西维来司他钠治疗脓毒症患者的有效性和安全性研究

Efficacy and safety of sivelestat sodium in patients with sepsis

目的:探讨西维来司他钠治疗脓毒症患者的有效性和安全性。方法:对2019年1月1日至2022年1月1日郑州大学第一附属医院重症监护病房(ICU)收治的141例成人脓毒症患者的临床资料进行回顾性分析,根据是否应用西维来司他钠分为西维来司他钠组(70例)和对照组(71例)。有效性指标有治疗前及治疗7 d的氧合指数、降钙素原(PCT)、C-反应蛋白(CRP)、白细胞计数(WBC)、序贯器官衰竭评分(SOFA)、急性生理学与慢性健康状况评分Ⅱ(APACHEⅡ),以及呼吸机使用时间、ICU住院时间、总住院时间和ICU病死率;安全性指标有血小板计数(PLT)、肝肾功能。结果:两组患者治疗前在年龄、性别、基础疾病、感染部位、基础用药、病原学、氧合指数、生化指标、SOFA评分、APACHEⅡ评分等方面差异均无统计学意义。与对照组比较,西维来司他钠组治疗7 d氧合指数显著升高〔mmHg(1 mmHg≈0.133 kPa):233.5(181.0,278.0)比202.0(153.0,243.0),P<0.01〕,PCT、CRP、丙氨酸转氨酶(ALT)和APACHEⅡ评分显著降低〔PCT(μg/L):0.87(0.41,1.61)比1.53(0.56,5.33),CRP(mg/L):64.12(19.61,150.86)比107.20(50.30,173.00),ALT(U/L):25.0(15.0,43.0)比31.0(20.0,65.0),APACHEⅡ评分(分):14(11,18)比16(13,21),均P<0.05〕;而西维来司他钠组治疗7 d SOFA评分、WBC、血肌酐(SCr)、PLT、总胆红素(TBil)、天冬氨酸转氨酶(AST)与对照组相比差异无统计学意义〔SOFA(分):6.5(5.0,10.0)比7.0(5.0,10.0),WBC(×10^(9)/L):10.5(8.2,14.7)比10.5(7.2,15.2),SCr(μmol/L):76.0(50.0,124.1)比84.0(59.0,129.0),PLT(×10^(9)/L):127.5(59.8,212.3)比121.0(55.0,211.0),TBil(μmol/L):16.8(10.0,32.1)比16.6(8.4,26.9),AST(U/L):31.5(22.0,62.3)比37.0(24.0,63.0),均P>0.05〕。西维来司他钠组呼吸机使用时间、ICU住院时间较对照组明显缩短〔呼吸机使用时间(h):147.50(86.83,220.00)比182.00(100.00,360.00),ICU住院时间(d):12.5(9.0,18.3)比16.0(11.0,23.0),均P<0.05〕;但总住院时间和ICU病死率与对照组比较差异均无统计学意义〔总住院时间(d):20.0(11.0,27.3)比13.0(11.0,21.0),ICU病死率:17.1%(12/70)比14.1%(10/71),均P>0.05〕。结论:西维来司他钠治疗脓毒症患者安全有效;可改善氧合指数和APACHEⅡ评分,降低PCT和CRP水平,缩短呼吸机使用时间及ICU住院时间;用药期间未观察到肝肾功能损伤、血小板异常等不良反应。

Objective To investigate the efficacy and safety of sivelestat sodium in patients with sepsis.Methods The clinical data of 141 adult patients with sepsis admitted to the intensive care unit(ICU)of the First Affiliated Hospital of Zhengzhou University from January 1,2019 to January 1,2022 were retrospectively analyzed.The patients were divided into the sivelestat sodium group(n=70)and the control group(n=71)according to whether they received sivelestat sodium or not.The efficacy indexes included oxygenation index,procalcitonin(PCT),C-reactive protein(CRP),white blood count(WBC),sequential organ failure assessment(SOFA),acute physiology and chronic health evaluationⅡ(APACHEⅡ)before and after 7 days of treatment,as well as ventilator supporting time,the length of ICU stay,the length of hospital stay and ICU mortality.The safety indicators included platelet count(PLT)and liver and kidney function.Results There were no significant differences in age,gender,underlying diseases,infection site,basic drugs,etiology,oxygenation index,biochemical indexes,SOFA and APACHEⅡscores between the two groups.Compared with the control group,the oxygenation index in 7 days was significantly increased[mmHg(1 mmHg≈0.133 kPa):233.5(181.0,278.0)vs.202.0(153.0,243.0),P<0.01],the levels of PCT,CRP,alanine aminotransferase(ALT)and APACHEⅡscore were significantly decreased in the sivelestat sodium group[PCT(μg/L):0.87(0.41,1.61)vs.1.53(0.56,5.33),CRP(mg/L):64.12(19.61,150.86)vs.107.20(50.30,173.00),ALT(U/L):25.0(15.0,43.0)vs.31.0(20.0,65.0),APACHEⅡ:14(11,18)vs.16(13,21),all P<0.05].However,there were no significant differences in SOFA,WBC,serum creatinine(SCr),PLT,total bilirubin(TBil),aspartate aminotransferase(AST)in 7 days between the sivelestat sodium group and the control group[SOFA:6.5(5.0,10.0)vs.7.0(5.0,10.0),WBC(×10^(9)/L):10.5(8.2,14.7)vs.10.5(7.2,15.2),SCr(μmol/L):76.0(50.0,124.1)vs.84.0(59.0,129.0),PLT(×10^(9)/L):127.5(59.8,212.3)vs.121.0(55.0,211.0),TBil(μmol/L):16.8(10.0,32.1)vs.16.6(8.4,26.9),AST(U/L):31.5(22.0,62.3)vs.37.0(24.0,63.0),all P>0.05].The ventilator supporting time and the length of ICU stay in the sivelestat sodium group were significantly shorter than those in control group[ventilator supporting time(hours):147.50(86.83,220.00)vs.182.00(100.00,360.00),the length of ICU stay(days):12.5(9.0,18.3)vs.16.0(11.0,23.0),both P<0.05].However,there were no significant differences in the length of hospital stay and ICU mortality between the sivelestat sodium group and the control group[the length of hospital stay(days):20.0(11.0,27.3)vs.13.0(11.0,21.0),ICU mortality:17.1%(12/70)vs.14.1%(10/71),both P>0.05].Conclusions Sivelestat sodium is safe and effective in patients with sepsis.It can improve the oxygenation index and APACHEⅡscore,reduce the levels of PCT and CRP,shorten ventilator supporting time and the length of ICU stay.No adverse reactions such as liver and kidney function injury and platelet abnormality are observed.