RESUMO
OBJECTIVE: To investigate the effects of Silibinin capsules combined with routine therapy on serum oxidative injury and liver function of patients with alcoholic liver disease (ALD) complicated with early liver fibrosis.METHODS: The patients with ALD complicated with early liver fibrosis selected from our hospital during Apr. 2013-Jan. 2015 were divided into control group and study group according to random number table, with 38 cases in each group. Control group received routine symptomatic treatment [temperance, oral administration of Inosine tablets (0. 4 g/times, bid), vitamin and microelement supplementation, etc. ]. Study group was additionally given Silibinin capsule (70 mg/time, bid) orally, for consecutive 48 weeks, on the basis of control group. The clinical efficacies and the incidence of ADR were compared between 2 groups. The changes of serum oxidative injury indexes (SOD, MDA), liver fibrosis indexes [laminin (LN), hyaluronic acid (HA), type IV collagen (IV-C), type Ⅲ procollagen (PC Ⅲ)] and liver function indexes (ALT, AST) were recorded before and after treatment. RESULTS: Before treatment, there was no statistical significance in baseline information between 2 groups (P>0. 05). After treatment, total response rate of study was significantly higher than that of control group (P<0. 05), but there was no statistical significance in the incidence of ADR between 2 groups (P>0. 05). Compared with before treatment, serum levels of MDA, liver fibrosis indexes and liver function indexes in 2 groups were decreased significantly (P<0. 05), while SOD levels were increased significantly (P<0. 05); the improvement of study group was more significant than control group (P<0. 05). CONCLUSIONS: Silibinin capsules combined with routine treatment can enhance clinical efficacy of ALD patients with early liver fibrosis, mainly manifesting as improving oxidative stress, regulating liver function and inhibiting the development of liver fibrosis.
RESUMO
OBJECTIVE:To explore the factors,general rule and characteristics of adverse drug reactions(ADR)for references of safe and rational clinical medication.METHOD:A total of 412 ADR reports were collected and statistically analyzed in respect of age and sex of patients,route of administration,ADR degree,drug category,ADR-involving organs and clinical manifestations etc.RESULTS:ADR-involving drugs totaled 412 kinds,of which anti-infective agents occupied the first place,followed by Chinese patent medicines.274 ADR cases(66.50%)were induced by intravenous route.ADR occurred systemically and were characterized predominantly by allergic reactions of skin and its appendants,followed by damage of nervous system.70 were new but common ADR cases,while 2 were new severe cases.CONCLUSION:It is necessary to strengthen ADR monitoring and publicizing of ADR-related knowledge to guide the clinical rational use of drugs and reduce the repetitive occurrence of ADR.