The Protective Effects of Sivelestat Sodium on the Basis of Corticosteroid Therapy in Patients With Moderate-to-Severe Acute Respiratory Distress Syndrome.

Objective: We aimed to evaluate the protective effects of sivelestat sodium on the basis of corticosteroid therapy in patients with moderate-to-severe acute respiratory distress syndrome (ARDS). Methods: We retrospectively investigated 127 patients with confirmed moderate-to-severe ARDS treated in the intensive care unit (ICU) at Dazhou Central Hospital. Patients were divided into the control group (corticosteroids alone) and the combination therapy of steroids and sivelestat sodium (CTSSS) group according to the therapeutic interventions. The primary outcome was in-hospital mortality. And the baseline characteristics and laboratory findings of patients were collected for analysis. Results: The overall mortality rate in 127 patients was 48.8%. There was no statistically significant difference in in-hospital mortality between the CTSSS group and the control group (45.3% vs. 56.1%). In the subgroup of patients aged < 80 years or with an Acute Physiology and Chronic Health Evaluation (APACHE) II score < 30, CTSSS could reduce the risk of mortality (odds ratio [OR] = 0.41, 95% confidence interval [CI], 0.17-0.96, p=0.041; OR = 0.31, 95% CI, 0.13-0.77, p=0.012; respectively). Among patients aged 80 years or older, those with CTSSS exhibited a significantly elevated risk of mortality (OR = 13; 95% CI, 1.20-140.73; p=0.035). Conclusion: Compared with corticosteroids alone, CTSSS could improve oxygenation index, increase lymphocyte count, protect extrapulmonary organs and reduce in-hospital mortality rate in patients with moderate-to-severe ARDS in specific subgroups (age < 80 years or APACHE II score < 30). It might be advisable to avoid CTSSS in moderate-to-severe ARDS patients aged 80 years or older. Prospective studies involving larger sample sizes are needed to verify these findings.