基于FAERS的罗米司亭和艾曲泊帕ADE信号挖掘与分析 点击下载
| 论文标题： | 基于FAERS的罗米司亭和艾曲泊帕ADE信号挖掘与分析 |
| 英文标题： | |
| 中文摘要： | 目的 为临床安全使用血小板生成素受体激动剂类药物罗米司亭和艾曲泊帕提供参考。方法利用美国FDA不良事件报告系统（FAERS）收集罗米司亭和艾曲泊帕从在美国上市至2022年9月30日的药物不良事件（ADE）报告，利用报告比值比（ROR）法与英国药品和健康产品管理局的综合标准法对2种药物的ADE信号进行分析。结果共收集到罗米司亭和艾曲泊帕的ADE报告分别为14021、4431份，性别构成均为女性多于男性。经信号筛选，得到罗米司亭563个ADE信号，累及25个系统器官分类（SOC）；艾曲泊帕433个ADE信号，累及26个SOC。2种药物发生频次最多的ADE信号均为血小板计数降低（分别为2060、1585例），在其药品说明书中均有记载；按信号强度排序，罗米司亭的血小板生成素水平异常（ROR值为2268.85）和艾曲泊帕的登革病毒检测阳性（ROR值为954.50）位列第一，且均未被其药品说明书记载。结论罗米司亭和艾曲泊帕的ADE主要累及血液及淋巴系统，且新的可疑高风险信号较多。 |
| 英文摘要： | OBJECTIVE To provide a reference for the safe use of thrombopoietin receptor agonists romiplostim and eltrombopag in clinic. METHODS FDA adverse event reporting system （FAERS） in the United States was adopted to collect adverse drug event （ADE） reports of romiplostim and eltrombopag from their launch in the United States to September 30， 2022； the ADE signals of the two drugs were analyzed using the reporting odds ratio （ROR） method and the comprehensive standard method of the UK Medicines and Healthcare Products Regulatory Agency. RESULTS A total of 14 021 and 4 431 ADE reports were collected about romiplostim and eltrombopag， respectively， with a gender composition of more females than males. After signal screening， 563 ADE signals were obtained about romiplostim， involving 25 system organ classes （SOC）； eltrombopag had 433 ADE signals， involving 26 SOC. The most frequently reported ADE for both drugs was platelet count decreased （2 060， 1 585 cases）， which was mentioned in their drug instructions. In terms of signal intensity， romiplostim exhibited the highest signal for abnormal thrombopoietin levels （ROR of 2 268.85）， while eltrombopag had the highest signal for positive dengue virus test （ROR of 954.50）， with neither of these signals mentioned in their respective drug instructions. CONCLUSIONS The ADE of romiplostim and eltrombopag mainly affects the blood and lymphatic system， and there are many new suspicious high-risk signals. |
| 期刊： | 2023年第34卷第19期 |
| 作者： | 邵鑫；蒋先虹；尤俊；刘易陇 |
| 英文作者： | SHAO Xin，JIANG Xianhong，YOU Jun，LIU Yilong |
| 关键字： | 罗米司亭；艾曲泊帕；药品不良事件；信号挖掘；报告比值比法；综合标准法 |
| KEYWORDS： | romiplostim； eltrombopag； adverse drug event； signal mining； reporting odds ratio method； comprehensive |
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| 文件大小： | 619.60Kb |
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