地西他滨上市后血液及淋巴系统疾病不良反应信号检测与分析

目的：检测和分析地西他滨上市后不良反应信号，为临床安全合理用药提供参考。方法：采用数据挖掘法对美国食品药品监督管理局不良事件报告系统数据库进行地西他滨不良反应信号检测，并利用SPSS19.0分析性别，年龄，用药时长及给药剂量对目标信号的影响。结果：在纳入分析的11 951 487份不良反应报告中，以地西他滨为首要怀疑药物不良反应报告2 225份，经ROR法检测，共得到167个地西他滨不良反应信号，其中血液及淋巴系统和感染疾病分布最多。经统计学分析，与其他系统不良反应相比，血液及淋巴系统在性别（P=0.027）和年龄（P=0.023）分布中差异有统计学意义；在用药时长和给药剂量分布中差异无统计学意义。结论：男性患者，66~79岁患者发生血液及淋巴系统疾病不良反应风险较大，但仍需进行进一步信号评价和验证，以期为临床合理用药提供依据。

Signal detection and evaluation of adverse drug reactions of decitabine in blood and lymphatic system in postmarketing experiences

OBJECTIVE To detect and analyze the ADR signals of decitabine in postmarketing experiences,and provide references for clinical medication.METHODS Data mining was used to detect the ADR signals in the FAERS and analyze signal effect factors,i.e.,gender,age,medication duration and dosage,by SPSS 19.0.RESULTS Totally 11 951 487 reports were found for all drugs,2 225 reports among them were mainly induced by decitabine.A total of 167 signals related to decitabine were identified.Blood and lymphatic system disorders and infections contained the most ADR signals.There exited significant difference in the gender (P=0.027) and age (P=0.023),but not in medication duration or the dosage compared with other ADRs.CONCLUSION Male and the age of 66 to 79 are two risk factors of blood and lymphatic disorders.Further research is needed to provide references for safety in clinical medication.