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. 2023 Apr 28;11(2):304-313.
doi: 10.14218/JCTH.2022.00091. Epub 2022 Jun 6.

An-Luo-Hua-Xian Pill Improves the Regression of Liver Fibrosis in Chronic Hepatitis B Patients Treated with Entecavir

Yi-Qi Liu  1 , Chi Zhang  1 , Jia-Wen Li  1 , Li-Hua Cao  2 , Zhan-Qing Zhang  3 , Wei-Feng Zhao  4 , Qing-Hua Shang  5 , Da-Zhi Zhang  6 , An-Lin Ma  7 , Qing Xie  8 , Hong-Lian Gui  8 , Guo Zhang  9 , Ying-Xia Liu  10 , Jia Shang  11 , Shi-Bin Xie  12 , Jun Li  13 , Xu-Qing Zhang  14 , Zhi-Qiang Zou  15 , Yu-Ping Chen  16 , Zong Zhang  17 , Ming-Xiang Zhang  18 , Jun Cheng  19 , Fu-Chun Zhang  20 , Li-Hua Huang  21 , Jia-Bin Li  22 , Qing-Hua Meng  23 , Hai-Bin Yu  23 , Yu-Qiang Mi  24 , Yan-Zhong Peng  25 , Zhi-Jin Wang  26 , Li-Ming Chen  27 , Fan-Ping Meng  27 , Wan-Hua Ren  28 , Lang Bai  29 , Yi-Lan Zeng  30 , Rong Fan  31 , Xian-Zhi Lou  32 , Wei-Feng Liang  33 , Hui Liu  34 , Hui Zhuang  35 , Hong Zhao  1   36 , Gui-Qiang Wang  1   36
Affiliations

An-Luo-Hua-Xian Pill Improves the Regression of Liver Fibrosis in Chronic Hepatitis B Patients Treated with Entecavir

Yi-Qi Liu et al. J Clin Transl Hepatol. .

Abstract

Background and aims: Chronic hepatitis B (CHB) can cause liver fibrosis and lead to cirrhosis and cancer. As the effectiveness of antiviral therapy to reverse liver fibrosis is limited, We aimed to evaluate the effect of An-Luo-Hua-Xian pill (ALHX) on fibrosis regression in CHB patients treated with entecavir (ETV).

Methods: Treatment-naïve patients with CHB were randomly treated with ETV alone or combined with ALHX (ETV+ALHX) between October 1, 2013 and December 31, 2020. Demographic, laboratory, and liver histology data before and after 78 weeks of treatment were collected. The Ishak fibrosis score (F) was used and fibrosis regression required a decrease in F of ≥1 after treatment.

Results: A total of 780 patients were enrolled, and 394 with a second liver biopsy after treatment were included in the per-protocol population, 132 in ETV group and 262 in ETV+ALHX group. After 78 weeks of treatment, the fibrosis regression rate in the ETV+ALHX group was significantly higher than that of the ETV group at baseline F≥3 patients: 124/211 (58.8%) vs. 45/98 (45.9%), p=0.035. The percentage of patients with a decreased liver stiffness measurement (LSM) was higher in the ETV+ALHX group: 156/211 (73.9%) vs. 62/98 (63.%), p=0.056. Logistic regression analysis showed that ETV combined with ALHX was associated with fibrosis regression [odds ratio (OR)=1.94, p=0.018], and a family history of hepatocellular carcinoma was on the contrary. (OR=0.41, p=0.031).

Conclusions: ETV combined with ALHX increased liver fibrosis regression in CHB patients.

Keywords: Chronic hepatitis B; Liver fibrosis; Randomized controlled trial; Regression.

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Conflict of interest statement

The authors have no conflict of interests related to this publication.

Figures

Fig. 1
Fig. 1. Flowchart of enrollment.
Fig. 2
Fig. 2. Distribution of fibrosis scores in both study groups before and after 78 weeks of treatment.
Fig. 3
Fig. 3. Distribution of LSM, APRI and FIB-4 in the study groups before and after treatment (A, B, C) and changes in the groups before and after treatment (D, E, F).
See this image and copyright information in PMC

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