Clinical trial with a new immunomodulatory strategy: Treatment of severe sepsis with ulinastatin and maipuxin

National Medical Journal of China

Volumn 87, Issue 7, 2007, Pages 451-457

  Lin, Hong Yuan ^a  

^a CHINESE PLA GENERAL HOSPITAL   (China)

Author keywords

Drug therapy; Immunotherapy; Sepsis

Indexed keywords

ANTIBIOTIC AGENT; CD14 ANTIGEN; HLA DR ANTIGEN; MAIPUXIN; THYMOSIN ALPHA1; ULINASTATIN; UNCLASSIFIED DRUG;

ADULT; AGED; APACHE; ARTICLE; ARTIFICIAL VENTILATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOSE RESPONSE; DRUG EFFICACY; FEMALE; HUMAN; IMMUNOMODULATION; IMMUNOTHERAPY; INTENSIVE CARE UNIT; LENGTH OF STAY; MAJOR CLINICAL STUDY; MALE; MONOCYTE; MORTALITY; MULTICENTER STUDY; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; SEPSIS;

ADJUVANTS, IMMUNOLOGIC; ADULT; AGED; DRUG THERAPY, COMBINATION; DRUGS, CHINESE HERBAL; FEMALE; GLYCOPROTEINS; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; SEPSIS; THYMOSIN; TREATMENT OUTCOME; TRYPSIN INHIBITORS;

EID: 34247463353     PISSN: 03762491     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (46)

