100例中药注射剂不良反应/事件分析

Analysis of 100 Adverse Drug Reactions/Events Induced by Traditional Chinese Medicine Injections

目的探讨中药注射剂不良反应/事件发生的特点,为临床合理用药提供参考。方法采用回顾性分析方法对2004年1月至2008年8月山东省淄博市药品不良反应监测中心收到的100例中药注射剂不良反应/事件报告表进行统计分析。结果100例中药注射剂不良反应/事件报告中,0～9岁年龄组发生不良反应/事件33例,比例最高;患者不良反应/事件以全身性损害最为常见。结论临床应慎用中药注射剂,加强对中药注射剂不良反应/事件的监测,提高临床用药安全。

Objective Analyzed serious adverse drug reaction/events（ADR/ADE） of Traditional Chi- nese Medicine（TCM） injections to provide the references information for rational drug in clinical practice. Methods 100 serious ADR/ADE reports of TCM injections collected by Zibo Center for ADR/ADE Monitoring fi：om January 2004 to August 2008 were analyzed using retrospective study method. Results Higher ADR/ADE occurrence is observed in children than other age groups.The main symptoms of ADR/ADE were found in the body as a whole-general disorders. Conclusion ADR/ADE caused by TCM injections should be con-cerned, and ADR/ADE should be intensively monitored and treated timely.