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自体动静脉内瘘(arteriovenous fistula, AVF)是血液透析病人首选的血管通路,但是长期使用会出现内瘘狭窄甚至闭塞,导致功能丧失,常见因素包括血栓形成以及内膜增生[1]。近年来腔内介入治疗已在血管通路中广泛开展,其中球囊扩张成形术在重建狭窄AVF血运方面有重要意义。然而普通球囊扩张存在反复再狭窄问题,含紫杉醇成分的药物涂层球囊能够通过抑制内膜增生从而提高治疗的通畅率,该方法已经在冠状动脉和股腘动脉的疗效中得到了证实[2-3],但在血管通路中的研究仍然较少。为此,我们进行了一项单中心回顾性研究,比较药物涂层球囊和普通球囊在治疗自体AVF狭窄中的疗效。现作报道。
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选择2019年2月至2020年2月我科行血液透析治疗后发生自体AVF狭窄病人42例,根据治疗方式分为药物涂层球囊组(DCB组)20例和普通球囊组(CB组)22例。纳入标准:(1)年龄≥18周岁;(2)肾衰竭需行维持性血液透析治疗;(3)内瘘已成熟,至少成功进行一次血液透析;(4)符合AVF狭窄诊断标准[4](彩色多普勒超声或CT血管造影证实内瘘狭窄内径>50%);(5)血流量不足,无法行透析治疗;(6)触诊时内瘘震颤减弱或消失,听诊无血管杂音;穿刺困难等;(7)首次出现AVF狭窄;(8)内瘘吻合方式为桡动脉-头静脉端侧吻合;(9)取得病人知情同意。排除标准:其他重要脏器功能障碍;恶性肿瘤疾病;严重感染性瘘管;妊娠或哺乳期妇女;对造影剂、紫杉醇过敏;无法配合随访病人;预期寿命 < 12个月。本研究经医院伦理委员会批准,病人知情同意并签署知情同意书。2组病人一般资料差异均无统计学意义(P>0.05)(见表 1),具有可比性。
分组 n 男 女 年龄/岁 内瘘狭窄发生时间/周 透析龄/月 狭窄部位 原发病 吻合口附近静脉段 动脉段 穿刺点 其他部位 糖尿病肾病 高血压相关肾病 慢性肾小球肾炎 不明原因 DCB组 20 12 8 63.3±10.7 3.2±1.2 22.6±5.9 11(55.0) 3(15.0) 5(25.0) 1(5.0) 7(35.0) 3(15.0) 8(40.0) 2(10.0) CB组 22 13 9 59.9±11.7 3.0±1.1 22.0±7.4 10(45.5) 4(18.2) 6(27.3) 2(9.1) 9(40.9) 3(13.6) 7(31.8) 3(13.6) t — 0.00 0.98 0.56 0.29 0.52△ 0.42△ P — >0.05 >0.05 >0.05 >0.05 >0.05 >0.05 △示χ2值 表 1 2组病人一般资料比较(x±s)
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术前彩色多普勒超声或CT血管造影证实AVF狭窄内径超过50%,常规消毒铺巾局麻准备后,以头静脉近心端穿刺,采用Seldinger法置入5F或6F动脉鞘,彩色超声引导下沿动脉鞘进入微导丝,通过狭窄部位,根据病人病变长度选择合适的药物涂层球囊(商品名:APERTO OTW)或普通球囊尺寸(球囊导管直径等于狭窄部位正常血管直径或>1 mm),沿导丝进入药物涂层球囊或普通球囊,完全覆盖病变部位。CB组逐渐加压至适当压力(低于爆破压),扩张1~2次,每次维持2 min左右,见球囊逐渐膨起至球囊压迹消失;DCB组用普通球囊进行预扩张后,再用药物涂层球囊逐渐加压至球囊完全打开并维持2 min左右。术后复查彩色超声证实狭窄段明显改善,残余狭窄 < 30%,且触及内瘘处有震颤,拔除动脉鞘,5-0血管缝合线荷包缝合,术毕。
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技术成功标准:彩色多普勒超声或CT血管造影显示残余狭窄 < 30%;临床成功标准:术后可进行至少一次血液透析治疗,透析时血流量>200 mL/min,触及内瘘处有震颤。
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比较2组手术前后狭窄处内径和透析血流量;比较2组术后1、6、12个月时AVF初级通畅率;比较2组术后1个月内并发症发生情况。
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采用t检验和χ2检验。
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2组病人手术均取得技术成功和临床成功,成功率均为100%。2组术前狭窄处内径和透析血流量差异均无统计学意义(P>0.05);术后,2组狭窄处内径和透析血流量均较术前明显改善(P < 0.01),但2组间差异均无统计学意义(P>0.05)(见表 2)。
分组 n 狭窄处内径/mm 透析血流量/(mL/min) 术前 DCB组 20 1.4±0.3 124.8±16.0 CB组 22 1.3±0.4 119.1±15.3 t — 0.91 1.18 P — >0.05 >0.05 术后 DCB组 20 3.4±0.5** 258.0±14.7** CB组 22 3.2±0.4** 251.6±8.9** t — 1.44 1.72 P — >0.05 >0.05 组内配对t检验:**P < 0.01 表 2 2组病人手术前后狭窄处内径及透析血流量比较(x±s)
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术后1个月,2组初级通畅率差异无统计学意义(P>0.05);术后6个月,DCB组初级通畅率高于CB组(P < 0.05);术后12个月,DCB组初级通畅率仍高于CB组,但差异无统计学意义(P>0.05)(见表 3)。
分组 n 术后1个月 术后6个月 术后12个月 DCB组 20 20(100.0) 17(85.0) 14(70.0) CB组 22 20(90.9) 12(54.5) 10(45.5) χ2 — 0.43 4.55 2.58 P — >0.05 < 0.05 >0.05 表 3 2组病人AVF初级通畅率比较[n;百分率(%)]
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DCB组发生血肿1例,经局部加压包扎后恢复正常,未出现血栓形成和感染,并发症发生率为5.00%(1/20);CB组发生血肿1例,血栓形成1例,经局部加压包扎以及手术取栓治疗后恢复正常,未出现感染,并发症发生率为9.09%(2/22),2组病人术后1个月内并发症发生率差异无统计学意义(χ校正2=0.01,P>0.05)。
