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Effect of Shuanghu Qinggan Granule (双虎清肝颗粒) and Yigan Yiqi Jieyu Granule (乙肝益气解郁颗粒) plus lamivudine on chronic hepatitis B patients: A randomized double-blind placebo-controlled trial

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Abstract

Objective

To observe the clinical efficacy and safety of Shuanghu Qinggan Granule (双虎清肝颗 粒, SQG) plus Yigan Yiqi Jieyu Granule (乙肝益气解郁颗粒, YYJG) combined with lamivudine (LAM) on chronic hepatitis B (CHB) patients.

Methods

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.

Results

(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).

Conclusion

The protocol of SQG and YYJG combined with LAM to treat CHB showed superior efficacy than LAM monotherapy.

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Author information

Authors and Affiliations

  1. Department of Gastroenterology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China

    Yong-an Ye  (叶永安), De-lu Tian  (田德录), Zhi-hong Li  (李志红), Wei-guo Ma  (马卫国), Yu-fen Wang  (王玉芬) & Xiao-ke Li  (李小科)

  2. Department of Hepatology, Shanghai Shuguang Hospital, Shanghai, 201210, China

    Jian Jiang  (蒋 健) & Jian-jie Chen  (陈建杰)

  3. Department of Integrated Chinese and Western Medicine, 302 Military Hospital of China, Beijing, 100039, China

    Jun Li  (李 筠)

  4. Epidemic Research Center, The Third Hospital Affiliated to Peking University, Beijing, 100191, China

    Yi-ming Zhao  (赵一鸣)

  5. Department of Integrated Chinese and Western Medicine, Beijing Ditan Hospital, Beijing, 100015, China

    Rong-bing Wang  (王融冰)

  6. Department of Hepatology, Hospital Affiliated to Changchun University of Chinese Medicine, Changchun, 130021, China

    Shi-zhong Yang  (杨世忠) & Tie-jun Liu  (刘铁军)

  7. Department of Hepatology, The First Hospital Affiliated to Tianjin University of Chinese Medicine, Tianjin, 300193, China

    Feng-zhen Shao  (邵凤珍)

  8. Department of Hepatology, Shanghai Longhua Hospital, Shanghai, 200032, China

    Guang Ji  (季 光) & Wei Zhang  (张 玮)

  9. Department of Hepatology, Shenzhen Hospital of Chinese Medicine, Shenzhen, Guangdong province, 581033, China

    Da-qiao Zhou  (周大桥)

  10. Department of Hepatology, Shaanxi Provincial Hospital of Chinese Medicine, Xi’an, 710003, China

    Dong-sheng Cheng  (成东生)

  11. Department of Hepatology, The First Hospital Affiliated to Hunan University of Chinese Medicine, Changsha, 410007, China

    Ke-wei Sun  (孙克伟)

  12. School of Applied Science and Information Engineering, Beijing University of Science and Technology, Beijing, 100083, China

    Le-quan Min  (闵乐泉)

Authors
  1. Yong-an Ye  (叶永安)
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  2. De-lu Tian  (田德录)
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  3. Jian Jiang  (蒋 健)
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  4. Jun Li  (李 筠)
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  5. Jian-jie Chen  (陈建杰)
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  6. Zhi-hong Li  (李志红)
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  7. Wei-guo Ma  (马卫国)
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  8. Yi-ming Zhao  (赵一鸣)
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  9. Rong-bing Wang  (王融冰)
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  10. Shi-zhong Yang  (杨世忠)
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  11. Feng-zhen Shao  (邵凤珍)
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  12. Guang Ji  (季 光)
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  13. Da-qiao Zhou  (周大桥)
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  14. Tie-jun Liu  (刘铁军)
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  15. Dong-sheng Cheng  (成东生)
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  16. Wei Zhang  (张 玮)
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  17. Ke-wei Sun  (孙克伟)
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  18. Yu-fen Wang  (王玉芬)
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  19. Le-quan Min  (闵乐泉)
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  20. Xiao-ke Li  (李小科)
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Corresponding author

Correspondence to Yong-an Ye  (叶永安).

Additional information

Supported by the National 10th-Five Years Project (No. 2004BA721A03), and the Project of Beijing Technology Plan (No. D08050700630801)

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Ye, Ya., Tian, Dl., Jiang, J. et al. Effect of Shuanghu Qinggan Granule (双虎清肝颗粒) and Yigan Yiqi Jieyu Granule (乙肝益气解郁颗粒) plus lamivudine on chronic hepatitis B patients: A randomized double-blind placebo-controlled trial. Chin. J. Integr. Med. (2016). https://doi.org/10.1007/s11655-016-2519-9

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  • DOI: https://doi.org/10.1007/s11655-016-2519-9

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