当飞利肝宁胶囊治疗非酒精性单纯性脂肪肝患者113例临床研究  

Clinical Study on Dangfei Liganning Capsule for Nonalcoholic Simple Fatty Liver Disease:a Report on 113 Cases

作　　者：李朝敏[1] 龚枚[1] 李明权[1] 夏庆[2] 陈远平[3] 

机构地区：[1]成都中医药大学附属医院内分泌科、四川省成都市金牛区十二桥路39号,610072 [2]四川大学华西医院 [3]广西中医学院第一附属医院

出　　处：《中医杂志》2012年第1期38-41,共4页Journal of Traditional Chinese Medicine

摘　　要：目的评价当飞利肝宁胶囊治疗湿热内蕴型非酒精性单纯性脂肪肝的有效性和安全性。方法选择非酒精性单纯性脂肪肝湿热内蕴证患者230例,符合全分析集(full analysis set,FAS)患者227例,其中当飞利肝宁胶囊组(试验组)113例,安慰剂组(对照组)114例,疗程均为12周,以治疗后肝/脾CT比值变化、肝/脾CT比值复常率以及中医证候评价有效性,以不良反应、实验室检查及心电图评价安全性。结果两组治疗后肝/脾CT值较治疗前差异有统计学意义(P<0.01),两组治疗后比较差异有统计学意义(P<0.01)。试验组肝/脾CT比值复常率为47.79%(54/113),优于对照组的22.81%(26/114),组间比较差异具有统计学意义(P<0.01)。试验组总有效率为76.11%,对照组为55.26%,两组比较差异有统计学意义(P<0.01)。两组治疗后脘腹痞闷、口干口苦评分较治疗前降低(P<0.01);并且试验组治疗后明显低于对照组(P<0.01)。试验组治疗后丙氨酸氨基转移酶(ALT)较治疗前降低(P<0.01),对照组ALT较治疗前也有降低但差异无统计学意义(P>0.05),治疗后两组患者其他肝功能及血脂指标较治疗前比较差异均无统计学意义(P>0.05)。结论当飞利肝宁胶囊对非酒精性单纯性脂肪肝湿热内蕴证患者有较好的治疗作用,临床应用安全。Objective To evaluate the effect and safety of Dangfei Liganning Capsule [Capsule of Dangyao （Swertia sinensis ） and Shuifeiji （Silybum marianum） for the liver diseases] in the treatment of nonalcoholic simple fatty liver disease with the damp-heat retention syndrome in TCM. Methods A multicentric, randomized, double-blind, placebo parallel controlled trial was conducted in the treatment of nonalcoholic simple fatty liver disease. Totally 230 patients accorded with the standards of diagnosis of nonalcoholic simple fatty liver disease and damp-heat retention syndrome in TCM were in cluded, of which, 227 were of full analysis set （FAS）, and were randomized into Dangfei Liganning Capsule group （trial, 113 cases） and placebo group （control, 114 cases）. The course of treatment was of 12 weeks. The effect was evaluated with the changes in the liver/spleen CT ratio, liver/spleen CT recovery ratio, and improvement of TCM symptoms, while the safety was assessed with the adverse events, laboratory examination, and changes in ECG. Results After treatment, the liver/spleen CT ratio of both groups was significantly different from that before treatment （P〈0. 01）, and the difference between the two groups was statistically signif- icant （P〈0.01）. In the trial group, the liver/spleen CT recovery rate was 47. 79% （54/113 cases）, while that of controlled group was 22.81 % （26/114 cases）. The difference between groups was statistically significant （P〈0.01）. The total effective rate of the trial group and the control group was 76.11% and 55.26% respectively, the difference was significant （P〈0. 01）. The epigastric distention and fullness and dry mouth and bitter taste of both groups after treatment were significantly alleviated, being significantly different from those of before treatment （P〈0.01）. The difference in the between-group comparison after treatment was statistically significant （P〈0.01）, the trial group was superior to the control group. The ALT decrease of

关 键 词：当飞利肝宁胶囊 非酒精性单纯性脂肪肝 湿热内蕴证 临床疗效 

分 类 号：R259[医药卫生—中西医结合]