中药注射剂不良反应103例回顾性分析

目的：探讨中药注射剂不良反应（ ADR）发生的规律及特点，为安全合理使用中药注射剂提供参考。方法对安徽省淮南新华医疗集团新华医院2010年1月至2013年12月663例ADR报告进行归纳整理，其中103例中药注射剂ADR报告，按患者年龄、性别、给药途径、报告来源、评价、临床表现、ADR涉及系统/器官等方面进行统计、分析。结果103例ADR报告中，共涉及26种药品，均为静脉给药方式，有90例（87.37％）发生在用药30 min 以内，男女性别比例为60：43，60岁以上老年患者 ADR 发生率最高（54.37％），以皮肤及附件损害为主（35例，33．98％），灯盏花素ADR例数最多（15例，14．56％）。结论应坚持开展中药注射剂ADR监测与上市后再评价，规范、合理使用中药注射剂，保障用药安全。

An retrospective analysis of adverse drug reaction in 103 cases of traditional Chinese medicine injection

Objective To understand the rules and characteristics of adverse drug reaction （ ADR） in Xinhua Hospital of Xinhua Medical Group （ Huainan City Anhui Province ）′s traditional Chinese medicine （ TCM） injection ca-ses,and to provide reference for rational and safety usage of TCM injection .Methods Reorganization was preformed on 663 cases of ADR report from January 2010 to November 2013 in this hospital .We selected 103 cases of TCM in-jection′s ADR reports,and made statistics and analysis according to patients′age,sex,drug source,report source,eval-uation,clinical features,system and organ ADR involved,etc.Results 103 cases of ADR reports involved in 26 kinds of drugs.All of them were vein medication .87.37%of the above cases were happened in 30 minutes with gender ratio of 60：43.54.36%were old patients over 60 with the highest incidence rate .33.98%were skin and appendages dis-orders.14.56%were Breviscapine ADR reports which was the most one .Conclusion It must insist on monitoring ADR of TCM injection and re-evaluation of market products ,to use TCM injection normative and rational ,and guaran-tee the medication security .