拉考沙胺的药物不良事件信号挖掘与分析 点击下载
| 论文标题： | 拉考沙胺的药物不良事件信号挖掘与分析 |
| 英文标题： | |
| 中文摘要： | 目的 挖掘拉考沙胺的药物不良事件（ADE）信号，为临床安全用药提供参考。方法收集美国FDA不良事件报告系统2009年1月1日－2022年12月31日上报的拉考沙胺ADE数据，采用报告比值比法和贝叶斯可信区间递进神经网络法进行数据挖掘，利用《国际医学用语词典》（25.0版）ADE术语集中的系统器官分类（SOC）、首选术语（PT）进行分类统计。结果共得到拉考沙胺ADE报告21360份，包含203个ADE信号，涉及24个SOC，其中19个信号未被其药品说明书记录。发生频次排名前5位的PT分别为用药过量、装置使用过程中的技术性错误、产品使用问题、有意误用产品、治疗中断；信号强度排名前5位的PT分别为癫痫表现类型变化、先天性口角降肌发育不全、多重耐药性、脑手术、迷走神经刺激器植入。其药品说明书未记录的ADE包括先天性口角降肌发育不全、多重耐药性、线粒体DNA突变、分裂性身份识别障碍、先天性外耳异常等。结论对于拉考沙胺发生频次多且药品说明书已记录的ADE，如心动过缓、房室传导阻滞等，临床在治疗期间应根据患者情况适时调整剂量，避免出现严重的ADE；对于新的可疑的ADE（如先天性口角降肌发育不全、线粒体DNA突变、过熟儿、分裂性身份识别障碍、色素尿、行为障碍、分离性障碍等）应警惕和识别，以确保患者用药安全。 |
| 英文摘要： | OBJECTIVE To mine adverse drug event （ADE） signals of lacosamide， and to provide references for clinically safe drug use. METHODS ADE data for lacosamide reported to the United States FDA adverse event reporting system from January 1， 2009， to December 31， 2022， were collected. Data mining was conducted using the reporting odds ratio method and Bayesian confidence propagation neural network method. Classification statistics were performed using the system organ class （SOC） and preferred terms （PT） from ADE terminology set of Medical Dictionary for Regulatory Activities （Version 25.0）. RESULTS A total of 21 360 lacosamide ADE reports were received， identifying 203 ADE signals across 24 SOCs， with 19 signals not included in the drug’s instruction. The top five PTs ranked by occurrence frequency were medication overdose， technical errors during device use， product use issues， intentional product misuse， and therapy discontinuation. The top five PTs ranked by signal strength were changes in seizure presentation type， congenital hypoplasia of depressor anguli oris muscle， multidrug resistance， brain surgery， and vagus nerve stimulator implantation. ADEs not recorded in the drug instruction included congenital hypoplasia of depressor anguli oris muscle， multidrug resistance， mitochondrial DNA mutation， dissociative identity disorder， and congenital auricular anomaly. CONCLUSIONS For lacosamide-induced ADEs that occur frequently and are already listed in the drug’s instructions， such as bradycardia and atrioventricular block， the clinical application should be careful and attentive， adjusting the dosage timely according to the patient’s condition to avoid severe ADEs. Newly discovered suspect ADEs， such as congenital hypoplasia of depressor anguli oris muscle， mitochondrial DNA mutation， overmature infant， dissociative identity disorder， pigmenturia， behavioral disorders， and dissociative disorders， should be vigilantly recognized to ensure the safety of drug use. |
| 期刊： | 2024年第35卷第10期 |
| 作者： | 尹悦勤；周朱珺；李成敏；徐妮；娄月芬 |
| 英文作者： | YIN Yueqin，ZHOU Zhujun，LI Chengmin，XU Ni，LOU Yuefen |
| 关键字： | 拉考沙胺；药物不良事件；药物不良反应；信号挖掘 |
| KEYWORDS： | lacosamide； adverse drug events； adverse drug reaction； signal detection |
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