中国输血杂志2026，Vol.39Issue(8)：1004-1011,1025,9.DOI:10.13303/j.cjbt.issn.1004-549x.2026.08.002
自制活化凝血酶原复合物的安全性和有效性评价
Preliminary evaluation of the safety and efficacy of a self-prepared activated prothrombin complex concentrate
摘要
Abstract
Objective To evaluate the in vitro procoagulant efficacy and in vivo potential thrombogenic risk of self-pre-pared activated prothrombin complex concentrate(aPCC).Methods The preparation was administered at a dose of 0.5 IU per milliliter of plasma.For in vitro assays,the self-prepared aPCC concentrate was added to plasma spiked with factor Ⅷ(FⅧ)inhibitors.Calibrated automated thrombin generation(CAT),prothrombin time(PT),activated partial thrombo-plastin time(APTT),thrombin time(TT),and fibrinogen(Fib)quantification were performed.Normal saline and FEIBA® were set as controls to evaluate the procoagulant capacity of the self-prepared aPCC concentrate.For in vivo animal studies,the self-prepared aPCC concentrate was injected into rats via the jugular vein.A ferric chloride(FeCl3)filter pa-per patch was applied to induce carotid arterial thrombosis.Laser speckle blood flow imaging was used to continuously moni-tor thrombus formation in the rat carotid artery.Plasma samples were collected from rats for CAT,PT,APTT,TT and Fib testing,with normal saline and FEIBA® as controls to evaluate the potential thrombogenic risk of the self-prepared aPCC concentrate.Results Supplementation with aPCC significantly shortened APTT and PT values in inhibitor-spiked plasma(all P<0.001).There were no statistically significant differences in APTT and PT between FEIBA® and self-prepared aPCC(P>0.05).CAT results demonstrated that adding aPCC to inhibitor-containing plasma markedly increased endoge-nous thrombin potential(ETP)and peak thrombin concentration(Peak)(P<0.001),with both parameters higher than those of normal plasma(P<0.05).No significant intergroup difference in ETP was observed between self-prepared aPCC and FEIBA®(P>0.05).Carotid blood flow imaging in rats revealed that,compared with FEIBA®,thrombi induced by self-prepared aPCC were smaller and less stable,and all underwent spontaneous lysis,accompanied by better restoration of ca-rotid blood perfusion.Conclusion The self-prepared aPCC restores coagulation function in inhibitor-spiked plasma to a comparable extent as FEIBA®,while exhibiting a lower thrombogenic risk.关键词
活化凝血酶原复合物(aPCC)/FⅧ旁路活性(FEIBA)/自动标准化凝血酶生成试验(CAT)/血栓风险Key words
activated prothrombin complex concentrate(aPCC)/factor eight bypassing activity(FEIBA)/calibrated automated thrombin generation(CAT)/thrombotic risk分类
医药卫生引用本文复制引用
潘旭,黄雨薇,毛烈火,孙盼,李长清,杜晞,马莉..自制活化凝血酶原复合物的安全性和有效性评价[J].中国输血杂志,2026,39(8):1004-1011,1025,9.基金项目
四川省科技计划项目,活化凝血酶原复合物制品的研究与开发(2021YFS0056) （2021YFS0056）
