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Study · Randomized controlled trial · n = 502 · 2023

3 results

Association between pretreatment lymphocyte count and efficacy of immune-enhancing therapy in acute necrotising pancreatitis: a post-hoc analysis of the multicentre, randomised, placebo-controlled TRACE trial.

Ke L, Mao W, Shao F, Zhou J, Xu M, Chen T, Liu Y, Tong Z, Windsor J, Ma P, Li W

EClinicalMedicine24 Mar 2023Cited by 4 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with acute necrotising pancreatitis and baseline ALC of at least 0.8 x 10^9/L, thymosin alpha‑1 reduced the risk of infected pancreatic necrosis versus placebo.

    In plain wordsIn adults with acute necrotising pancreatitis and a higher lymphocyte count, thymosin alpha‑1 lowered the risk of infected pancreatic necrosis compared with placebo.

    Outcome
    DecreaseInfected pancreatic necrosis, baseline ALC 0.8 x 10^9/L or higher
    Study

    n = 290

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Infection and antimicrobial activity · Infection
    Studied dose
    1.6 mg every 12 h for the first 7 days, then 1.6 mg once a day for 7 days · subcutaneous · 14 daysAs given in this study (human).

    Measurements

    Covariate-adjusted risk difference
    −0.12 risk difference
    baseline ALC >=0.8 x 10^9/L

    Source sentences

    Summary
    Within the subgroup of patients with baseline ALC≥0.8 × 10ˆ9/L (n = 290), the Tα1 therapy significantly reduced the risk of IPN (covariate adjusted risk difference, -0.12; 95% CI, -0.21,-0.02; p = 0.015).
    2 context sentences
    Summary · context
    A post-hoc analysis of data from a multicentre, double-blind, randomised, placebo-controlled trial testing the efficacy of Tα1 therapy in patients with predicted severe ANP was performed.
    Summary · context
    Patients from 16 hospitals of China were randomised to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the frst 7 days and 1.6 mg once a day for the following 7 days or a matching placebo during the same period.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with acute necrotising pancreatitis, the effect of thymosin alpha‑1 on infected pancreatic necrosis showed a uniform trend toward larger effects in patients with higher baseline absolute lymphocyte count.

    In plain wordsIn adults with acute necrotising pancreatitis, thymosin alpha‑1 tended to work better in patients with higher blood lymphocyte counts at the start.

    Outcome
    Not applicableTreatment effect by baseline lymphocyte count (trend across subgroups)
    Study

    n = 502

    Comparator
    Placebo
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1.6 mg every 12 h for the first 7 days, then 1.6 mg once a day for 7 days · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Across the three subgroups, there was a uniform trend toward more significant treatment effects in patients with higher baseline ALC.
    2 context sentences
    Summary · context
    A post-hoc analysis of data from a multicentre, double-blind, randomised, placebo-controlled trial testing the efficacy of Tα1 therapy in patients with predicted severe ANP was performed.
    Summary · context
    Patients from 16 hospitals of China were randomised to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the frst 7 days and 1.6 mg once a day for the following 7 days or a matching placebo during the same period.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with acute necrotising pancreatitis and baseline ALC between 0.79 and 2.00 x 10^9/L, thymosin alpha‑1 reduced infected pancreatic necrosis most.

    In plain wordsIn adults with acute necrotising pancreatitis, patients with mid-range lymphocyte counts benefited most from thymosin alpha‑1 in lowering infected pancreatic necrosis.

    Outcome
    DecreaseInfected pancreatic necrosis, baseline ALC 0.79 to 2.00 x 10^9/L
    Study

    n = 263

    Comparator
    Placebo
    Outcome group
    Infection and antimicrobial activity · Infection
    Studied dose
    1.6 mg every 12 h for the first 7 days, then 1.6 mg once a day for 7 days · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Patients with baseline ALC between 0.79 and 2.00 × 10ˆ9/L benefited most from the Tα1 therapy in reducing IPN (n = 263).
    2 context sentences
    Summary · context
    A post-hoc analysis of data from a multicentre, double-blind, randomised, placebo-controlled trial testing the efficacy of Tα1 therapy in patients with predicted severe ANP was performed.
    Summary · context
    Patients from 16 hospitals of China were randomised to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the frst 7 days and 1.6 mg once a day for the following 7 days or a matching placebo during the same period.

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

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT02473406

Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis

Weiqin Lin = 50827 Mar 2018 to 24 Mar 2021

Pancreatitis, Acute Necrotizing

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

    10 Oct 2026, 08:19 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

Subjects

Terms as the source lists them.

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