复方利血平氨苯蝶啶片不良反应自发报告分析  

Analysis of spontaneous reports adverse drug reactions induced by compound reserpine and triamterene tablets

作　　者：方振威[1] 赵翊如 张泽华 刘嵘捷 林阳[1] FANG Zhen-wei;ZHAO Yi-ru;ZHANG Ze-hua;LIU Rong-jie;LIN Yang(Department of Pharmacy,Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China;Department of Clinical Pharmacy,School of Pharmaceutical Sciences,Capital Medical University,Beijing 100069,China;China Resources Double-Crane Pharmaceutical Co.,Ltd.Pharmacovigi-lance Department,Beijing 100121,China)

机构地区：[1]首都医科大学附属北京安贞医院药事部,北京100029 [2]首都医科大学药学院临床药学系,北京100069 [3]华润双鹤药业股份有限公司药物警戒管理部,北京100121

出　　处：《临床药物治疗杂志》2024年第1期42-45,共4页Clinical Medication Journal

摘　　要：目的分析复方利血平氨苯蝶啶片不良反应(ADR)自发报告数据,为临床安全用药提供参考。方法检索2014年1月至2022年10月国家不良反应监测中心收集的复方利血平氨苯蝶啶片ADR报告,对报告中性别、年龄、累及系统器官及临床表现、严重ADR等信息进行统计分析。结果近9年共收到6104例ADR报告,男女比例为1.20∶1,65岁以下与65岁以上比例为1.57∶1。6104例报告合计报道9569例次事件,主要累及的系统器官为神经系统(2792例,占29.18%)、胃肠系统(2779例,占29.04%)和全身性疾病及给药部位反应(1462例,占15.28%),主要临床表现为恶心(1601例,占16.73%)、头晕(1078例,占11.27%)和乏力(1062例,占11.10%)。在6104例ADR中,严重165例(2.70%)、低血压相关102例(1.67%)、抑郁相关43例(0.70%)、胃肠出血相关14例(0.23%)、心动过缓相关6例(0.10%)。结论复方利血平氨苯蝶啶片安全性良好,在真实世界中所致ADR的临床表现主要为恶心、头晕、乏力,同时低血压、抑郁、胃肠出血、心动过缓相关ADR报告占比极低。Objective To analyze the spontaneous reports of adverse drug reactions(ADRs)induced by compound reser⁃prine and triamterene tablets to understand the characteristics of their ADRs,thereby providing references for the clinically safe use of these drugs.Methods ADR reports of compound reserpine and triamterene tablets collected by the National Center for ADR Monitoring between January 2014 and October 2022 were retrieved and sorted out.Statistical analysis was performed on gender,age,system organ class affected,clinical manifestation,and serious cases of the ADRs.Results In the past nine years,a total of 6104 ADR reports were received.The ratio of male to female was 1.20∶1 and below 65 years old to above 65 years,old was 1.57∶1.A total of 9569 events were reported in 6104 cases,mainly involving the nervous system(2792,29.18%),gastrointestinal system(2779,29.04%)and general disorders(1462,15.28%).The main clinical manifestations were nausea(1601,16.73%),dizziness(1078,11.27%)and fatigue(1062,11.10%).There were 165 severe ADR reports(2.70%),102 ADR reports were related to hypotension(1.67%),43 ADR reports were related to depression(0.70%),14 ADR reports were related to gastrointestinal bleeding(0.23%),and 6 ADR reports related to bradycardia(0.10%),in a total of 6104 reports.Conclusion The compound reserpine and triamterene tablets have good safety.In the real world,the clinical manifestations of ADRs caused by compound reserpine and triamterene tablets mainly include nausea,dizziness,and fatigue,while reports of hypotension,depression,gastrointestinal bleeding and bradycardia are extremely low in proportion.

关 键 词：复方利血平氨苯蝶啶片 不良反应 安全性 

分 类 号：R969.3[医药卫生—药理学] R972.4[医药卫生—药学]