To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm / 中国结合医学杂志
Chinese journal of integrative medicine
; (12): 226-232, 2017.
Article
en En
| WPRIM
| ID: wpr-327234
Biblioteca responsable:
WPRO
ABSTRACT
The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in mainland China recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300,000 patients for more than 4 years, a theoretical research question emerges, that is, how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level, which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore, multiple information sources were explored and extracted from preclinical experiments for toxicity, postmarketing clinical trials for effificacy and safety evaluation, registry study for surveillance, retrospective data analysis from hospital information system and spontaneous response system, and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this fifield both in China and abroad are urgently needed.
Palabras clave
Texto completo:
1
Base de datos:
WPRIM
Asunto principal:
Vigilancia de Productos Comercializados
/
Investigación
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Medicamentos Herbarios Chinos
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Sistema de Registros
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Ensayos Clínicos como Asunto
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Sistemas de Información en Hospital
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Usos Terapéuticos
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Evaluación Preclínica de Medicamentos
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
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Informe de Investigación
Tipo de estudio:
Diagnostic_studies
/
Prognostic_studies
Aspecto:
Implementation_research
Límite:
Humans
Idioma:
En
Revista:
Chinese journal of integrative medicine
Año:
2017
Tipo del documento:
Article