国产和进口羟乙基淀粉对凝血功能影响的临床研究

Comparative Research of Two Kinds of Hydroxyethyl Starch on Coagulation

目的：观察国产和进口6%羟乙基淀粉130/0.4行术前急性高血容量血液稀释（AHH）后机体凝血功能和血小板功能的变化,验证国产胶体有效性及安全性。方法：选择20例全麻胃肠外科手术病人,美国麻醉医师协会分级（ASA）Ⅰ-Ⅱ级,体重40-80kg,失血量在400-1000ml,无贫血、凝血障碍及严重心肝肾功能不全患者。随机分为A组进口6%羟乙基淀粉130/0.4组和B组国产6%羟乙基淀粉130/0.4组,术前30min输晶体液10ml/kg,插管后予国产或进口注射液10ml/kg,2h内输注完毕,结束后15min观察凝血酶原时间（PT）,部分凝血酶原时间（APTT）,Sonoclot凝血及血小板功能分析仪测凝血形成时间（ACT）、凝血速率（Clot Rate）、快速血小板功能（qPF）和血小板功能（PF）。结果：两组输注前后,除B组国产CR值及PT值有在正常值范围内的明显差异,其它观察指标的差异均没有统计学意义（P〉0.05）。结论：国产6%羟乙基淀粉130/0.4按10ml/kg的剂量进行AHH不会影响血小板功能和凝血功能,与进口万汶有相似的临床安全性。

Objective ：To evaluate the effect of acute hypervolemic hemodilution （AHH） with different Hydroxyethyl Starch products on coagulation and function of platelet during operation. Methods： Twenty ASA Ⅰ-Ⅱ , weighed 40 - 80kg, undergoing major abdominal surgery were randomly divided into two groups; group A （imported 6%Hydroxyethyl Starch 130/0.4） and group B（Tian Qingning, 6%Hydroxyethyl Starch 130/0. 4 made in china）. 10ml/kg crystalloid solution was gave before the operation, then these two fluid 10ml/kg after intubation. Collect the data of PT, APTT, ACT, Clot Rate, qPF and PF. Results： Only CR and PT were significant changed, but still in normal scale. Conclusion： Tian Qingning is as safe as imported 6%Hydroxyethyl Starch 130/0. 4.