克唑替尼不良反应与影响因素分析

目的:探究克唑替尼不良反应发生类别、发生时间、严重程度、发生机制及其影响因素等,为临床合理用药提供依据。方法:收集北京协和医院2015年1月至2019年6月应用克唑替尼患者63例,记录相关临床信息、治疗方案等,应用SPSS 21.0统计软件对数据进行分析。结果:克唑替尼不良反应的影响因素中,合并用药差异有统计学意义(P<0.05)。51例不良反应(adverse drug reactions,ADRs)中,6例为严重不良反应,45例为一般不良反应。最常见的ADRs累及器官系统为:肝胆损害(37.9%)、消化系统损害(24.2%)、泌尿系统损害(9.7%)、血液及循环系统损害(8.9%)。严重ADRs临床表现为转氨酶升高,窦性心动过缓和骨髓抑制。60 d以内ADRs累计发生率为80.6%,肝损伤主要发生时间为10~30 d(53.2%),消化道反应发生时间为0~10 d(90.0%),泌尿系统损伤主要发生在30~60 d(33.3%)。提及合并用药的患者有34例,涉及54个药物品种。结论:临床实践中应关注克唑替尼引起的ADRs,根据不良反应发生类别、时间、影响因素制定合理的临床监测和剂量调整方案,强化安全用药理念。

Analysis adverse reactions and influencing factors of crizotinib

OBJECTIVE To explore the type, time, severity, mechanism and influencing factors of crizotinib adverse reaction, so as to provide reference for clinical rational drug use.METHODS 63 cases of patients who used crizotinib in our hospital were collected from January 2015 to June 2019, relevant clinical information and treatment plan were recorded, and the data were analyzed by SPSS 21.0 statistical software.RESULTS The influencing factors of crizotinib ADRs included the location of the disease and the combination of drugs, and the difference was statistically significant (P<0.05). Among the 51 cases of ADRs, 6 cases were serious adverse reactions and 45 cases were general adverse reactions.The most common ADRs involving the organ system were liver damage (37.9%), digestive system damage (24.2%), urinary system damage (9.7%), and blood and circulatory system damage (8.9%). Serious adverse reactions were elevated transaminase, sinus bradycardia and myelosuppression.The cumulative incidence of ADRs within 60 days was 80.6%, including 10-30 days for liver injury (53.2%), 0-10 days for digestive tract reaction (90.0%), 30-60 days for urinary system injury (33.3%). 34 patients with 54 drug varieties were mentioned.CONCLUSION In clinical practice, adverse drug reaction caused by crizotinib should be payed more attention, and reasonable clinical monitoring and dose adjustment programs should be developed according to the type, time and influencing factors of adverse reactions, so as to strengthen the concept of safe drug use.