To investigate the effect of sivelestat sodium on the prognosis in patients with acute lung injury ( ALI ) and acute respiratory distress syndrome ( ARDS ).

Databases including PubMed, EBSCO, Springer, Ovid, Wanfang data, CNKI and China Biology Medicine ( CBM ) were searched to identify randomized controlled trials ( RCTs ) regarding sivelestat sodium treatment for ALI/ARDS published from 1985 to December 2014. The patients in treatment group received intravenous infusion of sivelestat sodium, and those in control group received normal saline. The items for analysis were 28-day mortality, duration of mechanical ventilation, length of intensive care unit ( ICU ) stay, and oxygenation index on day 3. According to the evaluation method of Cochrane system, data extraction and quality assessment from the literature were carried out. Meta-analysis was performed using RevMan 5.3. The publication bias was analyzed with funnel plot.

Five RCTs with a total of 780 participants were included, with 389 patients in sivelestat sodium group, and 391 in control group. Meta analysis showed: compared with control group, sivelestat sodium could not lower the 28-day mortality [ odds ratio ( OR ) = 0.91, 95% confidence interval ( 95%CI ) = 0.66-1.26, P = 0.58 ], or shorten the duration of mechanical ventilation or length of ICU stay [ duration of mechanical ventilation: mean difference ( MD ) = -0.02, 95%CI = -0.29 to 0.24, P = 0.87; length of ICU stay: MD = -9.63, 95%CI = -23.34 to 4.08, P = 0.17 ], but it could improve oxygenation index on day 3 ( MD = 0.88, 95%CI = 0.39 to 1.36, P = 0.000 4 ). Heterogeneity was not significant for the main analysis and no publication bias was shown on funnel plot.

Sivelestat sodium gave rise to a better oxygenation on day 3, but did not change the length of mechanical ventilation and ICU stay, and it did not improve 28-day mortality in ALI and ARDS.

Sivelestat sodium; Acute lung injury; Acute respiratory distress syndrome; Meta-analysis