Effect of ursodeoxycholic acid with traditional Chinese medicine on biochemical response in patients with primary biliary cholangitis: a real-world cohort study
10.3760/cma.j.issn.1007-3418.2018.12.007
- VernacularTitle: 熊去氧胆酸联合中药治疗对原发性胆汁性胆管炎患者生物化学应答的影响：一项基于真实世界的队列研究
- Author:
Jialiang CHEN
1
;
Xue YANG
1
;
Qun ZHANG
2
;
Le SUN
2
;
Yao LIU
1
;
Bingbing ZHU
2
;
Xianbo WANG
1
Author Information
1. Center of Integrative Medicine, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
2. Department of Gastroenterology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
- Publication Type:Journal Article
- Keywords:
Cholangitis, biliary;
Drugs, Chinese herbal;
Biochemical response;
Ursodeoxycholic acid;
Integrative medicine
- From:
Chinese Journal of Hepatology
2018;26(12):909-915
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To examine the effects of ursodeoxycholic acid combined with Traditional Chinese Medicine on biochemical response in patients with primary biliary cholangitis.
Methods:According to the method of receiving treatment, 197 patients with primary biliary cholangitis were divided into Traditional Chinese Medicine plus Western medicine group (93 cases, 47.2%) and Western medicine group (104 cases, 52.8%). From the baseline date, the combined group was treated with ursodeoxycholic acid plus traditional Chinese medicine decoction or Chinese patent medicine for at least one month and the Western medicine group simply took ursodeoxycholic acid . Additionally, Traditional Chinese medicine decoction prescriptions were mainly Xiaoyaosan and Yinchenhao. Chinese patent medicine were restricted to Biejia Ruangan tablets, Fuzheng Huayu capsules, Jiuweigantai capsules and Yinzhihuang capsules, which were used to treat liver fibrosis and cholestasis. The primary efficacy endpoint was defined as ALP level < 1.67 × ULN and ≥ 15% decrease in ALP with baseline level and TBIL≤ULN after 12 months of treatment.
Results:The overall biochemical response rate of patients was 35.0% (69/197). The response rate of TCM+ Western medicine group was 43.0% (40/93), and that of Western medicine group was 27.9% (29/104). The difference between the two groups was statistically significant (χ2 = 4.936, P < 0.05). Further analysis showed that the Chinese and Western medicine group was superior to the Western medicine group alone in reducing γ-glutamyltransferase (GGT) and TBiL [the median decline were GGT: 160.1 U/L and 111.3 U/L (Z = -2.474, P < 0.05), TBiL: 5.2 umol/l and 3.1 umol/l (Z = -2.125, P < 0.05)].
Conclusion:UDCA combined with TCM therapy can remarkably improve the biochemical response rate in patients with PBC and distinctly decrease the TBIL and GGT levels than UDCA monotherapy.
