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
Dans Chinois
| WPRIM
| ID: wpr-291282
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.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
Sujet Principal:
Surveillance post-commercialisation des produits de santé
/
Capsules
/
Médicaments issus de plantes chinoises
/
Chine
/
Marketing
/
Évaluation de médicament
/
Économie
Type d'étude:
Évaluation en économique de la santé
Limites du sujet:
Femelle
/
Humains
/
Mâle
Pays comme sujet:
Asie
langue:
Chinois
Texte intégral:
China Journal of Chinese Materia Medica
Année:
2013
Type:
Article
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