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一项比较羟乙基淀粉130/0.4与羟乙基淀粉200/0.5止血效果的随机双盲试验。

A randomized, blinded trial comparing the hemostatic effects of pentastarch versus hetastarch.

作者信息

Strauss Ronald G, Pennell Beverly J, Stump David C

机构信息

University of Iowa DeGowin Blood Center and the Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.

出版信息

Transfusion. 2002 Jan;42(1):27-36. doi: 10.1046/j.1537-2995.2002.00003.x.

Abstract

BACKGROUND

HES solutions provide a sterile, alternative colloidal fluid to albumin solutions and/or plasma in the management of patients who need plasma volume expansion. Solutions of HES are widely accepted internationally but are used only modestly in the United States, largely because of concerns over hemostasis.

STUDY DESIGN AND METHODS

A randomized, blinded, two-arm trial comparing the hemostatic effects of pentastarch versus hetastarch when infused in the clinically relevant dose of 90 g of HES dissolved in 1.5 L of saline was conducted. Multiple studies of fibrin clot formation, fibrinogen/fibrinolysis, and platelet (PLT) functions were performed before and on multiple occasions for 70 days following HES infusion.

RESULTS

Several significant abnormalities of hemostasis assay results occurred following HES infusions, with hetastarch causing significantly greater abnormalities than pentastarch. Individual clotting proteins and blood PLTs fell modestly because of plasma volume expansion and hemodilution. A fall in excess of that caused by hemodilution was demonstrated for von Willebrand factor antigen plus its associated FVIII and ristocetin cofactor activities. The partial thromboplastin time was prolonged, whereas the thrombin time was shortened. Plt function abnormalities were seen in most subjects to a modest degree. Studies of fibrinolysis were normal.

CONCLUSIONS

Solutions of hetastarch produce significant abnormalities of some hemostasis laboratory results when infused at clinically relevant doses, but it is unlikely that the modest hemostatic abnormalities produced at these doses per se would lead to clinical bleeding. Hetastarch causes greater hemostatic abnormalities than pentastarch, and because both HES solutions have comparable plasma volume-expanding effects, it is reasonable to prefer pentastarch as a plasma volume expander.

摘要

背景

羟乙基淀粉(HES)溶液为需要扩充血浆容量的患者提供了一种无菌的、可替代白蛋白溶液和/或血浆的胶体液。HES溶液在国际上被广泛接受,但在美国的使用却较为有限,这主要是因为对止血功能存在担忧。

研究设计与方法

开展了一项随机、双盲、双臂试验,比较了在临床上相关剂量(90 g HES溶解于1.5 L盐水中)下输注时,喷他淀粉与羟乙基淀粉的止血效果。在输注HES之前以及输注后70天内多次进行了纤维蛋白凝块形成、纤维蛋白原/纤维蛋白溶解和血小板(PLT)功能的多项研究。

结果

输注HES后,止血检测结果出现了若干显著异常,羟乙基淀粉导致的异常比喷他淀粉更显著。由于血浆容量扩充和血液稀释,个别凝血蛋白和血液中的PLT略有下降。血管性血友病因子抗原及其相关的FVIII和瑞斯托霉素辅因子活性下降幅度超过了血液稀释所致。部分凝血活酶时间延长,而凝血酶时间缩短。大多数受试者的血小板功能出现了轻度异常。纤维蛋白溶解研究结果正常。

结论

以临床相关剂量输注时,羟乙基淀粉溶液会使一些止血实验室结果出现显著异常,但这些剂量下产生的轻微止血异常本身不太可能导致临床出血。羟乙基淀粉比喷他淀粉引起的止血异常更严重,而且由于两种HES溶液具有相当的血浆容量扩充效果,因此选择喷他淀粉作为血浆容量扩充剂是合理的。

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