脓毒性休克患者早期目标导向性复苏的临床研究

The study of early goal-directed resuscitation for septic shock

目的:通过对早期脓毒性休克患者应用目标导向性治疗(EGDT)方案和常规治疗对比,观察患者90d内的治疗结局,探讨EGDT方案治疗的意义。方法:收集以我院为主的多家医院早期脓毒性休克患者1 001例患者,随机分为2组,其中EGDT组512例、常规治疗组489例。根据90d内全因病死率观察临床结局。结果:EGDT组死亡165例(32.2%),常规治疗组死亡163例(33.3%),相对危险度为0.97,P=0.9;EGDT组的绝对危险度降低了-1.1个百分点。包括健康相关的生活质量,发生严重不良反应的比例(EGDT组4%,常规治疗组6.3%,P=0.58),EGDT组与常规治疗组差异无统计学意义。结论:早期的脓毒性休克患者在严格的EGDT指导下进行静脉应用抗菌药物,液体复苏,血流动力学监测管理不能改善预后。

Objective：Comparing early goal-directed therapy（EGDT）and usual care for patients presenting with early sepsis shock.To investing the value of EGDT in the treatment of early sepsis shock.Method：We conducted a pragmatic randomized trial in our hospitals.Patients were randomized to receive EGDT（a 6 hours protocol）or usual care.A total of 1 001 patients were recruited in the study,with 512 assigned to EGDT group and 489 to usual care group.The primary outcome was all-cause mortality at 90 days.Result：By 90 days,165 of 512 patients（32.2%）in EGDT group and 163 of 489patients（33.3%）in usual care group had died（relative risk in EGDT was 0.97,P=0.9）,the absolute risk reduction of EGDT group had lower 1.1percentage points.Secondary outcome including health-relative quality of life,or rates of adverse events showed no significant differences between EGDT group and usual care group.Conclusion：Patients with early sepsis shock who increased use of administration antibiotics,intravenous fluid,hemodynamic management that conducted strictly by EGDT could not get improved outcome.