Practice of Post-marketing Safety Reevaluation of Salvianolate and Other TCM Injections in Our Hospital / 中国药房
China Pharmacy
;
(12): 3902-3905, 2015.
Article
in Chinese
| WPRIM
| ID: wpr-502683
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Observational study
/
Risk factors
Language:
Chinese
Journal:
China Pharmacy
Year:
2015
Type:
Article
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