摘要
目的挖掘和分析帕博利珠单抗上市后的不良事件信号,为临床安全用药提供数据支持。方法利用美国食品药品管理局公共数据公开项目(OpenFDA)检索帕博利珠单抗2014年9月4日~2021年8月31日不良事件报告数据,采用报告比值比(ROR)法和国际医学用语词典(MedDRA)的首选系统器官分类(SOC)与首选术语(PT)对挖掘的信号进行统计分类和分析。结果共检索到帕博利珠单抗相关不良事件报告30391份,根据筛选条件检测出a≥3且ROR的95%CI下限>1的不良反应风险信号54个,涉及12个系统器官,不良反应报告31745个。除了信号较为强烈的垂体炎、重症肌无力、肾上腺皮质功能不全、肺部炎症、心肌炎、自身免疫性肝炎、间质性肺炎和结肠炎、甲状腺功能减退及亢进等说明书已收录的不良事件外,呼吸衰竭、肺栓塞、急性肾损伤、肾功能衰竭、构音障碍、心力衰竭、口腔炎等说明书未收录的不良事件也显示出了较强信号。结论基于OpenFDA数据库能对帕博利珠单抗的药品不良反应(ADR)相关信息进行全面、多维度的挖掘分析,用药过程中应开展药学监护,及时处理不良反应,保证用药安全。
Objective To mine and analyze the adverse event signals of pembrolizumab after marketing,and to provide data support for drug safety in clinical practice.Methods Using the US Food and Drug Administration Public Data Open Project(OpenFDA)retrieved data from pembrolizumab adverse event reports from September 4,2014 to August 31,2021.And the mined signals were statistically classified and analyzed using the reported odds ratio(ROR)method and the preferred systematic organ classification(SOC)and preferred term(PT)of the International Medical Dictionary(MedDRA).Results A total of 30,391 adverse event reports related to pembrolizumab were retrieved.According to the screening conditions,54 adverse reaction risk signals with a≥3 and 95%CI lower limit of ROR>1 were detected,involving 12 system organs,and 31,745 adverse reaction reports.In addition to strong signals of hypophysitis,myasthenia gravis,adrenal insufficiency,lung inflammation,myocarditis,autoimmune hepatitis,interstitial pneumonia and colitis,hypothyroidism and hyperthyroidism and other adverse events included in the manual,respiratory failure,pulmonary embolism,acute kidney injury,renal failure,dysarthria,heart failure,stomatitis and other adverse events not included in the manual also demonstrated strong signals.Conclusion Based on OpenFDA database,the ADR information of pembrolizumab can be comprehensively and multi-dimensionally mined and analyzed.Pharmaceutical care should be carried out during drug use to timely deal with adverse reactions to ensure drug safety.
作者
邓高敏
黄光明
杨玉芳
张宏亮
黄兴振
DENG Gao-min;HUANG Guang-ming;YANG Yu-fang(Department of Pharmacy,Guangxi Medical University Cancer Hospital,Nanning 530021,China;不详)
出处
《中国处方药》
2023年第7期1-6,共6页
Journal of China Prescription Drug
基金
国家自然科学基金项目(8206080)
广西卫健委健康委自筹课题项目(Z20210980)。
