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Study · Systematic review · n = 721 · 2016

13 results

The efficacy of thymosin α1 as immunomodulatory treatment for sepsis: a systematic review of randomized controlled trials.

Liu F, Wang HM, Wang T, Zhang YM, Zhu X

BMC infectious diseases15 Sept 2016Cited by 41 (Europe PMC)

Summary

BackgroundThymosin α1 (Tα1) as immunomodulatory treatment is supposed to be beneficial for the sepsis patients by regulating T cell subsets and inflammatory mediators. However, limited by the small sample size and the poor study design, the persuasive power of the single clinical studies is weak. This meta-analysis aimed to investigate the impact of Tα1 on the sepsis patients.MethodsWe searched for the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CBM, VIP, CNKI, WANFANG, Igaku Chuo Zasshi (ICHUSHI) and Korean literature databases reporting the effects of Tα1 on outcomes in sepsis patients.ResultsAmong 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria. Mortality events were reported in 10 RCTs included 530 patients, and the meta-analysis showed significant decrease in Tα1 group compared with control group (RR 0.59, 95 % CI 0.45 to 0.77, p = 0.0001). The subgroup analysis showed no difference between the two dosages (RR 0.59, 95 % CI 0.43 to 0.81; RR 0.59, 95 % CI 0.35 to 0.98, respectively). In 9 RCTs, with a total of 489 patients, Tα1 administered once per day decrease APACHE II score significantly (SMD -0.80, 95 % CI -1.14 to -0.47, p < 0.0001) while Tα1 twice per day showed no effect (SMD 0.30, 95 % CI-0.10 to 0.70, p = 0.14). However, the length of ICU stay, the incidence of multiple organ failure (MOF) and duration of mechanical ventilation were not significantly affected by Tα1 treatment (SMD -0.52, 95 % CI -1.06 to 0.11, p = 0.06; SMD -0.49, 95 % CI -1.09 to 0.11, p = 0.11; SMD -0.37, 95 % CI -0.90 to 0.17, p = 0.17, respectively). As to the immunological indicators, the level of HLA-DR were increased by Tα1 (SMD 1.23, 95 % CI 0.28 to 2.18, p = 0.01) according to the pooled analysis of 8 studies involving 721 patients. Lymphocyte subsets CD3, CD4 and cytokines IL-6, IL-10 and TNF-α were also beneficially affected by Tα1 treatment.ConclusionsTα1 may be beneficial to sepsis patients in reducing mortality and modulating inflammation reactions. However, the quality of evidence supporting the effectiveness is low considering the small sample sizes and inadequate adherence to standardized reporting guidelines for RCTs among the included studies.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanSystematic reviewEfficacy outcome

    In patients with sepsis, HLA-DR levels were increased by thymosin α1 compared with control in a pooled analysis of 8 studies (SMD 1.23, 95 % CI 0.28 to 2.18).

    In plain wordsIn people with sepsis, thymosin α1 raised HLA-DR, an immune marker, compared with control in pooled trials.

    Outcome
    IncreaseHLA-DR level
    Study

    n = 721

    Comparator
    Control group
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Measurements

    SMD
    1.23
    HLA-DR

    Source sentences

    Summary
    As to the immunological indicators, the level of HLA-DR were increased by Tα1 (SMD 1.23, 95 % CI 0.28 to 2.18, p = 0.01) according to the pooled analysis of 8 studies involving 721 patients.
    1 context sentence
    Summary · context
    Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria.
  2. 02HumanSystematic reviewEfficacy outcome

    In patients with sepsis, thymosin α1 decreased mortality compared with control in a meta-analysis of 10 RCTs (RR 0.59, 95 % CI 0.45 to 0.77).

    In plain wordsIn people with sepsis, thymosin α1 lowered deaths compared with control in pooled trials.

    Outcome
    DecreaseMortality
    Study

    n = 530

    Comparator
    Control group
    Outcome group
    Mortality · Infection
    Studied dose
    Dose not stated

    Measurements

    RR
    0.59
    mortality

    Source sentences

    Summary
    Mortality events were reported in 10 RCTs included 530 patients, and the meta-analysis showed significant decrease in Tα1 group compared with control group (RR 0.59, 95 % CI 0.45 to 0.77, p = 0.0001).
    1 context sentence
    Summary · context
    Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria.
  3. 03HumanSystematic reviewEfficacy outcome

    In patients with sepsis, the mortality reduction with thymosin α1 did not differ between the two dosages in subgroup analysis (RR 0.59 and RR 0.59).

