Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection / 中国中药杂志
China Journal of Chinese Materia Medica
; (24): 2786-2788, 2011.
Article
em Zh
| WPRIM
| ID: wpr-293187
Biblioteca responsável:
WPRO
ABSTRACT
<p><b>OBJECTIVE</b>To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection.</p><p><b>METHOD</b>Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis.</p><p><b>RESULT</b>Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions.</p><p><b>CONCLUSION</b>The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.</p>
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
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
/
Injeções
/
Métodos
Idioma:
Zh
Revista:
China Journal of Chinese Materia Medica
Ano de publicação:
2011
Tipo de documento:
Article