2004-2013年5 703例复方氨基酸注射液(18AA)致不良反应/不良事件报告分析
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篇名: 2004-2013年5 703例复方氨基酸注射液(18AA)致不良反应/不良事件报告分析
TITLE:
摘要: 目的:探讨复方氨基酸注射液(18AA)致不良反应(ADR)/不良事件(ADE)的特点及规律,为临床合理用药提供参考。方法:采用回顾性研究方法,对2004年1月1日-2013年12月31日期间国家ADR监测系统数据库中收集的5 703例有效的复方氨基酸注射液(18AA)致ADR/ADE报告进行统计和分析。结果:5 703例ADR/ADE中,男性2 436例,女性3 265例,2例性别不详;ADR/ADE报告例数随患者年龄的增长逐步增加,60岁以上患者的报告例数占比最高(35.42%);ADR/ADE多数发生在用药30 min内(44.24%),其次是30 min~1 h(32.05%);ADR/ADE主要累及胃肠系统(32.76%),其次是全身性损害(25.01%);284例病例存在违反禁忌证用药(4.98%)。采用报告比值比法共生成风险信号3个,分别是头晕、过敏样反应和过敏性休克;采用χ2检验法共生成风险信号4个,分别是头晕、胸闷、过敏样反应和过敏性休克。结论:临床上应加强对复方氨基酸注射液(18AA)ADR/ADE的预防和风险信号监测,避免不合理用药,减少和防止相关ADR/ADE的重复发生。
ABSTRACT: OBJECTIVE:To investigate the characteristics and regularities of the adverse drug reaction/event (ADR/ADE) induced by Compound amino acid injection (l8AA), and to provide reference for clinical rational use of drugs. METHODS: A retrospective study was conducted to statistically analyze the 5 703 effective ADR/ADE reports induced by Compound amino acid injection (l8AA) collected by national ADR monitoring system from Jan. 1, 2004 to Dec. 31, 2013. RESULTS:In the 5 703 ADR/ADE reports, there were 2 436 cases of male, 3 265 cases of female, 2 cases of unknown gender; the ADR/ADE reports were gradually increased with the growth of patients’ age, especially the patients over 60 years old held the highest proportion (35.42%); the ADR/ADE most occurred in drug using within 30 minute (44.24%) followed by 30 min-1 h (32.05%); and the ADR/ADE mainly involved the gastrointestinal system damage(32.76%), followed by systemic damage (25.01%); moreover, there were 284 cases who using the drug against the contraindications (4.98%). Reporting odds ratio method showed 3 risk signals, including dizziness, allergic-like reactions and anaphylactic shock; Chi-square test method showed 4 risk signals, including dizziness, chest tightness, allergic-like reactions and anaphylactic shock. CONCLUSIONS: Clinic should strengthen prevention and signals monitoring of ADR/ADE induced by Compound amino acid injection (l8AA) to avoid irrational drug use, reduce and prevent the recurrence of ADR/ADE.  
期刊: 2016年第27卷第9期
作者: 李文武,王长之,马雪皎,刘超,刘伟,张惠霞
AUTHORS: LI Wenwu,WANG Changzhi,MA Xuejiao,LIU Chao,LIU Wei,ZHANG Huixia
关键字: 复方氨基酸注射液(18AA);不良反应/不良事件;报告;分析;风险信号
KEYWORDS: Compound amino acid injection (l8AA); Adverse reaction/event; Report; Analysis; Risk signal
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