摘要
目的:通过分析新型抗肿瘤药物维奈克拉(VEN)的药物不良事件(ADE)信号,为其临床安全合理用药提供参考。方法:利用OpenFDA公共数据开放项目检索药物不良事件报告系统(FAERS)数据库2016年4月至2023年3月维奈克拉的不良反应数据,采用报告比值比(ROR)法、英国药品和保健产品管理局(MHRA)综合标准法、贝叶斯可信区间递进神经网络(BCPNN)法、多项式伽马泊松分布缩减(MGPS)法挖掘和分析维奈克拉的ADE信号。结果:在从FAERS数据库收集的29849份报告中,确定了336份维奈克拉相关ADE报告,共累及27个系统器官分类(SOC)。发生例数较多的SOC依次为全身性疾病及给药部位各种反应,各类检查,感染及侵染类疾病,各类损伤、中毒及操作并发症,胃肠系统疾病、血液及淋巴系统疾病等。排除原发病本身因素及与药物无关的不良反应,常见的ADE主要包括血小板计数降低,感染性肺炎,发热等。严重的ADE(如:住院、死亡和危及生命)发生率较高。同时新发现维奈克拉说明书中未提及的可疑ADE有COVID-19、心房颤动、胸腔积液、真菌性肺炎等。结论:本研究结果与临床试验一致,同时还发现了维奈克拉潜在的新的ADE信号。本研究结果可为维奈克拉的临床使用及进一步安全性研究提供有价值的证据。
Objective:To provide a reference for the safe and rational clinical use of the novel antineoplastic drug venetoclax(VEN)by analyzing its adverse drug event(ADE)signals.Methods:The OpenFDA public data open access project was used to retrieve the adverse event data of venetoclax from April 2016 to March 2023 in the FDA adverse event reporting system(FAERS)database,and the ratio of reported ratios(ROR)method,the United Kingdom’s Medicines and Healthcare products Regulatory Agency(MHRA)comprehensive standard method,the Bayesian credible interval progression The neural network(BCPNN)method and polynomial gamma Poisson distribution shrinkage(MGPS)method were used to mine and analyse the ADE signals of venetoclax.Results:Among 29849 reports collected from the FAERS database,336 venetoclax-related ADE reports were identified,involving a total of 27 system organ classifications(SOCs).The SOCs with a higher number of occurrences were,in order,systemic diseases and various reactions at the site of administration,various examinations,infections and invasive diseases,various injuries,poisonings and operation complications,gastrointestinal system diseases,blood and lymphatic system diseases,and so on.Excluding the factors of the primary disease itself and the adverse reactions not unrelated to drugs,the common ADE mainly included decreased platelet count,infectious pneumonia,fever and so on.The incidence of serious ADE(e.g.hospitalization,deaths and life-threatening)was higher.Meanwhile,the newly identified suspected ADEs not mentioned in the specification of venetoclax were coronavirus disease 2019(COVID-19),atrial fibrillation,pleural effusion,and fungal pneumonia.Conclusions:The results of this study are consistent with clinical trials,but also identified potential new ADE signals for venetoclax.The results of this study may provide valuable evidence for the clinical use of venetoclax and further safety studies.
作者
黄晴
吴亚妹
李慧敏
张媛
陈鹏
刘晓东
Huang Qing;Wu Yamei;Li Huimin;Zhang Yuan;Chen Peng;Liu Xiaodong(No.5 Medical Center of the Chinese PLA General Hospital,Beijing 100039,China)
出处
《感染、炎症、修复》
2024年第2期119-129,共11页
Infection Inflammation Repair
