扶正化瘀联合恩替卡韦联合治疗慢性乙型肝炎并发肝纤维化

StephenW

Histological Outcome of Fuzheng Huayu plus Entecavir Combination Therapy in Chronic Hepatitis B Patients with Significant Liver Fibrosis
Hong-Lian Gui  1 , Chang-Qing Zhao  2 , Yan Wang  3 , Hong-Tu Gu  2 , Wei-Jing Wang  1   4 , Wei Cai  1 , Qing Guo  1 , Shi-San Bao  5 , Lie-Ming Xu  2 , Qing Xie  1
Affiliations
Affiliations

    1
    Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
    2
    Department of Liver Cirrhosis, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
    3
    Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
    4
    Department of Infectious Diseases, Ruijin North Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
    5
    Discipline of Pathology, School of Medicine Sciences and Bosch Institute, Charles Perkin Centre, University of Sydney, New South Wales, Australia.

    PMID: 33083250 PMCID: PMC7562803 DOI: 10.14218/JCTH.2020.00004

Abstract

Background and Aims: To evaluate the efficacy of Fuzheng Huayu (FZHY), a Chinese herbal formula, plus entecavir (ETV) in regression of liver fibrosis in chronic hepatitis B (CHB) patients with significant fibrosis/cirrhosis. Methods: The current study was a two-center, randomized, double-blind and placebo-controlled pilot study. Fifty-two currently untreated chronic hepatitis B patients with Ishak fibrosis score ≥3 points were identified and 1:1 randomized into FZHY plus ETV combination and placebo plus ETV groups. The second liver biopsy was performed after 48-week treatment. Necroinflammatory improvement and regression of fibrosis were assessed. Fine changes in different collagen features in paired liver biopsies were evaluated by dual-photon microscopy for both groups. Results: Forty-nine patients completed the full course of treatment; forty-six of them underwent second liver biopsy (for which twenty-two were in the combination group and twenty-four were in the control group). Compared to those in the control group, patients in the combination group had significantly higher rate of fibrosis regression (82% vs. 54%) (p<0.05). Furthermore, the necroinflammatory improvement was greater in the combination group than in the control group (59% vs. 25%, p<0.05). Among the more than 80 collagen parameters in the dual-photon analysis, 5 decreased significantly in the combination group compared to the control group (p<0.05). However, no significant improvement was detected in either biochemical, virologic or serologic responses between these two groups at week 48. Conclusions: The combination therapy of FZHY plus ETV for 48 weeks resulted in a higher rate of necroinflammatory improvement and fibrosis regression than ETV alone in chronic hepatitis B patients with significant fibrosis/cirrhosis. The clinical trial number is ChiCTR-TRC-11001377.

Keywords: Chronic hepatitis B; Entecavir; Fibrosis; Fuzheng Huayu tablet.

© 2020 Authors.

StephenW

扶正化瘀联合恩替卡韦联合治疗慢性乙型肝炎并发肝纤维化的组织学结果
桂红莲1，赵长青2，王艳3，谷洪图2，王伟京1 4，韦彩1，郭青1，十三宝5，徐烈明2，青谢1
隶属关系
隶属关系

    1个
    上海交通大学医学院附属瑞金医院传染病科，上海
    2
    上海中医药大学附属曙光医院肝硬化科，上海
    3
    南方医科大学附属南方医院感染科，广东广州
    4
    上海交通大学医学院附属瑞金北医院传染病科，上海
    5
    澳大利亚新南威尔士州悉尼大学查尔斯·珀金中心医学科学研究所和博世研究所病理学学科。

    PMID：33083250 PMCID：PMC7562803 DOI：10.14218 / JCTH.2020.00004

抽象

背景与目的：评价中药复方化瘀（FZHY）和恩替卡韦（ETV）在具有明显纤维化/肝硬化的慢性乙型肝炎（CHB）患者肝纤维化消退中的疗效。方法：目前的研究是一个两中心，随机，双盲和安慰剂对照的试验研究。确定了五十二例Ishak纤维化评分≥3分的未经治疗的慢性乙型肝炎患者，并将1：1随机分为FZHY + ETV组合和安慰剂+ ETV组。治疗48周后进行第二次肝活检。评估了炎性炎症改善和纤维化消退。通过双光子显微镜对两组肝脏活检中不同胶原蛋白特征的精细变化进行了评估。结果：49名患者完成了整个疗程；其中的46例接受了第二次肝活检（联合治疗组为22例，对照组为24例）。与对照组相比，联合组患者的纤维化消退率显着更高（82％比54％）（p <0.05）。此外，与对照组相比，联合组的坏死性炎症改善更大（59％比25％，p <0.05）。在双光子分析中，在80多个胶原参数中，与对照组相比，联合组中有5个显着下降（p <0.05）。然而，在第48周，两组之间在生化，病毒学或血清学反应方面均未见明显改善。结论：FZHY + ETV联合治疗48周导致的坏死性炎症改善和纤维化消退的发生率高于单独使用ETV的患者。患有严重纤维化/肝硬化的慢性乙型肝炎患者。临床试验编号是ChiCTR-TRC-11001377。

关键字：慢性乙型肝炎；恩替卡韦;纤维化;扶正化瘀片。

©2020作者。

StephenW

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