The Efficacy and Immunomodulatory Effects of Ulinastatin and Thymosin α1 for Sepsis: A Systematic Review and Meta-Analysis.

Wang FY, Fang B, Qiang XH, Yu TO, Zhong JR, Cao J, Zhou LX

BioMed research international31 May 2016Cited by 12 (Europe PMC)

PMID27340674PMCIDPMC4906180DOI10.1155/2016/9508493PepBankPUB-27340674

Summary

Objective. To systematically review the efficacy and potential immunomodulatory effect of ulinastatin combined with thymosin α1 (UTI) for sepsis. Design. A systematic review and meta-analysis of randomized controlled trials (RCTs). Data Sources. The following databases: PubMed, Embase, and Cochrane Central were searched to identify related clinical trials. The search terms were "ulinastatin", "thymosin", and "sepsis". Results. Six RCTs, 944 septic patients in total, were included in this meta-analysis. The result shows UTI increased the 28-day survival rate of septic patients, odds ratio (OR) = 2.01, 95% CI [1.53, 2.64]. After the treatment with UTI, the APACHE II score (four studies) dropped 4.72 further, mean = -4.72, 95% CI [-6.54, -2.91] (p < 0.00001). The mean time of ICU stay (four studies) in UTI group decreased 3.03 days further, mean = -3.03 [-6.99, 0.95] (p = 0.14), and mechanical ventilation time (four studies) decreased 2.05 days, mean = -1.81 [-2.96, -0.66] (p = 0.002). With the treatment of UTI, CD4+T cells raised 5.13%, mean = 5.13, 95% CI [2.75, 7.50] (p < 0.0001); there was no significant change in CD8+T cells, mean = -0.74 [-2.93, 1.45] (p = 0.51). Conclusion. According to this meta-analysis, with the treatment of UTI, the short-term survival rate of septic patients was increased and the illness severity was alleviated. ICU stay and mechanical ventilation time were effectively shortened. The beneficial effect of UTI might be due to the potential immunomodulatory effects of these two drugs.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone6

In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Thymosin alpha-1.

