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目的:探讨中药联合西药治疗妊娠期肝内胆汁淤积症(ICP)的临床指标及围产结局。方法:对2011年10月—2013年2月在本院诊断为妊娠期肝内胆汁淤积症的168例孕妇收住院,进行前瞻双盲的临床研究。随机分为2组。研究组:选择88例以中药汤剂联合西药(熊去氧胆酸)治疗;对照组:选择80例,单以熊去氧胆酸治疗。比较两组治疗前后的生化指标,甘胆酸(CG)、总胆汁酸(TBA)、丙氨酸转氨酶(ALT)、天冬氨酸转移酶(AST)、总胆红素(T-BIL)等水平变化及围产结局。结果:①治疗后生化指标,研究组比对照组明显改善,CG(4.7±3.6)v(s35.1±27.5)μmol/L、ALT(23.5±14.5)vs(96.1±20.7)U/L、AST(24.7±14.3)vs(90.5±19.8)U/L、TBA(4.6±3.5)vs(7.8±4.9)μmol/L、T-BIL(7.7±4.6)vs(15.7±10.6)μmol/L、D-BIL(4.4±2.3)vs(12.5±7.8)μmol/L,P<0.05;终止妊娠平均孕周:研究组比对照组明显延长(38.1±1.5)vs(35.6±1.7)周,早产率分别为7.9%vs 23.8%,P<0.05;②研究组与对照组胎儿窘迫(9.1%vs 26.3%)、羊水粪染(18.8%vs 41.3%)、新生儿窒息(0%vs 5%)、剖宫产率(29.5%vs 53.8%)、产后出血(2.3%vs 7.5%)比较,研究组均明显低于对照组,P<0.05,差异显著。结论:中药汤剂联合西药治疗妊娠期肝内胆汁淤积症较单西药治疗能明显改善临床经过,延长孕周,降低剖宫产率和改善围产结局。
Objective: To explore the clinical indicators and perinatal outcome of traditional Chinese medicine combined with western medicine in the treatment of intrahepatic cholestasis of pregnancy (ICP). METHODS: A total of 168 pregnant women admitted to our hospital from October 2011 to February 2013 in our hospital were diagnosed as intrahepatic cholestasis of pregnancy. The prospective, double-blind clinical study was conducted. Randomly divided into two groups. Study group: 88 cases were selected with traditional Chinese medicine decoction combined with western medicine (ursodeoxycholic acid); control group: 80 cases were selected and treated with ursodeoxycholic acid alone. Before and after treatment, the biochemical indexes, such as CG, TBA, ALT, T-BIL, Such as changes in level and perinatal outcome. Results: (1) The biochemical indexes after treatment were significantly improved in the study group compared with the control group (CG (4.7 ± 3.6) v (s35.1 ± 27.5) μmol / L, ALT 23.5 ± 14.5 vs 96.1 ± 20.7 U / T (4.6 ± 3.5) vs (7.8 ± 4.9) μmol / L, T-BIL (7.7 ± 4.6) vs (15.7 ± 10.6) μmol / L, D-BIL was (4.4 ± 2.3) vs (12.5 ± 7.8) μmol / L, P <0.05; mean gestational age at termination of pregnancy was significantly longer in the study group than in the control group (38.1 ± 1.5 vs 35.6 ± 1.7 weeks, (7.9% vs 23.8%, P <0.05). ②The study group and the control group were significantly associated with fetal distress (9.1% vs 26.3%), meconium stained amniotic fluid (18.8% vs 41.3%), neonatal asphyxia (0% vs 5% Cesarean section rate (29.5% vs 53.8%), postpartum hemorrhage (2.3% vs 7.5%), the study group were significantly lower than the control group, P <0.05, significant difference. Conclusion: Chinese medicine decoction combined with Western medicine treatment of intrahepatic cholestasis of pregnancy compared with single Western medicine can significantly improve clinical experience, prolong gestational age, reduce cesarean section rate and improve perinatal outcome.