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Study · Randomized controlled trial · n = 508 · 2022

5 results

Immune enhancement in patients with predicted severe acute necrotising pancreatitis: a multicentre double-blind randomised controlled trial.

Ke L, Zhou J, Mao W, Chen T, Zhu Y, Pan X, Mei H, Singh V, Buxbaum J, Doig G, He C, Gu W and 25 more

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Lu W, Tu S, Ni H, Zhang G, Zhao X, Sun J, Chen W, Song J, Shao M, Tu J, Xia L, He W, Zhu Q, Li K, Yao H, Wu J, Fu L, Jiang W, Zhang H, Lin J, Li B, Tong Z, Windsor J, Liu Y, Li W

Intensive care medicine17 Jun 2022Cited by 45 (Europe PMC)

PMID35713670 (opens in a new tab)PMCIDPMC9205279 (opens in a new tab)DOI10.1007/s00134-022-06745-7 (opens in a new tab)PepBankPUB-35713670
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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with predicted severe acute necrotising pancreatitis, infected pancreatic necrosis occurred in 15.7% with thymosin α1 and 18.1% with placebo, a non-significant difference (p = 0.48).

    In plain wordsIn people with severe acute pancreatitis, thymosin α1 did not lower infected pancreatic necrosis compared with placebo.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeInfected pancreatic necrosis during index admission
    Study

    n = 508

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

    Measurements

    IPN incidence
    15.7%
    Tα1 group
    IPN incidence
    18.1%
    placebo group

    Source sentences

    Summary
    During the index admission, 40/254(15.7%) patients in the Tα1 group developed IPN compared with 46/254 patients (18.1%) in the placebo group (difference -2.4% [95% CI - 7.4 to 5.1%]; p = 0.48).
    2 context sentences
    Summary · context
    We conducted a multicentre, double-blind, randomised, placebo-controlled trial involving ANP patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and a computed tomography (CT) severity score ≥ 5 admitted within 7 days of the advent of symptoms.
    Summary · context
    Enrolled patients were assigned to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the first 7 days and 1.6 mg once a day for the subsequent 7 days or matching placebos (normal saline).
  2. 02HumanRandomized controlled trialSafety outcome

    In patients with predicted severe acute necrotising pancreatitis, new-onset organ failure did not differ between thymosin α1 and placebo.

    In plain wordsIn people with severe acute pancreatitis, new organ failure was not different with thymosin α1 than with placebo.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeNew-onset organ failure
    Study

    n = 508

    Comparator
    Placebo (normal saline)
    Outcome group
    Adverse events · Whole body
    Studied dose
    1.6 mg every 12 h for 7 days, then 1.6 mg once a day for 7 days · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    There was no difference in other major complications, including new-onset organ failure (10.6% vs. 15%), bleeding (6.3% vs. 3.5%), and gastrointestinal fistula (2% vs. 2.4%).
    2 context sentences
    Summary · context
    We conducted a multicentre, double-blind, randomised, placebo-controlled trial involving ANP patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and a computed tomography (CT) severity score ≥ 5 admitted within 7 days of the advent of symptoms.
    Summary · context
    Enrolled patients were assigned to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the first 7 days and 1.6 mg once a day for the subsequent 7 days or matching placebos (normal saline).
  3. 03HumanRandomized controlled trialSafety outcome

    In patients with predicted severe acute necrotising pancreatitis, bleeding did not differ between thymosin α1 and placebo.

    In plain wordsIn people with severe acute pancreatitis, bleeding was not different with thymosin α1 than with placebo.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeBleeding
    Study

    n = 508

    Comparator
    Placebo (normal saline)
    Outcome group
    Adverse events · Whole body
    Studied dose
    1.6 mg every 12 h for 7 days, then 1.6 mg once a day for 7 days · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    There was no difference in other major complications, including new-onset organ failure (10.6% vs. 15%), bleeding (6.3% vs. 3.5%), and gastrointestinal fistula (2% vs. 2.4%).
    2 context sentences
    Summary · context
    We conducted a multicentre, double-blind, randomised, placebo-controlled trial involving ANP patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and a computed tomography (CT) severity score ≥ 5 admitted within 7 days of the advent of symptoms.
    Summary · context
    Enrolled patients were assigned to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the first 7 days and 1.6 mg once a day for the subsequent 7 days or matching placebos (normal saline).
  4. 04HumanRandomized controlled trialSafety outcome

    In patients with predicted severe acute necrotising pancreatitis, gastrointestinal fistula did not differ between thymosin α1 and placebo.

    In plain wordsIn people with severe acute pancreatitis, gut fistula was not different with thymosin α1 than with placebo.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeGastrointestinal fistula
    Study

    n = 508

    Comparator
    Placebo (normal saline)
    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    1.6 mg every 12 h for 7 days, then 1.6 mg once a day for 7 days · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    There was no difference in other major complications, including new-onset organ failure (10.6% vs. 15%), bleeding (6.3% vs. 3.5%), and gastrointestinal fistula (2% vs. 2.4%).
    2 context sentences
    Summary · context
    We conducted a multicentre, double-blind, randomised, placebo-controlled trial involving ANP patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and a computed tomography (CT) severity score ≥ 5 admitted within 7 days of the advent of symptoms.
    Summary · context
    Enrolled patients were assigned to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the first 7 days and 1.6 mg once a day for the subsequent 7 days or matching placebos (normal saline).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with predicted severe acute necrotising pancreatitis, results for infected pancreatic necrosis were similar across four predefined subgroups.

    In plain wordsIn people with severe acute pancreatitis, thymosin α1 showed no different result for infected pancreatic necrosis in four subgroups compared with placebo.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeInfected pancreatic necrosis across four predefined subgroups
    Study

    n: not reported in source

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

    Source sentences

    Summary
    During the index admission, 40/254(15.7%) patients in the Tα1 group developed IPN compared with 46/254 patients (18.1%) in the placebo group (difference -2.4% [95% CI - 7.4 to 5.1%]; p = 0.48). The results were similar across four predefined subgroups.
    2 context sentences
    Summary · context
    We conducted a multicentre, double-blind, randomised, placebo-controlled trial involving ANP patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and a computed tomography (CT) severity score ≥ 5 admitted within 7 days of the advent of symptoms.
    Summary · context
    Enrolled patients were assigned to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the first 7 days and 1.6 mg once a day for the subsequent 7 days or matching placebos (normal saline).

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

Subjects

Terms as the source lists them.

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