CAJ | 학술논문

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(3 g,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 x 2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.
목적 연구문동안산-조안산과립제치료비주정성지방성간염적림상료효화안전성.방법 용다중심개방성다제량평행대조적림상시험설계선택비주정성지방성간염환자,분별용문동안산-조안산과립제고제량(6g,2차/d,구복)화저제량(3 g,2차/d,구복)치료12주,관찰기료효화안전성.대불동자료채용pearson x 2검험혹Fisher학절개솔법、t검험혹비삼수검험진행통계학분석.결과 본시험공유87례환자입선,고제량조42례,저제량조45례；공탈락15례,고제량조4례,저제량조11례；실제완성병례수72례,고제량조38례,저제량조34례.치료후량조환자적간비CT비치분별위0.89±0.19급0.80±0.15,여치료전상비,S치분별위329급246；P치균＜ 0.0001,차이균유통계학의의；병차고제량조료효우우저제량조(Z=-2.1042,P＜ 0.05)；고제량조총유효솔위52.63％,저제량조총유효솔위38.23％.여치료전상비,ALT수평균현저강저,고、저제량조치료6주S치분별위324.5、223.0,P치균＜0.0001；치료12주S치분별위370.5、297.5,P치균＜0.0001,차이균유통계학의의；차치료12주후고제량조ALT수평적강저교저제량조경명현.고제량조강ALT적총유효솔위78.95％,고우저제량조적52.94％.고、저제량조6주화12주치료후AST、y-곡안선전이매현저저우치료전,차이균유통계학의의.치료12주후,량조적감유삼지수평야교치료전강저.공보도4례(4.6％)불량반응,기중저제량조2례(4.4％),고제량조2례(4.8％),균위위장도반응.결론 문동안산-조안산과립제치료비주정성지방성간염구유일정적림상료효,차안전성호.
Objeetive 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),γ-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 treatment,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％) 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 treatment (allP ＜ 0.01) and serum levels of TG after 12 weeks of treatment.The rate of adverse reactions was low and similar between the two groups (high-dose:4.8％ and lowdose:4.4％; all gastrointestinal).Conclusion Aspartate-ornithine granule therapy was an effective and safe treatment of nonalcoholic steatohepatitis,with the higher dose of 6 g bid po providing more robust clinical benefit without affecting the safety profile.