Safety evaluation of Xianling Gubao Capsule based on real-world study / 中草药
Chinese Traditional and Herbal Drugs
; (24): 5614-5618, 2018.
Article
em Zh
| WPRIM
| ID: wpr-851519
Biblioteca responsável:
WPRO
ABSTRACT
Objective To explore the characteristics of Xianling Gubao Capsule (XGC) induced adverse reactions, especially drug-induced liver injury, and the occurrence and prognosis of ADR, aiming to provide a reference for clinical rational drug use, and ideas for after-marketing re-evaluation of Chinese materia medica. Methods A total of 788 patients were enrolled in one tertiary hospital to observe the clinical application safety of XGC based on real-word study. Results Compared with the conventional treatment group, the incidence of ADR in the treatment group showed no significant difference (P > 0.05) in XGC group. XGC group had the highest incidence of adverse gastrointestinal reactions (83.0%), and a higher incidence of abdominal distension (P 0.05). Pre-drug liver abnormalities or patients with underlying liver disease were more likely to have drug induced liver injury (30.4%). Conclusion Monitoring adverse reactions of XGC should be enhanced in order to promote the rational use and ensure the safety in clinic.
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Índice:
WPRIM
Tipo de estudo:
Prognostic_studies
Idioma:
Zh
Revista:
Chinese Traditional and Herbal Drugs
Ano de publicação:
2018
Tipo de documento:
Article