单位：[a]Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing,临床科室国家中心肝病分中心首都医科大学附属北京友谊医院[b]Gastroenterology Department, Renji Hospital, Shanghai Jiao Tong University,Shanghai,[c]Department of Gastroenterology, Xijing Hospital, Fourth Military Medical University, Xi’an,[d]Clinical Research Center for Autoimmune Liver Disease, BeijingYou-an Hospital Capital Medical University, Beijing,[e]Department of Infectious Diseases, Huaxi Hospital, Chengdu,四川大学华西医院[f]Department of Infectious Diseases, ZhejiangUniversity 1st Affiliated Hospital, Hangzhou,[g]Department of Comprehensive Treatment II, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University,Shanghai,[h]Department of Gastroenterology and Hepatology, Chinese People’s Liberation Army General Hospital, Beijing,[i]Department of Infectious Diseases, RuijinHospital, Shanghai,[j]Hepatology Department, Nanfang Hospital, Southern Medical University, Guangzhou,[k]Liver Fibrosis Noninvasive Diagnosis and Treatment Center,302 Military Hospital, Beijing,[l]Department of Infectious Diseases, Sun Yat-Sen University 3rd Affiliated Hospital, Guangzhou,中山大学附属第三医院[m]Liver Disease Center, Beijing DitanHospital, Capital Medial University, Beijing,[n]Department of Gastroenterology and Hepatology, Zhongshan Hospital, Fudan University,[o]Shanghai Public Health Center,Shanghai,[p]Department of Infectious Disease, Peking University First Hospital, Beijing,[q]Department of Infectious Diseases, Changzheng Hospital, Second MilitaryMedical University, Shanghai,[r]Department of Infectious Diseases, Hangzhou Sixth People’s Hospital, Hangzhou,[s]Department of Gastroenterology, The 1st AffiliatedHospital of Kunming Medical University, Kunming, China,昆明医科大学附属第一医院[t]Department of Infectious Diseases, The Third People’s Hospital Affiliated to Shanghai Jiaotong UniversitySchool of Medicine, Shanghai,[u]Hepatology Unit, Peking University People’s Hospital, Beijing,[v]Department of Infectious Diseases, Shanghai Huashan Hospital,[w]Department of Infectious Diseases, 85th PLA Hospital, Shanghai,[x]Department of Gastroenterology, First Affiliated Hospital, Sun Yat-sen University, Guangzhou,院本部南沙医院东院内科消化内科内科消化内科内科消化内科中山大学附属第一医院[y]Institute and Department of Infectious Diseases, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan,华中科技大学同济医学院附属同济医院[z]Department ofBiostatistics, Peking University First Hospital, Beijing, China.
Aim: Tauroursodeoxycholic acid (TUDCA) is a taurine conjugated form of ursodeoxycholic acid (UDCA) with higher hydrophility. To further evaluate the efficacy and safety of TUDCA for primary biliary cholangitis (PBC), we performed this study on Chinese patients. Methods: 199 PBC patients were randomly assigned to either 250mg TUDCA plus UDCA placebo or 250mg UDCA plus TUDCA placebo, 3 times per day for 24 weeks. The primary endpoint was defined as percentage of patients achieving serum alkaline phosphatase (ALP) reduction of more than 25% from baseline. Results: At week 24, 75.97% of patients in the TUDCA group and 80.88% of patients in the UDCA group achieved a serum ALP reduction of more than 25% from baseline (P=0.453). The percentage of patients with serum ALP levels declined more than 40% following 24 weeks of treatment was 55.81% in the TUDCA group and 52.94% in the UDCA group (P=0.699). Both groups showed similar improvement in serum levels of ALP, aspartate aminotransferase, and total bilirubin (P>0.05). The proportion of patients with pruritus/scratch increased from 1.43% to 10.00% in UDCA group, while there's no change in TUDCA group (P=0.023). Both drugs were well tolerated, with comparable adverse event rates between the 2 groups. Conclusions: TUDCA is safe and as efficacious as UDCA for the treatment of PBC, and may be better to relieve symptoms than UDCA.
基金：
Beijing Trendful Kangjian Medical Information Consulting Co., Ltd.; Major Science and Technology Special Project of China Twelfth Five-year Plan [2012ZX10002003]
第一作者单位：[a]Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing,
通讯作者：
通讯机构：[a]Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing,[*a]Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, National Clinical Research Center for Digestive Diseases, 95 Yong-an Road, Xicheng District, Beijing 100050, China
推荐引用方式(GB/T 7714)：
Hong Ma,Minde Zeng,Ying Han,et al.A multicenter, randomized, double-blind trial comparing the efficacy and safety of TUDCA and UDCA in Chinese patients with primary biliary cholangitis[J].MEDICINE.2016,95(47):doi:10.1097/MD.0000000000005391.
APA：
Hong Ma,Minde Zeng,Ying Han,Huiping Yan,Hong Tang...&Jidong Jia.(2016).A multicenter, randomized, double-blind trial comparing the efficacy and safety of TUDCA and UDCA in Chinese patients with primary biliary cholangitis.MEDICINE,95,(47)
MLA：
Hong Ma,et al."A multicenter, randomized, double-blind trial comparing the efficacy and safety of TUDCA and UDCA in Chinese patients with primary biliary cholangitis".MEDICINE 95..47(2016)
