Shengmai Injection as adjunctive therapy in sepsis and septic shock: a retrospective cohort study.

Background: Sepsis and septic shock constitute critical global health burdens associated with substantial mortality. Shengmai Injection (SMI), a classic traditional Chinese medicine formulation endowed with anti-inflammatory and immunomodulatory properties, has demonstrated efficacy as an adjunctive therapy in critical illness. Nevertheless, high-level clinical evidence supporting its routine application remains limited. This work sought to systematically explore the therapeutic efficacy of adjunctive SMI intervention in patients with sepsis and septic shock. Materials and methods: Mass spectrometry was employed to identify chemical constituents of SMI. This multicenter retrospective cohort study enrolled patients meeting Sepsis 3.0 diagnostic criteria for sepsis or septic shock at the Guangdong Provincial Hospital of Traditional Chinese Medicine from February 2016 to June 2024. After 1:1 propensity score matching (PSM) to balance baseline confounders, clinical outcomes were compared between the SMI and control groups. The primary endpoint was 28-day mortality. Secondary outcomes included hospital and intensive care unit (ICU) stay, ventilation and fever duration, and changes in SOFA score, APACHE II scores, procalcitonin (PCT), lactate, and blood cell counts at days 3-7 post-treatment. A subgroup analysis was further conducted among patients with septic shock. Results: A total of 130 components were identified in SMI. The retrospective study involving 436 enrolled patients (136 in the septic shock subgroup) showed that SMI shortened ICU stay, ventilation duration, and fever duration, and reduced post-treatment SOFA, APACHE II scores, PCT, platelet count, and lactate levels. Cox regression analysis revealed that post-treatment SOFA score (HR = 1.133), PCT (HR = 1.024), lactate (HR = 1.432), and SMI course (HR = 0.830) were independent predictors of 28-day mortality. Subgroup analysis of 72 patients with septic shock demonstrated that SMI reduced invasive ventilation duration, improved post-treatment SOFA and APACHE II scores, and decreased platelet and lactate levels. However, SMI did not significantly reduce 28-day mortality in patients with sepsis or septic shock. Conclusion: Adjunctive SMI therapy was associated with certain beneficial physiological effects, including improvements in inflammatory and metabolic markers and organ function, without conferring a significant survival benefit regarding 28-day mortality. Post-treatment PCT and lactate levels serve as powerful prognostic biomarkers for disease progression. Further prospective randomized controlled trials (RCTs) are required to corroborate these observations and consolidate clinical evidence.