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Purpose <p>Patients with tuberculosis (TB)-related sepsis often experience profound immune dysregulation and poor clinical outcomes. Evidence of immunomodulatory therapeutic efficacy in this population remains limited. We evaluated the association between thymosin α1 (Tα1) use and 28-day all-cause mortality in critically ill TB-related sepsis patients and explored whether the strength of this association varied with the baseline lymphocyte count.</p> Methods <p>This single-centre retrospective cohort study included critically ill, adult TB-related sepsis patients admitted to the intensive care unit (ICU) in 2017–2025. Exposure was any Tα1 use during ICU stay. The primary outcome was 28-day mortality. Association analyses included multivariable Cox regression, restricted mean survival time (RMST) analyses, and exploratory restricted cubic spline (RCS) modelling. Sensitivity analyses were performed.</p> Results <p>Among 327 patients, 160 received Tα1 and 167 served as controls. Tα1 use was associated with a lower hazard of 28-day mortality after adjustment for baseline covariates (adjusted hazard ratio, 0.54; 95% confidence interval, 0.36–0.79; <i>P</i> = 0.002); sensitivity analyses showed estimates of similar direction. The proportional hazards assumption was violated; consequent RMST analysis revealed longer adjusted restricted mean survival in the Tα1 group. Exploratory RCS modelling suggested nonlinear variability in the association between Tα1 use and 28-day mortality across baseline lymphocyte counts, which appeared more pronounced at intermediate lymphocyte counts (approximately 0.8–1.2 × 10⁹/L); however, this data-driven pattern is hypothesis-generating.</p> Conclusion <p>Among ICU patients with TB-related sepsis, Tα1 use was associated with lower observed 28-day mortality, but causality cannot be inferred. The identified variability in this association across baseline lymphocyte counts requires external validation.</p> Clinical trial number <p>Not applicable.</p>

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Association between thymosin α1 therapy and 28-day mortality risk in critically ill patients with tuberculosis-related sepsis: a retrospective cohort study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年8月5日

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  • Tingting Wang,
  • Shun Tan,
  • Qiang Gao,
  • Ya Dong Luo,
  • Ping Yang,
  • An Zhang

摘要

Purpose

Patients with tuberculosis (TB)-related sepsis often experience profound immune dysregulation and poor clinical outcomes. Evidence of immunomodulatory therapeutic efficacy in this population remains limited. We evaluated the association between thymosin α1 (Tα1) use and 28-day all-cause mortality in critically ill TB-related sepsis patients and explored whether the strength of this association varied with the baseline lymphocyte count.

Methods

This single-centre retrospective cohort study included critically ill, adult TB-related sepsis patients admitted to the intensive care unit (ICU) in 2017–2025. Exposure was any Tα1 use during ICU stay. The primary outcome was 28-day mortality. Association analyses included multivariable Cox regression, restricted mean survival time (RMST) analyses, and exploratory restricted cubic spline (RCS) modelling. Sensitivity analyses were performed.

Results

Among 327 patients, 160 received Tα1 and 167 served as controls. Tα1 use was associated with a lower hazard of 28-day mortality after adjustment for baseline covariates (adjusted hazard ratio, 0.54; 95% confidence interval, 0.36–0.79; P = 0.002); sensitivity analyses showed estimates of similar direction. The proportional hazards assumption was violated; consequent RMST analysis revealed longer adjusted restricted mean survival in the Tα1 group. Exploratory RCS modelling suggested nonlinear variability in the association between Tα1 use and 28-day mortality across baseline lymphocyte counts, which appeared more pronounced at intermediate lymphocyte counts (approximately 0.8–1.2 × 10⁹/L); however, this data-driven pattern is hypothesis-generating.

Conclusion

Among ICU patients with TB-related sepsis, Tα1 use was associated with lower observed 28-day mortality, but causality cannot be inferred. The identified variability in this association across baseline lymphocyte counts requires external validation.

Clinical trial number

Not applicable.