国产羟乙基淀粉用于老年人急性等容血液稀释的临床研究

A clinical study of homemade hydroxyethyl starch in the elderly with acute normovolemic hemodilution

目的观察国产羟乙基淀粉在老年患者急性等容血液稀释中的疗效及安全性。方法60例70--85岁，ASAⅠ～Ⅱ级于全身麻醉下行择期手术的患者，随机分别I组（国产羟乙基淀粉组）和Ⅱ组（进口羟乙基淀粉组），30例／组，2组均于术前采集自体血10mL／kg至储血袋，然后分别静脉输注国产、进口羟乙基淀粉25mL／kg，2组均于手术结束前1h回输自体血10mL／kg。分别于人室后即刻（T0）、术中自体血回输前（T1）、手术结束离室时（T2）、抽取动脉血，检测血红蛋白（Hb）、红细胞压积（Het）、电解质（K＋、Na＋、Ca2’）及凝血酶原时间（PT）、凝血酶时间（TT）、活化部分凝血活酶时间（APTT），同时记录Tn及术后24h、48h（T3、T4）的β2-微球蛋白（β2-MG）、血尿素氮（BUN）、血肌酐（Cr）。结果2组患者术中、术后Hb、HCt均较术前有所下降（P〈0．05）；术中、术后电解质（K＋、Na＋、Ca2＋）、凝血功能（P丁、TT、APTT）无明显变化；2组患者术后肾功能（β2-MG、BUN、Cr）与术前相比，无明显改变（P〉0．05；）。2组患者各项指标组间比较无差异。结论国产羟乙基淀粉可适用于老年患者的急性等容血液稀释，其疗效及安全性与进口羟乙基淀粉相当。

Objective To study the efficacy and safety of homemade hydroxyethyl starch in the elderly with acute normovolemic hemodilution. Methods Sixty patients aged from 70 to 85 years were randomly divided into two groups： group I with homemade hydroxyethyl starch and group II with imported hydroxyethyl starch. Autoblood was collected with the volume of 10 mL/kg in all patients of two groups before operation, then the patients were infused homemade and import- ed hydroxyethyl starch with the volume of 25 mL/kg respectively in two groups. The autoblood was infused back in all patients one hour before the end of operation. Blood sample was drawn via artery in the timepoints of entering the operation （T0）, before the autoblood infusion back （T1）, leaving the operation （T2）. The hemoglobin （Hb）, hematocrit （Hct）, electrolyte （K＋ ,Na＋ ,Ca2＋ ）, Pro- thrombin time （PT）, thrombin time （TT）, activated partial thromboplastin time （APTT） were recorded. And the ~ - microglobulin （~ - MG）, blood urea nitrogen （BUN）, Creatinine （Cr） were recorded in the time points of To, 24 h and 48 h after the operation （T3,T4）. Results Hb and Hct in To were lower than those in T1, T2, the electrolyte and coagulation function were not changeable during the operation, and The renal function was stable before and after the operation. All parameters had no difference in two groups. Conclusion Homemade hydroxyethyl starch was eligible for the elderly with the acute normovolemic hemodilution depending on the comparable effi- cacy and safety to the import acute normovolemic hemodilution.