国产新型肺动脉取栓装置的动物实验研究  

Animal experimental study of a novel domestic pulmonary artery thrombectomy device

作　　者：张文广[1] 张萌帆 陈鹏飞[1] 石晓静 周朋利[1] 任建庄[1] 韩新巍[1] Zhang Wenguang;Zhang Mengfan;Chen Pengfei;Shi Xiaojing;Zhou Pengli;Ren Jianzhuang;Han Xinwei(Department of Interventional Radiology,Institute of Interventional Radiology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,China;Experimental Animals Center of Zhengzhou University,Zhengzhou 450000,China)

机构地区：[1]郑州大学第一附属医院介入科郑州大学介入治疗研究所,郑州450000 [2]郑州大学实验动物中心,郑州1450000

出　　处：《中华血管外科杂志》2023年第4期362-367,共6页Chinese Journal of Vascular Surgery

基　　金：河南省科技攻关项目(222102310168);河南省高校重点研究项目(23A320056);河南省中青年卫生健康创新人才杰青项目(JQRC2023002)。

摘　　要：目的评价国产新型肺动脉血栓取出装置在动物模型中的有效性和安全性。方法本研究为前瞻性随机对照研究。将15只实验白猪以随机数字表法随机分为肺动脉急性血栓取栓组(取栓组,n=6)、模拟肺动脉取栓组(模拟取栓组,n=6)和对照组(n=3)。取栓组肺动脉血栓建模成功后,用国产新型肺动脉取栓装置行经导管肺动脉抽栓实验,观察取栓前后肺动脉血流动力学变化和血栓负荷量的变化。模拟取栓组模拟取栓后观察30 d,将动物实施安乐死、解剖观察及取材进行组织病理学分析,观察测试段肺动脉组织,评估器械相关不良事件。对照组实验动物目标血管无血栓堵塞,不进行任何操作,组织病理学分析时与测试品作用过的血管作对照,评价血管修复情况。结果取栓组均成功建立肺动脉血栓模型,取栓(3.1±0.6)次,取栓后平均肺动脉压(mPAP)由(30.1±6.9)mmHg降至(18.7±3.4)mmHg(t=8.01,P=0.004),右心室收缩压(RVSP)由(51.2±7.6)mmHg降至(39.2±6.1)mmHg(t=6.37,P=0.021),差异均有统计学意义;肺动脉测试段直径由(10.6±1.5)mm减小至(9.7±1.7)mm,差异无统计学意义(t=0.77,P=0.475);取栓后血栓即刻清除率Ⅲ级为100%(6/6)。模拟取栓组取栓后30 d的靶血管管壁血栓、内皮化及肉芽肿与对侧血管相比,差异均无统计学意义(P>0.05),未出现器械相关不良事件。结论肺动脉血栓经导管机械取栓后mPAP、PVSP下降,国产新型肺动脉取栓装置治疗白猪肺动脉血栓安全有效。Objective To evaluate the efficacy and safety of a novel domestic pulmonary artery thrombectomy device(NDPATD)in animal experiment.MethodThis was a prospective randomized controlled study.Fifteen white pigs were divided into three groups using the random number table,including 6 pigs in the transcatheter mechanical thrombectomy(TMT)group,6 in the simulated pulmonary artery thrombectomy(PAT)group,and 3 in the blank control group.In the TMT group,the acute pulmonary artery thrombosis model was first established,followed by the application of TMT via the NDPATD,and the hemodynamic alterations in the pulmonary artery and thrombus burden were analyzed.In the simulated PAT group,the simulated thrombus removal was used and then analyzed.The animals in the blank control group were neither complicated with thrombus in the target vessels nor underwent invasive procedures and were only used as blank control to compare the histology across the groups.After 30 days,all animals were euthanized and studied by proper histologic and pathological methods,including the evaluation of pulmonary artery tissues and the adverse events of the NDPATD.ResultIn the TMT group,all animals successfully accessed PAT,and the times of thrombectomy was 3.1±0.6.After thrombectomy,the mean pulmonary artery pressure(mPAP)decreased from(30.1±6.9)mmHg to(18.7±3.4)mmHg(t=8.01,P=0.004),the right ventricular systolic pressure(RVSP)declined from(51.2±7.6)mmHg to(39.2±6.1)mmHg(t=6.37,P=0.021),and all these differences were statistically significant.The diameter of the tested pulmonary artery dropped from(10.6±1.5)mm to(9.7±1.7)mm,which was not statistically significant(t=0.77,P=0.475).The immediate clearance rate of thrombus reached GradeⅢin all 6 cases(6/6,100%).No statistically significant differences were found in the target vessel wall thrombus,endothelialization,and granulomas in the simulated PAT group at 30d after simulated thrombus removal compared with the contralateral vessels(P>0.05).No device-related adverse events occurred.ConclusionTh

关 键 词：动物实验 肺动脉 血栓清除 肺动脉血栓 

分 类 号：R-332[医药卫生] R543.2