关键词: 西维来司他钠, 急性肺损伤, 先天性心脏病, 体外循环, 炎症反应

Abstract:

Objective To evaluate the efficacy of Sivelestat Sodium in mitigating pulmonary injury and inflammatory responses in pediatric patients with congenital heart disease （CHD） following cardiopulmonary bypass （CPB）-assisted open-heart surgery. Methods This randomized controlled trial enrolled 100 children undergoing CPB-assisted CHD surgery at the Department of Pediatric Critical Care Medicine， Guizhou Hospital of Shanghai Children's Medical Center from January to June 2024. Patients were randomly assigned to receive either Sivelestat Sodium （treatment group， n = 50） or normal saline （control group， n = 50）. Baseline characteristics， inflammatory biomarkers， and cardiopulmonary function parameters were dynamically assessed at 0， 24， and 72 hours postoperatively. Results No statistically significant differences were observed between the two groups regarding baseline characteristics， clinical parameters， inflammatory markers， or cardiopulmonary function at 0 and 24 hours postoperatively. Compared with the control group， at 72 hours postoperatively， the treatment group exhibited significantly lower values in the following parameters： lung ultrasound score ［5.0 （4.0， 6.0） vs. 7 （5.5， 8.5）， P < 0.05］， white blood cell count ［8.8 （7.8， 11.1） ×10?/L vs. 11.1 （9.7， 12.0） ×10?/L， P < 0.05］， neutrophil count ［5.4 （4.1， 8.6） ×10?/L vs. 7.3 （6.2， 9.9） ×10?/L， P < 0.05］， interleukin-6 ［35.2 （28.4， 45.6） pg/mL vs. 52.8 （41.3， 68.9） pg/mL， P < 0.05］， C-reactive protein ［21 （12， 38） mg/L vs. 32 （18， 40） mg/L， P < 0.05］， procalcitonin ［1.46 （0.60， 2.29） ng/mL vs. 2.51 （1.80， 3.64） ng/mL， P < 0.05］， and tumor necrosis factor-α ［9.3 （6.4， 12.3） pg/mL vs. 11.7 （9.7， 16.0） pg/mL， P < 0.05］. The PaO?/FiO? ratio was significantly higher in the treatment group at 72 hours postoperatively ［404 （353， 553） mmHg vs. 355 （300， 417） mmHg， P < 0.05］. No statistically significant differences were found between groups at 72 hours for interleukin-10， left ventricular ejection fraction， velocity time integral， or N-terminal pro-B-type natriuretic peptide. Regarding clinical outcomes， the duration of invasive mechanical ventilation was significantly shorter in the treatment group compared with the control group （P = 0.019）. Conclusion Sivelestat Sodium effectively attenuates postoperative pulmonary dysfunction in children with CHD undergoing CPB-assisted surgery by suppressing neutrophil-mediated inflammatory cascades， resulting in reduced ventilator dependence and improved early recovery.

Key words: sivelestat sodium, acute lung injury, congenital heart disease, cardiopulmonary bypass, inflammatory response