Mining and analysis of adverse drug events signals of nilotinib based on FDA adverse event database

SU Hui; JIANG Tingting; ZHANG Ni; LI Yanping; CAI Yongqing; PENG Dan; LIU Yao

doi:10.6039/j.issn.1001-0408.2023.21.10

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Mining and analysis of adverse drug events signals of nilotinib based on FDA adverse event database

更新时间：2023-11-10

- Mining and analysis of adverse drug events signals of nilotinib based on FDA adverse event database
- ZHONGGUO YAOFANG Vol. 34, Issue 21, Pages: 2625-2630(2023)
- 作者机构：
  
  陆军特色医学中心药剂科，重庆　400042
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.21.10
  CLC： R969.3;R979.1
- Published：15 November 2023，
  
  Received：16 May 2023，
  
  Revised：10 October 2023，
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苏辉,蒋婷婷,张妮等.基于FAERS数据库对尼洛替尼ADE信号的挖掘与分析 ^Δ[J].中国药房,2023,34(21):2625-2630.

SU Hui,JIANG Tingting,ZHANG Ni,et al.Mining and analysis of adverse drug events signals of nilotinib based on FDA adverse event database[J].ZHONGGUO YAOFANG,2023,34(21):2625-2630.
苏辉,蒋婷婷,张妮等.基于FAERS数据库对尼洛替尼ADE信号的挖掘与分析 ^Δ[J].中国药房,2023,34(21):2625-2630. DOI： 10.6039/j.issn.1001-0408.2023.21.10.

SU Hui,JIANG Tingting,ZHANG Ni,et al.Mining and analysis of adverse drug events signals of nilotinib based on FDA adverse event database[J].ZHONGGUO YAOFANG,2023,34(21):2625-2630. DOI： 10.6039/j.issn.1001-0408.2023.21.10.

摘要

目的

为临床安全使用尼洛替尼提供参考。

方法

从美国FDA不良事件报告系统（FAERS）数据库提取2007年第1季度至2022年第4季度尼洛替尼的药品不良事件（ADE）报告，使用比例失衡测量法中的报告比值比（ROR）法和比例报告比值比（PRR）法挖掘潜在的ADE信号，同时与药品说明书和相关个案文献进行比对，并结合欧洲药品管理局制定的指定医疗事件（DME）清单来筛选和分析。

结果

获得以尼洛替尼为首要怀疑药物的ADE报告23 332份，检出阳性信号359个，共涉及24个系统器官分类（SOC），主要为各类检查、心脏器官疾病、血管与淋巴管类疾病、各类神经系统疾病等；椎动脉狭窄、冠状动脉狭窄、动脉性疾病、肝脏感染及第二种原发恶性肿瘤等ADE未在其药品说明书中提及。检出了7个DME，其中骨髓功能衰竭、肺动脉高压及耳聋未在其药品说明书中提及。

结论

所挖掘出的常见ADE信号与尼洛替尼的药品说明书一致；临床使用中应特别关注骨髓功能衰竭、肺动脉高压及耳聋等其药品说明书中未提及的DME，并密切监测患者心脏功能和血糖、血脂指标，以降低用药风险。

Abstract

OBJECTIVE

To provide a reference for safe drug use in clinic.

METHODS

ADE reports related to nilotinib from the first quarter of 2007 to the fourth quarter of 2022 were collected from the US FDA adverse event reporting system database. The reporting odds ratio （ROR） and proportional reporting ratio （PRR） of disproportionality measures were used to mine potential ADE signals，which were compared with drug instruction and related case report， and were screened and analyzed according to the designated medical events （DME） list formulated by the European Medicines Agency.

RESULTS

Totally 23 332 cases of ADE with nilotinib as the primary suspected drug were reported. A total of 359 positive signals were obtained，involving 24 system organ classes （SOC），mainly concentrated in various examinations，heart organ diseases，vascular and lymphatic diseases，all kinds of nervous system diseases，etc. Among them，ADEs such as vertebral artery stenosis，coronary artery stenosis，arterial disease，liver infection and the second primary malignant tumor were not mentioned in the instructions. Seven DMEs were detected，of which bone marrow failure，pulmonary hypertension and deafness were not mentioned in the drug instruction.

CONCLUSIONS

The common ADE signals of nilotinib excavated in this study are consistent with the instructions. In clinical use，special attention should be paid to DME not mentioned in the instructions such as bone marrow failure，pulmonary hypertension and deafness； cardiac function， blood glucose and blood lipid indexes should be monitored closely.

关键词

美国FDA不良事件报告系统数据库尼洛替尼药品不良事件信号挖掘比例失衡测量法指定医疗事件

Keywords

nilotinibadverse drug eventsignal miningdisproportionality measuresdesignated medical events

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