清疸止痒方治疗妊娠期肝内胆汁淤积症的临床研究

Clinical Study on Efficacy of Qingdan Zhiyang Recipe for Treatment of Intrahepatic Cholestasis of Pregnancy

【目的】探讨清疸止痒方治疗妊娠期肝内胆汁淤积症(intrahepatic cholestasis of pregnancy,ICP)的疗效。【方法】将60例符合ICP诊断标准的患者随机分为中药组和对照组各30例,对照组给予常规西药治疗(思美泰+鲁米那+地塞米松),中药组在对照组基础上加用清疸止痒方(茵陈蒿、田基黄、鸡内金、金钱草、白术、茯苓、溪黄草、栀子、白鲜皮、蝉蜕、丹参、赤芍、地肤子、鸡血藤、黄芩)治疗,观察2组治疗后生化指标[丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、总胆汁酸(TBA)、总胆红素(TBIL)、直接胆红素(DBIL)]、脐静脉TBA及脐动脉血流收缩期/舒张期比值(S/D)的变化,并比较2组围生儿结局。【结果】中药组治疗后ALT、AST、TBA、TBIL、DBIL水平均显著下降(P<0.001),分娩孕周显著延长,脐静脉TBA水平和脐动脉血流S/D均显著低于对照组(P<0.05或P<0.01)。中药组胎儿窘迫、新生儿窒息及低体质量儿发生率分别为10.00%、3.33%及6.67%,对照组分别为36.67%、26.67%及30.00%,2组比较差异均有统计学意义(P<0.05)。【结论】清疸止痒方能明显降低ICP患者生化指标、脐静脉总胆汁酸及脐动脉血流S/D,改善围生儿结局。

Objective To investigate the clinical efficacy of Chinese Herbal formulae of Qingdan Zhiyang Recipe in treating the patients with intrahepatic cholestasis of pregnancy （ICP） . Methods Sixty ICP patients were equally randomized into control group and trial group. Both groups were treated by conventional western medicine of S-adenosylmethionine （SAMe）, dexamethasone and luminal, and the trial group was additionally given Qingdan Zhiyang Recipe （mainly composed of Herba Artemisiae Scopariae, Herba Hyperici Japonici, Endothelium Corneum Gigeriae Galli, Herba Lysimachiae, Rhizoma Atractylodis Macrocephalae, Poria, Herba Rabdosiae Serrae, Fructus Gardeniae, Cortex Dictamni, Periostracum Cicadae, Radix Paeoniae, Fructus Kochiae, Caulis Spatholobi and Radix scutellariae） . Before and after treatment, we recorded and compared the perinatal outcomes including serum levels of alanine aminotransferase （ ALT）, aspartate aminotransferase （ AST）, total bile acid （ TBA）, total bilirubin （TBIL） and direct bilirubin （DBIL）, TBA of cord venous blood, and ratio of umbilical artery blood flow velocity peak to valley （S/D） . Results ALT, AST, TBA, TBIL and DBIL were significantly decreased after treatment in the trial group （P〈0.001 compared with those in the control group） . The pregnancy weeks at delivery were prolonged, and TBA value of cord venous blood and S/D value of umbilical artery blood flow in the trial group were significantly lower than those in the control group after treatment （P〈0.05 and P〈0.01 ）. The incidences of fetal distress, neonatal asphyxia and low-birth weight infants in the trial group were 10.00%, 3.33%, 6.67% respectively, significantly lower than those in the control group （36.67%, 26.67%, 30.00% respectively; P〈0.05 ） . Conclusion Qingdan Zhiyang Recipe can obvi- ously decrease biochemical indexes, TBA value of cord venous blood and S/D value of umbilical artery blood flow of ICP patients , and therefore can improve the perinatal outcomes.