    In plain wordsIn people with sepsis, thymosin α1 lowered deaths about equally with both dosages in pooled trials.

    Outcome
    No significant changeMortality by dosage subgroup
    Study

    n: not reported in source

    Comparator
    Control group
    Outcome group
    Mortality · Infection
    Studied dose
    Dose not stated

    Measurements

    RR
    0.59
    first dosage
    RR
    0.59
    second dosage

    Source sentences

    Summary
    The subgroup analysis showed no difference between the two dosages (RR 0.59, 95 % CI 0.43 to 0.81; RR 0.59, 95 % CI 0.35 to 0.98, respectively).
    1 context sentence
    Summary · context
    Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria.
  4. 04HumanSystematic reviewEfficacy outcome

    In patients with sepsis, thymosin α1 given once per day decreased the APACHE II score compared with control in a meta-analysis (SMD -0.80, 95 % CI -1.14 to -0.47).

    In plain wordsIn people with sepsis, thymosin α1 once a day lowered illness severity scores compared with control in pooled trials.

    Outcome
    DecreaseAPACHE II score with once-daily dosing
    Study

    n: not reported in source

    Comparator
    Control group
    Outcome group
    Intensive care and hospital outcomes · Whole body
    Studied dose
    once per dayAs given in this study (human).

    Measurements

    SMD
    −0.8
    APACHE II, once per day

    Source sentences

    Summary
    Tα1 administered once per day decrease APACHE II score significantly (SMD -0.80, 95 % CI -1.14 to -0.47, p < 0.0001)
    1 context sentence
    Summary · context
    Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria.
  5. 05HumanSystematic reviewEfficacy outcome

    In patients with sepsis, thymosin α1 given twice per day showed no effect on the APACHE II score compared with control in a meta-analysis.

    In plain wordsIn people with sepsis, thymosin α1 twice a day did not change illness severity scores compared with control in pooled trials.

    Outcome
    No significant changeAPACHE II score with twice-daily dosing
    Study

    n: not reported in source

    Comparator
    Control group
    Outcome group
    Intensive care and hospital outcomes · Whole body
    Studied dose
    twice per dayAs given in this study (human).

    Measurements

    SMD
    0.3
    APACHE II, twice per day

    Source sentences

    Summary
    Tα1 twice per day showed no effect (SMD 0.30, 95 % CI-0.10 to 0.70, p = 0.14).
    1 context sentence
    Summary · context
    Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria.
  6. 06HumanSystematic reviewEfficacy outcome

    In patients with sepsis, length of ICU stay was not significantly affected by thymosin α1 in a meta-analysis.

    In plain wordsIn people with sepsis, thymosin α1 did not clearly change length of intensive care stay in pooled trials.

    Outcome
    No significant changeLength of ICU stay
    Study

    n: not reported in source

    Comparator
    Control group
    Outcome group
    Intensive care and hospital outcomes · Whole body
    Studied dose
    Dose not stated

    Measurements

    SMD
    −0.52
    length of ICU stay

    Source sentences

    Summary
    However, the length of ICU stay, the incidence of multiple organ failure (MOF) and duration of mechanical ventilation were not significantly affected by Tα1 treatment (SMD -0.52, 95 % CI -1.06 to 0.11, p = 0.06; SMD -0.49, 95 % CI -1.09 to 0.11, p = 0.11; SMD -0.37, 95 % CI -0.90 to 0.17, p = 0.17, respectively).
    1 context sentence
    Summary · context
    Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria.
  7. 07HumanSystematic reviewEfficacy outcome

    In patients with sepsis, the incidence of multiple organ failure was not significantly affected by thymosin α1 in a meta-analysis.

    In plain wordsIn people with sepsis, thymosin α1 did not clearly change multiple organ failure in pooled trials.

    Outcome
    No significant changeIncidence of multiple organ failure
    Study

    n: not reported in source

    Comparator
    Control group
    Outcome group
    Intensive care and hospital outcomes · Whole body
    Studied dose
    Dose not stated

    Measurements

    SMD
    −0.49
    multiple organ failure

    Source sentences

    Summary
    However, the length of ICU stay, the incidence of multiple organ failure (MOF) and duration of mechanical ventilation were not significantly affected by Tα1 treatment (SMD -0.52, 95 % CI -1.06 to 0.11, p = 0.06; SMD -0.49, 95 % CI -1.09 to 0.11, p = 0.11; SMD -0.37, 95 % CI -0.90 to 0.17, p = 0.17, respectively).
    1 context sentence
    Summary · context
    Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria.
  8. 08HumanSystematic reviewEfficacy outcome

    In patients with sepsis, duration of mechanical ventilation was not significantly affected by thymosin α1 in a meta-analysis.

