山东省8566例新的药品不良反应报告分析
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篇名: 山东省8566例新的药品不良反应报告分析
TITLE: Analysis of 8 566 New ADR Reports in Shandong Province
摘要: 目的:了解山东省新的药品不良反应(ADR)发生的现状及特点,为保障患者用药安全提供参考。方法:调取2019年10月-2020年3月上报至山东省ADR监测中心自发呈报系统新的ADR报告的相关数据,对报告类型、上报机构、报告人职业和患者性别、年龄、药物类型、累及器官/系统、临床表现等情况进行统计分析。结果与结论:共筛选出新的ADR报告8566例,占有效ADR的10.81%;其中新的一般的ADR有7961例(占92.94%),新的严重的ADR有605例(占7.06%)。新的ADR中,上报机构以医疗机构(占98.42%)为主,报告人职业以医师(占78.44%)为主;女性(4860例)略多于男性(3698例),45岁及以上人群(占70.00%)居多;静脉滴注(占47.67%)为主要给药途径。新的ADR怀疑药品排名前5位的药品类别依次为中药制剂(34.50%)、抗微生物药物(13.75%)、循环系统用药(11.41%)、神经系统用药(6.39%)、血液系统药物(4.81%),分别涉及517、91、64、53、50个品种,其中左氧氟沙星注射液致新的严重的ADR数量最多(24例)。新的一般的ADR主要累及胃肠系统、皮肤及其附件,临床表现为恶心、呕吐、皮疹等;新的严重的ADR主要造成全身性损害,临床表现为过敏性休克、胸闷、寒战等。建议临床加强对中药制剂、抗微生物药物、循环系统用药等药物的ADR监测,保障患者临床用药安全。
ABSTRACT: OBJECTIVE:To investigate the occurrence and characteristics of new adverse drug reactions (ADR)in Shandong province,so as to provide reference for the safety of drug use in the clinic. METHODS :The data of new ADR reports were collected from Spontaneous Reporting System of Shandong ADR Monitoring Center during Oct. 2019 to Mar. 2020. Those reports were analyzed statistically in respects of report types ,reporting institution ,reporters’occupation,gender and age of patients ,drug type ,organs/ systems involved ,clinical manifestations. RESULTS & CONCLUSIONS :A total of 8 566 new ADR reports were screened out , accounting for 10.81% of the effective ADRs. Among them ,there were 7 961 new and general ADR (92.94%)and 605 new and serious ADRs (7.06%). For the new ADR ,the reporting institutions were mainly medical institutions (98.42%),and the reporters ’ occupation were mainly doctors (78.44%). Female (4 860 cases)was slightly more than male (3 698 cases);most of them were 45 years old and above (70.00%),and intravenous drip (47.67%)was the main route of administration. The top five ADR suspected drugs were TCM preparations (34.50%),anti-microbials(13.75%),circulatory system drugs (11.41%),nervous system drugs (6.39%)and blood system drugs (4.81%),involving 517,91,64,53,50 types,respectively,among which Levofloxacin injection caused the most serious ADR (24 cases). The new and general ADR mainly involved gastrointestinal system ,skin and its appendant ; their clinical manifestations were nausea ,vomiting,rash,etc. New and serious ADR mainly caused systemic damage ;their clinical manifestations were anaphylactic shock ,chest tightness and shivering ,etc. It is suggested to strengthen the ADR monitoring of TCM preparations,anti-microbials,circulatory system drugs and other drugs ,so as to ensure the safety of clinical drug use.
期刊: 2021年第32卷第04期
作者: 刘宝生,周秀丽,宫凯凯
AUTHORS: LIU Baosheng ,ZHOU Xiuli,GONG Kaikai
关键字: 山东省;新的;药品不良反应;报告分析;用药安全
KEYWORDS: Shandong province ;New;Adverse drug reactions ;Report analysis ;Safety of drug u se
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