乌司他丁对急性重症脑出血致全身炎症反应综合征的疗效及作用机制研究

摘要

目的 评价乌司他丁治疗急性重症脑出血所致全身炎症反应综合征(systemic inflammatory response syndrome,SIRS)患者的临床疗效、安全性及其作用机制.方法 将急性重症脑出血所致SIRS,且未行手术治疗的100例患者随机分为治疗组和对照组各50例,两组均给予相同的常规治疗,治疗组加用乌司他丁,对照组给予等量生理盐水作为对照,治疗前后测定患者血清肿瘤坏死因子-α(TNF-α)、白细胞介素(IL)-1、IL-6.结果 乌司他丁治疗组患者治疗第1、7天的血清TNF-d[(9.65±3.72) pg/mL,(6.82±4.64) pg/mL]、IL-1[(5.33±2.36) pg/mL,(3.62±2.56) pg/mL]、IL-6[(11.65±5.67)pg/mL,(8.52±4.85) pg/mL]均明显低于对照组(P＜0.05);治疗组患者治疗后7、28 d NIHSS评分[(14.5±5.2)分,(12.1±5.4)分]及MODS的发生率(40.8％,66.6％)均明显低于对照组(P＜0.05).结论 乌司他丁能够有效降低重症脑出血所致SIRS患者的血清TNF-α、IL-1、IL-6水平,从而降低多器官功能障碍综合征(MODS)的发生率,改善预后.%Objective To evaluate the clinical efficacy,safety and mechanism of action of ulinastatin for the treatment of systemic inflammatory response syndrome (SIRS) associated with acute severe cerebral hemorrhage.Methods The patients with acute severe cerebral hemorrhage-associated SIRS were randomized into the treatment group and control group to receive standard of care.Ulinastatin was administered as add-on in the treatment group and the same volume of physiological saline was administered as control in the control group.Serum TNF-α,IL-1 and IL-6 levels were measured before and after treatment.Results One hundred patients with acute severe cerebral hemorrhage-associated SIRS were randomized into the treatment group (n =50) and control group (n =50).No significant differences in population data were seen between both groups.At Day 1 and Day 7,the ulinastatin treatment group had statistically significantly lower serum levels than the control group [(9.65 ± 3.72) pg/mL,(6.82 ± 4.64) pg/mL],IL-1 [(5.33 ± 2.36) pg/mL,(3.62 ± 2.56) pg/mL] and IL-6[(11.65 ± 5.67) pg/mL,(8.52 ± 4.85) pg/mL] (P ＜ 0.05).At Day 7 and Day 28,the treatment group had a statistically significantly lower NIHSS score and incidence of multiple organ dysfunction syndrome (MODS) than the control group [(14.5 ± 5.2) scores,(12.1 ± 5.4) scores,(40.8％,66.6％)],(P ＜ 0.05).Conclusion Ulinastatin effectively reduces the serum TNF-α,IL-1 and IL-6 levels in patients with acute severe cerebral hemorrhage-associated SIRS,thus reducing the incidence of MODS and improving prognosis.