Study of post marketing safety reevaluation of shenqi fuzheng injection.
- Author:
Qing-Hua AI
;
Yuan-Yuan LI
;
Yan-Ming XIE
- Publication Type:Journal Article
- MeSH:
Adverse Drug Reaction Reporting Systems;
Drug-Related Side Effects and Adverse Reactions;
Drugs, Chinese Herbal;
administration & dosage;
adverse effects;
Humans;
Injections;
Product Surveillance, Postmarketing
- From:
China Journal of Chinese Materia Medica
2014;39(18):3633-3636
- CountryChina
- Language:Chinese
-
Abstract:
In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction (ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used.
