Clinical safety studies based on 30 026 post-marketing cases of Shenqi Fuzheng injection by intensive hospital monitoring nested NCCS.
- Author:
Lian-xin WANG
;
Yan-ming XIE
;
Qing-hua AI
;
Wen-fu XU
- Publication Type:Journal Article
- MeSH:
Case-Control Studies;
Drug Hypersensitivity;
etiology;
Drugs, Chinese Herbal;
adverse effects;
Humans;
Injections;
Product Surveillance, Postmarketing;
Prospective Studies
- From:
China Journal of Chinese Materia Medica
2015;40(24):4739-4745
- CountryChina
- Language:Chinese
-
Abstract:
This study adopted a large sample, multicenter, registered hospital centralized monitoring nested prospective case-control study design. From the real world clinical application of Shenqi Fuzheng injection, monitored 30 026 cases of patients with the use of Shenqi Fuzheng injection. A total of 51 adverse drug reaction (ADR) cases was monitored, including 1 case of severe adverse reactions. ADR incidence rate was 1.7 per 1,000. Blood samples were collected from patients with allergic reactions and their matched controls. Related biological indicators of allergic reactions were unified detected and analysed in order to explore the mechanism of allergic reaction and promote the clinical safety.
