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羟乙基淀粉 130/0.4/9 与 5%白蛋白对肝及胰腺手术中安全性、容量效果及糖萼降解影响的开放性随机试验

Open randomized trial of the effects of 6% hydroxyethyl starch 130/0.4/9 and 5% albumin on safety profile, volume efficacy, and glycocalyx degradation in hepatic and pancreatic surgery.

机构信息

Department of Anesthesiology, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.

出版信息

J Anesth. 2020 Dec;34(6):912-923. doi: 10.1007/s00540-020-02847-y. Epub 2020 Sep 8.

Abstract

PURPOSE

The aim of this study was to evaluate the effects of hydroxyethyl starch (HES) 130/0.4/9 compared to 5% albumin on renal and coagulation safety profiles, volume efficacy and glycocalyx degradation in major abdominal surgery.

METHODS

The study was approved by the institutional ethics committee as a single center, open-labeled randomized trial. Fifty patients undergoing hepatic or pancreatic surgery were randomly assigned to the HES group (n = 25), who received HES 130/0.4/9, or the Albumin group (n = 25), who received 5% albumin. Ringer's acetate solution (3 ml/kg/h) and colloid solution (2 mL/kg/h) were infused and goal-directed fluid management was performed to stabilize hemodynamics. Perioperative changes and differences in serum creatinine, N-acetyl-beta-d-glucosaminidase (NAG), hemodynamics, coagulation parameters and glycocalyx biomarkers were compared between the groups. Blood loss and requirements for transfusion and vasoactive agents were also examined. Statistical analysis was performed by Mann-Whitney U tests, chi-square or Fisher exact test, with P < 0.05 taken to be significant.

RESULTS

Serum creatinine levels did not differ between the HES and Albumin groups (median: 0.67 vs. 0.75 mg/dL at anesthesia induction, 0.82 vs. 0.83 mg/dL at ICU admission, 0.67 vs. 0.73 mg/dL one day after surgery, 0.68 vs. 0.70 mg/dL one month after surgery). NAG, coagulation parameters, hemodynamics, glycocalyx biomarkers, intraoperative blood loss, transfusion and use of vasoactive agents did not differ between the groups.

CONCLUSION

HES 130/0.4/9 can be used as safely and effectively as 5% albumin. Glycocalyx degradation did not differ between use of these solutions in major abdominal surgery.

摘要

目的

本研究旨在评估羟乙基淀粉(HES)130/0.4/9 与 5%白蛋白对大型腹部手术患者肾脏和凝血安全性、容量疗效和糖萼降解的影响。

方法

该研究经机构伦理委员会批准,为单中心、开放标签的随机试验。50 例接受肝或胰腺手术的患者被随机分为 HES 组(n=25),给予 HES 130/0.4/9;白蛋白组(n=25),给予 5%白蛋白。给予醋酸林格氏液(3 ml/kg/h)和胶体溶液(2 mL/kg/h)输注,并进行目标导向的液体管理以稳定血流动力学。比较两组患者围手术期血清肌酐、N-乙酰-β-D-氨基葡萄糖苷酶(NAG)、血流动力学、凝血参数和糖萼生物标志物的变化和差异。还检查了出血量以及输血和血管活性药物的需求。采用 Mann-Whitney U 检验、卡方检验或 Fisher 确切检验进行统计学分析,P<0.05 为差异有统计学意义。

结果

HES 组和白蛋白组的血清肌酐水平无差异(麻醉诱导时中位数:0.67 vs. 0.75 mg/dL,ICU 入院时中位数:0.82 vs. 0.83 mg/dL,术后第 1 天中位数:0.67 vs. 0.73 mg/dL,术后第 1 个月中位数:0.68 vs. 0.70 mg/dL)。两组的 NAG、凝血参数、血流动力学、糖萼生物标志物、术中出血量、输血和血管活性药物的使用均无差异。

结论

HES 130/0.4/9 可与 5%白蛋白一样安全有效地使用。在大型腹部手术中使用这些溶液不会导致糖萼降解的差异。

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