摘要
目的分析PD-1/PD-L1抑制剂致心肌炎的风险,为安全用药提供参考。方法收集FAERS数据库2014年第1季度至2022年第4季度收录的帕博利珠单抗、纳武利尤单抗、阿替利珠单抗和度伐利尤单抗致心肌炎不良事件(AE)报告,采用报告比值比(ROR)法评价4种药物与心肌炎之间的相关性。比较不同品种PD-1/PD-L1抑制剂致心肌炎的风险信号强度,并对心肌炎患者的主要特点(性别、年龄、结局和发生时间等)进行描述性分析。结果共收集到帕博利珠单抗、纳武利尤单抗、阿替利珠单抗、度伐利尤单抗相关心肌炎AE报告分别为458、723、143、189例,共1513例,ROR(95%CI)值分别为27.75(25.24~30.52)、27.34(25.31~29.54)、25.76(21.83~30.40)、25.45(22.02~29.41),风险信号强度为帕博利珠单抗≈纳武利尤单抗>阿替利珠单抗≈度伐利尤单抗。有可用数据的报告中,男性多于女性(885∶471),65岁及以上者占70.34%(856/1217)。心肌炎中位发生时间为27 d,心肌炎可导致38.86%(588/1513)患者死亡。结论不同品种PD-1/PD-L1抑制剂致心肌炎风险有所差异,多发生于治疗早期,65岁以上男性多见。心肌炎是PD-1/PD-L1抑制剂的严重AE,应引起临床关注。
Objective To analyze the risk of myocarditis caused by PD-1/PD-L1 inhibitors and provide a reference for safe medication use.Methods The adverse event(AE)reports of myocarditis related to pembrolizumab,nivolumab,atezolizumab,and durvalumab were collected in the FDA adverse event reporting system(FAERS)from the first quarter of 2014 to the fourth quarter of 2022.The correlation between the 4 drugs and myocarditis was evaluated using the reporting odds ratio(ROR)method.The risk signal strengths of myocarditis due to different PD-1/PD-L1 inhibitors were compared,and the main characteristics(sex,age,outcome,and time of occurrence)were analyzed descriptively.Results A total of 458,723,143 and 189 AE reports of myocarditis associated with pembrolizumab,nivolumab,atezolizumab,and durvalumab were collected respectively,totaling 1513 cases.The ROR(95%CI)values were 27.75(25.24 to 30.52),27.34(25.31 to 29.54),25.76(21.83 to 30.40),25.45(22.02 to 29.41)respectively,indicating that the risk signal strengths for pembrolizumab and nivolumab were higher than atezolizumab and durvalumab.Among reports with available data,males were more frequent than females(885∶471),and 70.34%(856/1217)of patients were 65 years old and over.The median onset time was 27 days.Myocarditis could result in death in 38.86%(588/1513)of patients.Conclusion The risk of myocarditis varies among different PD-1/PD-L1 inhibitors,often occurring in the early stage of treatment and predominantly in men over 65 years old.Myocarditis is a serious AE of PD-1/PD-L1 inhibitors and should be of clinical concern.
作者
尹岳松
吴玉佩
李阳
张丽娜
YIN Yue-song;WU Yu-pei;LI Yang;ZHANG Li-na(Department of Oncology,Hebei General Hospital,Shijiazhuang 050051,China;Department of Pharmacy,Hebei General Hospital,Shijiazhuang 050051,China;Department of Cardiology,Hebei General Hospital,Shijiazhuang 050051,China)
出处
《临床药物治疗杂志》
2023年第11期76-80,共5页
Clinical Medication Journal
基金
河北省重点研发计划项目(20377769D)
河北省医学科学研究课题计划(20230424)。
