title: Shenfu injection for improving cellular immunity and clinical outcome in patients with sepsis or septic shock.
abstract: OBJECTIVE
  To assess the efficacy of Shenfu injection (SFI) for enhancing cellular immunity and improving the clinical outcomes of patients with septic shock.
  
  
  METHODS
  Patients with sepsis were randomly assigned to receive either SFI at a dose of 100mL every 24hours for 7 consecutive days or a placebo in addition to conventional therapy. The immunologic parameters were collected on days 1, 3, and 7 after the above treatments, and the clinical outcomes were updated for 28days.
  
  
  RESULTS
  Of these160 patients, 3 were excluded from the analysis due to protocol violation and withdrawal of consent; thus, 157 completed the study (78 in the SFI group and 79 in the placebo group). We found that SFI increased both CD4+and CD8+T cells in peripheral blood and up-regulated HLA-DR expression in monocytes (P<.05). Furthermore, SFI was also found to restore ex vivo monocytic tumor necrosis factor α and interleukin 6 proinflammatory cytokine release in response to the endotoxin (P<.05). Importantly, the SFI group showed better clinical outcomes than did the placebo group in terms of the duration of vasopressor use (P=.008), Acute Physiology and Chronic Health Evaluation II score (P=.034), Marshall score (P=.01), and length of intensive care unit stay (10.5±3.2 vs 12.2±2.8days; P=.012). However, the 28-day mortality rate was not significantly different between the SFI (20.5%; 16/78) and placebo groups (27.8%; -22/79; P=.28).
  
  
  CONCLUSIONS
  These findings suggest that SFI can enhance the cellular immunity of patients with septic shock and could be a promising adjunctive treatment for patients with septic shock.
authors.affiliation: Department of Critical Care Medicine, The Sixth Affiliated Hospital of Wenzhou Medical College, Lishui People's Hospital, Lishui, Zhejiang 323000,China.
authors.forename: Ning
authors.initials: N
authors.lastname: Zhang
authors.affiliation: Department of Medical Statistics, Zhoupu Hospital Affiliated to Shanghai University of Medicine & Health Sciences, Shanghai 201318, China.
authors.forename: Jianhua
authors.initials: J
authors.lastname: Liu
authors.affiliation: Department of Critical Care Medicine, The Sixth Affiliated Hospital of Wenzhou Medical College, Lishui People's Hospital, Lishui, Zhejiang 323000,China; Department of Critical Care Medicine, Zhoupu Hospital Affiliated to Shanghai University of Medicine & Health Sciences, Shanghai 201318, China. Electronic address: 1201zeliang_qiu@tongji.edu.cn.
authors.forename: Zeliang
authors.initials: Z
authors.lastname: Qiu
authors.affiliation: Department of Traditional Chinese Medicine, The Sixth Affiliated Hospital of Wenzhou Medical College, Lishui People's Hospital, Lishui, Zhejiang,China.
authors.forename: Yiping
authors.initials: Y
authors.lastname: Ye
authors.affiliation: Department of Critical Care Medicine, The Sixth Affiliated Hospital of Wenzhou Medical College, Lishui People's Hospital, Lishui, Zhejiang 323000,China.
authors.forename: Jian
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Department of Critical Care Medicine, The Sixth Affiliated Hospital of Wenzhou Medical College, Lishui People's Hospital, Lishui, Zhejiang 323000,China.
authors.forename: Tianzheng
authors.initials: T
authors.lastname: Lou
mesh_terms: D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007111:Immunity, Cellular / Q000187:drug effects* / Q000276:immunology; D007267:Injections; D016753:Interleukin-10 / Q000378:metabolism; D015850:Interleukin-6 / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D018805:Sepsis / Q000097:blood / Q000188:drug therapy* / Q000276:immunology*; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000378:metabolism
chemical_list: D004365:Drugs, Chinese Herbal; C508609:IL10 protein, human; C508600:IL6 protein, human; D015850:Interleukin-6; C492793:Shen-Fu; D014409:Tumor Necrosis Factor-alpha; D016753:Interleukin-10