RESUMO
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.
RESUMO
OBJECTIVE: It is found that there are differences in quality of drugs on the market. In order to get safe, effective and rational drug use, we suggest that the evaluation of drugs be mandatory. METHODS: The drugs have been evaluated from angles of clinic effectiveness, bioequivalence, pharmacoeconomics and pharmaceutics. RESULTS: Different evaluating ways showed different characteristies. CONCLUSION: The quality control by pharmaceutical methods is one of the easiest and the most economic ways to do.