Key result
Ulinastatin significantly reduced the incidence of early postoperative cognitive dysfunction compared to placebo in elderly patients undergoing surgery (RR 0.29).
Why the study?
Studies have reported controversial results regarding whether ulinastatin improves postoperative cognitive function by inhibiting inflammatory mediators in elderly surgical patients.
Does ulinastatin reduce the incidence of postoperative cognitive dysfunction in elderly patients undergoing surgery?
Meta-Analysis (n=828)
Does ulinastatin reduce the incidence of postoperative cognitive dysfunction in elderly patients undergoing surgery?
Relative Risk: 0.29 (95% CI 0.21–0.41)
p-value: p=<0.00001
Prophylactic intravenous ulinastatin significantly reduces the incidence of early postoperative cognitive dysfunction and improves cognitive scores in elderly surgical patients.
May support ulinastatin prophylaxis to reduce early POCD in elderly surgical patients; confirms benefit in Level 1 meta-analysis.
Background: Postoperative cognitive dysfunction (POCD) is associated with neuroinflammation by triggering the systemic inflammatory responses. Related studies have demonstrated that ulinastatin, which is a urinary trypsin inhibitor, inhibited the release of inflammatory mediators and improved postoperative cognitive function in elderly patients undergoing major surgery. However, there are controversial results put forwarded by some studies. This systemic review aimed to evaluate the effect of ulinastatin on POCD in elderly patients undergoing surgery. Methods: We searched PubMed, Embase, Cochrane Library, Web of Science, and Ovid to find relevant randomized controlled trials (RCTs) of ulinastatin on POCD in elderly patients undergoing surgery. The primary outcomes included the incidence of POCD and the Mini-Mental State Examination (MMSE) scores. The secondary outcome was the levels of inflammatory cytokines such as tumor necrosis factor (TNF)-α, S100β, C-reactive protein (CRP), interleukin (IL)-6, and IL-10. RevMan 5.3 was used to conduct the meta-analysis. Results: Ten RCTs were included finally. Compared with controls, ulinastatin significantly reduced the incidence of POCD [risk ratio (RR) = 0.29, 95% CI 0.21–0.41, test of RR = 1: Z = 7.05, p < 0.00001]. In addition, patients in the ulinastatin group have lower levels of TNF-α, S100β, CRP, and IL-6 and higher level of IL-10 in serum following surgery. Conclusion: These findings suggested that ulinastatin can be used as an anti-inflammatory drug for POCD prevention in elderly patients undergoing surgery. Systematic Review Registration Number: CRD42019137449.
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Duan et al. (2021) conducted a meta-analysis in Early postoperative cognitive dysfunction (POCD) (n=828). Ulinastatin vs. Placebo (normal saline) was evaluated on Incidence of postoperative cognitive dysfunction (POCD) (RR 0.29, 95% CI 0.21-0.41, p=<0.00001). Ulinastatin significantly reduced the incidence of early postoperative cognitive dysfunction compared to placebo in elderly patients undergoing surgery (RR 0.29).
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