1. Angus DC, Linde-Zwirble WT, Lidicker J, et al. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome and associated costs of care. Crit Care Med, 2001, 29: 1303-1310.
2. Chinese source.
3. Bone RC, Balk RA, Cerra FB, et al. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis: ACCP/SCCM Consensus Conference Committee. Chest, 1992, 101: 1644-1655.
4. Marshall JC, Cook DJ, Christou NV, et al. Multiple organ dysfunction score: A reliable descriptor of a complex clinical outcome. Crit Care Med, 1995, 23: 1638-1652.
5. Dellinger RP, Carlet JM, Masur H, et al. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med, 2004, 32: 858-873.
6. Cronin L, Cook DJ, Carlet J, et al. Corticosteroid treatment for sepsis: a critical appraisal and meta-analysis of the literature. Crit Care Med, 1995, 23: 1430-1439.
7. Natanson C, Esposito CJ, Banks SM. The sirens songs of confirmatory sepsis trials: selection bias and sampling error. Crit Care Med, 1998, 26: 1927-1931.
8. Bone B.C. Sir Isaac Newton, sepsis, SIRS, and CARS. Crit Care Med, 1996, 24: 1125-1128.
9. Richard S Hotchkiss, Irene E Karl. The pathophysiology and Treatment of Sepsis. N Engl J Med, 2003, 348: 138-150.
10. James A Russell. Management of Sepsis. N Engl J Med, 2006, 355: 1699-1713.
11. Docke WD, Randow F, Syrbe U, et al. Monocyte deactivation in septic patients: restoration by IFN-gamma treatment. 1997, 3: 678-681.
12. Chinese source.
13. Heidecke CD, Hensler T, Weighardt H, et al. Selective defects of T lymphocyte function in patients with lethal intraabdominal infection. Am J Surg, 1999, 178: 288-292.
14. Munford RS, Pugin J. Normal responses to injury prevent systemic inflammation and can be immunosuppressive. Am J Respir Crit Care Med, 2000, 163: 316-321.
15. Goris RJA, te Boekhorst TPA, Nuytinck JKS, et al. Multiple organ failure: Generalized autodestructive inflammation? Arch Surg, 1985, 120: 1109-1115.
16. Marshall JC, Sweeney D: Microbial infection and the septic response in critical surgical illness: Sepsis, not infection, determines outcome. Arch Surg, 1990, 125: 17-23.
17. Roumen RMH, Redl. H, Schlag G, et al. Inflammatory mediators in relation to the development of multiple organ failure in patients after severe blunt trauma. Crit Care Med, 1995, 23: 474-480.
18. Hotchkiss RS, Swanson PE, Freeman BD, et al Apoptotic cell death in patients with sepsis, shock, and multiple organ dysfunction. Crit Care Med, 1999, 27: 1230-1251.
19. Hotchkiss RS, Tinsley KW, Swanson PE, et al. Sepsis-induced apoptosis causes progressive profound depletion of B and CD4 + T lymphocytes in humans. J Immunol, 2001, 166: 6952-6963.
20. Hotchkiss RS, Tinsley KW, Swanson PE, et al. Depletion of dendritic cells, but not macrophages, in patients with sepsis. J Immunol, 2002, 168: 2493-2500.
21. Jimenez MF, Watson RW, Parodo J, et al. Dysregulated expression of neutrophil apoptosis in the systemic inflammatory response syndrome. Arch Surg, 1997, 132: 1263-1269.
22. Fialkow L, Filho LF, Bozzetti MC. Neutrophil apoptosis: a marker of disease severity in sepsis and sepsis-induced acute respiratory distress syndrome. Critical Care, 2006, 10: R155.
23. Levyn MM, Fink MP, Marshall JC, et al. 2001 SCCM/ESICM/ACCP/SIS International Sepsis Definitions Conference. Intensive Care Med, 2003, 29: 530-538.
24. Fukuzuka K, Edwards CK III, Clare-Salzler M, et al. Glucocorticoid-induced, caspase-dependent organ apoptosis early after burn injury. Am J Physiol Regul Integr Comp Physiol, 2000, 278: R1005-R1018.
25. Oberholzer A, Oberholzer C, Moldawer LL. SEPSIS SYNDROMES: UNDERSTANDING THE ROLE OF INNATE AND ACQUIRED IMMUNITY. Shock, 2001, 16: 83-96.
26. Michael J. Pugia. Pathophysiology and diagnostic value of urinary trypsin inhibitors. Clin Chem Lab Med, 2005, 43: 1-16.
27. Cai M, Ogawa R. Effects of free radical scavengers, methylprednisolone, and ulinastatin on acute xanthine and xanthine oxidase-induced lung injury in rats. Circ Shock. 1994, 43: 71-78.
28. Manamiya Y, Abo S, Kitamura M, et al. The effectiveness of ulinastatin on granulocyte H202 production in acute lung injury rat model. Nippon Kyobu Geka Gakkai Zasshi. 1993, 41: 2364-2371.
29. H. Onai and S. Kudo: Suppression of superantigen-induced lung injury andvasculitis by preadministration of human urinary trypsin inhibitor, European Journal of Clinical Investigation, 2001, 31: 272-280.
30. Nakane M, Iwama H. Intra-Alveolar Urinary Trypsin Inhibitor Can not Inhibit Polymorphonuclear Elastase Activity in the Lung in Postsurgical Patients with Acute Respiratory Distress Syndrome. Surgery Today, 1999, 29: 1030-1033.
31. Baumann CA, Badamchian M, Goldstein AL. Thymosin alpha1 is a time and dose-dependent antagonist of dexamethasone-induced apoptosis of marine thymocytes in vitro. Int J Immunopharmacol, 2000, 22: 1057-1066.
32. Baumann C A, Badamchian M, Goldstein A L. Thymosin 1 antagonizes dexamethasone and CD3-induced apoptosis of CD4 + CD8 + thymocytes through the activation of cAMP and protein kinase C dependent second messenger pathways. Mechanisms of Ageing and Development, 1997, 94: 85-101.
33. Romani L, Bistoni F, Gaziano R, et al. Thymosin 1 activates dendritic cells for antifungal Th1 resistance through Toll-like receptor signaling. Blood, 2004, 103: 4232-4239.
34. Huang Y, Chen Z, Zhou C, et al. The modulation of thymosin alpha 1 in the maturation, differentiation and function of marine bone marrow-derived dendritic cells in the absence or presence of tumor necrosis factor-alpha. Int Immunopharmacol, 2004, 4: 539-546.
35. Li CL, Zhang T, Saibara T, et al. Thymosin alpha1 accelerates restoration of T cell-mediated neutralizing antibody response in immunocompromised hosts. Int Immunopharmacol, 2002, 2: 39-46.
36. Ishitsuka H, Umeda Y, Nakamura J, et al. Protective activity of thymosin against opportunistic infections in animal models. Cancer Immunol. Immunother, 1983, 14: 145-149.
37. Wakefield CH, Carey PD, Foulds S, et al. Changes in major histocompatibility complex class II expression in monocytes and T cells of patients developing infection after surgery. Br J Surg, 1993, 80: 205-209.
38. Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med, 2001, 345: 1368-1377.
39. Annane D, Sebille V, Charpentier C, et al. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA, 2002, 288: 862-887.
40. Bernard GR, Vincent JL, Laterre PF, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med, 2001, 344: 699-709.
41. The Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med, 2000, 342: 1301-1308.
42. van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in the critically ill patients. N EngI J Med, 2001, 345: 1359-1367.
43. Chinese source.
44. Chinese source.
45. Molor-Erdene P, Okajima K, Isobe H, et al. Urinary trypsin inhibitor reduces LPS-induced hypotension by suppressing tumor necrosis factor-α production through inhibition of Egr-1 expression. Am J Physiol Heart Circ Physiol, 2005, 288: H1265-H1271.
46. Toshiyuki Yano. Neuroprotective Effect of Urinary Trypsin Inhibitor against Focal Cerebral Ischemia-Reperfusion Injury in Rats. Anesthesiology, 2003, 98: 465-473.