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基于FAERS的美法仑不良反应信号挖掘与分析
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| 篇名： | 基于FAERS的美法仑不良反应信号挖掘与分析 |
| TITLE： | Mining and analysis of adverse drug reaction signals of melphalan based on FAERS |
| 摘要： | 目的 挖掘美法仑的不良反应（ADR）信号，为临床安全使用提供参考。方法利用OpenVigil2.1数据平台，收集美国FDA不良事件报告系统（FAERS）数据库中2004年第1季度至2022年第2季度的美法仑相关ADR报告，利用比例失衡法中的报告比值比（ROR）法和综合标准法（MHRA）进行数据挖掘，根据《国际医学用语词典》（24.0版）ADR术语集中的系统器官分类（SOC）和首选术语（PT）对ADR报告进行描述和分类。结果共检索到目标药物美法仑相关ADR报告17046份，ADR报告数呈波动上升趋势；ADR报告涉及患者以男性为主（43.28%），且集中于50～＜75岁（35.09%），主要上报国家为美国（23.97%）；共涉及严重结局22842例次，以住院或延长住院为主（24.45%）。共挖掘到403个ADR信号，涉及23种SOC，主要为血液及淋巴系统疾病（801例次，13.77%），其次为眼器官疾病（755例次，12.97%）和感染及侵袭类疾病（716例次，12.30%）。报告例次排名靠前的ADR信号涉及发热性中性粒细胞减少、腹泻、发热及黏膜炎等PT，肺炎、脓毒症、玻璃体积血、脉络膜视网膜萎缩、骨髓增生异常综合征等PT未被药品说明书收录；信号强度排名靠前的ADR信号涉及脉络膜营养不良、脉络膜视网膜萎缩、眼球萎缩等PT，且上述3种PT均未被药品说明书收录。结论美法仑导致的ADR主要包括血液及淋巴系统疾病、眼器官疾病和感染及侵袭类疾病；使用美法仑前，临床应做好用药评估，并在治疗期间重点关注患者的血液指标和眼部毒性反应，以保障治疗的安全性。 |
| ABSTRACT： | OBJECTIVE To mine the adverse drug reaction （ADR） signals of melphalan， so as to provide reference for clinically safe drug use. METHODS Using OpenVigil 2.1 data platform， relative ADR reports of melphalan from the first quarter of 2004 to the second quarter of 2022 in FAERS database were collected； data mining was conducted using the reported odds ratio （ROR） method and Medicines and Healthcare Products Regulatory Agency （MHRA） method of disproportional method. ADR reports were described and classified according to the system organ class （SOC） and preferred term （PT） in Medical Dictionary for Regulatory Activities （24.0 edition）. RESULTS A total of 17 046 ADR reports related to the target drug melphalan were retrieved， and the number of ADR reports showed a fluctuating upward trend； the majority of patients were male （43.28%）， and were concentrated between the ages of 50-＜75 （35.09%）， with the main reporting country being the United States （23.97%）； ADR report involved a total of 22 842 severe outcomes， mainly including hospitalization or extended hospitalization （24.45%）. Totally 403 ADR signals were detected， involving 23 SOC， mainly including blood and lymphatic system diseases （801 cases， 13.77%）， followed by eye organ diseases （755 cases， 12.97%） and infectious and invasive diseases （716 cases， 12.30%）. The ADR signals ranked high in the number of reported cases included febrile neutropenia， diarrhea， fever and mucositis and other PT； PT such as pneumonia， sepsis， vitreous hemorrhage， chorioretinal atrophy， myelodysplastic syndrome were not recorded in drug instructions. The ADR signals with high signal strength ranking included choroidal dystrophy， chorioretinal atrophy， eyeball atrophy and other PT， and above three types of PT were not included in the drug instructions. CONCLUSIONS ADRs caused by melphalan mainly include blood and lymphatic system diseases， eye organ diseases， and infectious and invasive diseases； before using melphalan， it is necessary to evaluate the drug use of patients， and pay close attention to the patient’s blood indicators and eye toxicity reaction， so as to guarantee the safety of treatment. |
| 期刊： | 2023年第34卷第12期 |
| 作者： | 狄潘潘；梁海；王杰；胡云飞；贾淑云 |
| AUTHORS： | DI Panpan，LIANG Hai，WANG Jie，HU Yunfei，JIA Shuyun |
| 关键字： | 美法仑；美国FDA不良事件报告系统；药物不良反应；数据挖掘；比值失衡法 |
| KEYWORDS： | melphalan； FAERS database； adverse drug reactions； data mining； disproportional method |
| 阅读数： | 234 次 |
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