二猪解毒方治疗乙型肝炎肝硬化高甲胎蛋白血症的疗效：一

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二猪解毒方治疗乙型肝炎肝硬化高甲胎蛋白血症的疗效：一项随机、双盲、安慰剂对照临床试验
陈天阳 1 , 麦景银 2 , 张平 3 , 雪建华 4 , 何胜丽 5 , 君喜 4 , 陈建杰 1 4 , 程阳 1 4

隶属关系隶属关系
    1    上海市浦东新区张横路528号上海中医药大学附属曙光医院。    2    中国上海市长宁区新华路40号上海光华中西医结合医院。    3    中国上海市浦东新区蔡伦路1200号上海中医药大学外语中心。    4    中国上海市华夏东路46号浦东区传染病医院肝病科。    5    上海市闵行区瑞丽路106号复旦大学附属肿瘤医院闵行分院

    PMID：34559118 DOI：10.1097/MD.0000000000027231

抽象的背景：乙型肝炎肝硬化伴高甲胎蛋白血症是肝硬化进展为肝细胞癌（HCC）的中间阶段，现代医学尚无有效治疗肝癌前病变的方法。近几十年来，临床和实验证据表明，中医药对乙型肝炎肝硬化具有一定的有益作用。因此，本试验旨在评估中药二珠解毒方（EZJDR）治疗乙型肝炎肝硬化合并高甲胎蛋白血症的疗效和安全性。方法：我们设计了一项随机、双盲、安慰剂对照的临床试验。共有 72 名乙型肝炎肝硬化伴高甲胎蛋白血症患者随机分为 2 个平行组。对照组的患者接受类似于 EZJDR 的安慰剂颗粒。在 EZJDR 组中，患者每天在饭后接受 EZJDR 两次，持续 48 周。主要疗效指标是血清甲胎蛋白 (AFP) 和甲胎蛋白异质体 (AFP-L3) 的变化；疗效的次要指标为肝功能指标变化、HBV-DNA水平；肝硬度测量（LSM）；肝门静脉直径；治疗期间的 T 淋巴细胞亚群指标。所有数据将记录在病例报告表中，并通过统计分析系统软件进行分析。还将评估不良事件。结果：结果显示，EZJDR能显着抑制乙肝肝硬化合并高甲胎蛋白血症患者的AFP和AFP-L3水平，具有较好的安全性。伦理与传播：研究方案经上海中医药大学附属曙光医院医学伦理委员会批准（NO.2018-579-08-01）。试验注册：本试验在中国临床试验中心注册（NO.ChiCTR1800017165）。版权所有 © 2021 作者。由 Wolters Kluwer Health, Inc. 出版。

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Efficacy of erzhu jiedu recipe on hepatitis B cirrhosis with hyperalphafetoproteinemia: A randomized, double-blind, placebo-controlled clinical trial
Tian-Yang Chen  1 , Jing-Yin Mai  2 , Ping Zhang  3 , Jian-Hua Xue  4 , Sheng-Li He  5 , Jun Xi  4 , Jian-Jie Chen  1   4 , Yang Cheng  1   4
Affiliations
Affiliations

    1
    Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No.528 Zhangheng Road, Pudong District, Shanghai, China.
    2
    Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital, No.40 Xinhua Road, Changning District, Shanghai, China.
    3
    Foreign Language Center of Shanghai University of Traditional Chinese Medicine, No.1200 Cailun Road, Pudong District, Shanghai, China.
    4
    Department of Liver Disease, Hospital for Infectious Diseases of Pudong District, No.46 East Huaxia Road, Shanghai, China.
    5
    Minhang Branch of Tumor Hospital Affiliated to Fudan University, No.106 Ruili Road, Minhang District, Shanghai, China.

    PMID: 34559118 DOI: 10.1097/MD.0000000000027231

Abstract

Background: Hepatitis B cirrhosis with hyperalphafetoproteinemia is the intermediate stage of liver cirrhosis progressing to hepatocellular carcinoma (HCC), there is no effective way to treat precancerous lesions of liver in modern medicine. In recent decades, clinical and experimental evidence shows that Chinese medicine (CM) has a certain beneficial effect on Hepatitis B Cirrhosis. Therefore, this trial aims to evaluate the efficacy and safety of a CM erzhu jiedu recipe (EZJDR) for the treatment of Hepatitis B Cirrhosis with Hyperalphafetoproteinemia.

Methods: We designed a randomized, double blind, placebo-controlled clinical trial. A total of 72 patients of Hepatitis B Cirrhosis with hyperalphafetoproteinemia were randomized in 2 parallel groups. Patients in the control group received placebo granules similar to the EZJDR. In the EZJDR group, patients received EZJDR twice a day, after meals, for 48 weeks. The primary efficacy measures were changes in serum alpha-fetoprotein (AFP) and alpha-fetoprotein alloplasm (AFP-L3); The secondary indicators of efficacy are changes in liver function indicators, HBV-DNA level; Liver stiffness measurement (LSM); Hepatic portal vein diameter; T lymphocyte subgroup indexes during treatment. All data will be recorded in case report forms and analyzed by Statistical Analysis System software. Adverse events will also be evaluated.

Results: The results showed that EZJDR can significantly inhibit the levels of AFP and AFP-L3 in patients with hepatitis B cirrhosis and hyperalphafetoproteinemia and have good security.

Ethics and dissemination: The study protocol was approved by the Medical Ethics Committee of Shuguang Hospital, affiliated with University of Traditional Chinese Medicine, Shanghai (NO.2018-579-08-01).

Trial registration: This trial was registered on Chinese Clinical Trial Center (NO.ChiCTR1800017165).

Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

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https://journals.lww.com/md-jour ... hepatitis_B.27.aspx