3430例观察注射用丹参多酚酸冻干粉上市后临床应用安全性

Post-market safety observation on 3430 patients with treatment of Injectable Dan-Shen-Zong-Fen-Suan powder

目的对注射用丹参多酚酸冻干粉的临床应用的安全性进行扩大人群范围的上市后安全性再评价。方法采用观察性研究方法 ,通过2012年7月~2013年7月期间北京中医药大学东直门医院等63家医院的3430例患者的用药情况、患者信息及发生的不良反应。结果共观察记录到,不良反应为16例29例次,发生率为0.466%（16/3430）,其中重度不良反应为0例,中度不良反应为10例次（占全部ADR的34.48%）,轻度不良反应为19例次（占全部ADR的65.52%）。结论注射用丹参多酚酸冻干粉临用应用不良反应发生率低,安全性较高;临床实践的规范性对临床用药安全存在影响,应加强中药注射剂临床应用的监督、培训与指导。

Objective To investigate the safety of Total Salvianolic Acids Powder for Injection （TSAPI） in clinical practice,use of preparation in larger population were post-market re-evaluated. Methods According to a protocol of pro- spective cohort study were was designed and 3430 patients in 63 hospitals were enrolled between July,2012 and July,2013. The patents information,medication,and adverse reactions （ADRs） were recorded during this period. Results Total six- teen patients were recorded as 29 cases of ADRs with incidence of 0. 446% （16/3430）. Of these ADRs,none were was e- valuated as severe, 10 cases were evaluated as moderate （34.48% in total ADRs） , as well as 19 were evaluated as minor （65. 562% in total ADRs）. Conclusion The application of TSAPI in clinical is highly safety due to the low incidence of ADRs. The medication safety would be affected by the normalization of clinical practice. Thus, there is more attentions should be paid in the supervision, staff-training and medication directions of TCM injections.