摘要信息：Background:Systemic inflammatory response syndrome (SIRS) after surgery for acute Stanford type A aortic dissection (ATAAD) via cardiopulmonary bypass (CPB) are strongly associated with mortality. Although the sivelestat sodium has been approved for the treatment of patients with acute lung injury, there is currently no enough evidence for improving inflammatory response and reducing the associated mortality. Our study aims to investigate the efficacy and safety of sivelestat sodium for the treatment of inflammatory response in acute Stanford type A aortic dissection. Methods:A total of 71 ATAAD patients who received surgical treatment at our center from January 2021 to December 2021 retrospectively reviewed. Patients were divided into the sivelestat sodium group and the control group. Clinical information including the postoperative oxygenation index (PaO2/FiO2), white blood cell (WBC) count, procalcitonin (PCT) level, interleukin-6 (IL-6) level, duration of ventilator use (hours), intensive care unit stay (days), and 28-day mortality rate, were collected. The statistical inference differences between the groups were compared using the non-paired Student's t-test, Wilcoxon rank sum test, chi squared test and repeated analysis of variance (ANOVA). Results:There were no significant differences between the sivelestat sodium group and the control group in terms of baseline characteristics (all P>0.05). The mortality rate was decreased in the sivelestat sodium group than the control group (10% vs. 13.73%). The subgroup analysis showed that for patients with a mechanical ventilation duration >96 h, the 48-h oxygenation index (149±53 vs. 260±66, P=0.001), and the 72-h oxygenation index (165±66 vs. 288±95, P=0.002) were significantly lower in the control group than the sivelestat sodium group. And the postoperative WBC count (P=0.015) and PCT level (P=0.033) were significantly lower in the sivelestat sodium group than the control group in post-operative day 4. Conclusions:Sivelestat sodium can improves the postoperative oxygenation index and inflammatory response for ATAAD patients requiring mechanical ventilation for extended periods.

摘要信息：Background:Sivelestat, a neutrophil elastase inhibitor, is specifically developed to mitigate the occurrence of acute lung injury (ALI) in individuals who are undergoing cardiovascular surgery. However, its impact on patients who are at a heightened risk of developing ALI after scheduled cardiac surgery has yet to be determined. In order to address this knowledge gap, we undertook a study to assess the efficacy of sivelestat in protecting the lungs of these patients. Methods:We conducted a prospective cohort study involving 718 patients who were at high risk of developing postoperative acute lung injury (ALI) and underwent scheduled cardiac surgery between April 25th, 2022, and September 7th, 2023. Among them, 52 patients received sivelestat (administered at a dosage of 0.2mg/kg/h for 3 days), while 666 patients served as controls, not receiving sivelestat. The control conditions were the same for all patients, including ventilation strategy, extubating time, and fluid management. Subsequently, a propensity-score matched cohort was established, consisting of 40 patients in both the sivelestat and control groups. The primary outcome measure encompassed a composite of adverse outcomes, including 30-day mortality, ALI, acute respiratory distress syndrome (ARDS), and others. Secondary outcomes assessed included pneumonia, ventricular arrhythmias, mechanical ventilation (MV) time, and more. Results:After conducting propensity matching in our study, we observed that there were no significant differences in 30-day mortality between the sivelestat and control groups (0% vs 2.5%, P=0.32). However, the use of sivelestat exhibited a significant reduction in the incidence of acute lung injury/acute respiratory distress syndrome (ALI/ARDS) compared to the control group (0% vs 55%, P<0.01), pneumonia (0 vs 37.5%, P<0.01), MV time (median:8 hours, IQR:4-14.8 hours vs median: 15.2 hours, IQR:14-16.3 hours, P<0.01). Compared to the control group, the sivelestat could significantly decrease white cell count (P<0.01), neutrophile percentage (P<0.01) and C-reactive protein (P<0.01) in the period of postoperative 5 days. Conclusion:The prophylactic administration of sivelestat has shown promising results in reducing the occurrence of acute lung injury/acute respiratory distress syndrome (ALI/ARDS) in patients with a heightened risk of developing these conditions after elective cardiac surgery. Our study findings indicate that sivelestat may provide protective effects by suppressing inflammation triggered by neutrophil activation, thereby safeguarding pulmonary function.

摘要信息：Background: The sivelestat is a neutrophil elastase inhibitor thought to have an effect against acute lung injury (ALI) in patients after scheduled cardiac surgery. However, the beneficial effect of sivelestat in patients undergoing emergent cardiovascular surgery remains unclear. We aim to evaluate the effect of sivelestat on pulmonary protection in patients with ALI after emergent cardiovascular surgery. Methods: Firstly, a case-control study in 665 patients undergoing emergent cardiovascular surgery from January 1st, 2020 to October 26th, 2022 was performed. 52 patients who received sivelestat (0.2mg/kg/h for 3 days) and 613 age- and sex-matched controls. Secondly, a propensity-score matched cohort (sivelestat vs control: 50 vs 50) was performed in these 665 patients. The primary outcome was a composite of adverse outcomes, including 30-day mortality, ECMO, continuous renal replacement therapy (CRRT) and IABP, etc. The secondary outcome included pneumonia, ventricular arrhythmias and mechanical ventilation time, etc. Results: In propensity-matched patients, the 30-day mortality (16% vs 24%, P=0.32), stroke (2% vs 8%, P=0.17), ECMO(6% vs 10%, P=0.46), IABP(4% vs 8%, P=0.40) and CRRT(8% vs 20%, P=0.08) had no differences between sivelestat and control group; sivelestat could significantly decrease pneumonia (40% vs 62%, P=0.03), mechanical ventilation time (median: 96hours, IQR:72-120hours vs median:148hours, IQR:110-186hours, P<0.01), bilateral pulmonary infiltrates (P<0.01), oxygen index (P<0.01), interleukin-6(P=0.02), procalcitonin(P<0.01) and C-reactive protein(P<0.01). Conclusion: Administration of sivelestat might improve postoperative outcomes in patients with ALI after emergent cardiovascular surgery. Our results show that sivelestat may be considered to protect pulmonary function against inflammatory injury by CPB.