恩替卡韦联合中草药治疗HBeAg阳性慢性乙型肝炎患者：一项随

StephenW

Entecavir combining Chinese herbal medicine for HBeAg-positive chronic hepatitis B patients: a randomized, controlled trial
Xiaoke Li  1 , Daqiao Zhou  2 , Xiaoling Chi  3 , Qin Li  4 , Li Wang  5 , Bingjiu Lu  6 , Dewen Mao  7 , Qikai Wu  8 , Xianbo Wang  9 , Mingxiang Zhang  10 , Jingdong Xue  11 , Yong Li  12 , Wei Lu  13 , Jianchun Guo  14 , Feng Jiang  1 , Xinwei Zhang  15 , Zhiguo Li  1 , Xianzhao Yang  1 , Hui Guo  16 , Danan Gan  1 , Liyun He  17 , Lin Luo  17 , Ludan Zhang  1 , Hongbo Du  18 , Yong'an Ye  19
Affiliations
Affiliations

    1
    Department of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China.
    2
    Department of Hepatology, Shenzhen TCM Hospital, No. 1 Fuhua Road, Futian District, Shenzhen, 518033, China.
    3
    Department of Hepatology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Dade Road 111, Guangzhou, 510120, Guangdong, China.
    4
    Department of Hepatology, Mengchao Hepatobiliary Hospital of Fujian Medical University, No. 312 Xihong road, Gulou District, Fujian, 350025, Fuzhou, China.
    5
    Department of Hepatology, Public Health Clinical Center of Chengdu, No. 377 Jingming Road, Jinjiang District, Chengdu, 610066, Sichuan, China.
    6
    Department of Hepatology, Liaoning Hospital of TCM, Huanggu District, No. 33, Beiling Street, Shenyang, 110032, Liaoning, China.
    7
    Department of Hepatology, The First Affiliated Hospital of Guangxi University of Chinese Medicine, No. 89-9, Dongge road, Nanning, 530023, Guangxi, China.
    8
    Department of Hepatology, The Third People's Hospital of Shenzhen, No. 29 Bujibulan Road, Longgang District, Shenzhen, 518112, China.
    9
    Department of Hepatology, Beijing Ditan Hospital, No. 8 Jingshun East Road, Chaoyang District, Beijing, 100015, China.
    10
    Department of Hepatology, The Sixth People's Hospital of Shenyang, No. 85 Heping south road, Heping District, Shenyang, 110006, Liaoning, China.
    11
    Department of Hepatology, Shaanxi Hospital of TCM, No. 4 Xihuamen, Lianhu District, Xi'an, 710003, Shaanxi, China.
    12
    Department of Hepatology, The Affiliated Hospital of Shandong University of TCM, No. 42 Wenhua West Road, Jinan, 250011, Shandong, China.
    13
    Department of Hepatology, Tianjin Second People's Hospital, No.7 Sudi South Road, Nankai District, Tianjin, 300192, China.
    14
    Department of Hepatology, Xixi Hospital of Hangzhou, No. 2 Hengbu road, Liuxiazhen, Xihu District, Hangzhou, 310023, Zhejiang, China.
    15
    Department of Liver Disease, Fifth Medical Center of Chinese PLA General Hospital, No.100 West Fourth Ring Road, Beijing, 100039, China.
    16
    Department of Hepatology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314 An Shan Xi Road, Nan Kai District, Tianjin, 300193, China.
    17
    Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine Sciences, No. 16, Dongzhimen South Street, Dongcheng District, Beijing, 100700, China.
    18
    Department of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China. [email protected].
    19
    Department of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China. [email protected].

    PMID: 33128206 DOI: 10.1007/s12072-020-10097-z

Abstract

Background and aim: Traditional Chinese medicine (TCM) is widely accepted and prescribed in China alongside Nucleoside analogs (NAs). In this double-blind, placebo-controlled, randomized, multi-center trial, we evaluated whether entecavir (ETV) plus TCM formulas Tiao-Gan-Yi-Pi granule (TGYP) and Tiao-Gan-Jian-Pi-Jie-Du granule (TGJPJD) increase the rate of hepatitis B e antigen (HBeAg) loss in Chinese patients.

Methods: 596 eligible participants were randomly assigned, in a 1:1 ratio, to two study groups in this 108-week trial: The experiment group was assigned ETV plus the TCM formula. The control group was assigned ETV plus a TCM placebo. We compared the rate of HBeAg loss by the end of week 108 between the two arms as the primary outcome. Secondary outcomes included hepatitis B surface antigen (HBsAg) level, proportion of undetectable HBV-DNA, and liver enzymes (ALT, AST, GGT) at week 108.

Results: The combination therapy achieved superior HBeAg loss at 108 weeks, without additional adverse events. The rate of HBeAg loss at week 108 was 37.54% (95% CI 31.9-43.2%) in the experiment group and 27.21% (95% CI 22.0-32.4%) in the control group. There was a statistically significant difference between the two arms of 10.33% (95% CI 8.4-12.3%, p = 0.008). The DNA loss rate, serum HBsAg level, and liver enzymes were similar between the groups by the end of 108th week.

Conclusion: Combining the Chinese herbal formula with ETV therapy demonstrated superior HBeAg clearance compared with ETV monotherapy. This finding indicates that this combined therapy could produce an improved therapeutic effect and safety profile.

Clinical trial number: ChiCTR-TRC-12002784 (Chinese Clinical Trial Registry).

Keywords: Chronic hepatitis B; Tiao-gan-jian-pi-jie-du granule; Tiao-gan-yi-pi granule; Traditional Chinese medicine.

