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Study · Systematic review · n = 1,927 · 2025

6 results

Efficacy of thymosin α1 for sepsis: a systematic review and meta-analysis of randomized controlled trials.

Gu B, Zhou Y, Nie Y, Wang L, Liang L, Liao Z, Wen J, Guan X, Chen M, Wu J, Pei F

Frontiers in cellular and infection microbiology3 Sept 2025Cited by 2 (Europe PMC)

PMID40969554 (opens in a new tab)PMCIDPMC12440967 (opens in a new tab)DOI10.3389/fcimb.2025.1673959 (opens in a new tab)PepBankPUB-40969554
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Summary

BackgroundDespite advances in understanding sepsis pathophysiology and extensive research, few treatments effectively target its underlying immune dysfunction. Thymosin α1 (Tα1) shows promise as an immunomodulator, but its impact on sepsis remains unclear.MethodsA search strategy was designed to include any prospective clinical studies using Tα1 for assessing 28-day mortality in patients with sepsis, excluding combination therapy studies. We conducted trial sequential analysis (TSA) to assess the robustness of meta-analyses findings. Heterogeneity of treatment effects (HTE) was conducted based on individual data from two multicenter randomized clinical trials (RCTs), with result credibility assessed through the instrument to assess the credibility of effect modification analyses (ICEMAN).ResultsOut of 3003 identified studies, 11 RCTs met the inclusion criteria (967 patients in Tα1 group and 960 patients in control group). The comprehensive meta-analysis demonstrated a significant reduction in 28-day mortality associated with Tα1 administration (OR 0.73, 95%CI: 0.59-0.90, P = 0.003). Nonetheless, analyses of high-quality (OR 0.82, 95%CI: 0.65-1.03, P = 0.09) and multi-center (OR 0.86, 95%CI: 0.68-1.08, P = 0.20) subgroups did not reveal a mortality benefit. The HTE analysis of multiple subgroups in two large RCTs (representing 75% of the total patients) showed heterogeneity. Potential benefits were noted in subgroups of cancer (moderate credibility), diabetes (low credibility), and coronary heart disease (low credibility). Furthermore, the trial sequential analysis (TSA) suggests that the current sample size is inadequate.ConclusionTα1 has the potential to decrease 28-day mortality rates in patients with sepsis; however, it is crucial to recognize that its efficacy differs among various subgroups. These observations underscore the significance of personalized immunotherapy strategies in forthcoming clinical trials.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42024628937.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanSystematic reviewEfficacy outcome

    In patients with sepsis, thymosin α1 was associated with a significant reduction in 28-day mortality in the pooled analysis of 11 RCTs.

    In plain wordsIn people with sepsis, thymosin α1 was linked to fewer deaths within 28 days in pooled trials.

    Peptide
    Thymosin alpha-1
    Outcome
    Decrease28-day mortality, all trials
    Study

    n = 1,927

    Outcome group
    Mortality · Infection
    Studied dose
    Dose not stated

    Measurements

    OR
    0.73 ratio
    28-day mortality

    Source sentences

    Summary
    The comprehensive meta-analysis demonstrated a significant reduction in 28-day mortality associated with Tα1 administration (OR 0.73, 95%CI: 0.59-0.90, P = 0.003).
    1 context sentence
    Summary · context
    Out of 3003 identified studies, 11 RCTs met the inclusion criteria (967 patients in Tα1 group and 960 patients in control group).
  2. 02HumanSystematic reviewEfficacy outcome

    In patients with sepsis, the high-quality trial subgroup showed no significant 28-day mortality benefit with thymosin α1.

    In plain wordsIn people with sepsis, the higher-quality trials alone did not show fewer deaths within 28 days with thymosin α1.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant change28-day mortality, high-quality trials
    Study

    n: not reported in source

    Outcome group
    Mortality · Infection
    Studied dose
    Dose not stated

    Measurements

    OR
    0.82 ratio
    high-quality trials

    Source sentences

    Summary
    analyses of high-quality (OR 0.82, 95%CI: 0.65-1.03, P = 0.09)
    1 context sentence
    Summary · context
    Out of 3003 identified studies, 11 RCTs met the inclusion criteria (967 patients in Tα1 group and 960 patients in control group).
  3. 03HumanSystematic reviewEfficacy outcome

    In patients with sepsis, the multi-center trial subgroup showed no significant 28-day mortality benefit with thymosin α1.

    In plain wordsIn people with sepsis, the multi-center trials alone did not show fewer deaths within 28 days with thymosin α1.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant change28-day mortality, multi-center trials
    Study

    n: not reported in source

    Outcome group
    Mortality · Infection
    Studied dose
    Dose not stated

    Measurements

    OR
    0.86 ratio
    multi-center trials

    Source sentences

    Summary
    and multi-center (OR 0.86, 95%CI: 0.68-1.08, P = 0.20)
    1 context sentence
    Summary · context
    Out of 3003 identified studies, 11 RCTs met the inclusion criteria (967 patients in Tα1 group and 960 patients in control group).
  4. 04HumanSystematic reviewEfficacy outcome

    In patients with sepsis and cancer, a potential benefit of thymosin α1 was noted in the heterogeneity analysis (moderate credibility).

    In plain wordsIn people with sepsis and cancer, thymosin α1 showed a possible benefit in one subgroup analysis, with moderate credibility.

    Peptide
    Thymosin alpha-1
    Outcome
    Decrease28-day mortality in patients with cancer
    Study

    n: not reported in source

    Outcome group
    Mortality · Infection
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Potential benefits were noted in subgroups of cancer (moderate credibility), diabetes (low credibility), and coronary heart disease (low credibility).
    1 context sentence
    Summary · context
    The HTE analysis of multiple subgroups in two large RCTs (representing 75% of the total patients) showed heterogeneity.
  5. 05HumanSystematic reviewEfficacy outcome

    In patients with sepsis and diabetes, a potential benefit of thymosin α1 was noted in the heterogeneity analysis (low credibility).

    In plain wordsIn people with sepsis and diabetes, thymosin α1 showed a possible benefit in one subgroup analysis, with low credibility.

    Peptide
    Thymosin alpha-1
    Outcome
    Decrease28-day mortality in patients with diabetes
    Study

    n: not reported in source

    Outcome group
    Mortality · Infection
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Potential benefits were noted in subgroups of cancer (moderate credibility), diabetes (low credibility), and coronary heart disease (low credibility).
    1 context sentence
    Summary · context
    The HTE analysis of multiple subgroups in two large RCTs (representing 75% of the total patients) showed heterogeneity.
  6. 06HumanSystematic reviewEfficacy outcome

    In patients with sepsis and coronary heart disease, a potential benefit of thymosin α1 was noted in the heterogeneity analysis (low credibility).

    In plain wordsIn people with sepsis and coronary heart disease, thymosin α1 showed a possible benefit in one subgroup analysis, with low credibility.

    Peptide
    Thymosin alpha-1
    Outcome
    Decrease28-day mortality in patients with coronary heart disease
    Study

    n: not reported in source

    Outcome group
    Mortality · Infection
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Potential benefits were noted in subgroups of cancer (moderate credibility), diabetes (low credibility), and coronary heart disease (low credibility).
    1 context sentence
    Summary · context
    The HTE analysis of multiple subgroups in two large RCTs (representing 75% of the total patients) showed heterogeneity.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

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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