摘要
目的：探索我院开展中药注射剂上市后安全性再评价的研究思路与方法。方法：采用队列内病例-对照研究，以注射用丹参多酚酸盐为例进行实践。选取我院2012年5月至2013年10月1000例使用注射用丹参多酚酸盐的冠心病稳定性心绞痛患者为研究对列，观察其不良反应/不良事件（ADR/ADE）的发生情况，结果采用SPSS 20.0软件进行Logistic回归分析。结果：患者的ADR/ADE发生率为0.6％，均为偶见（0.1％～1％），级别为“一般”，主要表现为皮疹（66.67％），主要累及器官为皮肤及其附件（66.67％）；经Logistic回归分析显示，性别、合并用药、年龄是ADR/ADE发生的危险因素。结论：对中药注射剂进行上市后安全性再评价，不仅弥补了中药注射剂在药品上市前评价的不足，发现可能存在的迟发、严重的ADR/ADE和药物相互作用，还可为临床合理用药提供依据，确保患者安全、合理用药。
OBJECTIVE：To explore the idea and method of post-marketing safety reevaluation of TCM injection in our hospi-tal. METHODS：In case-control study,salvianolate for injection was chosen for practice. 1 000 patients with stable angina receiv-ing Salvianolate for injection in our hospital during May 2012-Oct. 2013 were selected as subjects. The occurrence of ADR/ADE were observed and Logistic regression analysis was conducted by using SPSS 20.0 software. RESULTS：The incidence of ADR/ADE was 0.6%,and rare（0.1%-1%）. The ADR/ADE were general and mainly manifested as erythra（66.67%）. Skin and its ap-pendants were main organs involved in ADR（66.67%）. Logistic regression analysis showed that gender,drug combination and age are risk factors of ADR/ADE. CONCLUSIONS：The post-marketing safety reevaluation of TCM injection not only make up for the deficiency of pre-marketing safety evaluation of TCM injection and find out potential delayed and severe ADR/ADE and drug inter-action,but also provide reference for rational drug use in the clinic and guarantee the safe and rational drug use.
出处
《中国药房》
CAS
北大核心
2015年第28期3902-3905,共4页
China Pharmacy
基金
浙江省金华市科技局社会发展类一般项目(No2012-3-030)