药物涂层球囊和普通球囊在自体动静脉内瘘狭窄中的疗效比较
Comparison of drug-coated balloon and common balloon in the treatment of autogenous arteriovenous fistula stenosis
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摘要:
目的比较药物涂层球囊和普通球囊在自体动静脉内瘘狭窄中的疗效。 方法选择42例自体动静脉内瘘狭窄病人为研究对象,根据治疗方式分为药物涂层球囊组(DCB组)20例和普通球囊组(CB组)22例。DCB组病人采用紫杉醇释放高压分流球囊扩张成形术,CB组病人采用普通球囊扩张成形术。比较2组手术成功率和手术前后狭窄处内径、透析血流量,并比较术后1、6、12个月动静脉内瘘初级通畅率和术后1个月内并发症发生情况。 结果2组手术成功率均为100%。2组病人术前狭窄处内径及透析血流量差异均无统计学意义(P>0.05);术后2组狭窄处内径及透析血流量均较术前明显改善(P < 0.01),但2组间差异均无统计学意义(P>0.05)。术后1个月和12个月,2组病人动静脉内瘘初级通畅率差异均无统计学意义(P>0.05);术后6个月,DCB组初级通畅率高于CB组(P < 0.05)。2组病人术后1个月内并发症发生率差异无统计学意义(P>0.05)。 结论与普通球囊血管成形术相比,药物涂层球囊血管成形术在治疗自体动静脉内瘘狭窄病变方面存在一定优势,可作为治疗自体动静脉内瘘狭窄安全、有效的选择之一。 Abstract:ObjectiveTo compare the efficacy of drug-coated balloon and common balloon in the treatment of autogenous arteriovenous fistula stenosis. MethodsA total of 42 patients with arteriovenous fistula stenosis were selected as the subjects.According to the treatment methods, 42 patients were divided into drug-coated balloon group(DCB group)(n=20) and common balloon group(CB group)(n=22).Patients in DCB group were treated with paclitaxel release high pressure shunt balloon dilatation, while the patients in CB group were treated with common balloon dilatation.The success rate of operation, diameter and dialysis blood flow of stenosis before and after operation, primary patency rate of arteriovenous fistula at 1, 6 and 12 months after operation and complications within one month after operation were compared between the two groups. ResultsThe success rate of operation in both groups was 100%.Before and after operation, the difference of diameter of stenosis and dialysis blood flow between the two groups were not statistically significant(P>0.05).After operation, the internal diameter and dialysis blood flow of the stenosis were significantly improved in the two groups compared with those before operation(P < 0.01), but there was no significant difference between the two groups(P>0.05).At 1 and 12 months after operation, there was no significant difference in the primary patency rate of arteriovenous fistula between the two groups (P>0.05).At 6 months after operation, the primary patency rate in DCB group was higher than that in CB group(P < 0.05).There was no significant difference in the incidence of complications at 1 month after operation between the two groups(P>0.05). ConclusionsDrug coated balloon angioplasty is superior to common balloon angioplasty in the treatment of autogenous arteriovenous fistula stenosis, which can be used as one of the safe and effective option for the treatment of autogenous arteriovenous fistula stenosis. -
Key words:
- arteriovenous fistula stenosis /
- hemodialysis /
- drug-coated balloon /
- common balloon
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表 1 2组病人一般资料比较(x±s)
