2004-2013年5703例复方氨基酸注射液(18AA)致不良反应/不良事件报告分析

Analysis on the ADR/ADE Reports Induced by Compound Amino Acid Injection(18AA)from 2004 to 2013

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30min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χ~2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。

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.