178例中药不良反应/事件分析

摘 要:目的 通过对我院中药不良反应/事件的归纳整理，了解我院中药不良反应/事件的分布状况及特点，以便有针对性地实行监控，促进临床合理用药。方法 对我院自2006年1月至2008年8月上报的178例中药ADR报告进行分类统计和分析。结果 178例中药ADR报告中，女性居多（66.29%），涉及药品105种。178例中，141例（79.21%）发生在开始用药1小时以后；12例(6.74%)发生在开始用药后10分钟内。100例（56.18%）首次用药出现过敏。主要的ADR类型为皮肤及其附件损害；以发生频率排序，前3位均为中药注射剂；中成药的新的ADR共99例（55.62%）。 结论 加强中药不良反应的监控力度，保障患者用药安全。

Retrospective Analysis of 178 Traditional Chinese Medicine ADR/ADE Reports

Objective Analyzed serious adverse drug reaction/event（ADR/ADE） of traditional Chinese medicine （TCM） occurred in our hospital and discuss the related factors of ADR/ADE. Methods 178 ADR reports of TCM collected by our hospital from JUN.2006 to AUG.2008 were analyzed using retrospective study method. Results Among the 178 ADR/ADE reports, 105 kinds of drugs were involved in different dosage forms and specifications, 96 （53.93%） ADR reports were happened in one hour. skin and its adjunct is likely to be the most affected organ, the top three of occurrence frequency in ADR/ADE were injections; and the reports of new ADR/ADE caused by Chinese patent medicine is 99（55.62%）. 11 severe adverse reactions were occurred, and oral drugs accounted for a higher proportion.Conclusion ADR monitoring should be strengthened to improve the rational use of drug.