Effect of Shuanghu Qinggan Granule () and Yigan Yiqi Jieyu Granule () plus lamivudine on chronic hepatitis B patients: A randomized double-blind placebo-controlled trial.
机构:[1]Department of Gastroenterology, Dongzhimen HospitalAffiliated to Beijing University of Chinese Medicine, Beijing(100700), China[2]Department of Hepatology, ShanghaiShuguang Hospital, Shanghai (201210), China[3]Department of Integrated Chinese and Western Medicine, 302 MilitaryHospital of China, Beijing (100039), China[4]Epidemic Research Center, The Third Hospital Affiliated to PekingUniversity, Beijing (100191), China[5]Department of IntegratedChinese and Western Medicine, Beijing Ditan Hospital, Beijing(100015), China[6]Department of Hepatology, HospitalAffiliated to Changchun University of Chinese Medicine,Changchun (130021), China[7]Department of Hepatology, TheFirst Hospital Affi liated to Tianjin University of Chinese Medicine,Tianjin (300193), China[8]Department of Hepatology, ShanghaiLonghua Hospital, Shanghai (200032), China[9]Department of Hepatology, Shenzhen Hospital of Chinese Medicine, Shenzhen(581033), Guangdong province, China深圳市康宁医院深圳医学信息中心[10]Department of Hepatology, Shaanxi Provincial Hospital of Chinese Medicine,Xi'an (710003), China[11]Department of Hepatology, The FirstHospital Affiliated to Hunan University of Chinese Medicine,Changsha (410007), China[12]School of Applied Scienceand Information Engineering, Beijing University of Science andTechnology, 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.
基金:
National 10th-Five Years Project (No.2004BA721A03), and the Project of Beijing Technology Plan (No.D08050700630801)
语种:
外文
PubmedID:
中科院(CAS)分区:
出版当年[2015]版:
大类|4 区医学
小类|4 区全科医学与补充医学
最新[2025]版:
大类|4 区医学
小类|4 区全科医学与补充医学
第一作者:
第一作者机构:[1]Department of Gastroenterology, Dongzhimen HospitalAffiliated to Beijing University of Chinese Medicine, Beijing(100700), China
通讯作者:
推荐引用方式(GB/T 7714):
Ye Yong-An,Tian De-Lu,Jiang Jian,et al.Effect of Shuanghu Qinggan Granule () and Yigan Yiqi Jieyu Granule () plus lamivudine on chronic hepatitis B patients: A randomized double-blind placebo-controlled trial.[J].Chinese Journal of Integrative Medicine.2016,doi:10.1007/s11655-016-2519-9.
APA:
Ye Yong-An,Tian De-Lu,Jiang Jian,Li Jun,Chen Jian-Jie...&Li Xiao-Ke.(2016).Effect of Shuanghu Qinggan Granule () and Yigan Yiqi Jieyu Granule () plus lamivudine on chronic hepatitis B patients: A randomized double-blind placebo-controlled trial..Chinese Journal of Integrative Medicine,,
MLA:
Ye Yong-An,et al."Effect of Shuanghu Qinggan Granule () and Yigan Yiqi Jieyu Granule () plus lamivudine on chronic hepatitis B patients: A randomized double-blind placebo-controlled trial.".Chinese Journal of Integrative Medicine .(2016)