Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients:A Randomized Controlled 48-Week Trial  

作　　者：LI Xiao-ke ZHANG Ming-xiang SHAO Feng-zhen ZHOU Da-qiao XUE Jing-dong LIU Tie-jun CHI Xiao-ling LU Bing-jiu WANG Xian-bo LI Qin LI Jun MAO De-wen YANG Hua-sheng YANG Hong-zhi ZHAO Wen-xia LI Yong ZHANG Guo-liang ZHAO Yi-ming ZOU Jian-dong LIU Meng-yang ZHANG Ke-ke YANG Xian-zhao GAN Da-nan LI Ying ZHANG Peng LI Zhi-guo LI Shuo YE Yong-an 

机构地区：[1]Department of Gastroenterology,Institute of Liver Disease,Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine,Beijing(100700),China [2]Department of Hepatology,the Sixth People's Hospital of Shenyang,Shenyang(110006),China [3]Department of Hepatology,the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin(300000),China [4]Departm ent of Hepatology,Shenzhen Traditional Chinese Medicine Hospital,Shenzhen(518033),C hina [5]D e pa rtm e nt of H e pa to log y,Shaanxi H o spital of T radition al C hinese M edicine,Xi'an(710003),China [6]Affiliated Hospital of Changchun U niversity of Chinese M edicine,C hangchun(130021),China [7]Departm ent of Hepatology,Guangdong Hospital of Traditional Chinese Medicine,Guangzhou(510006),China [8]Department of Hepatology,Liaoning Hospital of Traditional Chinese Medicine,Shenyang(110032),China [9]Department of Hepatology,Beijing Ditan Hospital,Beijing(100015),China [10]Department of Hepatology,Mengchao Hepatobiliary Hospital of Fujian Medical University,Fuzhou(350025),China [11]Department of Hepatology,the 302 Military Hospital of PLA,Beijing(100039),China [12]Department of Hepatology,the First Affiliated Hospital of Guangxi University of Chinese Medicine,Nanning(530023),China [13]Department of Integrated Traditional Chinese Medicine and Western Medicine,Beijing YouAn Hospital,Capital Medical University,Beijing(100069),China [14]Department of Traditional Chinese Medicine,Third Affiliated Hospital of Sun Yat-sen University,Guangzhou(510630),China [15]Department of Gastroenterology,the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou(450000),China [16]Department of Hepatology,Shandong Hospital of Traditional Chinese Medicine,Jinan(250011),China [17]Department of Gastroenterology,Anhui Hospital of Traditional Chinese Medicine,Hefei(230031),China [18]Research Center of Clinical Epidemiology,Peking University Third Hospital,Beijing(100191),China [19]Clinical Research Center,Affiliated Hospital of Nanjing Un

出　　处：《Chinese Journal of Integrative Medicine》2020年第5期330-338,共9页中国结合医学杂志（英文版）

基　　金：Supported by the China National Science and Technology Major Projects,11th 5-year Project(No.2008ZX10005-006)。

摘　　要：Objective:To evaluate the effects of a 48-week course of adefovir dipivoxil(ADV)plus Chinese medicine(CM)therapy,namely Tiaogan Jianpi Hexue(调肝健脾和血)and Tiaogan Jiedu Huashi(调肝解毒化湿)fomulae,in hepatitis B e antigen(HBeAg)-positive Chinese patients.Methods:A total of 605 HBeAg-positive Chinese CHB patients were screened and 590 eligible participants were randomly assigned to 2 groups in 1:1 ratio including experimental group(EG,received ADV plus CM)and control group(CG,received ADV plus CM-placebo)for 48 weeks.The major study outcomes were the rates of HBeAg and HBV-DNA loss on week 12,24,36,48,respectively.Secondary endpoints including liver functions(enzymes and bilirubin readings)were evaluated every 4 weeks at the beginning of week 24,36,and 48.Routine blood,urine,and stool analyses in addition to electrocardiogram and abdominal B scan were monitored as safety evaluations.Adverse events(AEs)were documented.Results:The combination therapy demonstrated superior HBeAg loss at 48 weeks,without additional AEs.The full analysis population was 560 and 280 in each group.In the EG,population achieved HBeAg loss on week 12,24,36,and 48 were 25(8.90%),34(12.14%),52(18.57%),and 83(29.64%),respectively;the equivalent numbers in the CG were 20(7.14%),41(14.64%),54(19.29%),and 50(17.86%),respectively.There was a statistically significant difference between two groups on week 48(P<0.01).No additional AEs were found in EG.Subgroup analysis suggested different outcomes among treatment patterns.Conclusion:Combination of CM and ADV therapy demonstrated superior HBeAg clearance compared with ADV monotherapy.The finding indicates that this combination therapy may provide an improved therapeutic effect and safety profile(ChiCTR-TRC-11001263).

关 键 词：ADEFOVIR dipivoxil Tiaogan Jianpi Hexue Tiaogan Jiedu Huashi Chinese medicine HBEAG combination therapy 

分 类 号：R512.62[医药卫生—内科学]