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基于FAERS数据库的7类液体治疗药品的安全信号挖掘
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| 篇名： | 基于FAERS数据库的7类液体治疗药品的安全信号挖掘 |
| TITLE： | Safety Signal Mining for 7 Kinds of Fluid Therapy Drug Based on FAERS Database |
| 摘要： | 目的：基于美国FDA不良事件报告系统（FAERS），对液体治疗常用的7类药品（普通林格液、乳酸林格液、醋酸林格液、羟乙基淀粉、琥珀酰明胶、右旋糖酐、人血白蛋白）相关的不良事件进行数据挖掘，为临床液体治疗药品的安全使用提供参考。方法：在FAERS数据库中下载2004年第1季度－2019年第4季度共64个季度的相关数据，经数据清洗后，提取以7类常用液体治疗药品为首要怀疑药品及次要怀疑药品的不良事件报告病例，利用报告比值比法（ROR）和比例报告比值法（PRR）进行不良事件信号挖掘。结果：共提取到相关报告病例2383例，其中普通林格液26例（占1.09％）、乳酸林格液479例（占20.10％）、醋酸林格液65例（占2.73％）、羟乙基淀粉256例（占10.74％）、琥珀酰明胶79例（占3.32％）、右旋糖酐154例（占6.46％）、人血白蛋白1324例（占55.56％）；男性879例（占36.89％），女性985例（占41.33％），其他不详；年龄主要在18～64岁（950例，占39.87％）；报告者以医师为主（634例，占26.60％）。382例（占16.03％）病例死亡。各类液体治疗药品的不良事件报告中，乳酸林格液（70例，占14.61％）与人血白蛋白（259例，19.56％）死亡病例占比最高。各类药品报告例数排名前3位的不良事件多为免疫系统疾病、心脏器官疾病及血管与淋巴管类疾病。结论：液体治疗药品的不良事件主要与免疫系统和心脏器官有关。在治疗过程中，尤其是对存在过敏史以及心脏基础疾病的患者，应加强监测患者容量指标；在使用胶体注射液治疗过程中，还应重点关注肾脏及泌尿系统相关不良事件、密切监测肾功能。 |
| ABSTRACT： | OBJECTIVE：To mine t he data of adverse even ts of 7 kinds of commonly used fluid therapy drugs （normal Ringer ’ s solution ，Ringer’s lactate solution ，Ringer’s acetate solution ，hydroxyethyl starch ，succinylated gelatin ，dextran and human albumin） based on FAERS database of FDA ，in order to provide reference for carrying out fluid therapy in clinic safely. METHODS：Data from the first quarter of 2004 to the fourth quarter of 2019（64 quarters）in FAERS database were downloaded. After data cleaning ，adverse drug event report cases related to 7 kinds of fluid therapy drug as the primary and secondary suspected drugs were extracted ，and ADR signal was mined by using the reporting odds ratio method （ROR）and the proportional reporting ratio method （PRR）. RESULTS ：A total of 2 383 adverse event reports were extracted ，including 26 reports（1.09％）of normal Ringer’s solution ，479 reports（20.10％）of Ringer ’s lactate solution ，65 reports（2.73％）of Ringer ’s acetate solution ，256 reports （10.74％）of hydroxyethyl starch ，79 reports（3.32％）of succinylated gelatin ，154 reports（6.46％）of dextran ，1 324 reports （55.56％）of human albumin. Totally 879 cases（36.89％）were male and 985 cases（41.33％）were female ，the rest were unknown. The main age was 18-64 years old （950 cases，39.87％）；most of the reporters were doctors （634 cases，26.60％）. Totally 382 cases（16.03％）died. Among the adverse event reports of fluid therapy drugs ，70 cases（14.61％）administered Ringer ’s lactated solution and 259 cases（19.56％）administered human albumin died. Among them ，the top three adverse events in the number of reports were immune system diseases ，heart organ diseases ，vascular and lymphatic diseases. CONCLUSIONS ：ADRs of fluid therapy drugs are mainly related to immune system and heart organ. In the process of them ，especially for patients with allergic history and heart disease ，patients’volume indicators should be closely monitored ；during fluid therapy ，especially during the use of colloids ， great importance should be attached to renal and urinary system related adverse events ， and renal function should be closely monitored . |
| 期刊： | 2021年第32卷第05期 |
| 作者： | 李丹，吴斌，徐珽 |
| AUTHORS： | LI Dan ，WU Bin ，XU Ting |
| 关键字： | 液体治疗；美国FDA；不良事件报告系统；数据挖掘 |
| KEYWORDS： | Fluid therapy ；FDA；Adverse event reporting |
| 阅读数： | 726 次 |
| 本月下载数： | 30 次 |
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