北京地区西妥昔单抗注射液不良反应调研分析

目的 西妥昔单抗是重组嵌合型单克隆抗体和表皮生长因子受体抑制剂上市已超过15年,但是仍缺乏上市后不良反应(adverse drugreaction, ADR)监测系统性评估。方法 收集2016年1月1日至2020年12月31日北京市药品不良反应监测数据库中涉及怀疑药品西妥昔单抗的ADR报告,通过SPSS 22.0软件对数据进行统计分析。结果 共485例ADR报告纳入研究,男女比例为1.56∶1。ADR主要涉及系统-器官为皮肤及其附件,其次为全身性损害、胃肠系统及血液系统等。深静脉血栓占比1.03%,高于说明书中偶见ADR频率。过敏反应多在用药后2 h内发生,以皮肤反应为主。严重ADR占比43.51%,患者的性别、年龄与ADR的严重程度和发生时间没有明显相关性(P>0.05)。报告人员缺乏对新的ADR判断,死亡病例记录不详实,死亡病例中肺栓塞和间质性肺炎不良事件可能与西妥昔单抗相关。结论 西妥昔单抗治疗发生严重ADR占比较高,老年患者与中青年患者相比无明显差异。深静脉血栓发生频率高于说明书中描述的频率。由于缺乏详实的病例信息,无法明确西妥昔单抗与死亡病例的因果关系,需关注发生肺栓塞和间质性肺炎不良事件的患者,需加强上报人员药物警戒相关培训,提高上报信息的准确性和完整性,为患者安全用药提供科学依据。

Investigation and Analysis of Adverse Reactions of Cetuximab Injection in Beijing

OBJECTIVE Cetuximab is a recombinant chimeric monoclonal antibody and epidermal growth factor receptor inhibitor, which has been more than 15 years sincethe market, but there is still a lack of systematic post market assessment of adverse drug reaction(ADR). METHODS Collected the ADR reports of the suspected drug cetuximab in the Beijing Adverse Drug Reaction Monitoring Database from January 1, 2016 to December 31, 2020. The data statistical analysis was performed through SPSS 22.0 software. RESULTS A total of 485 ADRs were included in the study. The male to female ratio of ADRs were 1.56∶1. ADR mainly affected by the system-organ classes were the skin and appendages disorders, followed by body as whole-general disorders, gastrointestinal system disorders and blood system disorders.Deepveinthrombosis(DVT) accountsfor 1.03%, which was higher than the occasional ADR in the instructions. Allergic reactions mostly occurred with in 2 hours after medication, mainly skin reactions. Besides, severe ADR accounted for 43.51%. There was no correlation between characteristics of patients and ADRs(P>0.05). The reporters lacked judgment on the new ADRs, and the records of death cases were not detailed.Pulmonary embolismand interstitial pneumonia may be related to cetuximab, which may result in the death. CONCLUSION Severe ADR accounts for a relatively high proportion, and there is no significant difference between elderly patients and young and middle-aged patients. The frequency of DVT is higher than the frequency described in the instructions. Due to the lack of detailed case information, it is impossible to clarify the causal relationship between cetuximab and death. More attention should be paid to patients with ADR of pulmonary embolismand interstitial pneumonia.Inaddition, there is an urgent necessary to strengthen the pharmacovigilance training of the reporting personnel, improve the accuracy and completeness of the reported information,which would provide a theoretical basis for the safe medication of patients.