研究单位：[1]Beijing Friendship Hospital[2]Beijing Trendful Kangjian Medical Information Consulting Limited Company[3]Beijing 302 Hospital,Beijing,Beijing,China[4]Beijing Ditan Hospital,Beijing,Beijing,China[5]Beijing Friendship Hospital,Beijing,Beijing,China[6]Beijing Youan Hospital,Beijing,Beijing,China[7]Chinese PLA General Hospital,Beijing,Beijing,China[8]Peiking University First Hosptial,Beijing,Beijing,China[9]Peking University People''s Hospital,Beijing,Beijing,China[10]First Affiliated Hospital,SunYat-Sen University,Guangzhou,Guangdong,China[11]Nanfang Hospital of Southern Medical University,Guangzhou,Guangdong,China[12]Third Affiliated Hospital,SunYat-Sen University,Guangzhou,Guangdong,China[13]Tongji Hospital,Wuhan,Hunan,China[14]85 Military Hospital,Shanghai,Shanghai,China[15]Eastern Hepatobiliary Surgery Hospital,Shanghai,Shanghai,China[16]Huashan Hospital,Shanghai,Shanghai,China[17]NO.3 People''s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai,Shanghai,China[18]RenJi Hospital,Shanghai,Shanghai,China[19]RuiJin Hospital,Shanghai,Shanghai,China[20]ShangHai Changzheng Hospital,Shanghai,Shanghai,China[21]Shanghai Public Health Clinical Center,Shanghai,Shanghai,China[22]Shanghai Zhongshan Hospital,Shanghai,Shanghai,China[23]Xijing Hospital,Xian,Shanxi,China[24]West China Hospital,Chengdu,Sichuan,China[25]First Affiliated Hospital Of KunMing Medical College,Kunming,Yunnan,China[26]The Sixth People''s Hospital of Hangzhou,Hangzhou,Zhejiang,China[27]First Affiliated Hospital of Zhejiang University,Zhejiang,Zhejiang,China
Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation. The more hydrophilic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of UDCA, and has been approved by state food and drug administration in China for treatment of cholesterol stones. So it is necessary to verify the efficacy and safety of TUDCA in the treatment of adult primary biliary cirrhosis. In this randomized, double-blinded, double-dummy, parallel-controlled and multicenter clinical trial, we detect the proportion of patients who had AKP decline more than 25% as the primary outcome; decline of AKP, total bilirubin, GGT, ALT and AST as secondary outcomes after patients were treated with TUDCA or UDCA for 24 weeks.