分组 n 男 女 年龄/岁 内瘘狭窄发生时间/周 透析龄/月 狭窄部位 原发病 吻合口附近静脉段 动脉段 穿刺点 其他部位 糖尿病肾病 高血压相关肾病 慢性肾小球肾炎 不明原因 DCB组 20 12 8 63.3±10.7 3.2±1.2 22.6±5.9 11(55.0) 3(15.0) 5(25.0) 1(5.0) 7(35.0) 3(15.0) 8(40.0) 2(10.0) CB组 22 13 9 59.9±11.7 3.0±1.1 22.0±7.4 10(45.5) 4(18.2) 6(27.3) 2(9.1) 9(40.9) 3(13.6) 7(31.8) 3(13.6) t — 0.00 0.98 0.56 0.29 0.52△ 0.42△ P — >0.05 >0.05 >0.05 >0.05 >0.05 >0.05 △示χ2值 表 2 2组病人手术前后狭窄处内径及透析血流量比较(x±s)
分组 n 狭窄处内径/mm 透析血流量/(mL/min) 术前 DCB组 20 1.4±0.3 124.8±16.0 CB组 22 1.3±0.4 119.1±15.3 t — 0.91 1.18 P — >0.05 >0.05 术后 DCB组 20 3.4±0.5** 258.0±14.7** CB组 22 3.2±0.4** 251.6±8.9** t — 1.44 1.72 P — >0.05 >0.05 组内配对t检验:**P < 0.01 表 3 2组病人AVF初级通畅率比较[n;百分率(%)]
分组 n 术后1个月 术后6个月 术后12个月 DCB组 20 20(100.0) 17(85.0) 14(70.0) CB组 22 20(90.9) 12(54.5) 10(45.5) χ2 — 0.43 4.55 2.58 P — >0.05 < 0.05 >0.05 -
[1] 徐元恺, 甄景琴, 张文云, 等. 内瘘静脉最小内径可作为判断自体动静脉内瘘狭窄的指标[J]. 中华肾脏病杂志, 2017, 33(3): 187. doi: 10.3760/cma.j.issn.1001-7097.2017.03.005 [2] 高一菁, 李庞, 卢升陨, 等. 药物涂层球囊治疗股腘动脉疾病的中期疗效分析[J]. 中华血管外科杂志, 2020, 5(4): 255. doi: 10.3760/cma.j.cn101411-20200730-00082 [3] 张大鹏, 王乐丰, 刘宇, 等. 药物涂层球囊与药物洗脱支架治疗冠状动脉原发病变的疗效与安全性比较[J]. 中华心血管病杂志, 2020, 48(7): 600. doi: 10.3760/cma.j.cn112148-20200327-00254 [4] 金其庄, 王玉柱, 叶朝阳, 等. 中国血液透析用血管通路专家共识(第2版)[J]. 中国血液净化, 2019, 18(6): 365. doi: 10.3969/j.issn.1671-4091.2019.06.001 [5] ROY-CHAUDHURY P, WANG Y, KRISHNAMOORTHY M, et al. Cellular phenotypes in human stenotic lesions from haemodialysis vascular access[J]. Nephrol Dial Transplant, 2009, 24(9): 2786. doi: 10.1093/ndt/gfn708 [6] HAMMES M. Hemodynamic and biologic determinates of arteriovenous fistula outcomes in renal failure patients[J]. Biomed Res Int, 2015, 2015: 171674. [7] KUKITA K, OHIRA S, AMANO I, et al. 2011 update Japanese society for dialysis therapy guidelines of vascular access construction and repair for chronic hemodialysis[J]. Ther Apher Dial, 2015, 19(51): 1. [8] HU H, WU Z, ZHAO J, et al. Stent graft placement versus angioplasty for hemodialysis access failure: a meta-analysis[J]. J Surg Res, 2018, 226: 82. doi: 10.1016/j.jss.2018.01.030 [9] KIRTANE AJ, GUPTA A, IYENGAR S. Safety and efficacy of drug-eluting and bare metal stents comprehensive meta-analysis of randomized trials and observational studies[J]. Circulation, 2009, 119(25): 3196. [10] KARNABATIDIS D, KITROU P. Drug eluting balloons for resistant arteriovenous dialysis access stenosis[J]. J Vasc Access, 2017, 18(Suppl 1): 88. [11] VERBEECK N, PILLET JC, TOUKOUKI A, et al. Paclitaxel-coated balloon angioplasty of venous stenoses in native dialysis fistulas: primary and secondary patencies at 6 and 12 months[J]. J Belgian Soc Radiol, 2016, 100(1): 69. doi: 10.5334/jbr-btr.1159 [12] LOOKSTEIN RA, HARUGUCHI H, OURIEI K, et al. Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas[J]. N Engl J Med, 2020, 383(8): 733. doi: 10.1056/NEJMoa1914617 [13] 刘文敏. 普通球囊与药物涂层球囊治疗动静脉内瘘狭窄长期疗效的meta分析[D]. 石家庄: 河北医科大学, 2020.