01HumanNot a test of Thymosin alpha-1 aloneSystematic reviewEfficacy outcome
In septic patients, ulinastatin combined with thymosin α1 increased the 28-day survival rate in a meta-analysis (OR = 2.01, 95% CI [1.53, 2.64]).
In plain wordsIn people with sepsis, ulinastatin plus thymosin α1 raised 28-day survival in pooled trials; the effect of thymosin α1 alone is unknown.
Peptide
Thymosin alpha-1
Outcome
Increase28-day survival rate
Study
n: not reported in source
Outcome group
Mortality · Infection
Measurements
OR
2.01
28-day survival
Source sentences
Summary
The result shows UTI increased the 28-day survival rate of septic patients, odds ratio (OR) = 2.01, 95% CI [1.53, 2.64].
1 context sentence(design, population, supporting numbers)
Summary · context
Six RCTs, 944 septic patients in total, were included in this meta-analysis.
In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Thymosin alpha-1.
Show in the study text Report a problemFND-2734067401
02HumanNot a test of Thymosin alpha-1 aloneSystematic reviewEfficacy outcome
In septic patients, ulinastatin combined with thymosin α1 lowered the APACHE II score in a meta-analysis of four studies (mean = -4.72, 95% CI [-6.54, -2.91]).
In plain wordsIn people with sepsis, ulinastatin plus thymosin α1 lowered illness severity scores in pooled trials; the effect of thymosin α1 alone is unknown.
Peptide
Thymosin alpha-1
Outcome
DecreaseAPACHE II score
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Whole body
Measurements
Mean difference
−4.72 points
APACHE II
Source sentences
Summary
After the treatment with UTI, the APACHE II score (four studies) dropped 4.72 further, mean = -4.72, 95% CI [-6.54, -2.91] (p < 0.00001).
1 context sentence(design, population, supporting numbers)
Summary · context
Six RCTs, 944 septic patients in total, were included in this meta-analysis.
In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Thymosin alpha-1.
Show in the study text Report a problemFND-2734067402
03HumanNot a test of Thymosin alpha-1 aloneSystematic reviewEfficacy outcome
In septic patients, the decrease in ICU stay with ulinastatin combined with thymosin α1 was not significant in a meta-analysis (mean = -3.03 days, p = 0.14).
In plain wordsIn people with sepsis, ulinastatin plus thymosin α1 did not clearly shorten intensive care stay in pooled trials.
Peptide
Thymosin alpha-1
Outcome
No significant changeICU stay
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Whole body
Measurements
Mean difference
−3.03 days
ICU stay
Source sentences
Summary
The mean time of ICU stay (four studies) in UTI group decreased 3.03 days further, mean = -3.03 [-6.99, 0.95] (p = 0.14), and mechanical ventilation time (four studies) decreased 2.05 days, mean = -1.81 [-2.96, -0.66] (p = 0.002).
1 context sentence(design, population, supporting numbers)
Summary · context
Six RCTs, 944 septic patients in total, were included in this meta-analysis.
In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Thymosin alpha-1.
Show in the study text Report a problemFND-2734067403
04HumanNot a test of Thymosin alpha-1 aloneSystematic reviewEfficacy outcome
In septic patients, ulinastatin combined with thymosin α1 shortened mechanical ventilation time in a meta-analysis (mean = -1.81, p = 0.002).
In plain wordsIn people with sepsis, ulinastatin plus thymosin α1 shortened time on a ventilator in pooled trials; the effect of thymosin α1 alone is unknown.
Peptide
Thymosin alpha-1
Outcome
DecreaseMechanical ventilation time
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Respiratory
Measurements
Mean difference
−1.81 days
mechanical ventilation time
Source sentences
Summary
The mean time of ICU stay (four studies) in UTI group decreased 3.03 days further, mean = -3.03 [-6.99, 0.95] (p = 0.14), and mechanical ventilation time (four studies) decreased 2.05 days, mean = -1.81 [-2.96, -0.66] (p = 0.002).
1 context sentence(design, population, supporting numbers)
Summary · context
Six RCTs, 944 septic patients in total, were included in this meta-analysis.
In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Thymosin alpha-1.
Show in the study text Report a problemFND-2734067404
05HumanNot a test of Thymosin alpha-1 aloneSystematic reviewEfficacy outcome
In septic patients, ulinastatin combined with thymosin α1 raised CD4+ T cells in a meta-analysis (mean = 5.13%, 95% CI [2.75, 7.50]).
In plain wordsIn people with sepsis, ulinastatin plus thymosin α1 raised CD4+ immune cells in pooled trials; the effect of thymosin α1 alone is unknown.
Peptide
Thymosin alpha-1
Outcome
IncreaseCD4+ T cells
Study
n: not reported in source
Outcome group
Immune response · Immune and inflammation
Measurements
Mean difference
5.13%
CD4+ T cells
Source sentences
Summary
With the treatment of UTI, CD4+T cells raised 5.13%, mean = 5.13, 95% CI [2.75, 7.50] (p < 0.0001); there was no significant change in CD8+T cells, mean = -0.74 [-2.93, 1.45] (p = 0.51).
1 context sentence(design, population, supporting numbers)
Summary · context
Six RCTs, 944 septic patients in total, were included in this meta-analysis.
In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Thymosin alpha-1.
Show in the study text Report a problemFND-2734067405
06HumanNot a test of Thymosin alpha-1 aloneSystematic reviewEfficacy outcome
In septic patients, ulinastatin combined with thymosin α1 produced no significant change in CD8+ T cells in a meta-analysis (mean = -0.74, p = 0.51).
In plain wordsIn people with sepsis, ulinastatin plus thymosin α1 did not change CD8+ immune cells in pooled trials.
Peptide
Thymosin alpha-1
Outcome
No significant changeCD8+ T cells
Study
n: not reported in source
Outcome group
Immune response · Immune and inflammation
Measurements
Mean difference
−0.74
CD8+ T cells
Source sentences
Summary
With the treatment of UTI, CD4+T cells raised 5.13%, mean = 5.13, 95% CI [2.75, 7.50] (p < 0.0001); there was no significant change in CD8+T cells, mean = -0.74 [-2.93, 1.45] (p = 0.51).
1 context sentence(design, population, supporting numbers)
Summary · context
Six RCTs, 944 septic patients in total, were included in this meta-analysis.
In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Thymosin alpha-1.
Show in the study text Report a problemFND-2734067406

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Version history

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Version 3Current
9 Oct 2026, 18:17 UTC
Study results updated
Version 2
9 Oct 2026, 03:03 UTC
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 03:02 UTC
First added · source update from Europe PMC

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