基于自发呈报系统1 390例灯盏细辛注射液不良反应报告预警分析(3)
LI Yuan-yuan1， XIANG Yong-yang2， XIE Yan-ming1*， SHEN Hao1
(1. Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， Beijing 100700， China；
2. School of Statistics， Renmin University of China， Beijing 100872， China)
[Abstract] 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.
[Key words] spontaneous reporting system； parenterally administered Dengzhanxixin； pharmacovigilance； Bayesian method； proportional reporting ratio method
doi：10.4268/cjcmm20131816, http://www.100md.com(黎元元 向永洋 谢雁鸣 申浩)
(1. Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， Beijing 100700， China；
2. School of Statistics， Renmin University of China， Beijing 100872， China)
[Abstract] 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.
[Key words] spontaneous reporting system； parenterally administered Dengzhanxixin； pharmacovigilance； Bayesian method； proportional reporting ratio method
doi：10.4268/cjcmm20131816, http://www.100md.com(黎元元 向永洋 谢雁鸣 申浩)