Practice of Post-marketing Safety Reevaluation of Salvianolate and Other TCM Injections in Our Hospital

VernacularTitle:我院开展丹参多酚酸盐等中药注射剂上市后安全性再评价的实践Δ
Author: Shiwen LYU ; Jiayi GUO ; Yalan ZHU
Publication Type:Journal Article
Keywords: TCM injection; Safety reevaluation; Method establishment; Salvianolate for injection
From: China Pharmacy 2015;(28):3902-3905
CountryChina
Language:Chinese
Abstract: 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.