93例中药注射剂不良反应分析与原因探讨

目的了解中药注射剂发生不良反应的特点与规律,并分析其原因,为临床合理用药提供参考。方法采用回顾性分析方法,对2010年1月～2012年12月南通市第二人民医院收集到的93例中药注射剂不良反应病例进行统计,并分析引起中药注射剂不良反应的原因,对如何防范中药注射剂的不良反应提出建议。结果 93例中药注射剂不良反应报告共涉及19个品种,其中血塞通注射液发生最多,占15.1%,不良反应的临床表现以皮肤及其附件损害多见,产生中药注射剂不良反应的原因涉及药物制剂质量、患者因素、临床使用、药物研究等多方面的因素。结论应从基础研究、临床使用、上市后再评价等多方面加强对中药注射剂的管理,减少或避免中药注射剂不良反应造成的伤害。

Reasons analysis and evaluation of 93 cases of adverse drug reaction induced by traditional Chinese medicine injection

Objective To analyze the characteristics and the contributing factors of adverse drug reaction（ADR） of the traditional Chinese medicine（TCM） injection and provide alerts for clinical medicine. Methods 93 cases of TCM injection-induced ADR reported in the Second People＇s Hospital of Nantong City from January 2010 to December 2012 were analyzed statistically. Results 19 kinds of drugs were involved,most of which occurred Xiesaitong Injection,amounted to 15.1%. The clinical expression of ADR was showed mostly skin and its appendix harms. The cause of TCM injection-induced ADR related to the quality of pharmaceutical preparations,patient＇s conditions,clinical application,drug research and other factors. Conclusion It is necessary to strengthen the management of TCM injection,and ADR induced by TCM injection should be intensively monitored to avoid personal injury caused by irrational use.