Abstract
BackgroundSivelestat is widely used in treating acute lung injury (ALI)/acute respiratory distress syndrome (ARDS), although the clinical efficacy of sivelestat remains controversial. This study aimed to evaluate the impact of sivelestat in patients with ALI/ARDS.MethodsElectronic databases, PubMed, Embase, and the Cochrane Library, were searched to identify trials through April 2017. Randomized controlled trials (RCTs) were included irrespective of blinding or language that compared patients with and without sivelestat therapy in ALI/ARDS. A random-effects model was used to process the data, and the relative risk (RR) and standard mean difference (SMD) with corresponding 95% confidence intervals (CIs) were used to evaluate the effect of sivelestat.ResultsSix RCTs reporting data on 804 patients with ALI/ARDS were included. Overall, no significant difference was found between sivelestat and control for the risk of 28–30 days mortality (RR: 0.94; 95% CI: 0.71–1.23; P = 0.718). Sivelestat therapy had no significant effect on ventilation days (SMD: 0.05; 95% CI: −0.27 to 0.38; P = 0.748), arterial oxygen partial pressure (PaO2)/fractional inspired oxygen (FiO2) level (SMD: 0.48; 95% CI: −0.45 to 1.41; P = 0.315), and intensive care unit (ICU) stays (SMD: −9.87; 95% CI: −24.30 to 4.56; P = 0.180). The results of sensitivity analysis indicated that sivelestat therapy might affect the PaO2/FiO2 level in patients with ALI/ARDS (SMD: 0.87; 95% CI: 0.39 to 1.35; P < 0.001).ConclusionsSivelestat therapy might increase the PaO2/FiO2 level, while it had little or no effect on 28–30 days mortality, ventilation days, and ICU stays. These findings need to be verified in large-scale trials.
Highlights
Sivelestat is widely used in treating acute lung injury (ALI)/acute respiratory distress syndrome (ARDS), the clinical efficacy of sivelestat remains controversial
A systematic review and meta-analysis of Randomized controlled trials (RCTs) published through April 2017 were conducted to identify trials of sivelestat for patients with ALI/ARDS
Six RCTs were identified and included for the analysis of treatment effect of sivelestat in patients with ALI/ARDS [22,23,24,25,26,27], and the rest were excluded for the following reasons: conference abstracts without full text, retrospective study, and no desirable outcomes
Summary
Sivelestat is widely used in treating acute lung injury (ALI)/acute respiratory distress syndrome (ARDS), the clinical efficacy of sivelestat remains controversial. This study aimed to evaluate the impact of sivelestat in patients with ALI/ARDS. Acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) is characterized by abnormal pulmonary physiology and gas exchange properties [1, 2], which are common complications in various diseases, and is related to higher morbidity and mortality [3, 4]. The process of gas exchange is completed by mechanical ventilation. Mechanical ventilation does not significantly reduce the mortality caused by ALI/ARDS. The effect of most-employed treatment strategies, including high dose of steroids, aspirin, and ulinastain, in patients with ALI/ARDS remains limited [8].
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