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Background and Objective <p>Post-traumatic sepsis is associated with high mortality and limited treatment options. This study aimed to evaluate the safety and efficacy of ulinastatin in adult patients with post-traumatic sepsis, assess its potential as a therapeutic option, and provide a foundation for future large-scale trials.</p> Methods <p>A single-blind, randomized controlled trial was conducted involving 60 patients treated at the Eastern Theater General Hospital from October 2022 to June 2024. The primary endpoint was 28-day all-cause mortality. Secondary endpoints included the Sequential Organ Failure Assessment (SOFA) score, C-reactive protein (CRP), interleukin-6 (IL-6), procalcitonin (PCT) levels, Activities of Daily Living (ADL) score, Acute Physiology and Chronic Health Evaluation II (APACHE II) score, ICU length of stay, duration of mechanical ventilation, and other laboratory indicators.</p> Results <p>No statistically significant difference was observed in 28-day mortality between the ulinastatin and control groups (<i>p</i>&#xa0;&gt;&#xa0;0.05). However, the ulinastatin group exhibited significantly shorter ICU and hospital stays compared with the control group (<i>p</i>&#xa0;&lt;&#xa0;0.05), while the duration of mechanical ventilation showed no significant difference (<i>p</i>&#xa0;&gt;&#xa0;0.05). The ulinastatin group demonstrated significant improvements in CRP, IL-6, PCT levels, as well as SOFA and APACHE II scores (<i>p</i>&#xa0;&lt;&#xa0;0.05). Safety evaluations revealed a significant reduction in ALT and AST levels in the ulinastatin group (<i>p</i>&#xa0;&lt;&#xa0;0.05), with no serious adverse events reported.</p> Conclusion <p>While the 28-day mortality rate did not differ significantly between the two groups, ulinastatin was associated with shorter ICU and hospital stays, improvements in inflammatory markers and organ function, and demonstrated a favorable safety profile.</p>

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Efficacy and Safety of Ulinastatin in Post-traumatic Sepsis: A Randomized Controlled Trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月5日

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  • Ao Yang,
  • Rui Liu,
  • Kongbo Lv,
  • Weijun Chen,
  • Mengfei Han,
  • Zhizhou Yang

摘要

Background and Objective

Post-traumatic sepsis is associated with high mortality and limited treatment options. This study aimed to evaluate the safety and efficacy of ulinastatin in adult patients with post-traumatic sepsis, assess its potential as a therapeutic option, and provide a foundation for future large-scale trials.

Methods

A single-blind, randomized controlled trial was conducted involving 60 patients treated at the Eastern Theater General Hospital from October 2022 to June 2024. The primary endpoint was 28-day all-cause mortality. Secondary endpoints included the Sequential Organ Failure Assessment (SOFA) score, C-reactive protein (CRP), interleukin-6 (IL-6), procalcitonin (PCT) levels, Activities of Daily Living (ADL) score, Acute Physiology and Chronic Health Evaluation II (APACHE II) score, ICU length of stay, duration of mechanical ventilation, and other laboratory indicators.

Results

No statistically significant difference was observed in 28-day mortality between the ulinastatin and control groups (p > 0.05). However, the ulinastatin group exhibited significantly shorter ICU and hospital stays compared with the control group (p < 0.05), while the duration of mechanical ventilation showed no significant difference (p > 0.05). The ulinastatin group demonstrated significant improvements in CRP, IL-6, PCT levels, as well as SOFA and APACHE II scores (p < 0.05). Safety evaluations revealed a significant reduction in ALT and AST levels in the ulinastatin group (p < 0.05), with no serious adverse events reported.

Conclusion

While the 28-day mortality rate did not differ significantly between the two groups, ulinastatin was associated with shorter ICU and hospital stays, improvements in inflammatory markers and organ function, and demonstrated a favorable safety profile.