| 纵尚尚,杨小娟,高茂威,等.拉罗尼酶治疗黏多糖贮积症 Ⅰ型药品潜在不良事件的挖掘与分析[J].安徽医药,2024,28(5):1044-1050. |
| 拉罗尼酶治疗黏多糖贮积症 Ⅰ型药品潜在不良事件的挖掘与分析 |
| Mining and analysis of potential adverse events of aldurazyme in the treatment of mucopoly. saccharidosis type I |
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| DOI：10.3969/j.issn.1009-6469.2024.05.041 |
| 中文关键词: 拉罗尼酶 黏脂质累积病 黏多糖贮积症 Ⅰ 美国食品药品监督管理局不良事件系统 药品不良反应 风险信号 数据挖掘 |
| 英文关键词: Aldurazyme Mucolipidoses Mucopolysaccharidosis type Ⅰ FDA adverse event reporting system Adverse drugs events Risk signals Data mining |
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| 中文摘要: |
| 目的为临床合理安全的使用拉罗尼酶提供参考依据。方法通过对美国 FDA不良事件报告系统( FAERS)进行拉罗尼酶的药品不良事件的风险信号挖掘，采用比值比法( ROR)和综合标准法(MHRA)对所挖掘出的拉罗尼酶不良事件风险信号进行整理与分析。结果共挖掘出拉罗尼酶不良事件 2 795例，男性占 1 272例( 45.5%)与女性 1 242例( 44.4%)男女比例基本持平；数据上报人员主要是医护工作者( 1455例，占 52.1%)和消费者( 1 314例，占 47.0%)； AE报告中病人年龄2岁，以下 445例( 12.3%)2~17岁 1 191例( 42.6%)>17~64岁 638例( 22.8%)；全部 AE事件中死亡病例 526例( 18.9%)。共挖掘不良事件信号 61个，映射，15个系统器官分类( SOC)，。发热、肺炎、呕吐、呼吸困难、咳嗽、不适、荨麻疹及呼吸衰竭等为主要首选术语( PT)信号。结论基于 FARES数据库的挖掘分析可为临床合理安全的使用拉罗尼酶提供依据；拉罗尼酶应用的安全性及有效性仍需要进行长期研究，以确定其对生存和生活质量的全面影响。 |
| 英文摘要: |
| Objective To provide reference for the rational and safe use of aldurazyme in clinical practice.Methods By mining therisk signals of adverse events (AE) of aldurazyme in the FDA Adverse Event Reporting System (FAERS), the risk signals of adverseevents of aldurazyme were analyzed by the odds ratio method (ROR) and the comprehensive standard method (MHRA).Results In this study,2 795 cases of adverse events of aldurazyme were discovered, of which 1 272 cases were male (45.5%) and 1 242 cases were fe-male (44.4%), and the ratio of male to female was basically the same. Data reporting personnel were mainly medical workers (1 455 cas-es, accounting for 52.1%) and consumers (1 314 cases, accounting for 47.0%). In the AE report, 445 patients were under 2 years old(12.3%),1 191 patients were aged 2-17 (42.6%) and 638 patients were aged >17-64 (22.8%). There were 526 deaths (18.9%). A total of61 adverse event signals were mined and 15 system organ classification (SOC) were mapped. Fever, pneumonia, vomiting, dyspnea,cough, malaise, urticaria and respiratory failure were the main preferred term (PT) signals. Conclusions Mining analysis based onFARES database can provide a basis for rational and safe clinical use of aldurazyme.The safety and effectiveness of aldurazyme applica-tion still need long-term research to determine its overall impact on survival and quality of life. |
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