[Study of analysis 1 390 adverse drug reactions cases of parenterally administered dengzhan xixin based on China's spontaneous response system].
Adverse drug reaction (ADR) monitoring of spontaneous reporting system (SRS) data to detect signals, is the main method of pharmacovigilance by China food and drug administration (CFDA). This study conducted a data analysis of 1 390 ADR cases of parenterally administered Dengzhan Xixin based on China SRS data collected between Jan, 2009 and Dec, 2012. The proportional reporting ratio method (PRR) and Bayesian confidence propagation neural network method (BCPNN) were used for data mining analysis. The results showed that 71 cases of serious ADRs accounted for 1 390, 5.11% of cases reported. There were more men than women (613/593), and people over the age of 60 accounted for 64.03%. The most common ADRs were itching, rash, dizziness, chills, and palpitations. With damage to skin and its accessories 55 forming the highest percentage of ADRs. When propensity score method to control for confounding factors, PRR method and BCPNN methods were applied, headache, dizziness, palpitation, and chills were ADRs warning signals. Due to the limitation of the SRS data, the results still need to be combined with other research to form a comprehensive body of safety evidence, and to guide the rational clinical use and reduce risks.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. chibjyy@163.com
Yuan-Yuan
YY
Li
School of Statistics, Renmin University of China, Beijing 100872, China.
Yong-Yang
YY
Xiang
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Yan-Ming
YM
Xie
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Hao
H
Shen
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D002681:China / Q000453:epidemiology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007223:Infant; D007263:Infusions, Parenteral; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D055815:Young Adult
D004365:Drugs, Chinese Herbal