基于美国FAERS的伊沙佐米风险信号挖掘
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篇名: 基于美国FAERS的伊沙佐米风险信号挖掘
TITLE: Risk signal mining of ixazomib based on the database of FAERS
摘要: 目的 挖掘伊沙佐米的风险信号,为临床合理用药提供参考。方法利用OpenVigil2.1在线工具,提取美国FDA不良事件报告系统(FAERS)数据库中自伊沙佐米在美国上市(2015年11月20日)至OpenVigil网站最近更新(2023年3月31日)的药品不良事件(ADE)报告数据,采用比例失衡法中的报告比值比(PRR)法和贝叶斯置信区间递进神经网络(BCPNN)法进行数据挖掘,采用国际医学用语词典(MedDRA)25.1版对信号的系统器官分类(SOC)和首选术语(PT)进行标准化编码。结果共提取到以“伊沙佐米”为“首要怀疑药物”的ADE报告13841份,涉及患者以男性稍多(49.53%),且年龄多为65岁及以上(72.48%);报告来自57个国家/地区,以美国(52.90%)为主。共挖掘到阳性信号186个,强、中、弱信号分别有51、99、36个,累及SOC19个。发生频次和PRR信号强度均排在前50位的PT包括周围神经病(414例,强信号)、血小板计数降低(379例,强信号)、血小板减少症(360例,强信号)、血细胞减少症(75例,强信号)、神经病学症状(41例,强信号),累及SOC为各类神经系统疾病、各类检查和血液及淋巴系统疾病;累及胃肠系统疾病(2588例)的ADE发生次数最多,包括腹泻(1077例,强信号)、恶心(737例,中信号)、呕吐(459例,中信号)、便秘(275例,中信号)等;感染及侵染类疾病阳性信号包含PT最多,且多数未被药品说明书记载,其中强信号12个(1030例)、中信号30个(627例),主要涉及肺部感染、上呼吸道感染、胃肠道感染、脓毒症、带状疱疹等;心脏器官疾病中的心脏淀粉样变性(7例,强信号)、急性冠脉综合征(14例,强信号)和肾脏及泌尿系统疾病中的肾功能损害(91例,中信号)均为较强信号且均未被药品说明书记载。结论除需常规关注的伊沙佐米相关胃肠系统疾病、各类神经系统疾病、血液及淋巴系统疾病等常见ADE外,临床还需关注患者在治疗期间可能出现的各种感染,密切监测其心血管毒性和肾功能损害的发生。
ABSTRACT: OBJECTIVE To explore the risk signal of ixazomib and provide a reference for clinically rational drug use. METHODS The Open Vigil 2.1 online tool was used to extract the data of adverse drug events (ADE) reported by the database of FDA adverse event reporting system (FAERS) from the launch of ixazomib in America (November 20th, 2015) to the latest update of the Open Vigil website (March 31st, 2023). The data were mined by using the proportional reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) of the proportional imbalance method. The signals were coded by system organ class (SOC) and preferred term (PT) according to MedDRA v25.1. RESULTS A total of 13 841 ADE reports with ixazomib as the “primary subject” were extracted, involving slightly more male patients (49.53%), and most of them were 65 years old and above (72.48%); the reports came from 57 countries/regions, mainly America (52.90%). A total of 186 positive signals were excavated, with 51 high-intensity, 99 medium-intensity, and 36 low-intensity signals, involving 19 SOCs. The top 50 PT in frequency and signal intensity of PRR included neuropathy peripheral (414 cases, high-intensity signal), platelet count decreased (379 cases, high-intensity signal), thrombocytopenia (360 cases, high-intensity signal), cytopenia (75 cases, high-intensity signal) and neurological symptoms (41 cases, high-intensity signal). SOC involved included nervous system disorders, investigations, and blood and lymphatic system disorders. ADE occurred most frequently in gastrointestinal diseases (2 588 cases), including diarrhea (1 077 cases, high-intensity signal), nausea (737 cases, medium-intensity signal), vomiting (459 cases, medium-intensity signal), constipation (275 cases, medium-intensity signal), and so on. The positive signals of infections and infestations contained the largest number of PTs, and most of them were not recorded in the drug instruction, including 12 high-intensity signals (1 030 cases) and 30 medium-intensity signals (627 cases), which were mainly distributed in lung infection, upper respiratory infection, gastrointestinal infection, sepsis, herpes zoster and so on. The signals of cardiac amyloidosis (7 cases, high-intensity signal) and acute coronary syndrome (14 cases, high-intensity signal) of cardiac disorders and renal dysfunction (91 cases, medium-intensity signal) of renal and urinary disorders were all strong and had not been recorded in the drug instruction. CONCLUSIONS In addition to routine attention to the common ADE of ixazomib in gastrointestinal diseases,nervous system disorders and blood and lymphatic system disorders, clinical attention should also be paid to various infections that may occur during the treatment of patients, and the occurrence of cardiovascular toxicity and renal dysfunction should be monitored.
期刊: 2023年第34卷第22期
作者: 杨莉;赵新才;徐嵘;张剑萍
AUTHORS: YANG Li,ZHAO Xincai,XU Rong,ZHANG Jianping
关键字: 伊沙佐米;不良事件;美国FDA不良事件报告系统;信号挖掘
KEYWORDS: ixazomib; adverse drug event; FDA adverse event reporting system; signal mining
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