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羟乙基淀粉 6%(130/0.4)和白蛋白 5%对凝血形成和糖萼脱落的影响:一项前瞻性随机试验的亚组分析。

Effects of balanced hydroxyethyl starch 6% (130/0.4) and albumin 5% on clot formation and glycocalyx shedding: Subgroup analysis of a prospective randomized trial.

机构信息

Department of Anaesthesiology, Hospital of the University, Ludwig-Maximilians-University Munich, Marchioninistr, 15, 81377 Munich, Germany; Institute of Anesthesiology, Heart and Diabetes Center NRW, Ruhr University Bochum, Georgstr, 11, 32545 Bad Oeynhausen, Germany; Walter-Brendel-Centre of Experimental Medicine, Ludwig-Maximilians-University Munich, Marchioninistr, 15, 81377 Munich, Germany.

Institute of Anesthesiology, Heart and Diabetes Center NRW, Ruhr University Bochum, Georgstr, 11, 32545 Bad Oeynhausen, Germany.

出版信息

Thromb Res. 2019 Nov;183:111-118. doi: 10.1016/j.thromres.2019.10.020. Epub 2019 Oct 23.

Abstract

BACKGROUND

Intravenous fluids can impair coagulation and affect the endothelial glycocalyx, whereas glycocalyx shedding itself can cause an impairment of clot formation and firmness. We hypothesized that hydroxyethyl starch 6% (130/0.4) has a more distinct effect on coagulation and glycocalyx shedding than albumin 5%.

METHODS

Presented data derive from an exploratory subgroup analysis of a prospective randomized, single-blinded trial comparing albumin 5% versus balanced hydroxyethyl starch 6% (130/0.4). Patients between 46 and 85 years undergoing cystectomy were included. Prothrombin time, plasma fibrinogen concentration, partial thromboplastin time, thrombelastometry and platelet function were analyzed before and after surgery. Glycocalyx components were assessed before and after surgery, 2 to 4 h after surgery and at 1st and 3rd postoperative day. Primary outcome parameter was the change of thrombelastometric variables at the end of surgery. Further variables included calculated blood loss, infusion amount and transfusion rate.

RESULTS

55 patients (albumin group n = 28; hydroxyethyl starch group n = 27) were included. Thrombelastometric variables were significantly more compromised in the hydroxyethyl starch than in the albumin group whereas platelet function, glycocalyx shedding, partial thromboplastin time, prothrombin time and fibrinogen were not different between groups. Mean intraoperative calculated blood loss was higher in the hydroxyethyl starch group (1557 ± 825 ml versus 1245 ± 709 ml; p = 0.042). Transfusion requirements did not differ.

CONCLUSION

Rotational thrombelastometric variables were significantly more reduced when hydroxyethyl starch was used compared to albumin 5%. This effect was independent from a shedding of the endothelial glycocalyx. However, results presented here are from a subgroup analysis and must be considered with caution. Trial registration EudraCT number 2010-018343-34.

摘要

背景

静脉输液会影响凝血功能,并影响内皮糖萼,而糖萼脱落本身也会导致血栓形成和稳定性受损。我们假设羟乙基淀粉 6%(130/0.4)对凝血和糖萼脱落的影响比白蛋白 5%更明显。

方法

本研究数据源自一项前瞻性随机、单盲临床试验的探索性亚组分析,比较了白蛋白 5%与平衡型羟乙基淀粉 6%(130/0.4)。纳入年龄在 46 至 85 岁之间接受膀胱切除术的患者。分别在术前和术后分析凝血酶原时间、血浆纤维蛋白原浓度、部分凝血活酶时间、血栓弹力图和血小板功能。在术前、术后 2 至 4 小时以及术后第 1 和第 3 天评估糖萼成分。主要观察终点为手术结束时血栓弹力图变量的变化。其他变量包括计算的出血量、输液量和输血率。

结果

共纳入 55 例患者(白蛋白组 n=28;羟乙基淀粉组 n=27)。羟乙基淀粉组的血栓弹力图变量明显较白蛋白组受损,而血小板功能、糖萼脱落、部分凝血活酶时间、凝血酶原时间和纤维蛋白原在两组间无差异。羟乙基淀粉组术中计算的出血量较高(1557±825ml 比 1245±709ml;p=0.042)。输血需求无差异。

结论

与白蛋白 5%相比,使用羟乙基淀粉时旋转血栓弹力图变量明显降低。这种作用与内皮糖萼脱落无关。然而,这里呈现的结果是来自亚组分析,必须谨慎考虑。试验注册号 EudraCT 编号 2010-018343-34。

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