摘要
目的 :观察胆宁片对非酒精性脂肪性肝病 (NAFLD)的治疗效果及其安全性。方法 :多中心、开放、非随机临床试验 ,在综合治疗的基础上 ,应用胆宁片 (3～ 5片 /次 ,3次 /日 ,口服 ,共 3个月 )治疗 2 32例NAFLD ,其中男 189例 ,女 4 3例 ,平均年龄 (46 .1± 8.7)岁 ,基础疾病为体重过重和 /或中心性肥胖。结果 :胆宁片治疗后 ,临床症状改善率 85 .8% (16 9/ 197) ,其中以便秘改善效果最为显著 ;血清丙氨酸转氨酶异常改善率 78.2 % (133/ 170 ) ,从治疗前的 (6 2 .0± 2 7.4 )U/L下降至 (31.6± 15 .8)U/L ,P <0 .0 0 1;血脂异常改善率 4 5 .3% (5 3/ 134) ;并且 34% (79/ 2 32 )的患者B超脂肪肝程度下降 1个或 1个以上等级 ;全组病例不良反应发生率 15 .1% (35 / 2 32 ) ,主要表现为轻度腹泻。结论 :胆宁片对NAFLD有一定治疗效果 ,且不良反应轻微。
Objective:To evaluate the effectiveness and side effects of Chinese herb DANNING Tablet in short-term treatment of non-alcoholic fatty liver disease(NAFLD). Methods:232 patients with NAFLD were investigated by an open,non-randomized,multi-centrical clinical trial, of them 189 were male,43 were female,average age being (46.1±8.7) years. Course of the treatment of taking DANNING Tablet(3～5 Tab,tid,po)in addition to comprehensive therapy was 3 months.The associated diseases with NAFLD were overweight and central obesity.Results:After treatment of 3 months,the improved rate of symptoms of the patients was 85.8%(169/197),the constipation of the most patients disappeared at the end of the therapy,and the improved rates of abnormal level of ALT and lipids in the serum were 78.2%(133/170)and 45.3%(53/134),respectively. After therapy, the serum level of ALT decreased significantly,from (62.0±27.4)U/L to (31.6±15.8)U/L, P <0.001;Furthermore,the ultrasonographic findings of liver steatosis in some patients were also improved or even disappeared,the effective rate on steatosis was 34%(79/232).The rate of side effects was 15.1%(35/232),and the extent of the side effects was mild. The diarrhea was the main adverse effect. Conclusions:The results of the study show that DANNING Tablet is effective for the treatment of NAFLD,and without obvious side effects.
