羟乙基淀粉 130/0.4 及其对围手术期结局的影响：一项倾向评分匹配的对照观察研究。

Hydroxyethyl Starch 130/0.4 and Its Impact on Perioperative Outcome: A Propensity Score Matched Controlled Observation Study.

机构信息

From the Clinic of Anaesthesiology.

Department of Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-University Munich, Munich, Germany.

出版信息

Anesth Analg. 2018 Jun;126(6):1949-1956. doi: 10.1213/ANE.0000000000002778.

DOI:10.1213/ANE.0000000000002778

PMID:29324500

Abstract

BACKGROUND

Adverse effects of hydroxyethyl starches (HESs) have been verified in patients suffering from sepsis or kidney disease, but not in surgical patients at large. The investigation aimed to determine whether the use of HES 130/0.4 was associated with the incidence of acute postinterventional adverse events compared to Ringer's acetate alone in a perioperative setting.

METHODS

This propensity score matched, controlled observational study was performed in a single-centre university hospital. The perioperative data of 9085 patients were analyzed. Group matching was based on 13 categories including demographic data, type of procedure, and 5 preexisting comorbidities. Duration of procedure and intraoperative transfusion requirements were integrated in the matching process to reduce selection and indication bias. The primary outcome was incidence of postoperative kidney failure. Secondary outcomes were in-hospital mortality, fluid requirements, blood loss, hemodynamic stability, and the need for postoperative intensive care unit (ICU) treatment.

RESULTS

The administration of HES 130/0.4 was not associated with an increased frequency of postoperative kidney failure. In-hospital mortality (Ringer's acetate: 2.58%; HES 130/0.4: 2.68%) and the need for ICU care (Ringer's acetate: 30.5%; HES 130/0.4: 34.3%) did not differ significantly between groups. Significant intergroup differences were observed for mean blood loss (Ringer's acetate: 406 ± 821 mL; HES 130/0.4: 867 ± 1275 mL; P < .001) and median length of hospital stay (Ringer's acetate: 10.5 (5/17) days; HES 130/0.4: 12.0 (8/19) days; P < .001).

CONCLUSIONS

An association between intraoperative HES therapy and postoperative kidney failure was not observed in a mixed cohort of elective surgical patients. In addition, HES 130/0.4 was not associated with an increased morbidity or the need for ICU therapy in this propensity score matched study.

摘要

背景

羟乙基淀粉（HES）的不良反应已在脓毒症或肾病患者中得到验证，但在一般外科患者中尚未得到验证。本研究旨在确定在围手术期使用羟乙基淀粉 130/0.4 是否与单独使用醋酸林格氏液相比，与急性术后不良事件的发生率相关。

方法

这是一项在单中心大学医院进行的倾向评分匹配、对照观察性研究。分析了 9085 例患者的围手术期数据。组匹配基于 13 个类别，包括人口统计学数据、手术类型和 5 种预先存在的合并症。手术持续时间和术中输血需求被纳入匹配过程中，以减少选择和指示偏倚。主要结局是术后肾功能衰竭的发生率。次要结局包括院内死亡率、液体需求、失血量、血流动力学稳定性以及术后需要重症监护病房（ICU）治疗。

结果

羟乙基淀粉 130/0.4 的给药与术后肾功能衰竭的发生率增加无关。院内死亡率（醋酸林格氏液：2.58%；羟乙基淀粉 130/0.4：2.68%）和 ICU 治疗的需求（醋酸林格氏液：30.5%；羟乙基淀粉 130/0.4：34.3%）在两组之间无显著差异。两组间的平均失血量（醋酸林格氏液：406±821mL；羟乙基淀粉 130/0.4：867±1275mL；P<0.001）和中位住院时间（醋酸林格氏液：10.5（5/17）天；羟乙基淀粉 130/0.4：12.0（8/19）天；P<0.001）存在显著差异。