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Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial

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收录情况： ◇ SCIE

作者：
Qian Chen[1] * ; Chang Shu[2,3,4] * ; Arian D Laurence[5] ; Yan Chen[3,6,7] ; Bao-Gang Peng[8] ; Zuo-Jun Zhen[9] ; Jian-Qiang Cai[10] ; Yi-Tao Ding[11] ; Le-Qun Li[12] ; Yu-Bao Zhang[13] ; Qi-Chang Zheng[14] ; Ge-Liang Xu[15] ; Bo Li[16] ; Wei-Ping Zhou[17] ; Shou-Wang Cai[18] ; Xi-Yan Wang[19] ; Hao Wen[20] ; Xin-Yu Peng[21] ; Xue-Wen Zhang[22] ; Chao-Liu Dai[23] ; Ping Bie[24] ; Bao-Cai Xing[25] ; Zhi-Ren Fu[26] ; Lian-Xin Liu[27] ; Yi Mu[28] ; Ling Zhang[29] ; Qi-Shun Zhang[30] ; Bin Jiang[31] ; Hai-Xin Qian[32] ; Yi-Jun Wang[33] ; Jing-Feng Liu[34] ; Xi-Hu Qin[35] ; Qiang Li[36] ; Ping Yin[2,*1] ; Zhi-Wei Zhang[3,6,7,*2] ; Xiao-Ping Chen[3,6,7,*3] ;
机构： [1]Division of Gastroenterology, Department of Internal Medicine at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology (HUST), Wuhan, China [2]Department of Epidemiology and Biostatistics and State Key Laboratory of Environment Health, School of Public Health, Tongji Medical College, HUST, Wuhan, China [3]Hepatic Surgery Centre at Tongji Hospital, Tongji Medical College, HUST, Wuhan, China [4]Surgery administrator office at Tongji Hospital, Tongji Medical College, Hust, Wuhan, China [5]Hematology Department, The Newcastle upon Tyne Hospitals NHS Foundation Trust at Freeman Hospital, Newcastle, UK [6]Key Laboratory of Organ Transplantation, Ministry of Education and Ministry of Public Health, Wuhan, China [7]Hubei Province for the Clinical Medicine Research Center of Hepatic Surgery, Wuhan, China [8]Surgery Department, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China [9]Surgery Department, First People’s Hospital, Foshan, China [10]Surgery Department, Cancer Hospital of Chinese Academy of Medical Sciences, Beijing, China [11]Surgery Department, Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China [12]Surgery Department, Cancer Hospital Affiliated to Guangxi Medical University, Nanning, China [13]Surgery Department, Third Affiliated Hospital of Harbin Medical University, Harbin, China [14]Surgery Department, Wuhan Union Hospital of HUST, Wuhan, China [15]Surgery Department, Shengli Hospital Affiliated to Anhui Medical University, Hefei, China [16]Surgery Department, West China Hospital of Sichuan University, Chengdu, China [17]Surgery Department, Shanghai Eastern Hepatobiliary Surgery Hospital, Shanghai, China [18]Surgery Department, Chinese PLA General Hospital of Medical School of Chinese PLA, Beijing, China [19]Surgery Department, Cancer Hospital Affiliated to Xinjiang Medical University, Urumqi, China [20]Surgery Department, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China [21]Surgery Department, First Affiliated Hospital of Shihezi University School of Medicine, Shihezi, China [22]Surgery Department, China and Japan Union Hospital of Jilin Hospital, Changchun, China [23]Surgery Department, Shengjing Hospital of China Medial University, Shenyang, China [24]Surgery Department, Southwest University Hospital, Chongqing, China [25]Surgery Department, Beijing Cancer Hospital, Beijing, China [26]Surgery Department, Shanghai Changzheng Hospital, Shanghai, China [27]Surgery Department, First Affiliated Hospital of Harbin Medical University, Harbin, China [28]Surgery Department, Beijing Ditan Hospital Affiliated to Capital Medical University, Beijing, China [29]Surgery Department, Henan Cancer Hospital Affiliated to Zhengzhou University, Zhengzhou, China [30]Surgery Department, Guangxi Liuzhou Worker’s Hospital, Liuzhou, China [31]Surgery Department, Taihe Hospital Affiliated to Hubei University of Medicine, Shiyan, China [32]Surgery Department, First Affiliated Hospital of Suzhou Medical University, Suzhou, China [33]Surgery Department, Tianjin No.3 Hospital, Tianjin, China [34]Surgery Branch at the Hospital of Infectious and Contagious Diseases Affiliated to Fujian Medical University, Fuzhou, China [35]Surgery Department, Third People’s Hospital of Changzhou, Changzhou, China [36]Surgery Department, Tianjin Medical University Cancer Institute and Hospital (TMUCIH), Tianjin, China
出处：
DOI： 10.1136/gutjnl-2018-315983
ISSN：

