北京地区贝伐珠单抗不良反应报告分析及安全性研究

Analysis of adverse reaction reports of bevacizumab in Beijing area

目的:以临床实例出发探讨贝伐珠单抗导致不良反应的发生特点,为临床用药安全提供依据。方法:报道我院应用贝伐珠单抗引起死亡病例1例,并对2010年1月—2018年12月间70例北京市贝伐珠单抗不良反应(ADR)报告进行回顾性分析。结果:70例ADR报告中男42例,女28例。静脉滴注给药68例,胸膜腔内给药2例。用药剂量范围为100~915 mg。严重报告10例,死亡报告1例。ADR临床表现以心血管系统、呼吸系统和血液系统损害为主。存在超适应证用药问题。结论:贝伐珠单抗的安全性是应给予临床应关注的重要问题,应在合理使用的基础上,监测并及时处理其ADR。

Objective:To investigate the characteristics of adverse drug reactions(ADRs)of bevacizumab by analyzing clinical cases,thus to provide reference for rational use of the drug.Methods:A case of death caused by bevacizumab in our hospital was reported,and 70 adverse reactions cases of bevacizumab in Beijing from January2010 to December 2018 were retrospectively analyzed.Results:Among the 70 adverse reactions involved patients,42 were males and 28 were females,68 cases were intravenous drip administration and 2 cases were intrapleural administration.The dosage ranged from 100 mg to 915 mg.There were 10 serious cases and one death.The clinical manifestations of the ADRs were mainly cardiovascular,respiratory and blood system damages.There existed offlabel drug use.Conclusion:Safe use of bevacizumab is worth paying attention to by clinicians who should detect and deal with ADRs in time on the basis of rational use.