吉非替尼不良反应文献分析

目的：整理吉非替尼不良反应发生情况,包括常见的、药品说明书中未提及的罕见的药品不良反应,为临床合理用药提供参考。方法：对国内、外近5年应用吉非替尼出现的不良反应个案报道进行整理、归纳和分析。结果：吉非替尼不良反应的发生可累及多个器官和系统,其中皮肤及附件不良反应发生率最高,呼吸系统不良反应死亡率最高,循环系统和泌尿系统等也可发生严重不良反应。50～59岁年龄段不良反应发生率高,有12例（37.5%）。男性发生率高于女性。不良反应最快的可在用药后2～3 d内发生,最迟的可在持续用药2年后发生,用药后1～4周不良反应发生率最高。结论：临床应重视吉非替尼的不良反应,特别是监测和上报罕见、严重的不良反应。

Analysis of literature on adverse drug reactions of gifitinib

Objective： To Summarize the literature on adverse drug reactions（ADRs） of gifitinib,including common and rare ADRs which were not recorded in package insert,in order to provide reference for the rational use of the drug in clinic.Methods： The case reports of gefitinib ADRs which were published both at home and abroad in past 5 years were collected and analyzed.Results： ADRs of gefitinib involved multiple organs and systems,with the highest incidence rate being in skin and adnexa and the highest mortality rate being in respiratory system.Severe ADRs also occurred in circulatory and urinary systems.The high incidence rate of ADRs happened in the patients aged from 50 to 59 years old（12 cases,37.5%）.The incidence rate of ADRs in men was higher than that in women.ADRs of gefitinib could occur quickly in 2-3 d,and the latest ADRs could occur two years after its use.The highest rate happened during 1-4 weeks.Conclusion： Attention should be paid to ADRs of gefitinib,especially to monitoring and reporting rare and severe ADRs in clinic.