中药注射剂不良反应及其发生原因分析

Analysis on adverse reaction and its reasons of traditional Chinese medicine injection

目的对2750例中药注射剂药品的不良反应（ADR）进行报告分析,为临床合理用药提供参考依据。方法回顾性分析黄山市药监局统计2011年1月-2013年12月的2750例因中药注射剂出现ADR患者的临床资料,按患者的性别、年龄、引起ADR的药品种类及临床表现等进行统计分析。结果 2750例ADR报告中,40岁以上的人群占83.35%;以静脉滴注给药为主,共2611例（占94.94%）;ADR累及器官或系统以皮肤及其附件损害和心率以及心律紊乱为主,分别为327例、209例。结论应安全合理应用中药注射剂,注意可能发生的中药注射剂ADR,保障公众安全。

Medical College; Objective To analyze 2750 cases of adverse reaction（ADR） report of traditional Chinese medicine injection,and to provide references for clinical rational drug usage. Methods 2750 cases of ADR induced by Chinese medicine injection in Food and Drug Administration of Huangshan City from January 2011 to December 2013 were retrospectively analyzed,the data were analyzed statistically in respect of gender,age,drug classification and clinical manifestation. Results 2750 reports of ADR were analyzed as follows.In all the reports,83.35% of the patients were more than 40 years old,2611 cases were caused by intravenous infusion administration（94.94%）,the main target organs were skin and its appending organ（327 cases） and the clinical manifestation was heart disorder（209 cases）. Conclusion Chinese medicine injection should be used safely and rationally and the potential ADR caused by Chinese medicine injections should be noticed to ensure the safety of the public.