基于美国FDA不良事件数据库的注射用紫杉醇(白蛋白结合型)不良反应信号挖掘
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篇名: | 基于美国FDA不良事件数据库的注射用紫杉醇(白蛋白结合型)不良反应信号挖掘 |
TITLE: | ADR Signal Mining of Paclitaxel for Injection (Albumin-bound Type )Based on FDA Adverse Event Database |
摘要: | 目的:利用美国FDA不良事件报告系统(FAERS)数据库挖掘注射用紫杉醇(白蛋白结合型)的药品不良反应信号,为其临床安全合理用药提供参考。方法:采用报告比值比(ROR)法对美国FDA公共数据开放项目(Open-FDA)数据库中于2004年1月1日-2019年12月31日上报的的注射用紫杉醇(白蛋白结合型)的不良事件进行数据挖掘,分析不良事件涉及的人口学特征、不良反应构成和信号。结果:注射用紫杉醇(白蛋白结合型)的不良事件报告数分别为1659例,其中女性(1169例,占70.5%)多于男性(345例,占20.8%);年龄主要在45~64岁(519例,占31.3%)。该药的不良反应信号主要集中在神经系统、血液及淋巴系统、胃肠系统、肝胆系统、呼吸系统、胸及纵隔系统和全身性不良反应。分析发现了药品说明书未记载的阳性不良反应信号20个,包括白细胞减少、淋巴细胞减少、黄斑水肿、腹痛、吞咽困难、寒战、黄疸、肝衰竭、肝硬化、尿路感染、脓性分泌物、射血分数降低、低钙血症、低钾血症、低钠血症、骨痛、面瘫、精神状态变化、鼻出血、肺不张等,其中淋巴细胞减少、黄斑水肿、精神状态改变并未记录在该药的药品说明书中,其他则为药品说明书中已记录的不良反应的具体表现。结论:临床应用注射用紫杉醇(白蛋白结合型)时,除药品说明书中已提到的不良反应外,还应密切关注其神经毒性、淋巴细胞变化并定期进行眼部与精神状态监测,以避免因不良反应导致的停药或造成患者器官损害。 |
ABSTRACT: | OBJECTIVE:To utilize ADR signal of Paclitaxel for injection (albumin-bound type )by using FDA adverse event reporting system (FAERS),and to provide reference for rational use of drugs in the clinic. METHODS :The reporting odds ratio (ROR)method was used for data mining of adverse events (AEs)related to Paclitaxel for injection (albumin-bound type )reported by FDA public data program (Open-FDA)during Jan. 1st,2004-Dec. 31th,2019. The demographic characteristics ,constituents and signals of ADR were analyzed. RESULTS :A total of 1 659 AEs were identified for Paclitaxel for injection (albumin-bound type). The female (1 169 cases,70.5%)was more than the male (345 cases,20.8%). The age was mainly 45-64 years old (519 cases,31.3%). ADR signal mainly involved nerve system ,blood and lymphatic system ,gastrointestinal system ,hepatobiliary system,respiratory system ,thoracic and mediastinal system and general ADR. Twenty positive ADR signals which were not recorded in the drug instructions were found in the study ,mainly including leucopenia ,lymphopenia,macular edema ,abdominal pain,dysphagia,shivering,jaundice,liver failure ,cirrhosis,urinary tract infection ,purulent secretion ,decreased ejection fraction,hypocalcemia,hypokalemia,hyponatremia,bone pain ,facial paralysis ,mental state change ,epistaxis,atelectasis. Among them ,lymphopenia,macular edema and mental state changes were not recorded in the drug instructions ,while others were the specific manifestations of ADR recorded in the drug instructions. CONCLUSIONS :In the clinical application of Paclitaxel for injection(albumin-bound type ),in addition to ADR mentioned in the drug instructions ,great importance should be closely paid to neurotoxicity,lymphocyte changes ,regular eye monitoring 2021MSXM041) and mental state monitoring ,so as to avoid drug withdrawal or organ injury induced by ADR. |
期刊: | 2021年第32卷第03期 |
作者: | 王郁薇,蒙龙,刘箫 |
AUTHORS: | WANG Yuwei ,MENG Long,LIU Xiao |
关键字: | 注射用紫杉醇(白蛋白结合型);美国 FDA不良事件报告系统;不良事件;药品不良反应;信号挖掘 |
KEYWORDS: | Paclitaxel for injection (albumin-bound |
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