Meta Analysis

Fuzheng Huayu preparation (扶正化瘀胶囊/片) combined with tenofovir disoproxil fumarate on hepatitis B: a systematic review and Meta-analysis

  • Junli ZHANG ,
  • Ying HE ,
  • Xia ZHANG ,
  • Hongfang FU ,
  • Xiaoyu HU
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  • Department of Infectious Diseases, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China

Received date: 2022-01-22

  Accepted date: 2022-08-18

  Online published: 2023-03-14

Supported by

National Natural Science Foundation of China: the Molecular Mechanisms of Classical Prescription Sini Decoction plus Ginseng Soup to Rescue Acute Liver Failure: Regulating Hepatocyte Death Modes Mediated by PPARα/UCP2 Mitochondrial Uncoupling Pathway?(81973840)

Abstract

OBJECTIVE: To systematically evaluate the effectiveness of Fuzheng Huayu preparation (扶正化瘀胶囊/片, FZHY) plus tenofovir disoproxil fumarate (TDF) on hepatitis B.

METHODS: Numerous databases — PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure Database, WanFang Database, China Science and Technology Journal Database, and China Biological Medicine Database — were searched to identify the randomized controlled trials published from the inception of the database to November 2021. Two researchers independently conducted literature screening, data extraction, and bias risk assessment. RevMan 5.4 software was used for Meta-analysis.

RESULTS: Eight studies involving 990 patients met the inclusion criteria in the current Meta-analysis. Levels of alanine transaminase, aspartate aminotransferase, total bilirubin, hyaluronic acid, type III procollagen, laminin, and type IV collagen after combination therapy were significantly lower than those after TDF therapy alone. However, albumin levels did not differ significantly between the two regimens. Subgroup analysis based on disease progression suggested that the combination therapy improved albumin levels in patients with chronic hepatitis B but not in patients with hepatitis B-related cirrhosis. Moreover, subgroup analysis based on treatment duration suggested that the albumin levels were increased and the type III procollagen levels were decreased with the > 24-week combination therapy but not with the ≤ 24-week combination therapy.

CONCLUSIONS: A combination regimen of TDF and FZHY is more effective in treating hepatitis B than TDF alone. The combination therapy can effectively alleviate hepatic fibrosis and improve liver function. However, more standardized, high-quality studies with larger sample sizes are warranted to validate the study results.

Cite this article

Junli ZHANG , Ying HE , Xia ZHANG , Hongfang FU , Xiaoyu HU . Fuzheng Huayu preparation (扶正化瘀胶囊/片) combined with tenofovir disoproxil fumarate on hepatitis B: a systematic review and Meta-analysis[J]. Journal of Traditional Chinese Medicine, 2023 , 43(2) : 221 -230 . DOI: 10.19852/j.cnki.jtcm.20221108.005

