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乌司他丁对急诊脓毒症患者临床疗效研究——一项多中心随机对照试验

Observation on the efficacy of Ulinastatin in the treatment of severe sepsis diagnosed in emergency room-A multicenter randomized controlled trial
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摘要 目的观察乌司他丁治疗脓毒症患者的临床疗效。方法选择2015年10月至2018年12月河北省内九家三级甲等综合医院急诊科接诊的150例严重脓毒症患者作为研究对象,随机分为试验组75例,对照组75例。对照组给予常规治疗,试验组在对照组的基础上,给予乌司他丁2万单位/(kg·d),分3次静脉注射,注射时间30-60分钟,连续治疗7d。在治疗后0d、3d、7d分别计算两组急性生理与慢性健康状况评分系统Ⅱ(APACHEⅡ)、序贯器官衰竭估计(SOFA)评分、急性脓毒症病死率(MEDS)评分、多脏器功能障碍综合征(MODS)评分,分别测定乳酸(Lac)、降钙素原(PCT)、C反应蛋白(CRP)、脑钠肽(BNP)、D-二聚体(D-Dimer)、肌钙蛋白I(cTnI)、直接胆红素(TBIL)、肌酐(Cr)的值,统计机械通气时间、急诊ICU住院时间、28d病死率。结果治疗7d后,两组患者器官功能评价指标以及实验室指标较治疗前均显著降低(P<0.05),且试验组APACHEⅡ评分、SOFA评分、Lac较对照组降低更明显(APACHEⅡ评分:10.21±4.49 vs 12.91±5.47,SOFA评分:1.5(0,4)vs 3(0,7),Lac(mmol/L):1.05±0.46 vs 1.33±0.49),比较差异具有统计学意义(P<0.05)。试验组MEDS评分、MODS评分、CRP、D-Dimer、PCT、TBIL、cTnI、BNP、Cr、机械通气时间、急诊ICU住院时间、28d病死率较对照组均有下降趋势,但两组比较差异无统计学意义(P>0.05)。结论乌司他丁对严重脓毒症患者的重要脏器功能有一定保护作用,可改善患者的总体状态,减轻疾病的严重程度。 Objective To investigate the efficacy of ulinastatin in the treatment of severe sepsis diagnosed in emergency room.Methods From January 2015 to December 2017,150 patients with early severe sepsis in 9 Grade 3 A hospitals in Hebei Province were randomly divided into experimental group(n=75)and control group(n=75).The control group was given routine treatment,and the experimental group was given ulinastatin 20000 units/(kg·d),three times intravenously for 30 to 60 minutes.The experimental group was treated for 7 days.The acute physiology and chronic health score system Ⅱ(APACHE Ⅱ),sequential organ failure estimation(SOFA)score,acute sepsis mortality(MEDS)score and multiple organ dysfunction syndrome(MODS)score were calculated on the 0 th,3 rd and 7 th day after treatment.The values of lactic acid(Lac),procalcitonin(PCT),C-reactive protein(CRP),brain natriuretic peptide(BNP),D-Dimer,troponinI(cTnI),direct bilirubin(TBIL)and creatinine(Cr)were measured.The time of mechanical ventilation,the hospitalization time of emergency ICU and 28-day mortality were calculated.Results After 7 days of treatment,the organ function evaluation indexes and laboratory indexes of the two groups were significantly lower than those before treatment(P<0.05),and the APACHE Ⅱ score,SOFA score and Lac of the test group were significantly lower than those of the control group(APACHE Ⅱ score:10.21±4.49 vs 12.91±5.47,SOFA score:1.5(0,4)vs 3(0,7),Lac(mmol/L):1.05±0.46 vs 1.33±0.49).The difference was statistically significant(P<0.05).The MEDS score,MODS score,CRP,D-Dimer,PCT,TBIL,cTnI,BNP,Cr,mechanical ventilation time,emergency ICU hospitalization time and 28-day mortality in the test group were lower than those in the control group,but there was no significant difference between the two groups.Conclusions Ulinastatin has a certain protective effect on the important organ function of patients with severe sepsis diagnosed in emergency room,which can improve the overall state of patients and reduce the severity of the disease.
作者 秦延军 高恒波 彭广军 董士民 田英平 王维展 侯云生 焦清海 李勇 赵麦良 李建国 Qin Yanjun;Gao Hengbo;Peng Guangjun;Dong Shimin;Tian Yingping;Wang Weizhan;Hou Yunsheng;Jiao Qinghai;Li Yong;Zhao Mailiang;Li Jianguo(Department of Emergency,The Third Hospital of Hebei Medical University,Shijiazhuang,China;Department of Emergency,The Second Hospital of Hebei Medical University,Shijiazhuang,China;Department of Emergency,Affiliated Hospital of Hebei University,Baoding,China;Department of Emergency,Harrison International Peace Hospital Affiliated to Hebei Medical University,Hengshui,China;Department of Emergency,No.980 Hospital of Joint Logistical Support Force,Shijiazhuang,China;Department of IntensiveCare Unit,Handan City First Hospital,Handan,China;Department of Emergency,Cangzhou Central Hospital,Cangzhou,China;Department of Emergency,Xingtai People's Hospital,Xingtai,China;Department of Emergency,Hebei General Hospital,Shijiazhuang,Chin)
出处 《实用休克杂志(中英文)》 2021年第6期331-336,共6页 Journal of Practical Shock
基金 天普研究基金项目(项目编号:UF201336)
关键词 严重脓毒症 乌司他丁 疗效 多中心 前瞻性随机对照研究 Severe sepsis Ulinastatin Curative effect Multicenter Prospective randomized controlled studies
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