中国体外生命支持2025，Vol.23Issue(6)：522-526,5.DOI:10.13498/j.cnki.chin.j.ecls.2025.06.10
体外膜氧合套包血细胞破坏体外测试方法的建立
Establishment and Preliminary Application of an in Vitro Blood Cell Damage Evaluation Test Method for Extracorporeal Membrane Oxygenation
DONG Qi 1LIU Xiaoshuai 1LI Chengzhi 1Ralf BORCHARDT 2MENG Chen 1YAN Caixia 2ZHOU Na 2ZHENG Xiu'e 3ZHANG Jishun 1ZHANG Xiaohan1
作者信息
- 1. Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan Shandong 250101,China
- 2. Suzhou Feidun Medical Technology Co.,LTD,Suzhou Jiangsu 215000,China
- 3. Shandong Provincial Center for Food and Drug Evaluation and Inspection,Jinan Shandong 250000,China
- 折叠
摘要
Abstract
Objective This study aims to establish an in vitro testing method to evaluate the degree of blood cell damage caused by extracorporeal membrane oxygenation(ECMO)kits during use,in order to facilitate preclinical research and product performance assessment.Methods A test circuit was constructed under simulated clinical conditions,and evaluation indicators were established based on relevant standards and guidelines,including free hemoglobin(FHb),index of hemolysis(IH),platelet decline rate,and leukocyte decline rate.The ECMO kit was used to operate this test method,with samples collected at 0 h,0.5 h,3 h,and 6 h during the test.Results An experimental method for testing blood cell damage induced by ECMO kits was estab-lished,with the HI as an evaluation indicator for blood cell damage.Calculation formulas for the increase in free hemoglobin,and the decline rates of platelets and leukocytes were developed.The established method was applied to test the ECMO kit,which showed an increase in free hemoglobin levels and a decrease in platelet and leukocyte counts during the testing process.Specif-ically,the increase in free hemoglobin was 44～80 mg/(L·h),the platelet decline rate was 1.7%/h～27.8%/h,and the leukocyte decline rate was 1.5%/h～16.3%/h.Conclusion The in vitro testing method established in this study provides a scientific tool for evaluating overall blood cell damage caused by ECMO kits,improving the accuracy of test results and supporting the preclin-ical assessment of product safety and efficacy.关键词
体外膜氧合/血细胞破坏/游离血红蛋白/溶血指数/血小板下降率/白细胞下降率Key words
extracorporeal membrane oxygenation/blood cell damage/free hemoglobin/hemolysis index/platelet de-cline rate/leukocyte decline rate引用本文复制引用
DONG Qi,LIU Xiaoshuai,LI Chengzhi,Ralf BORCHARDT,MENG Chen,YAN Caixia,ZHOU Na,ZHENG Xiu'e,ZHANG Jishun,ZHANG Xiaohan..体外膜氧合套包血细胞破坏体外测试方法的建立[J].中国体外生命支持,2025,23(6):522-526,5.
