Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule / 中国中药杂志
China Journal of Chinese Materia Medica
; (24): 3790-3794, 2013.
Article
em Zh
| WPRIM
| ID: wpr-291282
Biblioteca responsável:
WPRO
ABSTRACT
By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.
Texto completo:
1
Índice:
WPRIM
Assunto principal:
Vigilância de Produtos Comercializados
/
Cápsulas
/
Medicamentos de Ervas Chinesas
/
China
/
Marketing
/
Avaliação de Medicamentos
/
Economia
Tipo de estudo:
Health_economic_evaluation
Limite:
Female
/
Humans
/
Male
País/Região como assunto:
Asia
Idioma:
Zh
Revista:
China Journal of Chinese Materia Medica
Ano de publicação:
2013
Tipo de documento:
Article