title: [Efficacy and safety of integrative medical program based on blood cooling and detoxification recipe in treating patients with hepatitis B virus related acute-on-chronic liver failure: a randomized controlled clinical study].
abstract: OBJECTIVE
  To evaluate the clinical efficacy and safety of integrative medical program based on blood cooling and detoxification recipe (BCDR) in treating patients with hepatitis B virus related acute-on-chronic liver failure (HBV-ACLF) of heat-toxicity accumulation syndrome (HTAS).
  
  
  METHODS
  Adopting randomized controlled clinical design, a total of 105 HBV-ACLF patients of HTAS were randomly assigned to the trial group (64 cases) and the control group (41 cases). Patients in the control group were treated with comprehensive Western therapy, while those in the trial group were treated with comprehensive Western therapy plus BCDR. All were treated for 8 weeks and followed up for 40 weeks. Effect and safety of the treatment were assessed, including fatality, liver functions [total bilirubin (TBIL), albumin (ALB), alanine aminotransferase (ALT), and aspartate transaminase (AST)], and prothrombin activity (PTA) after treatment and at week 48 of follow-ups.
  
  
  RESULTS
  After 8-week treatment, there was statistical difference in the overall fatality rate (15.63% vs 34.15%), the fatality rate in the mid-term (25.0% vs 64.7%), TBIL at week 8 (64.54 +/- 79.75), AST [at week 2: (178.97 +/- 44.24) U/L vs (288.48 +/- 58.49) U/L; at week 4: (61.65 +/- 27.36) U/L vs (171.12 +/- 89.11) U/L] and PTA [at week 4: (58.30 +/- 15.29) vs (42.56 +/- 15.27); at week 6: (60.77 +/- 20.40) vs (43.08 +/- 12.79)] (all P < 0.05). At week 48 of the followup, the fatality rate of the trial group (21.88%) decreased by 17. 14% when compared with that of the control group (39.02%; P < 0.05). No obvious adverse event occurred in the two groups during the 8-week treatment period.
  
  
  CONCLUSIONS
  BCDR could significantly reduce the mortality of HBV-ACLF patients.
authors.forename: Hui-Min
authors.initials: HM
authors.lastname: Liu
authors.forename: Xian-Bo
authors.initials: XB
authors.lastname: Wang
authors.forename: Yi-Xxin
authors.initials: YX
authors.lastname: Hou
authors.forename: Fang-Yuan
authors.initials: FY
authors.lastname: Gao
authors.forename: Feng-Xia
authors.initials: FX
authors.lastname: Sun
authors.forename: Yu-Yong
authors.initials: YY
authors.lastname: Jiang
authors.forename: Zhi-Yun
authors.initials: ZY
authors.lastname: Yang
authors.forename: Hong-Bo
authors.initials: HB
authors.lastname: Du
authors.forename: Xiao-Jing
authors.initials: XJ
authors.lastname: Wang
authors.forename: Gui-Qin
authors.initials: GQ
authors.lastname: Zhou
authors.forename: Yu-Ying
authors.initials: YY
authors.lastname: Yang
authors.forename: Rong-Bing
authors.initials: RB
authors.lastname: Wang
mesh_terms: D065290:Acute-On-Chronic Liver Failure / Q000188:drug therapy* / Q000821:virology; D000328:Adult; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D058625:End Stage Liver Disease; D005260:Female; D006515:Hepatitis B virus; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal