利胆退黄方治疗病毒性瘀胆型肝炎的临床研究  

Clinical research on Lidantuihuang Prescription in the treatment of viral cholestatic hepatitis

作　　者：张达坤[1] 杨永和[1] 蔡敏[1] 邝卫红[2] 

机构地区：[1]海南省中医院脾胃肝病科,海南海口570203 [2]广州中医药大学第一附属医院脾胃科,广东广州510405

出　　处：《海南医学》2014年第19期2830-2833,共4页Hainan Medical Journal

基　　金：国家自然科学基金(编号:81173437);国家"十二五"肝病临床重点专科项目资助[编号:琼财社(2011)2435号];广东省中医药管理局资助项目(编号:2008143)

摘　　要：目的评价利胆退黄方治疗肝胆湿热型病毒性瘀胆型肝炎的临床疗效及安全性,便于临床推广运用。方法采用多中心、随机对照平行研究,55例患者分为对照组(护肝降酶+熊去氧胆酸口服250 mg,bid)27例,治疗组(对照组治疗方案+利胆退黄方)28例,疗程4周。观察两组患者的临床疾病疗效、中医证候疗效和肝功能指标的变化。结果治疗组在改善临床疾病疗效、中医证候疗效方面明显优于对照组,差异有统计学意义(P<0.05);治疗组患者的总胆红素(TB)、直接胆红素(DB)、谷丙转氨酶(ALT)、Y-谷氨酰转酞酶(GGT)和碱性磷酸酶(ALP)分别为(37.91±21.30)μmol/L、(23.70±18.49)μmol/L、(40.50±13.90)μmol/L、(64.30±17.80)μmol/L、(125.60±21.30)μmol/L,明显低于对照组的(78.96±34.48)μmol/L、(66.40±30.28)μmol/L、(68.60±24.80)μmol/L、(90.10±27.80)μmol/L、(157.49±36.49)μmol/L,差异均有统计学意义(P<0.05);治疗组患者的血、尿常规、肾功能以及心电图等安全性观测指标均无异常,无因不良事件退出临床研究。结论利胆退黄方治疗肝胆湿热型病毒性瘀胆型肝炎安全有效,值得临床推广应用。Objective To evaluate the clinical efficacy and safety of Lidantuihuang Prescription in the treatment of liver and gallbladder damp-heat syndrome of cholestatic viral hepatitisease. Methods A multicenter, randomized, controlled parallel study was conducted with 55 patients involved, which were divided into two groups. The control group（27 cases） was treated with Liver JiangMei＋oral ursodeoxycholic acid 250 mg, bid, and the treatment group（28 cases） applied the same basic treatments and the Chinese decotion for 4 weeks. Changes in clinical comprehensive efficacy, TCM syndromes, and liver function [total bilirubin（TB）, direct bilirubin（DB）, alanine aminotransferase（ALT）, γ-glutamyl transpeptidase（GGT）, alkaline phosphatase（ALP） were observed. Results The treatment group was significantly better than the control group in clinical efficacy, TCM syndrome, P〈0.05. The blood serum levels of TB, DB, ALT, AST, ALP in treatment group were（37.91±21.30） μmol/L,（23.70±18.49） μmol/L,（40.50±13.90） μmol/L,（64.30 ± 17.80） μ mol/L,（125.60 ± 21.30） μ mol/L, all significantly lower than those in the control group：（78.96 ±34.48） μmol/L,（66.40±30.28） μmol/L,（68.60±24.80） μmol/L,（90.10±27.80） μmol/L,（157.49±36.49） μmol/L, P〈0.05. Safety indexes such as blood test, urine test, renal function and electrocardiogram showed no adverse events.Conclusion Lidantuihuang Prescription is efficient and safe for jaundice and liver-gallbladder damp-heat syndrome in cholestatic hepatitis virus, which is worthy of clinical promotion.

关 键 词：礼单退黄方 病毒性瘀胆型肝炎 疗效 

分 类 号：R575.1[医药卫生—消化系统]