门冬氨酸-鸟氨酸颗粒剂治疗非酒精性脂肪性肝炎的多剂量平行对照临床研究  

Aspartate-ornithine granules in the treatment of nonalcoholic steatohepatitis： a multiple-dose parallel controlled clinical trial

作　　者：田丽艳[1] 陆伦根[1] 唐承薇[2] 谢艳[2] 罗和生[3] 谭诗云[3] 庞智[4] 张亚历[5] 巩兰波[5] 厉有名[6] 陈韶华[6] 施军平[7] 

机构地区：[1]上海交通大学附属第一人民医院,200080 [2]四川大学华西医院 [3]武汉大学人民医院 [4]苏州市立医院 [5]南方医科大学附属南方医院 [6]浙江大学医学院附属第一医院 [7]杭州市第六人民医院

出　　处：《中华肝脏病杂志》2013年第7期528-532,共5页Chinese Journal of Hepatology

摘　　要：目的研究门冬氨酸-鸟氨酸颗粒剂治疗非酒精性脂肪性肝炎的临床疗效和安全性。方法用多中心开放性多剂量平行对照的临床试验设计选择非酒精性脂肪性肝炎患者，分别用门冬氨酸-鸟氨酸颗粒剂高剂量（6g，2次／d，口服）和低剂量（3g，2次／d，口服）治疗12周，观察其疗效和安全性。对不同资料采用pearson X2检验或Fisher确切概率法、t检验或非参数检验进行统计学分析。结果本试验共有87例患者入选，高剂量组42例，低剂量组45例；共脱落15例，高剂量组4例，低剂量组11例；实际完成病例数72例，高剂量组38例，低剂量组34例。治疗后两组患者的肝脾CT比值分别为0．89±0．19及0．80±0．15，与治疗前相比，S值分别为329及246；P值均〈0．0001，差异均有统计学意义；并且高剂量组疗效优于低剂量组（Z=2．1042，P〈0．05）；高剂量组总有效率为52．63%，低剂量组总有效率为38．23％。与治疗前相比，ALT水平均显著降低，高、低剂量组治疗6周S值分别为324．5、223．0，P值均〈0．0001治疗12周S值分别为370．5、297．5，P值均〈0．0001，差异均有统计学意义；且治疗12周后高剂量组ALT水平的降低较低剂量组更明显。高剂量组降ALT的总有效率为78．95％，高于低剂量组的52．94％。高、低剂量组6周和12周治疗后AST、Y-谷氨酰转移酶显著低于治疗前，差异均有统计学意义。治疗12周后，两组的甘油三酯水平也较治疗前降低。共报道4例（4．6％）不良反应，其中低剂量组2例（4．4%），高剂量组2例（4．8％），均为胃肠道反应。结论门冬氨酸-鸟氨酸颗粒剂治疗非酒精性脂肪性肝炎具有一定的临床疗效，且安全性好。To investigate the therapeutic efficacy and safety of aspartate-ornithine granules in patients with nonalcoholic steatohepatitis （NASH）. Methods Seventy-two patients with NASH were included in this multiple-dose parallel controlled clinical trial and received a 12-week course of aspartate-ornithine granule treatment at either high-dose （6 g bid po; n = 38） or low-dose （3 g bid po; n = 34）. Clinical efficacy was assessed by monitoring data from urinalysis, serologic tests （alanine aminotransferase （ALT）, aspartate aminotransferase （AST）, y-glutamyl transferase （GGT）, and triglyceride （TG））, and abdominal computed tomography （CT） scan. Safety was assessed by occurrence of adverse events （fatigue, anorexia, abdominal distension, nausea, and vomiting）. Statistical analyses were conducted to determine the significance of differences between parameters before （baseline） and after treatment. Results After 12 weeks of treamaent, the liver and spleen CT ratios in both the high-dose group （0.89±0.19） and the low-dose group （0.80±0.15） were significantly higher than at baseline （S = 329, P 〈 0.0001 and S = 246, P 〈 0.0001）; the overall improvement was more robust in the high-dose group （52.63%） than in the low-dose group （38.23%） （Z = -2.1042, P 〈 0.05）. After 6 and 12 weeks of treatment, the serum ALT levels in both the high-dose group and the low-dose group were significantly lower than at baseline （6 weeks： S = 324.5,P 〈 0.0001 ands = 223,P 〈 0.0001; 12 weeks： S = 370.5, P 〈 0.0001 ands = 297.5, P 〈 0.0001）; the overall improvement was more robust in the high-dose group （79.0~,4） than in the low-dose group （53.0%） （Z=2.0533,P 〈 0.05）. Similar trends were seen for the serum levels of AST and GGT after 6 and 12 weeks of trealment （all P 〈 0.01 ） and serum levels of TG afar 12 weeks of treatment. The rate of adverse reactions was low and similar between the two groups （high-dose： 4.8% and low- dose： 4.4%; al

关 键 词：脂肪性肝炎 非酒精性 治疗 门冬氨酸-鸟氨酸 

分 类 号：R575.1[医药卫生—消化系统]