References

1. Polaris Observatory Collaborators. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study. Lancet Gastroenterol Hepatol 2018; 3: 383-403.
2. Shah NJ, Aloysius MM, Sharma NR, Pallav K. Advances in treatment and prevention of hepatitis B. World J Gastrointest Pharmacol Ther 2021; 12: 56-78.
3. European Association for the Study of the Liver. EASL 2017 clinical practice guidelines on the management of hepatitis B virus infection. J Hepatol 2017; 67: 370-98.
4. Bataller R, Brenner DA. Liver fibrosis. J Clin Invest 2005; 115: 209-18.
5. Koyama Y, Xu J, Liu X, Brenner DA. New developments on the treatment of liver fibrosis. Dig Dis 2016; 34: 589-96.
6. Tan Z, Sun H, Xue T, et al. Liver fibrosis: therapeutic targets and advances in drug therapy. Front Cell Dev Biol 2021; 9: 730176.
7. Zhao CQ, Zhou Y, Ping J, Xu LM. Traditional Chinese Medicine for treatment of liver diseases: progress, challenges and opportunities. J Integr Med 2014; 12: 401-8.
8. Liu W, Li Z, Sun Z, et al. The components data of Fuzheng Huayu extracts, cordyceps sinensis mycelia polysaccharide, gypenosides and amygdalin. Data Brief 2019; 25: 104087.
9. Li H. Advances in anti hepatic fibrotic therapy with Traditional Chinese Medicine herbal formula. J Ethnopharmacol 2020; 251: 112442.
10. Feng Y, Cheung KF, Wang N, Liu P, Nagamatsu T, Tong Y. Chinese medicines as a resource for liver fibrosis treatment. Chin Med 2009; 4: 16.
11. Tang LR, Guo T, Tao YY, Mu YP, Liu CH. A systematic review of combinative effects of Fuzheng Huayu capsule with nucleotide analogues on liver fibrosis due to chronic hepatitis B. Zhong Xi Yi Jie He Gan Bing Za Zhi 2013; 23: 183-7.
12. Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. PLoS Med 2021; 18: e1003583.
13. Higgins JP, Altman DG, G?tzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011; 343: d5928.
14. Wang N. Effects of tenofovir dipivoxil fumarate tablets combined with Fuzheng Huayu capsule on liver function in patients with hepatitis B. Zhong Guo Yao Wu Jing Ji Xue 2020; 15: 111-4.
15. Li TH, Fu YC, Yang YK, Cui YF, Li QY, Tian Y. Clinical study on Fuzheng Huayu tablets combined with tenofovir dipivoxil in treatment of chronic hepatitis B. Xian Dai Yao Wu Yu Lin Chuang 2020; 35: 1787-90.
16. Wang XH. Clinical efficacy of tenofovir disoproxil fumarate combined with Fuzheng Huayu capsule in the treatment of chronic hepatic fibrosis of type B hepatitis. Yi Xue Shi Liao Yu Jian Kang 2019; 17: 166-7.
17. Hu HF, Liu W, Tan L. Effects of tenofovir disoproxil fumarate combined with Fuzheng Huayu on liver fibrosis degree and immune status of patients with hepatitis B cirrhosis. He Bei Yi Xue 2021; 27: 686-92.
18. Yu J, Wang XB, Cui WL. Clinical observation of tenofovir disoproxil fumarate combined with Fuzheng Huayu capsule in the treatment of hepatitis B cirrhosis. Lin Chuang Yan Jiu 2018; 26: 85-7.
19. Li W. Effect of tenofovir dipivoxil and Fuzheng Huayu capsule in the treatment of hepatitis B cirrhosis. Zhong Wai Yi Xue Yan Jiu 2021; 19: 16-8.
20. Ye XT, Sun QF, Fu RQ, Hong L, Zhou Y, Zhang WW. Clinical efficacy of tenofovir and Fuzheng Huayu capsule in treatment of patients with chronic hepatitis B liver cirrhosis. Shi Yong Gan Zang Bing Za Zhi 2021; 24: 143-4.
21. Zhang ZG, Gao FZ, Gao HB. Effect of Fuzheng Huayu capsule combined with tenofovir disoproxil fumarate on APRI score and serum indexes of hepatic fibrosis in compensated hepatitis B cirrhosis. Zhong Guo Shi Yong Yi Yao 2019; 14: 89-91.
22. Agarwal K, Brunetto M, Seto WK, et al. 96 weeks treatment of tenofovir alafenamide vs tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol 2018; 68: 672-81.
23. Tawada A, Kanda T, Yokosuka O. Current and future directions for treating hepatitis B virus infection. World J Hepatol 2015; 7: 1541-52.
24. Marcellin P, Gane E, Buti M, et al. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet 2013; 381: 468-75.
25. Kitrinos KM, Corsa A, Liu Y, et al. No detectable resistance to tenofovir disoproxil fumarate after 6 years of therapy in patients with chronic hepatitis B. Hepatology 2014; 59: 434-42.
26. Yang L, Liao JB, Liu AQ, et al. Advances in Traditional Chinese Medicine for liver disease therapy in 2020. Tradit Med Res 2021; 6: 133-46.
27. Cao M, Miao J, Wang L, Liu HZ, Cui HT, Bian YH. The advances of Traditional Chinese Medicine in the treatment of liver diseases in 2019. Tradit Med Res 2020; 5: 261-71.
28. Liu P, Hu YY, Liu C, et al. Multicenter clinical study on Fuzhenghuayu capsule against liver fibrosis due to chronic hepatitis B. World J Gastroenterol 2005; 11: 2892-9.
29. Deng X, Liang J, Wu FS, Li YB, Zhang YP, Tang YF. Influence of Fuzheng Huayu tablet on mental state and social function of patients with post-hepatitis B liver cirrhosis. Chin J Integr Med 2012; 18: 466-72.
30. Wang QL, Tao YY, Shen L, Cui HY, Liu CH. Chinese herbal medicine Fuzheng Huayu recipe inhibits liver fibrosis by mediating the transforming growth factor-β1/smads signaling pathway. Zhong Xi Yi Jie He Xue Bao 2012; 10: 561-8.
31. Chen J, Hu Y, Chen L, Liu W, Mu Y, Liu P. The effect and mechanisms of Fuzheng Huayu formula against chronic liver diseases. Biomed Pharmacother 2019; 114: 108846.
32. Ayling RM. Pitfalls in the interpretation of common biochemical tests. Postgrad Med J 2000; 76: 129-32.
33. Agbim U, Asrani SK. Non-invasive assessment of liver fibrosis and prognosis: an update on serum and elastography markers. Expert Rev Gastroenterol Hepatol 2019; 13: 361-74.
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