发热脓毒症患者的物理降温:一项随机对照临床研究

Physical cooling in sepsis patients with fever:a randomized controlled clinical study

目的脓毒症患者通常会出现发热,然而目前临床上针对发热的脓毒症患者是否需要进行降温治疗仍存在争议,本研究拟通过随机临床研究评估外部物理降温对脓毒症患者预后的影响。方法本研究为单中心、开放标签、随机临床试验,选取2020年6月至2020年12月苏北人民医院重症医学科收治的体温大于38.3℃成人脓毒症患者,按照1∶1的比例随机分配至控温组与对照组。控温组患者在入组4 h内将核心体温降至正常范围(36.5~37.5℃)并维持48 h,对照组行标准护理,不采用退热治疗。比较两组患者28 d病死率、72 h-Δ序贯器官衰竭评估(Sequential Organ Failure Assessment,SOFA)评分(定义为入组时SOFA评分减去72 h SOFA评分)、总住院时长、ICU住院时长。结果研究期间共纳入符合入选标准患者53例(男32例,女21例),其中控温组26例,对照组27例。两组间年龄、性别、感染来源、入组时SOFA评分及体温等基线数据特征均差异无统计学意义(P>0.05),控温组28 d病死率与对照组差异无统计学意义(RR=1.38,95%CI:0.62~3.07,P=0.430)。控温组72 h-ΔSOFA评分明显高于对照组,两组间均数差值为1.90(95%CI:0.09~3.71,P=0.040)。两组患者总住院时长、ICU住院时长和28 d生存率等均差异无统计学意义。结论外部物理降温不能显著降低脓毒症患者28 d病死率,但能明显降低脓毒症患者72 h SOFA评分,改善患者器官功能。

Objective Sepsis patients usually have a fever,but it is still controversial about whether sepsis patients with fever need cooling treatment.This study aimed to evaluate the effect of external physical cooling on the prognosis of sepsis patients.Methods This study was a single-center,open-label,randomized clinical trial.Adult sepsis patients with body temperature above 38.3℃admitted to the Critical Care Medicine of Northern Jiangsu People's Hospital from June 2020 to December 2020 were selected,and randomly assigned in a 1∶1 ratio to the cooling group and control group.Patients in the cooling group used external physical cooling methods to reduce their core body temperature to the normal range(36.5-37.5℃)within 4 h of enrollment and maintained for 48 h.Standard care was implemented in the control group at all times,and all antipyretic treatments were prohibited.The 28-day mortality,72 h-Δsequential organ failure assessment(SOFA)score(SOFA score at enrollment–SOFA score after 72 h),length of hospital stay and length of ICU stay were compared between the two groups.Results A total of 53 patients(32 males and 21 females)were enrolled in the study,including 26 patients in the cooling group and 27 patients in the control group.There were no statistical differences in age,sex,source of infection,SOFA score and body temperature between the two groups(all P>0.05).There was no significant difference in the 28-day mortality between the cooling group and the control group(RR=1.38,95%CI:0.62-3.07,P=0.430).The 72 h-ΔSOFA score of the cooling group was significantly higher than that of the control group,the mean difference between the two groups was 1.90(95%CI:0.09-3.71,P=0.040),and there was no significant difference in length of hospital stay,length of ICU stay and 28-day mortality between the two groups.Conclusions External physical cooling management can not significantly reduce the 28-day mortality of sepsis patients.However,external physical cooling can reduce the 72-h SOFA score in sepsis patients,and improve the organ function of patients.