基于自发呈报系统丹参多酚酸盐安全信号预警分析(3)
based on analysis of spontaneous reporting system data
LU Peng-fei1， XIANG Yong-yang2， XIE Yan-ming1*， CHANG Yan-peng1， WANG Zhi-guo1
(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] Spontaneous reporting system(SRS)is currently a basic method to monitor and find adverse drug reactions (ADR) signals used worldwide. This method can promptly and effectively discover ADR signals and is of great significance to effectively prevent and avoid ADRs. Parenterally administered salvianolate has the functions of activating blood circulation and removing stasis. It is mainly used in the treatment of stable angina pectoris. As the drug is widely used clinically and ADRs are increasingly reported promptly， ADR information in the national ADR monitoring center′s SRS database has also increased. How to quickly and effectively identify suspicious ADRs is a major concern.This study uses BCPNN and PRR to detect early warning signals. S739 ADR case reports were identified. There were 106 types， 1 310 events， and 24 serious ADR cases ( 3.25% of 739 case reports) There wre no deaths. The ten most frequent ADRs were： rash， dizziness， itch， headache， chills and breath， nausea， palpitation， anaphylactic reaction and hot. The drugs early warning signs were dizziness， headache， nausea， itchiness and rash estimated using PRR. Early warning signs based on BCPNN were dizziness and headache. The ADRs of dizziness and headache are early warning signals associated with the nervous system.
[Key words] spontaneous reporting system； salvianolate； pharmacovigilance； early warning signals； Bayesian confidence propagation neural network； proportional reporting ratio
doi：10.4268/cjcmm20131817, 百拇医药(卢鹏飞 向永洋 谢雁鸣 常艳鹏 王志国)
LU Peng-fei1， XIANG Yong-yang2， XIE Yan-ming1*， CHANG Yan-peng1， WANG Zhi-guo1
(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] Spontaneous reporting system(SRS)is currently a basic method to monitor and find adverse drug reactions (ADR) signals used worldwide. This method can promptly and effectively discover ADR signals and is of great significance to effectively prevent and avoid ADRs. Parenterally administered salvianolate has the functions of activating blood circulation and removing stasis. It is mainly used in the treatment of stable angina pectoris. As the drug is widely used clinically and ADRs are increasingly reported promptly， ADR information in the national ADR monitoring center′s SRS database has also increased. How to quickly and effectively identify suspicious ADRs is a major concern.This study uses BCPNN and PRR to detect early warning signals. S739 ADR case reports were identified. There were 106 types， 1 310 events， and 24 serious ADR cases ( 3.25% of 739 case reports) There wre no deaths. The ten most frequent ADRs were： rash， dizziness， itch， headache， chills and breath， nausea， palpitation， anaphylactic reaction and hot. The drugs early warning signs were dizziness， headache， nausea， itchiness and rash estimated using PRR. Early warning signs based on BCPNN were dizziness and headache. The ADRs of dizziness and headache are early warning signals associated with the nervous system.
[Key words] spontaneous reporting system； salvianolate； pharmacovigilance； early warning signals； Bayesian confidence propagation neural network； proportional reporting ratio
doi：10.4268/cjcmm20131817, 百拇医药(卢鹏飞 向永洋 谢雁鸣 常艳鹏 王志国)