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羟乙基淀粉130/0.4(6%)对大手术中失血及血液制品使用的影响:随机临床试验的汇总分析

The effects of hydroxyethyl starch 130/0.4 (6%) on blood loss and use of blood products in major surgery: a pooled analysis of randomized clinical trials.

作者信息

Kozek-Langenecker Sibylle A, Jungheinrich Cornelius, Sauermann Wilhelm, Van der Linden Philippe

机构信息

Department of Special Anesthesiology and Pain Management, Vienna Medical University, Währinger Gürtel 18-20, 1090 Vienna, Austria.

出版信息

Anesth Analg. 2008 Aug;107(2):382-90. doi: 10.1213/ane.0b013e31817e6eac.

DOI:10.1213/ane.0b013e31817e6eac
PMID:18633012
Abstract

BACKGROUND

The effects of different types of hydroxylethyl starch (HES) on blood coagulation closely depend on their physicochemical properties. HES with lower molar substitution and a lower in vivo molecular weight interferes relatively little with hemostasis and therefore results in lower perioperative blood losses and red blood cell (RBC) transfusion. To test this hypothesis, we analyzed pooled data from all available studies in major surgery comparing 6% HES 130/0.4 and 6% HES 200/0.5 from waxy maize starch.

METHODS

Estimated blood loss, drainage loss, calculated blood loss, transfused blood product volumes, and coagulation variables were examined for 24 h after the start of surgery. Groups were compared using analysis of variance, evaluating several covariates.

RESULTS

Four-hundred-forty-nine patients from seven clinical trials were analyzed, 228 received HES 130/0.4, and 221 received HES 200/0.5. For HES 130/0.4 patients, when compared to HES 200/0.5 patients, the estimated blood loss was reduced by 404 mL [P = 0.006], drainage loss was 272 mL less [P = 0.009], and calculated RBC loss was 149 mL less [P = 0.003]. RBC transfusion volumes were also lower for HES 130/0.4 by 137 mL [P = 0.004]. In the early postoperative phase, HES 130/0.4 was found to exert significantly less effect on measures of coagulation, especially activated partial thromboplastin time and von Willebrand factor (antigen and ristocetin cofactor), than HES 200/0.5.

CONCLUSIONS

Blood loss and transfusion requirements can be significantly reduced in major surgery when using third generation HES 130/0.4 (Voluven) compared to second generation waxy maize starch HES 200/0.5. Since HES 130/0.4 and HES 200/0.5 were found similar regarding volume efficacy in other studies, HES 130/0.4 is recommended in this clinical setting.

摘要

背景

不同类型的羟乙基淀粉(HES)对血液凝固的影响很大程度上取决于其物理化学性质。摩尔取代度较低且体内分子量较低的HES对止血的干扰相对较小,因此围手术期失血量和红细胞(RBC)输注量较低。为验证这一假设,我们分析了所有关于大手术的现有研究中的汇总数据,比较了来自糯玉米淀粉的6% HES 130/0.4和6% HES 200/0.5。

方法

在手术开始后24小时内检查估计失血量、引流损失量、计算失血量、输注的血液制品量和凝血变量。使用方差分析对各组进行比较,并评估几个协变量。

结果

分析了来自7项临床试验的449例患者,228例接受HES 130/0.4,221例接受HES 200/0.5。对于接受HES 130/0.4的患者,与接受HES 200/0.5的患者相比,估计失血量减少了404 mL [P = 0.006],引流损失量减少了272 mL [P = 0.009],计算得出的RBC损失量减少了149 mL [P = 0.003]。HES 130/0.4的RBC输注量也低137 mL [P = 0.004]。在术后早期,发现HES 130/0.4对凝血指标的影响明显小于HES 200/0.5,尤其是活化部分凝血活酶时间和血管性血友病因子(抗原和瑞斯托霉素辅因子)。

结论

与第二代糯玉米淀粉HES 200/0.5相比,在大手术中使用第三代HES 130/0.4(万汶)可显著减少失血量和输血需求。由于在其他研究中发现HES 130/0.4和HES 200/0.5在容量疗效方面相似,因此在这种临床情况下推荐使用HES 130/

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