Ulinastatin Injection For Sepsis:A Systematic Review

Background Sepsis refers to systemic inflammation caused by infection response syndrome(SIRS),is a common complication of severe trauma,burn,shock,major surgical operation after the critically ill patients,is also the important reasions to induce shock,multiple organ dysfunction or organ failure. Septic shock refers to sepsis with tissue hypoperfusion after fluid resuscitation is still difficult to reverse,showed after the initial fluid resuscitation sustained hypotension or keep a high level of blood lactate concentration.Sepsis has a high incidence and mortality rate,is one of the major causes of death in patients in intensive care unit(ICU),has become one of the ten major causes of death. A multi center epidemiological investigation show,severe sepsis in the incidence rate of ICU was 8.68%,the mortality rate as high as 44.7%,and the consumption of high medical costs,and brings great physical,psychological and economic burden to the parents.In USA,215000 people died of sepesis and its follow-up complications annually.The mortality of sepsis in ICU is about 30-40%,while the mortality of the elderly or patients with basic disease patients is more than 70%.Objective To evaluate the efficacy and safety of Ulinastatin injection in the treatment of sepsis.Methods The randomized controlled trials(RCTs), which is related to the therapeutic effect of Ulinastatin injection in the treatment of sepsis, was systematically evaluated with Revman 5.0 software. A computer-based online search of Pubmed, Ovid, Elsevier,CBM, CNKI, the VIP database was undertaken to identify relevant articles. 736 patients from 13 randomized controlled trials were enrolled into the Meta analysis, which were divided into test group(n=370) and contrast(n=366). Meta-analysis showed that tumor necrosis factor-α(TNF-α) of the Ulinastatin group has significant differences with the controlled group, as well as the Interleukin-6(IL-6), the White Blood Count(WBC),the C-reactive protein(CRP) and APACHE Ⅱ grade. Beneficial changes were observed in general. There is no difference in individual experiments. No adverse events were found.Conclusion Effects of ulinastatin in the treatment of sepsis is relatively safe,and in improving the prognosis of patients,correlation index has certain advantages,but the high quality research is still limited,and the lack of large-scale clinical trials demenstrated,there is no reliable,sufficient evidence to indicate that the effect of ulinastatin in treating sepsis safe,effective.Study carried out in future,we should overcome the limitations of current research,increasing enrollment,improved design,using a more objective,more recognized,with more points at the end of the efficacy index.The methodology is passable through the quality evaluation. However, a randomized double blind clinical trial is urgently needed because of the limitations of evaluation indexes.