五灵丸治疗妊娠肝内胆汁淤积症的临床及实验研究  

Clinical and Experimental Study on Wuling Pill in Treating Gestation Period Intrahepatic Cholestasis

作　　者：史佃云 陈华 田小芸[2] 肖梅 

机构地区：[1]解放军南京八一医院妇产科,南京210002 [2]南京军区总医院实验动物中心

出　　处：《中国中西医结合杂志》2006年第2期114-118,共5页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：江苏省自然科学基金项目(No.BS2000055)

摘　　要：目的评价传统中成药五灵丸治疗妊娠肝内胆汁淤积症(ICP)的疗效。方法临床研究将90例ICP患者以2∶1的比例随机分成观察和对照两组,观察组以五灵丸配合常规治疗;记录临床症状、实验室检查甘胆酸(CGA)、总胆红素(TB)、结合胆红素(DB)水平,并测血清谷丙转氨酶(ALT)、谷草转氨酶(AST)和碱性磷酸酶(ALP)的变化及分娩情况。动物实验先以雌二醇注射构建ICP大鼠模型,并给予五灵丸灌胃治疗;收集模型母鼠血、胎鼠血及羊水,检测CGA、TB、DB、ALT、AST、ALP水平;另收集模型母鼠的胆汁以观察排泄量、检测其CGA浓度。临床和动物试验时均以复方益肝灵为阳性对照。结果临床研究两组疗效比较,观察组60例显效47例(78.3%),有效13例(21.7%);对照组30例显效15例(50.0%),有效15例(50%);两组显效率比较,差异有显著性(χ2=7.17286,P<0.01);血CGA、ALT、AST及TB水平两组均有下降,但观察组血CGA、ALT、AST下降幅度大于对照组(P<0.05);而且观察组的羊水污染和早产的发生率也较低,新生儿出生体重和Apgar评分则高于对照组。实验研究中五灵丸可显著降低模型母鼠血及胎鼠血、羊水中CGA水平,并能促进胆汁的排泄,稀释胆汁中的CGA,也能降低胆红素水平,改善肝功能酶谱。以上效应均显示剂量依赖性。结论五灵丸治疗妊娠肝内胆汁淤积症具有更好的降胆酸及改善肝功能和妊娠结局的疗效作用。Objective To evaluate the curative effect of Wuling pill （WLP）, a traditional Chinese patent medicine, in treating gestation period intrahepatic cholestasis （GPI）. Methods In the clinical study, 90 GPI patients were divided into the treated group treated by conventional therapy plus WLP and the control group treated by conventional therapy plus compound Yiganling （YGL） with a ratio of 2：1. Clinical symptoms and accouchement condition were observed. Levels of cholyglycine acid （CGA）, total and direct bilirubin （TB and DB）, alanine aminotransferase （ALT）, aspartate aminotransferase （AST）, and alkaline phosphatase （ALP） were detected before and after treatment. For the experimental study, GPI rat model was induced by injecting estradiol benzoate to pregnant Wistar rats. The model rats in the treated group were administrated with WLP by gastro-perfusion and those in the control group, were administrated with YGL. Levels of CGA,TB,DB, ALT, AST and ALP in the mother and fetal rats, as well as in the amnionic fluid were determined. Besides, the volume of bile excreted by the mother rats was observed. Results In clinical trials, the markedly effective rate in the treated group （47 cases, 78.3 % ） was higher than that in the control group （15 cases, 50 % , χ^2 = 7. 17286, P〈0.01）. Levels of blood CGA, TB, ALT and AST were all decreased in both groups after treatment, but WLP showed a better efficacy than YGL （P 〈 0.05） in lowering CGA, ALT and AST. Moreover, the occurrence of meconium contaminated amnionic fluid and premature delivery were lower, while weight and Apgar grade of newborn babies were higher in the treated group than those in the control group. In animal experiment, WLP showed significant effects in decreasing CGA level in amniotic fluid, and in blood of the mother and fetal rats. In addition, it could also decrease the levels of bilirubin, ALT and AST, and promote the bile excretion to reduce CGA concentration in bile. All the above effects showed a dose dep

关 键 词：妊娠肝内胆汁淤积症 五灵丸 复方益肝灵 

分 类 号：R271.9[医药卫生—中西医结合]