前列腺素E_1治疗病毒性肝炎患者高胆红素血症的疗效和安全性

Efficacy and safety of PGE_1 in adults with viral icterohepatitis

目的观察前列腺素E1治疗病毒性肝炎高胆红素血症的疗效及全性。方法采用随机对照、单盲方法进行前瞻性试验。100例病毒性肝炎高胆红素血症患者随机分为试验组及对照组各50例,在综合治疗基础上,试验组加用前列腺素E1200μg/d,对照组加用门冬氨酸钾镁20ml/d,两药均加入250ml生理氯化钠溶液中静滴,疗程6周。结果试验组在临床症状、体征的改善、黄疸的消退和肝功能的恢复方面均明显优于对照组,治疗第3周时差异有显著意义(P<0.05),治疗结束时差异有非常显著意义(P<0·01);试验组的总有效率、早期重型肝炎存活率分别为80·0%和84·6%,均显著优于对照组的52·0%、38·5%(P<0·05,P<0·01),两组中晚期重型肝炎存活率分别为44·4%和25·0%,差异无显著意义(P>0·05)。结论PGE1治疗早期重型肝炎及急、慢性病毒性肝炎高胆红素血症疗效肯定,不良反应少。

Objective To evaluate the efficacy of PGE1 for the treatment of hyperbilirubinemia due to viral hepatitis. Methods A prospective, randomized, single blind and parallel control clinical study enrolled 100 patients with icterohepatitis,who were randomized 1：1 to two treatment groups; Each group was intravenously infused daily over a six-week treatment period： （ 1 ）200μg of PGE1 injection; （2）20ml of potassium-magnesium aspartate injection. Results The PGE1 treated patients were more superior in the recoveries of physical characteristics,icteric index and liver functions to the control group. The statistical difference of the PGE1 group from the potasslum-magnesium aspartate in the treatment of icterohepatitis occurred in the 3rd week of the therapy（P 〈 0.05）, and such difference became escalated at the end of therapy（P〈 0.01 ）. The overall response rate and the survive rate of early stage severe hepatitis were 80.0 % and 84.6 % （PGEt group） versus 52.0 % and 38.5 % （control group）, respectively（ P 〈 0.05 and P〈 0.01 ）. No significant difference for the treatment of the middle and late stage severe hepatitis in the survival rate was found between both groups（P 〉0.05）. Conclusion PGEI is effective in the treatment of the acute or chronic viral hepatitis and the hyperbilirubinemia caused by early stage severe hepatitis.