[1]Department of Gastroenterology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China. Yeyongan@vip.163.com.
[2]Department of Gastroenterology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.
[3]Department of Hepatology, Shanghai Shuguang Hospital, Shanghai, 201210, China.
[4]Department of Integrated Chinese and Western Medicine, 302 Military Hospital of China, Beijing, 100039, China.
[5]Epidemic Research Center, The Third Hospital Affiliated to Peking University, Beijing, 100191, China.
[6]Department of Integrated Chinese and Western Medicine, Beijing Ditan Hospital, Beijing, 100015, China.
[7]Department of Hepatology, Hospital Affiliated to Changchun University of Chinese Medicine, Changchun, 130021, China.
[8]Department of Hepatology, The First Hospital Affiliated to Tianjin University of Chinese Medicine, Tianjin, 300193, China.
[9]Department of Hepatology, Shanghai Longhua Hospital, Shanghai, 200032, China.
[10]Department of Hepatology, Shenzhen Hospital of Chinese Medicine, Shenzhen, Guangdong province, 581033, China.
[11]Department of Hepatology, Shaanxi Provincial Hospital of Chinese Medicine, Xi'an, 710003, China.
[12]Department of Hepatology, The First Hospital Affiliated to Hunan University of Chinese Medicine, Changsha, 410007, China.
[13]School of Applied Science and Information Engineering, Beijing University of Science and Technology, Beijing, 100083, China.
To observe the clinical efficacy and safety of Shuanghu Qinggan Granule ( , SQG) plus Yigan Yiqi Jieyu Granule (, YYJG) combined with lamivudine (LAM) on chronic hepatitis B (CHB) patients.;The study was a multicenter, randomized, double-blinded and parallel controlled trial. A total of 320 patients were randomly allocated into 2 groups equally: 160 patients (treatment group) were given SQG and YYJG combined with LAM; and 160 patients (control group) were given LAM plus Chinese herb placebo, respectively. Liver functions, hepatitis B envelop antigen (HBeAg) titer levels, and hepatitis B virus DNA (HBV-DNA) load were monitored.;(1) In the 48th week, the treatment group showed superior HBeAg seroconversion rate than that in the control group (38.0% vs. 24.0%, P<0.05). (2) In the 48th week, the treatment group demonstrated lower HBeAg titer than that in the control group (P<0.05). (3) In the 12th, 24th, 48th week, there was no statistical significance in HBV-DNA response rate between the two groups. (4) In the 12th week, the level of glutamyl transpeptidase (GGT) was significantly decreased in the treatment group compared with the control group (P<0.05); in the 36th week, the levels of alanine aminotransferase and aspartate transaminase were significantly lower in the treatment group than those in the control group (P<0.05).;The protocol of SQG and YYJG combined with LAM to treat CHB showed superior efficacy than LAM monotherapy.;