    In plain wordsIn people with sepsis, thymosin α1 did not clearly change time on a ventilator in pooled trials.

    Outcome
    No significant changeDuration of mechanical ventilation
    Study

    n: not reported in source

    Comparator
    Control group
    Outcome group
    Intensive care and hospital outcomes · Respiratory
    Studied dose
    Dose not stated

    Measurements

    SMD
    −0.37
    mechanical ventilation duration

    Source sentences

    Summary
    However, the length of ICU stay, the incidence of multiple organ failure (MOF) and duration of mechanical ventilation were not significantly affected by Tα1 treatment (SMD -0.52, 95 % CI -1.06 to 0.11, p = 0.06; SMD -0.49, 95 % CI -1.09 to 0.11, p = 0.11; SMD -0.37, 95 % CI -0.90 to 0.17, p = 0.17, respectively).
    1 context sentence
    Summary · context
    Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria.
  9. 09HumanSystematic reviewEfficacy outcome

    In patients with sepsis, CD3 lymphocyte levels were beneficially affected by thymosin α1 in a meta-analysis.

    In plain wordsIn people with sepsis, thymosin α1 changed CD3 immune cell levels in a favourable direction in pooled trials.

    Outcome
    Direction not reportedCD3 lymphocyte subset
    Study

    n: not reported in source

    Comparator
    Control group
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Lymphocyte subsets CD3, CD4 and cytokines IL-6, IL-10 and TNF-α were also beneficially affected by Tα1 treatment.
    1 context sentence
    Summary · context
    Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria.
  10. 10HumanSystematic reviewEfficacy outcome

    In patients with sepsis, CD4 lymphocyte levels were beneficially affected by thymosin α1 in a meta-analysis.

    In plain wordsIn people with sepsis, thymosin α1 changed CD4 immune cell levels in a favourable direction in pooled trials.

    Outcome
    Direction not reportedCD4 lymphocyte subset
    Study

    n: not reported in source

    Comparator
    Control group
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Lymphocyte subsets CD3, CD4 and cytokines IL-6, IL-10 and TNF-α were also beneficially affected by Tα1 treatment.
    1 context sentence
    Summary · context
    Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria.
  11. 11HumanSystematic reviewEfficacy outcome

    In patients with sepsis, IL-6 levels were beneficially affected by thymosin α1 in a meta-analysis.

    In plain wordsIn people with sepsis, thymosin α1 changed IL-6 levels in a favourable direction in pooled trials.

    Outcome
    Direction not reportedIL-6 level
    Study

    n: not reported in source

    Comparator
    Control group
    Outcome group
    Inflammation markers · Immune and inflammation
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Lymphocyte subsets CD3, CD4 and cytokines IL-6, IL-10 and TNF-α were also beneficially affected by Tα1 treatment.
    1 context sentence
    Summary · context
    Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria.
  12. 12HumanSystematic reviewEfficacy outcome

    In patients with sepsis, IL-10 levels were beneficially affected by thymosin α1 in a meta-analysis.

    In plain wordsIn people with sepsis, thymosin α1 changed IL-10 levels in a favourable direction in pooled trials.

    Outcome
    Direction not reportedIL-10 level
    Study

    n: not reported in source

    Comparator
    Control group
    Outcome group
    Inflammation markers · Immune and inflammation
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Lymphocyte subsets CD3, CD4 and cytokines IL-6, IL-10 and TNF-α were also beneficially affected by Tα1 treatment.
    1 context sentence
    Summary · context
    Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria.
  13. 13HumanSystematic reviewEfficacy outcome

    In patients with sepsis, TNF-α levels were beneficially affected by thymosin α1 in a meta-analysis.

    In plain wordsIn people with sepsis, thymosin α1 changed TNF-α levels in a favourable direction in pooled trials.

    Outcome
    Direction not reportedTNF-α level
    Study

    n: not reported in source

    Comparator
    Control group
    Outcome group
    Inflammation markers · Immune and inflammation
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Lymphocyte subsets CD3, CD4 and cytokines IL-6, IL-10 and TNF-α were also beneficially affected by Tα1 treatment.
    1 context sentence
    Summary · context
    Among 444 related articles, 19 randomized controlled trials (RCTs) met our inclusion criteria.

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 3Current

    9 Oct 2026, 18:17 UTC

    Study results updated

  2. Version 2

    9 Oct 2026, 03:03 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    9 Oct 2026, 03:02 UTC

    First added · source update from Europe PMC

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