Published online Feb 4, 2014. doi: 10.5492/wjccm.v3.i1.34
Revised: October 5, 2013
Accepted: November 2, 2013
Published online: February 4, 2014
Processing time: 257 Days and 23.8 Hours
AIM: To investigate the efficacy and safety of ulinastatin for patients with acute lung injury (ALI) and those with acute respiratory distress syndrome (ARDS).
METHODS: A systematic review of randomized controlled trials (RCTs) of ulinastatin for ALI/ARDS was conducted. Oxygenation index, mortality rate [intensive care unit (ICU) mortality rate, 28-d mortality rate] and length of ICU stay were compared between ulinastatin group and conventional therapy group. Meta-analysis was performed by using Rev Man 5.1.
RESULTS: Twenty-nine RCTs with 1726 participants were totally included, the basic conditions of which were similar. No studies discussed adverse effect. Oxygenation index was reported in twenty-six studies (1552 patients). Ulinastatin had a significant effect in improving oxygenation [standard mean difference (SMD) = 1.85, 95%CI: 1.42-2.29, P < 0.00001, I2 = 92%]. ICU mortality and 28-d mortality were respectively reported in eighteen studies (987 patients) and three studies (196 patients). We found that ulinastatin significantly decreased the ICU mortality [I2 = 0%, RR = 0.48, 95%CI: 0.38-0.59, number needed to treat (NNT) = 5.06, P < 0.00001], while the 28-d mortality was not significantly affected (I2 = 0%, RR = 0.78, 95%CI: 0.51-1.19, NNT = 12.66, P = 0.24). The length of ICU stay (six studies, 364 patients) in the ulinastatin group was significantly lower than that in the control group (SMD = -0.97, 95%CI: -1.20--0.75, P < 0.00001, I2 = 86%).
CONCLUSION: Ulinastatin seems to be effective for ALI and ARDS though most trials included were of poor quality and no information on safety was provided.
Core tip: Currently, many studies highlight the advantages of ulinastatin in lung protection, which is likely because acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) share a common pathogenesis with sepsis. We tried to provide more specific evidence on this practice by performing a meta-analysis. In our study (29 clinical trials included), we found that though all the studies were of low quality, ulinastatin might improve oxygenation and mortality and be truly effective in patients with ALI/ARDS.