胆宁片治疗非酒精性脂肪性肝病的多中心随机对照临床研究

目的：评价胆宁片治疗非酒精性脂肪性肝病的临床疗效。方法：多中心、随机、阳性药物平行对照,盲法评价。胆宁片治疗组102例,熊去氧胆酸（优思弗）对照组33例。分别于治疗前后评价体质量指数、主症改善率、肝功能和血脂、影像学改善及综合疗效等。结果：胆宁片和优思弗均能有效改善非酒精性脂肪性肝病患者体质量指数、肝区不适、乏力、食欲减退、肝功能、血脂及影像学异常表现等,胆宁片对体质量指数、肝区不适的改善作用优于优思弗。组织学证据证实胆宁片对非酒精性脂肪性肝病有较好的治疗效果。结论：胆宁片是治疗非酒精性脂肪性肝病的有效药物,其作用略优于优思弗。

Effectiveness of Danning Tablet in patients with non-alcoholic fatty liver of damp-heat syndrome type:A multicenter randomized control led trial

OBJECTIVE: To evaluate the efficacy and safety of Danning Tablet (DNT) in patients with non-alcoholic fatty liver disease (NAFLD) of damp-heat syndrome type. METHODS: A multicenter, randomized, double-blinded and positive drug parallel controlled trial was performed. One hundred and thirty-five patients were enrolled into the study and divided into two groups: DNT-treated group (n=102) and ursodeoxycholic acid (UDCA)-treated group (n=33). Body mass index (BMI), principal symptoms, liver function, blood lipids, iconographic, and compositional parameters were measured before and after treatment, respectively. RESULTS: In the two groups, BMI, distress in hepatic region, fatigue, anorexia, liver function, blood lipids and iconographic parameters were significantly improved, and the improvements of BMI, distress in hepatic region were better in DNT-treated group than in UDCA-treated group. The histological study also showed that DNT had positive effect in treatment of NAFLD. CONCLUSION: DNT is an effective drug to treat patients with NAFLD of damp-heat syndrome type and is more effective than UDCA.