Clinical efficacy of Biejiaruangan compound tablets in treatment of primary biliary cirrhosis
-
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...
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.
计量
- 文章访问数: 3004
- HTML全文浏览量: 16
- PDF下载量: 776
- 被引次数: 0