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 performed by SPSS 19.0. RESULTS: 173 signals related to pemetrexed were excavated in 5 397 235 reports, and the number of reported 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.
关键词
培美曲塞数据挖掘药物不良事件合理用药美国不良事件报告系统安全信号
Keywords
pemetrexedData miningAdverse drug eventRational drug useAmerican Adverse Events Reporting SystemSafety signals