微针注射球囊防治动脉狭窄的实验研究  

Experimental study on a novel microneedle injection balloon for prevention and treatment of arterial stenosis

作　　者：唐成海 谭最[1] Tang Chenghai;Tan Zui(Department of Cardiovascular Surgery,Zhongnan Hospital of Wuhan University,Hubei Provincial Engineering Research Center of Minimally Invasive Cardiovascular Surgery,Wuhan Clinical Research Center for Minimally Invasive Treatment of Structural Heart Disease,,Wuhan,430071,China)

机构地区：[1]武汉大学中南医院心血管外科,心脏大血管外科微创诊疗,湖北省工程研究中心,武汉市结构性心脏病微创诊疗临床研究中心,武汉430071

出　　处：《中华实验外科杂志》2023年第5期819-822,共4页Chinese Journal of Experimental Surgery

摘　　要：目的探讨在猪股动脉球囊血管成形术中,微针球囊注射紫杉醇到股动脉鞘的安全性与有效性。方法10只巴马香猪随机抽样分成3组,其中对照组与实验组各4只,选取单侧股动脉;空白对照组2只,选取双侧股动脉。在数字减影血管造影(DSA)造影下选取直径约4mm的股动脉作为靶血管,予以扩张至6mm达到血管损伤的目的。实验组应用微针球囊注射1ml紫杉醇显影剂复合物到动脉鞘;对照组应用药物涂层球囊(DCB)释放紫杉醇涂层到血管内膜;空白对照组应用微针球囊注射1ml生理盐水到动脉鞘。实验组与对照组分别于术后1h、48h、7d、14d检测紫杉醇血药浓度,在术后60d检测靶血管段的紫杉醇含量;术后60d3组靶血管均行苏木精-伊红(HE)染色,在镜下测量相关数据并应用SPSS20.0进行统计分析。结果实验组中紫杉醇血药浓度高于对照组,配对样本Wilcoxon秩和检验结果为0.068(0.010,0.092)、0.068(0.005,0.092)(Z=2.12,P<0.05)。血管狭窄率的比较中,对照组与实验组相当,均优于空白对照组,方差分析结果为(42±6)%、(46±8)%、(52±7)%(F=3.87,P<0.05),LSD法进行组间两两比较,对照组与空白对照组有统计学差异,其余组间差异无统计学意义。管腔面积/外膜面积比的比较中,实验组与对照组相当,均优于空白对照组,方差分析结果为(35±9)%、(33±7)%、(23±7)%(F=6.21,P<0.05),LSD法进行两两比较,实验组与空白对照组、对照组与空白对照组均有统计学差异,实验组与对照组差异无统计学意义。结论微针球囊注射紫杉醇到股动脉鞘是安全的,可以产生与DCB相同的防治动脉狭窄的效果,为ASO的腔内治疗提供了更多的选择。Objective To investigate the safety and efficacy of microneedle balloon injection of paclitaxel into the femoral sheath in pig femoral artery balloon angioplasty.Methods Totally,10 Bama pigs were randomly divided into 3 groups,4 in control group and 4 in experimental group,and unilateral femoral artery was selected.In blank control group(n=2),bilateral femoral arteries were selected.The femoral artery with a diameter of about 4 mm was selected as the target vessel under digital subtraction angiography(DSA),which was expanded to 6 mm to achieve the purpose of vascular injury.In the experimental group,1 ml paclitaxel developer complex was injected into the arterial sheath by microneedle balloon.In the blank control group,the drug-coated balloon(DCB)was used to release paclitaxel coating onto the vascular intima.In the control group,1 ml normal saline was injected into the arterial sheath by microneedle balloon.The blood concentration of paclitaxel in the experimental group and the control group was detected at 1 h,48 h,7 d,14 d after surgery,respectively,and the content of paclitaxel in the target vascular segment was detected at 60 d after surgery.Hematoxylin and eosin(HE)staining was performed on all target vessels of the three groups at 60 d after surgery,and relevant data were measured under the microscope and statistical analysis was performed with SPSS 20.0.Results The serum concentration of paclitaxel in the experimental group was higher than that in the control group,and the Wilcoxon rank sum test results of paired samples were 0.068(0.010,0.092),0.068(0.005,0.092)(Z=2.12,P<0.05).In the comparison of the rate of vascular stenosis,the control group was comparable to the experimental group,and both were better than the blank control group.The result of variance analysis was(42±6)%,(46±8)%,(52±7)%(F=3.87,P<0.05).Pairwise comparison between the two groups by LSD method showed a statisbetween the other groups.In the comparison of lumen area/membrane area ratio,the experimental group was comparable to the cont

关 键 词：下肢动脉狭窄 紫杉醇 球囊 微针 

分 类 号：R543.5[医药卫生—心血管疾病]