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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。
OBJECTIVE: To detect and analyze adverse reaction signals of decitabine marketed as a reference for clinical safety and rational drug use. Methods: Data mining method was used to detect adverse signals of decitabine in the adverse event reporting system database of the FDA. SPSS19.0 was used to analyze the influence of sex, age, duration of treatment and dose on the target signal. RESULTS: Of the 11 951 487 adverse reactions included in the analysis, 2,225 were reported as adverse reactions to decitabine, and 167 were detected by ROR. Adverse reactions to decitabine were obtained, of which blood And lymphatic system and infectious diseases most distributed. Statistically, there was significant difference in the distribution of blood and lymphatic system between gender (P = 0.027) and age (P = 0.023) compared with other systemic adverse reactions. There was no significant difference in the duration of drug administration and dose distribution Statistical significance. Conclusion: In male patients, patients with 66-79 years old have a greater risk of adverse reactions of blood and lymphatic system diseases. However, further evaluation and verification of signals are still needed in order to provide a basis for clinical rational drug use.