复方鳖甲软肝片治疗原发性胆汁性肝硬化的临床疗效评价

黄凌鹰; 周振华; 孙学华; 李曼; 朱晓骏; 金树根; 张鑫; 高月求

doi:10.3969/j.issn.1001-5256.2015.02.009

复方鳖甲软肝片治疗原发性胆汁性肝硬化的临床疗效评价

DOI: 10.3969/j.issn.1001-5256.2015.02.009

上海中医药大学附属曙光医院,上海市中医临床重点实验室

基金项目:

国家“艾滋病和病毒性肝炎等重大传染病防治”科技重大专项(2012ZX10005004-002、2012ZX-10005010-002-003)；国家自然科学基金(81102570、81202662)；中国肝炎防治基金会王宝恩肝纤维化研究基金(CFHPC20131045、CFHPC20131046)；教育部博士点专项基金(20123107110003)；上海市科委临床重点项目(11411951600)；上海市科委科技支撑项目(13401902900)；上海高校创新团队项目(第一期)；上海市卫生和计划生育委员会科研项目(2014Y0141)；上海市中医药事业发展三年行动计划项目(ZYSNXD-CC-ZDYJ015/048)；上海市科委扬帆计划(14YF1411600)；上海中医药大学预算内项目(2013JW40)；上海市重中之重临床医学中心(中医肝病)；

详细信息

中图分类号: R575.22
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出版历程
- 出版日期: 2015-02-20

Clinical efficacy of Biejiaruangan compound tablets in treatment of primary biliary cirrhosis

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai Key Laboratory of Traditional Chinese Clinical Medicine

Research funding:

摘要

摘要:
目的评价复方鳖甲软肝片治疗原发性胆汁性肝硬化（PBC）患者的临床疗效。方法按照随机双盲安慰剂对照设计方法,纳入上海中医药大学附属曙光医院2011年11月-2013年12月确诊的56例PBC患者,分为治疗组和对照组各28例。治疗组给予复方鳖甲软肝片（4片/次,3次/d,口服）联合熊去氧胆酸片（UDCA）（50 mg/片,1015 mg·kg-1·d-1）治疗。对照组给予空白安慰剂（4片/次,3次/日,口服）联合UDCA 50 mg/片,1015 mg·kg-1·d-1)治疗。两组患者均治疗12个月。观察治疗前后患者临床症状、PBC-40量表、肝功能（ALT、AST、ALP、GGT、TBil）、肝脏弹力硬度值的变化。组间计量资料比较采用t检验,计数资料比较采用χ2检验。结果治疗12个月后,治疗组患者肝功能ALT、AST、GGT、ALP、TBil均有显著下降,与治疗前相比差异有统计学意义（t值分别为3.2019、3.0953、3.0279,P值均<0.01;t值分别为2.4420、2.1621,P值均<0.05）,对照组患者肝功能仅GG...
- 肝硬化,胆汁性 /
- 复方鳖甲软肝片 /
- 牛磺,熊去氧胆酸 /
- 治疗结果
Abstract:
Objective To evaluate the clinical efficacy of Biejiaruangan compound tablets in the treatment of primary biliary cirrhosis( PBC). Methods In a randomized,double- blind,placebo- controlled study,56 patients with PBC were collected and equally divided into treatment group and control group. The treatment group was given Biejiaruangan compound tablets( 4 pills per dose,3 doses per day,oral administration) combined with ursodeoxycholic acid( UDCA) tablets( 50 mg / pill,10- 15 mg per kg per day). The control group was given placebo( 4 pills per dose,3 doses per day,oral administration) combined with UDCA tablets( 50 mg / pill,10- 15 mg per kg per day). All patients were treated for 12 months. Clinical symptoms,PBC- 40 scales,liver function [alanine aminotransferase( ALT),aspartate aminotransferase( AST),alkaline phosphatase( ALP),γ- glutamyl transpeptidase( GGT),and total bilirubin( TBil) ],and liver stiffness values in the two groups were evaluated before and after treatment. Comparison of continuous data between the two groups was made by t test,and comparison of categorical data was made by chi- square test. Results The levels of ALT,AST,GGT,ALP,and TBil in the treatment group significantly decreased after 12 months of treatment( t = 3. 2019,P < 0. 01; t = 3. 0953,P < 0. 01; t = 3. 0279,P < 0. 01;t = 2. 4420,P < 0. 05; t = 2. 1621,P < 0. 05). In the control group,only the level of GGT significantly decreased after treatment( t =1. 9981,P < 0. 01). The levels of GGT and ALP were significantly lower in the treatment group than in the control group( t = 2. 0061,P <0. 05; t = 2. 3106,P < 0. 05). The liver stiffness value in the treatment group significantly decreased after treatment( 14. 37 ± 10. 58 vs10. 02 ± 5. 96 k Pa,t = 2. 1134,P < 0. 05). The PBC- 40 scales of skin itch,fatigue,and social dimension in the treatment group significantly decreased after treatment for 12 months( t = 2. 5158,P < 0. 05; t = 2. 1409,P < 0. 05; t = 3. 2441,P < 0. 05). There were significant differences in scales of fatigue and social dimension between the two groups after 12 months of treatment( t = 3. 1491,P < 0. 05; t =2. 6287,P < 0. 05). Conclusion Biejiaruangan compound tablets can significantly improve liver function,reduce the liver stiffness value,and improve PBC- 40 scales of skin itch and fatigue in patients with PBC. This therapy holds promise for widespread clinical application.
- liver cirrhosis,biliary /
- Biejiaruangan compound tablets /
- tauro-ursodeoxycholic acid /
- treatment outcome