigilance & Clinical Trials

October 1-3, 2012 DoubleTree by Hilton Chicago-North Shore, USA

Yanming Xie

Scientific Tracks Abstracts: Clin Exp Pharmacol

Abstract:

In mainland China, some researchers has begun with pharmacovigilance study on Traditional Chinese medicine adverse drug reactions (ADRs), for usual methods can�t be used to detect those potential risk factors or signals of ADRs in time. 20,000 cases of ADRs were collected from China State Food and Drug Administration (SFDA) ADR surveillance database from 2001to 2009 and were described. Three classic ADR signals detection pharmacovigilance methods were used in this study to analyze selected data about Yuxingcao injection from Jan. 2005 to Apr. 2007. Three methods are reporting odds ratio (ROR), proportional reporting ratio (PRR) and bayesian confidence propagation neural network (BCPNN). Risk signals were detected at four quarters of the year 2005 by ROR and PRR and from the third quarter of the year 2005 by BCPNN. And all signals were detected at the first quarter, the second quarter and the fourth quarter of the year 2006 by three methods. All signals were the same found by ROR and PRR, but a little different from BCPNN. The date of detecting these signals and their developing trend were the same with stopping using Yuxingcao injection time by China SFDA. Pharmacovigilance analysis should be based on reliable ADRs reporting timely. A real-time surveillance on ADRs of post- marked Traditional Chinese Medicine needs huge massive data sets from the real word. Meanwhile, confounder controlling and data standardizing should be considered carefully during statistic analysis and data mining.

Biography :

Yanming Xie is the deputy director of Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences. She graduated from Norman Bethune University of Medical Science in 1983 in China. She had education in clinical medicine and her research interests are traditional Chinese medicine, evidence based Chinese medicine and study in pharmacovigilance. She is undertaking many researches in the areas of clinical trials of interventions in Traditional Chinese Medicine, stroke, primary osteoporosis and geriatric diseases. Yanming Xie has published more than 200 papers and served as editorial board members of more than 5 peer reviewed journals in China.