Lipo PGE_1治疗肝肾综合征的临床研究

Clinical study of patients with hepatorenal syndrome treated with Lipo PGE_1

目的 :评价前列腺素E1脂微球制剂 (LipoPGE1)治疗肝肾综合征的有效性和安全性。方法 :2 6例肝肾综合征患者随机分成治疗组和对照组 ,每组 1 3例。治疗组应用LipoPGE12 0 μg ,1次 /d;对照组用螺内酯 ( 40mg ,3次 /d)及呋赛米 ( 40mg,2次 /d) ,疗程均为 1 4d。 结果 :治疗组肌酐浓度治疗后显著降低 ( 1 95 .90±4 0 .96μmol/L降至 1 1 2 .4 2± 4 0 .69μmol/L ,P <0 .0 1 ) ,2 4h尿量显著增加 (由 4 76.1 5± 1 68.4 0ml增至 1 5 69.2 3± 776.89ml,P <0 .0 1 ) ,肝功能各项指标明显好转。对照组仅谷丙转氨酶治疗后有改善 ,其余指标均加重。治疗后两组比较 ,差异显著 (P <0 .0 1 )。两组治疗期间均无严重副作用、并发症及停药事件。结论 :LipoPGE1治疗肝肾综合征疗效确切 。

Objective:To evaluate the efficacy and safety of lipo prostaglandin E 1(Lipo PGE 1)in the treatment of severe hepatitis with hepatorenal syndrome.Methods:26 cases of severe hepatopathy with hepatorenal syndrome were randomly divided into two groups:therapy group(Lipo PGE 1)and control(spironolactone and furosemide). Each group had 13 patients. Dosage regimens were Lipo PGE 1 20 μg once a day in therapy group and spironolactone 40 mg three times a day and furosemide 40 mg twice a day in the control. Duration of treatment was 14 days.Results:Within group comparison before and after treatment:in the Lipo PGE 1 group serum creatinine reduced markedly from 195.90±40.90 μmol/L to 112.42±40.69 μmol/L and volume of urine of 24 hours increased significantly from 476.15±168.40 ml to 1569.23±776.89 ml, while in the control the above indexes only slightly improved. There was a significant difference between groups comparison(P<0.01).The therapy group was better than the control in the degree of liver function improved before and after treatment(P<0.01). Two groups had no severe side-effect, complication and stop-drug events during therapy.Conclusion:Lipo PGE 1 was effective and safe in the treatment of severe hepatopathy with hepatorenal syndrome.