Background:
Ulinastatin has been prescribed to treat
sepsis. However, there is doubt regarding the extent of any improvement in outcomes to guide future decision making. Objectives: To evaluate the effects of
ulinastatin on mortality and related outcomes in
sepsis patients. Methods: Thirteen randomized controlled trials and two prospective studies published before September 1, 2018, that included 1358 patients with
sepsis, severe sepsis, or
septic shock were evaluated. The electronic databases searched in this study were PubMed, Medline, Embase, and China National Knowledge Infrastructure (CNKI) for Chinese Technical Periodicals. Results:
Ulinastatin significantly decreased the all-cause mortality {odds ratio (OR) = 0.48, 95% confidence interval (CI) [0.35-0.66], p < 0.00001, I2 = 13%}, Acute Physiology, Age, Chronic Health Evaluation II (APACHE II) score {mean difference (MD) = -2.40, 95% CI [-4.37, -0.44], p = 0.02, I2 = 66%}, and reduced the incidence of
multiple organ dysfunction syndrome (
MODS) (OR = 0.3, 95% CI [0.18, 0.49], p < 0.00001, I2 = 0%).
Ulinastatin also decreased the serum levels of
IL-6 (MD = -88.5, 95% CI [-123.97, -53.04], p < 0.00001), TNF-α (MD = -56.22, 95% CI [-72.11, -40.33], p < 0.00001), and increased the serum levels of
IL-10 (MD = 37.73, 95% CI [16.92, 58.54], p = 0.0004).
Ulinastatin administration did not lead to any difference in the occurrence of adverse events. Conclusions:
Ulinastatin improved all-cause mortality and other related outcomes in patients with
sepsis or
septic shock. The results of this meta-analysis suggest that
ulinastatin may be an effective treatment for
sepsis and
septic shock.