胆宁片治疗非酒精性脂肪性肝病(湿热型)的临床研究

目的 评价胆宁片治疗非酒精性脂肪性肝病(湿热型)的临床疗效。方法 采用多中心、随机、阳性药物平行对照，盲法评价；胆宁片治疗组102例，优思弗(熊去氧胆酸片)对照组33例，分别于治疗前后评价体重指数、主症改善率、肝功能和血脂、影像学改善、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(湿热型)患者体重指数、肝区不适、乏力、食欲减退、肝功能、血脂、影像学等，其中对体重指数、主症改善胆宁片优于对照组。组织学的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(湿热型)的有效药物，其作用略优于优思弗。

Clinical Study on Treatment of Non-alcoholic Fatty Liver of Damp-heat Syndrome Type by Danning Tablet

ObjectiveTo evaluate the therapeutic effect of Danning Tablet (DNT) on patients with non-alcoholic fatty liver (NAFL) of damp-heat Syndrome type. MethodsMulti-center randomized double-blinded positive medicine parallel controlled method was adopted. One hundred and two patients were treated with DNT and 33 patients treated with Ursodeoxycholic acid (UDCA) as control. Indexes including body mass index (MBI), principal symptom, liver function, blood lipids, iconographic parameters and comprehensive efficacy were measured before and after treatment in the two groups respectively. ResultsDNT and UDCA had the effect in improving BMI, distress in hepatic region, fatigue, anorexia, liver function, blood lipids and iconographic parameters, etc. DNT showed effects in improving BMI and distress in hepatic region better than those of UDCA. Histological examination also showed that DNT had good therapeutic effect. ConclusionDNT is an effective medicine for NAFL patients of damp-heat Syndrome type, and its efficacy is better than that of UDCA.