Randomized Clinical Trial
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World J Gastroenterol. Dec 28, 2014; 20(48): 18458-18465
Published online Dec 28, 2014. doi: 10.3748/wjg.v20.i48.18458
Clinical trial with traditional Chinese medicine intervention ''tonifying the kidney to promote liver regeneration and repair by affecting stem cells and their microenvironment'' for chronic hepatitis B-associated liver failure
Han-Min Li, Zhi-Hua Ye, Jun Zhang, Xiang Gao, Yan-Ming Chen, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo
Han-Min Li, Xiang Gao, Xin Yao, Jian-Xun Gu, Lei Zhan, Yang Ji, Jian-Liang Xu, Ying-He Zeng, Fan Yang, Lin Xiao, Guo-Guang Sheng, Wei Xin, Qi Long, Qing-Jing Zhu, Zhao-Hong Shi, Lian-Guo Ruan, Jia-Yao Yang, Chang-Chun Li, Hong-Bin Wu, Sheng-Duo Chen, Xin-La Luo, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei Province, China
Zhi-Hua Ye, Hubei University of Chinese Medicine, Wuhan 430065, Hubei Province, China
Jun Zhang, Jingzhou Hospital of Traditional Chinese Medicine, Jinzhou 434000, Hubei Province, China
Yan-Ming Chen, Tianjin Key Laboratory for Modern Drug Delivery and High-Efficiency, School of Pharmaceutical Science and Technology, Tianjin University, Tianjin 300072, China
Author contributions: Li HM and Ye ZH contributed equally to this work; Li HM designed the research; Yao X, Gu JX, Zhan L, Ji Y, Xu JL, Zeng YH, Yang F, Xiao L, Sheng GG, Xin W, Long Q, Zhu QJ, Shi ZH, Ruan LG, Yang JY, Li CC, Wu HB, Chen SD and Luo XL performed the research; Chen YM was responsible for the identification of Chinese medicine and supervision of drugs; Ye ZH, Zhang J and Gao X analyzed the data; Li HM and Ye ZH wrote the paper.
Supported by National Science and Technology Key Projects on “Major Infectious Diseases such as HIV/AIDS, Viral Hepatitis Prevention and Treatment”, No. 2008ZX10005-007; Research Projects of Key Disease of National Traditional Chinese Medicine (Hepatopathy) Clinical Research Center (Hubei Province), No. JDZX2012054; National Natural Science Foundation of China, No. 81373513, No. 90709041, No. 30672590, No. 30271562, No. 30371787, No. 81102531 and No. 81274147; Key Projects of Natural Science Foundation of Hubei Province, No. 2011CDB463; Specialized Research Fund for the Doctoral Programs in Institution of Higher Education, No. 20124230110001; Key Subjects of Department of Science and Technology of Wuhan City, No. 201260523199
Correspondence to: Han-Min Li, MD, PhD, Professor, Hepatopathy Institute, Affiliated Hospital of Hubei University of Chinese Medicine, Huayuan No. 4, Wuchang District, Wuhan 430061, Hubei Province, China. lihanmin69@126.com
Telephone: +86-27-88929180 Fax: +86-27-88929180
Received: April 20, 2014
Revised: July 3, 2014
Accepted: August 13, 2014
Published online: December 28, 2014
Core Tip

Core tip: We conducted a randomized controlled clinical trial to observe the effects of traditional Chinese medicine intervention “tonifying the kidney to promote liver regeneration and repair by affecting stem cells and their microenvironment” (“TTK”) in treating liver failure due to chronic hepatitis B virus infection. The fatality rate in the group treated with “TTK” was significantly lower than those in the other two groups (16.67% vs 51.61%, 35.38%, P = 0.010). The mechanism for this effect may be related to promotion of liver regeneration and repair through affecting stem cells and their microenvironment.