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

摘要

目的：检测和分析培美曲塞上市后的安全信号，为临床合理用药提供参考。方法：采用数据挖掘法对美国不良事件报告系统数据库中培美曲塞的安全信号进行检测，并利用SPSS 19.0软件分析性别、年龄、剂量、适应证对目标信号的影响。结果：在纳入分析的5397235份报告中，共挖掘出173个培美曲塞安全信号，其中血液及淋巴系统报告数最多（491份），胃肠系统信号数最多（17个）。经统计学分析，相比其他系统不良事件，血液及淋巴系统和胃肠系统在性别（P＝0.075）和年龄（P＝0.726）分布中无统计学意义，在剂量（P＝0.007）和适应证（P＝0.001）分布中有统计学意义。结论：临床使用培美曲塞时应重视监测血液及淋巴系统和胃肠系统不良事件，尤其是合并使用非甾体抗炎药时。%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.