Document Detail

Treatment of patients with severe sepsis using ulinastatin and thymosin alpha1: a prospective, randomized, controlled pilot study.
MedLine Citation:
PMID:  19493408     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Tradition treatment of sepsis and new therapies, including high dose corticosteroids and non-steroidal anti-inflammatory drugs, have proven unsuccessful in improving survival. This study aimed to evaluate the potential efficacy of immunomodulating therapy using Ulinastatin (UTI) plus Thymosin alpha1 (Talpha1) for improving organ function and reducing mortality in patients with severe sepsis. METHODS: A prospective study was carried out with randomized and controlled clinical analysis of 114 patients conforming to the enrollment standard. All patients had severe sepsis and received standard supportive care and antimicrobial therapy. Fifty-nine patients were also administered UTI plus Talpha1 (defined as Group A), 55 patients were given a placebo (defined as Group B). Clinical parameters were determined by evaluation with the Acute Physiology and Chronic Health Evaluation II (APACHE II), multiple organ failure (MOF) and the Glasgow Coma Scores (GCS) on entry and after therapy on the 3rd, 8th, and 28th day. By flow cytometery and ELISA lymphocyte subsets and cytokines were analyzed. Survival analysis was determined by the Kaplan-Meier method at 28, 60, and 90 days. RESULTS: Based on comparison of the two groups, patients in Group A exhibited a better performance in organ failure scores which was noticeable soon after initiation of treatment. Patients in Group A also demonstrated a better resolution of pre-existing organ failures during the observation period. After initiation of treatment, significant improvements in the CD(4)(+)/CD(8)(+) ratio, a quicker balance between proinflammatory mediators such as tumor necrosis factor alpha, interleukin 6 and anti-inflammatory cytokines including interleukin 4 and interleukin 10 were found. This was followed by cumulative survival increases of 17.3% at 28 days, 28.9% at 60 days, and 31.4% at 90 days in Group A. The reduction in mortality was accompanied by a considerably shorter stay in the ICU and a shorter length of supportive ventilation, antimicrobial and dopamine therapy. CONCLUSION: UTI plus Talpha(1) has a beneficial role in the treatment of severe sepsis.
Hao Chen; Ming-yan He; Yu-min Li
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Chinese medical journal     Volume:  122     ISSN:  0366-6999     ISO Abbreviation:  Chin. Med. J.     Publication Date:  2009 Apr 
Date Detail:
Created Date:  2009-06-04     Completed Date:  2009-10-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7513795     Medline TA:  Chin Med J (Engl)     Country:  China    
Other Details:
Languages:  eng     Pagination:  883-8     Citation Subset:  IM    
The Key Laboratory of Organ Transplantation of Public Health Ministry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang 310003, China.
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MeSH Terms
Adjuvants, Immunologic / therapeutic use*
CD4-Positive T-Lymphocytes / immunology
CD8-Positive T-Lymphocytes / immunology
Glycoproteins / therapeutic use*
Interleukin-10 / metabolism
Interleukin-6 / metabolism
Lymphocyte Subsets / immunology
Middle Aged
Sepsis / drug therapy*,  metabolism,  mortality
Survival Analysis
Thymosin / analogs & derivatives*,  therapeutic use
Treatment Outcome
Trypsin Inhibitors / therapeutic use*
Tumor Necrosis Factor-alpha / metabolism
Reg. No./Substance:
0/Adjuvants, Immunologic; 0/Glycoproteins; 0/Interleukin-6; 0/Trypsin Inhibitors; 0/Tumor Necrosis Factor-alpha; 0/thymalfasin; 130068-27-8/Interleukin-10; 61512-21-8/Thymosin; 80449-32-7/urinastatin

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