654-2辅助治疗胆汁淤积型药物性肝炎的临床分析

Clinical Analysis of 654-2 in Treatment of Cholestatic drug-induced Hepatitis

目的:评价山莨菪碱(654-2)治疗胆汁淤积型药物性肝炎的疗效及安全性。方法:采用随机、对照的研究方法将胆汁淤积型药物性肝炎54例,随机分为糖皮质激素组(n=24)及654-2组(n=30)两组。两组给予同样的基础护肝治疗:卧床休息、补充能量和维生素(10%葡萄糖注射液250 ml+ATP 40 mg+CoA 100 U+Vic 3.0+Vikl 30 mg)、10%葡萄糖注射液250 ml+门冬氨酸钾镁液2支。糖皮质激素组在上述基础治疗的同时口服强的松60 mg/d,早晨1次口服,血胆红素下降50%以上时,每周减20 mg,减至20mg/d时,改为每周减10 mg,减致10 mg维持5 d可直接停药,以4周为1疗程;654-2组给予上述同样的基础护肝治疗并加用654-2 40 mg加入10%葡萄糖注射液250 ml中静脉滴注,1次/d,以4周为1疗程,可连续使用至ALT、ALP、TBIL基本正常。全部患者随访2周。治疗前后进行肝功能、凝血功能、血液流变学检查。结果:治疗2周后激素组与654-2组的有效率分别为87.5%与93.3%,4周后分别为87.5%与96.7%,;两组近期效果无统计学差异(P>0.05)。治疗后,654-2组血液流变学指标的改善较激素组好,且654-2组不良反应轻微,随访2周,总胆红素未出现反弹。结论:654-2联合内科综合治疗能更有效地改善胆汁淤积型药物性肝炎的临床症状和肝功能指标,与传统激素疗法近期效果相当,且无明显毒副作用。

Objective：To evaluate the clinical effect and safety of 654 - 2 in treatment of cholestatic druginduced hepatitis. Methods： Fifty-four cholestatic drug-induced hepatitis patients were randomly divided into two group, steroid treatment group（n = 24） and 654-2 treatment group（n = 30）. Two group both give the same foundation treatment：Rest、supplementary energy and vitamin（10% GS 250 ml ＋ ATP 40 mg ＋ CoA 100 U ＋ Vic 3.0 ＋ Vikl 30 mg）, 10 % GS 250 ml ＋ potassium - magnesium Aspartate 40 ml· by intravenous. 24 cases of the steroid treatment group was treated with regular treatment plus prednisone 60 mg once daily by orally, TBIL was reduced more than 50 %, prednisone was regularil reduced. 654-2 treatment group was given the same regular treament plus 654-2 40 mg once daily by intravenous drip. The therapeutic course to both group were 4 weeks and two weeks＇ follow-up. Hepatic functions, serum ALT, ALP, TBIL and Hemorheology were measured before and after the treatment. Results：After 2 weeks＇ treatment, effective rate in the two group were 87.5% and 93.3 %, After 4 weeks, treatment, Effective rate in the two group were 87.5 % and 96.7 %. Short - term effect was not significantly different between the two group（P ~0.05）. After treatment, Hemorheology in the 654- 2 treatment group were significantly better than that in the steroid treatment group. Two weeks follow - up did not show reverse in the patients with persistent 654 - 2 administration. The side effect of 654 - 2 was mild in the whole process of treatment. Conclusions：Using conventional therapy, combined therapy with 654 -2 is more ef- fective in improving the symptom and liver function of patients with cholestatic drug - induced hepatitis. And 654 - 2 has no evident side effect in such patients.