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脓毒症患者中平衡晶体液与生理盐水的比较: SMART 临床试验的二次分析。

Balanced Crystalloids versus Saline in Sepsis. A Secondary Analysis of the SMART Clinical Trial.

机构信息

Division of Allergy, Pulmonary, and Critical Care Medicine.

Department of Biostatistics.

出版信息

Am J Respir Crit Care Med. 2019 Dec 15;200(12):1487-1495. doi: 10.1164/rccm.201903-0557OC.

Abstract

Administration of intravenous crystalloid solutions is a fundamental therapy for sepsis, but the effect of crystalloid composition on patient outcomes remains unknown. To compare the effect of balanced crystalloids versus saline on 30-day in-hospital mortality among critically ill adults with sepsis. Secondary analysis of patients from SMART (Isotonic Solutions and Major Adverse Renal Events Trial) admitted to the medical ICU with an code for sepsis, using multivariable regression to control for potential confounders. Of 15,802 patients enrolled in SMART, 1,641 patients were admitted to the medical ICU with a diagnosis of sepsis. A total of 217 patients (26.3%) in the balanced crystalloids group experienced 30-day in-hospital morality compared with 255 patients (31.2%) in the saline group (adjusted odds ratio [aOR], 0.74; 95% confidence interval [CI], 0.59-0.93;  = 0.01). Patients in the balanced group experienced a lower incidence of major adverse kidney events within 30 days (35.4% vs. 40.1%; aOR, 0.78; 95% CI, 0.63-0.97) and a greater number of vasopressor-free days (20 ± 12 vs. 19 ± 13; aOR, 1.25; 95% CI, 1.02-1.54) and renal replacement therapy-free days (20 ± 12 vs. 19 ± 13; aOR, 1.35; 95% CI, 1.08-1.69) compared with the saline group. Among patients with sepsis in a large randomized trial, use of balanced crystalloids was associated with a lower 30-day in-hospital mortality compared with use of saline.Clinical trial registered with www.clinicaltrials.gov (NCT02444988).

摘要

静脉输注晶体溶液是治疗脓毒症的基本疗法,但晶体溶液成分对患者预后的影响尚不清楚。比较平衡晶体溶液与生理盐水在脓毒症危重症成人患者 30 天院内死亡率方面的效果。使用多变量回归控制潜在混杂因素,对 SMART (等渗溶液和主要不良肾脏事件试验)中收入重症监护病房并诊断为脓毒症的患者进行二次分析。在 SMART 中纳入的 15802 例患者中,有 1641 例患者收入重症监护病房诊断为脓毒症。与生理盐水组(255 例,31.2%)相比,平衡晶体组(217 例,26.3%)患者 30 天内院内死亡率降低(调整后比值比[OR],0.74;95%置信区间[CI],0.59-0.93; = 0.01)。平衡组患者在 30 天内发生主要不良肾脏事件的发生率更低(35.4% vs. 40.1%;调整后 OR,0.78;95% CI,0.63-0.97),血管加压素停药天数(20 ± 12 天 vs. 19 ± 13 天;调整后 OR,1.25;95% CI,1.02-1.54)和无肾脏替代治疗天数(20 ± 12 天 vs. 19 ± 13 天;调整后 OR,1.35;95% CI,1.08-1.69)均多于生理盐水组。在一项大型随机试验中,与生理盐水相比,平衡晶体溶液的使用与脓毒症患者 30 天内的院内死亡率降低相关。临床试验在 www.clinicaltrials.gov 注册(NCT02444988)。

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