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基于美国FAERS数据库挖掘与分析阿伐替尼ADE信号
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| 篇名： | 基于美国FAERS数据库挖掘与分析阿伐替尼ADE信号 |
| TITLE： | Mining and analysis of the ADE signals of avapritinib based on FAERS database |
| 摘要： | 目的 为阿伐替尼的临床安全应用提供参考。方法从美国FAERS数据库收集2020年1月9日至2022年9月30日关于阿伐替尼的药品不良事件（ADE）报告，采用比例失衡法中的报告比值比法和比例报告比法进行数据挖掘与分析。结果共收集到以阿伐替尼为首要怀疑药物的ADE报告10895份，排除无效信号后得到201个ADE信号，涉及19个系统器官分类。耳鸣、痴呆、四肢厥冷、血铁减少、血糖下降、发热、维生素D下降、维生素B12下降等ADE，以及肌肉骨骼及结缔组织疾病、生殖系统及乳腺疾病这2个SOC中的所有ADE均未被该药的药品说明书收载。用药信息完整的ADE报告有670份，以神经系统（230份，占34.33%）和眼器官（277份，占41.34%）的ADE报告占比较大。与其他系统相比，日剂量和用药疗程对神经系统及眼器官ADE的影响显著（P＜0.05），患者年龄对神经系统ADE的影响显著（P＜0.05）。结论年龄≥65岁、日剂量300mg/d、用药疗程31～90d的患者使用阿伐替尼后发生神经系统ADE的风险较高；而日剂量300mg/d、用药疗程31～90d的患者还容易发生眼器官ADE。临床在使用阿伐替尼过程中，应重点关注患者眼部、神经系统方面的异常表现，并及时予以干预。 |
| ABSTRACT： | OBJECTIVE To provide reference for clinically safe application of avapritinib. METHODS The adverse drug event （ADE） reports of avapritinib from January 9th，2020，to September 30th，2022 were collected from FDA Adverse Event Reporting System （FAERS） database. For data mining and analysis，reporting odds ratio （ROR） method and proportional reporting ratio （PRR） method in the proportional imbalance method were utilized. RESULTS A total of 10 895 ADE reports with avapritinib as the main suspect drug were gathered，and 201 ADE signals involving 19 systematic organ classifications were found after eliminating invalid signals. The instruction of the drugs did not mention any of the ADE，including tinnitus，dementia，chilly limbs， the reduction of blood iron，the reduction of blood sugar，fever，the reduction of vitamin D and vitamin B12，as well as all ADE in the 2 SOCs of musculoskeletal and connective tissue illnesses，diseases of the reproductive system，and diseases of the breast. The majority of the ADE reports 670 cases with complete drug information were for the nervous system （230 cases，accounting for 34.33%） and ocular organ （277 cases，accounting for 41.34%）. Compared with other systems，daily dose and treatment course showed significant effects on ADE of neurological system and ocular organ （P＜0.05），and the patient’s age had a significant impact on the ADE of the nervous system （P＜0.05）. CONCLUSIONS A greater incidence of ADE after using avapritinib is present in patients older than 65 with a daily dose of 300 mg/d and a treatment period lasting between 31 and 90 days； patients receiving a daily dose of 300 mg/d and a treatment regimen lasting 31 to 90 days are more likely to experience ADE of the ocular organ. Attention should be given to the aberrant symptoms of the patient’s eyes and nervous system throughout clinical use of avapritinib，and prompt intervention should be given. |
| 期刊： | 2023年第34卷第13期 |
| 作者： | 胡颖；李建萍；唐斌；丁乔 |
| AUTHORS： | HU Ying，LI Jianping，TANG Bin，DING Qiao |
| 关键字： | 阿伐替尼；药品不良事件；比例失衡法；信号挖掘；药物不良反应 |
| KEYWORDS： | avapritinib； adverse drug event； proportional imbalance method； signal mining； adverse drug reaction |
| 阅读数： | 192 次 |
| 本月下载数： | 9 次 |
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