丁二磺酸腺苷蛋氨酸治疗妊娠期肝内胆汁淤积症疗效评价

Clinical Evaluation on Ademetionine 1,4-Butanedisulfonate in Treating Intrahepatic Cholestasis of Pregnancy

目的探讨丁二磺酸腺苷蛋氨酸治疗妊娠期肝内胆汁淤积症(ICP)的有效性及安全性。方法将2015年1月至2017年10月收治的妊娠期ICP患者90例按随机数字表法分为A,B,C 3组,每组30例。A组口服丁二磺酸腺苷蛋氨酸肠溶片0.5 g,每日2次;B组给予丁二磺酸腺苷蛋氨酸注射剂1.0 g,静脉滴注;C组口服熊去氧胆酸胶囊0.5 g。3组均以7 d为1个疗程,持续治疗3个疗程。结果 A组、B组黄疸消退时间均短于C组,但皮肤瘙痒评分高于C组(P<0.05),B组黄疸消退时间短于A组(P<0.05);C组丙氨酸氨基转移酶(ALT)、天门冬酸氨基转移酶(AST)、总胆汁酸(TBA)均低于A组和B组,总胆红素(TBIL)高于A组和B组(P<0.05)。A组和B组胎儿早产率低于C组(P<0.05);3组用药期间不良反应发生率、停药后反跳发生率比较差异均无统计学意义(P>0.05)。结论丁二磺酸腺苷蛋氨酸注射剂与肠溶片治疗妊娠期ICP的疗效及安全性无差异,对患者瘙痒症状与ALT,AST,TBA等指标改善不如熊去氧胆酸,但注射剂对TBIL的抑制起效更快,可缩短黄疸消退时间,降低早产率,对母婴具有较高的安全性。

Objective To investigate the clinical effect and safety of ademetionine 1,4-butanedisulfonate in the treatment of intrahepatic cholestasis（ ICP） of pregnancy. Methods Totally 90 patients with ICP of pregnancy admitted to our hospital from January 2015 to October 2017 were divided into group A,B,C by the random number table method,30 cases in each group. The group A was treated with0. 5 g Ademetionine 1,4-Butanedisulfonate Enteric Coated Tablets, po, bid. The group B was treated with 1. 0 g Ademetionine 1,4-Butanedisulfonate Injection,ivgtt. The group C was treated with 0. 5 g ursodeoxycholic acid,po. 7 d was a course of treatment,and the 3 groups were treated continuously for 3 courses. Results After treatment, the disappearance time of jaundice in group A and group B was shorter than that in group C,but the scores of itchy skin in group A and group B were higher than that of group C（ P 〈 0. 05）,the disappearance time of jaundice in group B was shorter than that in group A（ P 〈 0. 05）. After treatment,the levels of ALT,AST,TBA in group C were lower than those in group A and group B, but the level of TB in group C was higher than those in group A and group B（ P 〈 0. 05）. The premature birth rates of group A and group B were lower than that in group C（ P 〈 0. 05）. There were no significant differences in the incidence of adverse reactions during the medication period and the incidence of rebound after drug withdrawal among the three groups（ P 〉 0. 05）. Conclusion The efficacy and safety of Ademetionine 1,4-Butanedisulfonate Injection and Ademetionine 1,4-Butanedisulfonate Enteric Coated Tablets in the treatment of ICP of pregnancy are not different,their effects on itchy symptoms and ALT,AST and TBA are not better than those of ursodeoxycholic acid. However,their effects on inhibitions of TBIL are faster,they can shorten the disappearance time of jaundice,reduce the rate of premature delivery,and have higher safety for mothers and infants.