Clinical safety studies based on 30 026 post-marketing cases of Shenqi Fuzheng injection by intensive hospital monitoring nested NCCS / 中国中药杂志
China Journal of Chinese Materia Medica
;
(24): 4739-4745, 2015.
Artículo
en Chino
| WPRIM
| ID: wpr-236050
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.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Vigilancia de Productos Comercializados
/
Medicamentos Herbarios Chinos
/
Estudios de Casos y Controles
/
Estudios Prospectivos
/
Hipersensibilidad a las Drogas
/
Inyecciones
Tipo de estudio:
Ensayo Clínico Controlado
/
Estudio observacional
/
Factores de riesgo
Límite:
Humanos
Idioma:
Chino
Revista:
China Journal of Chinese Materia Medica
Año:
2015
Tipo del documento:
Artículo
Similares
MEDLINE
...
LILACS
LIS