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.
Article
em Zh
| WPRIM
| ID: wpr-236050
Biblioteca responsável:
WPRO
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:
1
Base de dados:
WPRIM
Medicinas Tradicionais:
Medicinas_tradicionales_de_asia
/
Medicina_china
Assunto principal:
Vigilância de Produtos Comercializados
/
Medicamentos de Ervas Chinesas
/
Estudos de Casos e Controles
/
Estudos Prospectivos
/
Hipersensibilidade a Drogas
/
Injeções
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Risk_factors_studies
Idioma:
Zh
Revista:
China Journal of Chinese Materia Medica
Ano de publicação:
2015
Tipo de documento:
Article