StephenW

恩替卡韦联合中草药治疗HBeAg阳性慢性乙型肝炎患者：一项随机对照试验
李晓科1，周大桥2，迟晓玲3，秦丽4，王丽5，兵久路6，毛德文7，吴启凯8，王宪博9，张明祥10，京东学11，永利12，渭路13 ，郭建春14，冯江1，张新伟15，李志国1，咸先潮1，郭慧16，大南干1，何立云17，林洛17，张庐丹1，洪博都18，叶永安19
联系
联系

    1片
    北京中医药大学附属东直门医院消化内科，北京中医药大学肝病研究所，北京市东城区海云沧路5号，北京100700
    2
    深圳市福田区福华路1号深圳市中医院肝病科，广东深圳518033
    3
    广州中医药大学附属第二医院肝病科，广东省大德路111号广东省中医院，广东广州510120
    4
    福建医科大学孟潮肝胆医院肝病科，福建福州鼓楼区西虹路312号，福建福州350025。
    5
    四川省成都市锦江区经明路377号成都公共卫生临床中心肝病科，四川610066。
    6
    辽宁省沉阳市北陵街33号辽宁省中医院，皇姑区中医院肝科，辽宁沉阳110032
    7
    广西中医药大学第一附属医院肝科，广西南宁530023，东阁路89-9号
    8
    深圳市龙岗区布拉兰路29号深圳市第三人民医院肝科，广东深圳518112
    9
    北京市朝阳区京顺东路8号北京地坛医院肝科，北京100015
    10
    辽宁省沉阳市和平区和平南路85号，沉阳市第六人民医院肝科，辽宁沉阳110006。
    11
    陕西省中医院，陕西省西安市莲湖区西华门4号，肝科，陕西西安710003
    12
    山东中医药大学附属医院肝科，山东济南25001文化南路42号
    13
    天津市第二人民医院肝科，天津市南开区苏堤南路7号，天津300192。
    14
    杭州市西湖区柳下镇横步路2号杭州西溪医院肝科，杭州310023
    15
    中国人民解放军总医院第五医学中心肝病科，北京西四环100号，北京100039
    16
    天津市中医药大学附属第一教学医院肝科，天津市南开区鞍山西路314号，天津300193。
    17
    中国中医科学院基础临床医学研究所，北京东城区东直门南大街16号，北京100700
    18
    北京中医药大学附属东直门医院消化内科，北京中医药大学肝病研究所，北京东城区海云沧路5号，北京100700 [email protected]。
    19
    北京中医药大学东直门医院消化内科，北京中医药大学肝病研究所，北京东城区海云沧路5号，北京100700 [email protected]。

    PMID：33128206 DOI：10.1007 / s12072-020-10097-z

抽象

背景与目的：中药（TCM）和核苷类似物（NAs）在中国已被广泛接受和开处方。在这项双盲，安慰剂对照，随机，多中心试验中，我们评估了恩替卡韦（ETV）加上调肝益皮颗粒（TGYP）和调肝健肌Pi Du Du颗粒（TGJPJD）可以增加中国患者乙型肝炎e抗原（HBeAg）丢失率。
方法：在这项为期108周的试验中，将596名符合条件的参与者以1：1的比例随机分配到两个研究组：实验组被分配了ETV加中药配方。对照组被分配ETV加中药安慰剂。我们比较了第108周结束时两组之间的HBeAg丢失率作为主要结局。次要结果包括第108周时的乙型肝炎表面抗原（HBsAg）水平，无法检测到的HBV-DNA比例和肝酶（ALT，AST，GGT）。

结果：联合疗法在108周时实现了较好的HBeAg丢失，没有其他不良事件。实验组第108周的HBeAg丢失率为37.54％（95％CI 31.9-43.2％），对照组为27.21％（95％CI 22.0-32.4％）。两组之间有10.33％的统计差异（95％CI 8.4-12.3％，p = 0.008）。到第108周结束时，两组之间的DNA丢失率，血清HBsAg水平和肝酶相似。

结论：中药配方与ETV治疗相结合比ETV单药治疗具有更高的HBeAg清除率。该发现表明该联合疗法可产生改善的治疗效果和安全性。

临床试验编号：ChiCTR-TRC-12002784（中国临床试验注册中心）。

关键字：慢性乙型肝炎；调肝健脾解毒颗粒;调肝益脾颗粒;中药。

lancas

单药ETV 108周也有27.21%清除率。。。。。我去，这也不差啊

小牡丹

蒙人不好。恩替卡韦与E抗原没有关系，否则 ，恩替卡韦说明书岂能不大吹特吹。中医药调理免疫系统，可以增加体质，促进E抗原消失，这个可以有。

遥望曙光

很久没来论坛了，总是没那么幸运，恩替卡韦已经10年了，基本是要终身了。

齐欢畅

中药配方与ETV治疗相结合比ETV单药治疗具有更高的HBeAg清除率

乙肝人1949

扯蛋蛋玩，职称论文

StephenW

回复 乙肝人1949 的帖子

596病人, 两年治疗, 你觉得是 "扯蛋蛋玩"?

newchinabok

以前吃过好多中药，偏方，打胸腺肽，还有蚂蚁粉，蜂王浆，气功，全国到处找名医。也没治好我的病。主流，非主流治乙肝方法全试过。

newchinabok

中国刚发明普通干挠素，粉剂，长春生物制品研究所生产，坐飞机去买，隔一天打一针，发烧了半年，还在坚持，还没治好