Novel radiopaque ethanol injection:physicochemical properties,animal experiments,and clinical application in vascular malformations  

作　　者：Yu-Chen Shen De-Ming Wang Xi-Tao Yang Zhen-Feng Wang Ming-Zhe Wen Yi-Feng Han Lian-Zhou Zheng Ruo-Yu Di Chun-Yu Jiang Jing-Bing Wang Jian-Xiong You Li-Ming Zhang Li-Xin Su Xin-Dong Fan 

机构地区：[1]Vascular Anomaly Center,Department of Interventional Therapy,Shanghai Ninth People’s Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200011,China

出　　处：《Military Medical Research》2025年第3期339-353,共15页军事医学研究(英文版)

基　　金：supported by the Transverse Research Project of Shanghai Ninth People’s Hospital(JYHX2022007);the Clinical Research Program of Ninth People’s Hospital,Shanghai Jiao Tong University School of Medicine(JYLJ202111).

摘　　要：Background:Despite the efficacy of absolute ethanol(EtOH),its radiolucency introduces several risks in interventional therapy for treating vascular malformations.This study aims to develop a novel radiopaque ethanol injection(REI)to address this issue.Methods:Iopromide is mixed with ethanol to achieve radiopacity and improve the physicochemical properties of the solution.Overall,82 male New Zealand white rabbits are selected for in vivo radiopacity testing,peripheral vein sclerosis[animals were divided into the following 5 groups(n=6):negative control(NC,saline,0.250 ml/kg),positive control(EtOH,0.250 ml/kg),low-dose REI(L-D REI,0.125 ml/kg),moderate-dose REI(M-D REI,0.250 ml/kg),and highdose REI(H-D REI 0.375 ml/kg)],pharmacokinetic analyses(the blood sample was harvested before injection,5 min,10 min,20 min,40 min,1 h,2 h,4 h,and 8 h after injection in peripheral vein sclerosis experiment),peripheral artery embolization[animals were divided into the following 5 groups(n=3):NC(saline,0.250 ml/kg),positive control(EtOH,0.250 ml/kg),L-D REI(0.125 ml/kg),M-D REI(0.250 ml/kg),and H-D REI(0.375 ml/kg)],kidney transcatheter arterial embolization[animals were divided into the following 4 groups(n=3):positive control(EtOH,0.250 ml/kg),L-D REI(0.125 ml/kg),M-D REI(0.250 ml/kg),and H-D REI(0.375 ml/kg);each healthy kidney was injected with saline as negative control],and biosafety evaluations[animals were divided into the following 5 groups(n=3):NC(0.250 ml/kg),high-dose EtOH(0.375 ml/kg),L-D REI(0.125 ml/kg),M-D REI(0.250 ml/kg),and H-D REI(0.375 ml/kg)].Then,a prospective cohort study involving 6 patients with peripheral venous malformations(VMs)is performed to explore the clinical safety and effectiveness of REI.From Jun 1,2023 to August 31,2023,6 patients[age:(33.3±17.2)years]with lingual VMs received sclerotherapy of REI and 2-month follow-up.Adverse events and serious adverse events were evaluated,whereas the efficacy of REI was determined by both the traceability of the REI under DSA throughout the entire injectio

关 键 词：Vascular malformation ETHANOL SCLEROTHERAPY RADIOPACITY IOPROMIDE Radiopaque ethanol injection(REI) 

分 类 号：R543[医药卫生—心血管疾病]