摘要：
Objective T here is little evidence that adjuvant therapy after radical surgical resection of hepatocellular carcinoma (HCC) improves recurrence-free survival (RFS) or overall survival (OS). We conducted a multicentre, randomised, controlled, phase IV trial evaluating the benefit of an aqueous extract of Trametes robinophila Murr (Huaier granule) to address this unmet need. Design and results A total of 1044 patients were randomised in 2: 1 ratio to receive either Huaier or no further treatment (controls) for a maximum of 96 weeks. The primary endpoint was RFS. Secondary endpoints included OS and tumour extrahepatic recurrence rate (ERR). The Huaier (n= 686) and control groups (n= 316) had a mean RFS of 75.5 weeks and 68.5 weeks, respectively (HR 0.67; 95% CI 0.55 to 0.81). The difference in the RFS rate between Huaier and control groups was 62.39% and 49.05% (95% CI 6.74 to 19.94; p= 0.0001); this led to an OS rate in the Huaier and control groups of 95.19% and 91.46%, respectively (95% CI 0.26 to 7.21; p= 0.0207). The tumour ERR between Huaier and control groups was 8.60% and 13.61% (95% CI - 12.59 to - 2.50; p= 0.0018), respectively. Conclusions T his is the first nationwide multicentre study, involving 39 centres and 1044 patients, to prove the effectiveness of Huaier granule as adjuvant therapy for HCC after curative liver resection. It demonstrated a significant prolongation of RFS and reduced extrahepatic recurrence in Huaier group.

基金：
Major and Special Program of Hepatic Surgery Clinical Study Center of Hubei Province, China [2014BKB089, 2013BCB026]; National Natural Science Foundation of ChinaNational Natural Science Foundation of China [81471612, 81372495, 81573262]; Fundamental Research Funds for the Central Universities, HUSTFundamental Research Funds for the Central Universities [2016YXZD042]; Twelfth Five-Year Plan for Major and Special Program of the National Science and Technology (2012-2015)
语种：
外文
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PubmedID：
中科院(CAS)分区：
出版当年[2018]版：
大类 | 1 区 医学
小类 | 1 区 胃肠肝病学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 胃肠肝病学
JCR分区：
出版当年[2018]版：
Q1 GASTROENTEROLOGY & HEPATOLOGY
最新[2023]版：
Q1 GASTROENTEROLOGY & HEPATOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

第一作者：
第一作者机构： [1]Division of Gastroenterology, Department of Internal Medicine at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology (HUST), Wuhan, China
共同第一作者：
通讯作者：
通讯机构： [2]Department of Epidemiology and Biostatistics and State Key Laboratory of Environment Health, School of Public Health, Tongji Medical College, HUST, Wuhan, China [3]Hepatic Surgery Centre at Tongji Hospital, Tongji Medical College, HUST, Wuhan, China [6]Key Laboratory of Organ Transplantation, Ministry of Education and Ministry of Public Health, Wuhan, China [7]Hubei Province for the Clinical Medicine Research Center of Hepatic Surgery, Wuhan, China [*1]Department of Epidemiology and Biostatistics and State Key Laboratory of Environment Health, School of Public Health, Tongji Medical College, HUST, Wuhan, 430030, RR China [*2]Hepatic Surgery Centre at Tongji Hospital of Tongji Medical College of HUST, Jie Fang Avenue 1095, Wuhan 430030, PR China [*3]Tongji Hospital of Tongji Medical College of HUST, Jie Fang Avenue 1095, Wuhan 430030, PR China
推荐引用方式(GB/T 7714)：
Qian Chen,Chang Shu,Arian D Laurence,et al.Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial[J].GUT.2018,67(11):2006-2016.doi:10.1136/gutjnl-2018-315983.
APA：
Qian Chen,Chang Shu,Arian D Laurence,Yan Chen,Bao-Gang Peng...&Xiao-Ping Chen.(2018).Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial.GUT,67,(11)
MLA：
Qian Chen,et al."Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial".GUT 67..11(2018):2006-2016

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