危重病严重脓毒症/脓毒性休克患者早期规范化液体复苏治疗——多中心、前瞻性、随机、对照研究

目的 探讨早期目标导向治疗(EGDT)对严重脓毒症/脓毒性休克患者的影响.方法 采用多中心、前瞻性、随机、对照研究方法,选择2005年1月至2008年1月浙江省8家三级甲等医院重症监护病房(ICU)住院的314例严重脓毒症/脓毒性休克患者,按随机数字表法分为常规组(151例)和EGDT组(163例).常规组以中心静脉压(CVP)、收缩压(SBP)和平均动脉压(MAP)、尿量变化指导液体复苏;EGDT组在此基础上增加中心静脉血氧饱和度(ScvO2)为观测指标进行复苏;对患者进行输液、输血和强等治疗,6 h内达标.比较两组患者28 d生存率、ICU住院病死率(主要终点)以及ICU住院时间、机械通气时间、抗生素使用时间、新发感染率和疾病严重程度评分(次要终点)的差异.结果 可供分析的有效病例中EGDT组为157例,常规组为146例.EGDT组28 d生存率较常规组增高约17.7%(75.2%比57.5%,P=0.001),EGDT组ICU住院病死率较常规组降低约15.7%(35.0%比50.7%,p=0.035).与常规组比较,EGDT能明显善患者的急性生理学与慢性健康状况评分系统Ⅱ(APACHEⅡ)评分(分:14.4±8.5比18.0±7.1,P=0.043)、多器官功能障碍综合征(MODS)评分(分:5.8±3.1比8.9±3.7,P=0.014)和感染相关器官功能衰竭评分系统(SOFA)评分(分:5.6±2.9比10.4±3.7,P=0.001),减少抗生素使用时间(d:13.4±10.0比19.7±13.5,P=0.004),降低新发感染的发生率(37.6%比53.4%,p=0.014);EGDT对ICU住院时间、机械通气间均无明显影响.结论 EGDT能显著改善ICU中严重脓毒症/脓毒性休克患者28 d生存率和临床疾病严重程度评分,减少抗生素使用时间及降低新发感染的发生率.

The effect of early goal-directed therapy on treatment of critical patients with severe sepsis/septic shock:a multi-center, prospective, randomized, controlled study

Objective To investigate the effect of early goal-directed therapy (EGDT) on treatment of critical patients with severe sepsis/septic shock.Methods A multi-center, prospective, randomized,controlled study was deployed.Totally 314 critical patients, from eight comprehensive hospitals in Zhejiang Province admitted during January, 2005 to January, 2008, suffering from severe sepsis/septic shock were randomized into conventional treatment group (n=151) and EGDT group (n = 163), the patients of the former underwent fluid resuscitation guided by central venous pressure (CVP), systolic blood pressure (SBP) or mean artery pressure (MAP) and urinary output (UO), and the latter guided by CVP, SBP orMAP and UO plus central venous oxygen saturation (ScvO2).The patients were treated with fluid, blood transfusions and cardiac stimulants in a period of 6 hours after enrollment to reach the goal.The difference of 28-day survival rate and intensive care unit (ICU) mortality (primary end points), the length of ICU stay,the duration of mechanical ventilation, duration of antibiotics treatment, incidence of newly occurredinfection, and severity scores (secondary end points) were compared between two groups.Results Finally,a total of 303 patients were eligible to enter this study, with 157 patients in EGDT group and 146 patients in conventional treatment group.In comparison with conventional treatment group, the 28-day survival rate of EGDT group was increased by 17.7% (75.2% vs.57.5%, P=0.001) and the ICU mortality of EGDT group was decreased by 15.7% (35.0% vs.50.7%, P=0.035), the acute physiology and chronic health evaluation Ⅱ(APACHE Ⅱ) score (14.4±8.5 vs.18.0±7.1, P=0.043), multiple organ dysfunction syndrome (MODS) score (5.8±3.1 vs.8.9±3.7, P=0.014) and sepsis-related organ failure assessment (SOFA) score (5.6 ± 2.9 vs.10.4 ± 3.7, P = 0.001) were significantly decreased in EGDT group.Meanwhile, a significant shortening of duration of using antibiotics was also found (13.4±10.0) days vs.(19.7 ± 13.5) days, P = 0.004], with a lowering of incidence of occurrence of new infection (37.6% vs.53.4%, P=0.014).There were no differences in other parameters for secondary end points.Conclusion EGDT improves 28-day survival rate and clinical scores, and it shows beneficial effects on outcome of critical patients with severe sepsis/septic shock.