Safety Signal Detection of Pemetrexed in American Adverse Events Reporting System
10.6039/j.issn.1001-0408.2016.20.16
- VernacularTitle:美国不良事件报告系统数据库中培美曲塞安全信号的检测
- Author:
Yan ZHONG
;
Guizhi BIAN
;
Zhiyong ZHANG
- Publication Type:Journal Article
- Keywords:
Pemetrexed;
Data mining;
Adverse drug event;
Rational drug use;
American adverse events reporting system;
Safety signals
- From:
China Pharmacy
2016;27(20):2786-2789
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To detect and analyze the safety signals of pemetrexed in post-marketing,and provide references for rational drug use in the clinic. METHODS:A form of data mining techniques was used to detect the safety signals of pemetrexed in American adverse events reporting system and the analysis of signal effect factors i.e.,gender,age,dosage and indication was per-formed by SPSS 19.0. RESULTS:173 signals related to pemetrexed were excavated in 5 397 235 reports,and the number of report-ed adverse event in blood-lymphatic system was the most(491)and the number of signals in gastrointestinal system was the most (17). There was no statistical significance in the distribution of blood-lymphatic system and gastrointestinal system in gender(P=0.075) and age (P=0.726) compared to other system adverse event,but there was statistical significance in dosage (P=0.007) and indication(P=0.001). CONCLUSIONS:Adverse events induced by pemetrexed in blood-lymphatic system and gastrointestinal system should be monitored at the same time,especially combined with non-steroidal anti-inflammatory drugs.
