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聚四氟乙烯与变性同种异体静脉移植物用于血液透析通路的比较:一项前瞻性随机多中心试验。SMASH研究组。血液透析通路中移植物材料的研究。

A comparison between PTFE and denatured homologous vein grafts for haemodialysis access: a prospective randomised multicentre trial. The SMASH Study Group. Study of Graft Materials in Access for Haemodialysis.

作者信息

Bosman P J, Blankestijn P J, van der Graaf Y, Heintjes R J, Koomans H A, Eikelboom B C

机构信息

Department of Vascular Surgery, University Hospital Utrecht, The Netherlands.

出版信息

Eur J Vasc Endovasc Surg. 1998 Aug;16(2):126-32. doi: 10.1016/s1078-5884(98)80153-6.

DOI:10.1016/s1078-5884(98)80153-6
PMID:9728431
Abstract

OBJECTIVES

To compare patency and complication rates of polytetrafluoroethylene (PTFE) grafts and denatured homologous vein (DHV) grafts for long-term haemodialysis.

DESIGN

A prospective randomised multicentre trial.

MATERIALS

One hundred and thirty-one patients were enrolled between September 1994 and April 1997. Sixty-three DHV grafts and 68 PTFE grafts were implanted in 60 meals and 71 females. Complications and interventions were monitored. Patency rates, complication rates, and intervention rates of PTFE and DHV were compared.

RESULTS

The mean follow-up was 313 days for DHV (range 1-771) and 339 (3-909) days for PTFE. The total follow-up was 54.1 patient-years for DHV and 63.1 for PTFE. The 1-year primary patency rates were 30% and 40% for DHV and PTFE respectively. Secondary patency rate was 63% for both DHV and PTFE. Most frequent complication was thrombosis. A total of 75 thrombotic events (1.39 per patient-year) occurred in 35 (56%) DHV grafts and 78 (1.24 per py) in 36 (53%) PTFE grafts. A total of nine infections were seen in nine (14%) DHV grafts, whereas 21 infections in 20 (29%) PTFE grafts were seen (p = 0.08). All but one infected DHV graft could be salvaged with systemic antibiotics. In contrast, surgical intervention was necessary in nine PTFE grafts (p = 0.02). For aneurysms, eight DHV and two PTFE grafts needed revision (p = 0.03).

CONCLUSION

Patency rates between DHV and PTFE were not different. More infections were seen in PTFE grafts, and significantly more PTFE grafts needed surgical revision or removal because of infection. Significantly more DHV grafts were surgically revised or removed because of aneurysms.

摘要

目的

比较聚四氟乙烯(PTFE)移植物和变性同种异体静脉(DHV)移植物用于长期血液透析的通畅率和并发症发生率。

设计

一项前瞻性随机多中心试验。

材料

1994年9月至1997年4月期间纳入了131例患者。在60例男性和71例女性患者中植入了63条DHV移植物和68条PTFE移植物。对并发症和干预情况进行监测。比较了PTFE和DHV的通畅率、并发症发生率及干预率。

结果

DHV的平均随访时间为313天(范围1 - 771天),PTFE为339天(3 - 909天)。DHV的总随访时间为54.1患者年,PTFE为63.1患者年。DHV和PTFE的1年初级通畅率分别为30%和40%。DHV和PTFE的次级通畅率均为63%。最常见的并发症是血栓形成。35条(56%)DHV移植物共发生75次血栓事件(每患者年1.39次),36条(53%)PTFE移植物共发生78次(每患者年1.24次)。9条(14%)DHV移植物出现9次感染,而20条(29%)PTFE移植物出现21次感染(p = 0.08)。除1条感染的DHV移植物外,其余均可通过全身使用抗生素挽救。相比之下,9条PTFE移植物需要手术干预(p = 0.02)。对于动脉瘤形成,8条DHV移植物和2条PTFE移植物需要修复(p = 0.03)。

结论

DHV和PTFE之间的通畅率无差异。PTFE移植物出现更多感染,且因感染需要手术修复或移除的PTFE移植物显著更多。因动脉瘤形成而进行手术修复或移除的DHV移植物显著更多。

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