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双嘧达莫联合阿司匹林对血液透析人工血管开放性影响研究

    文献标题:Effect of Dipyridamole plus Aspirin on Hemodialysis Graft Patency
    期刊来源:NEJM
    期刊影响因子:47.05
    PMID:
 19458364

    研究背景: 
人工血管-动静脉瘘狭窄导致的血栓是血液透析患者各种并发症的主要病因。程序式介入治疗可以保证人工血管的通透性但价格昂贵。尽管药理学上未获证实,双嘧达莫因其抗血管增殖活性,在改善人工血管通透性方面可能具有广阔应用前景。


    方法: 
采用随机,双盲,安慰剂对照设计,在成功植入人工血管后,治疗组每日两次给予双嘧达莫缓释片200mg联合阿司匹林25mg,服药直至主要研究中终点--无助力条件下畅通首次丧失(无助力条件下畅通是指无血栓条件下的人工血管畅通或非介入治疗辅助条件下的人工血管畅通);次要研究终点指人工血管植入失败和死亡。采用COX比例风险模型对主要研究终点和次要研究终点进行分析,并用事先指定变量进行校正。


图  Kaplan-Meler法估算无助力条件下畅通首次丧失的累积发病率  
缓释双嘧达莫(ERDP)-阿司匹林组的中位通畅持续时间为5.8月(95%可信区间CI
为 4.3~ 7.1),安慰剂对照组中位通畅持续时间为4.3月(95%可信区间CI为3.6~ 5.4)。


    结果:
全美13个中心共649名患者随机分至治疗组和对照组,其中治疗组321人服用双嘧达莫联合阿司匹林,对照组328人服用安慰剂,共4.5年,并在服药结束后继续随访六个月。第一年人造血管在无助力条件下保持通畅的比例,治疗组28%,对照组23%。治疗组的人造血管在无助力条件下保持通畅的时间显著长于对照组,狭窄发生率显著低于对照组。治疗组和对照组,在人工血管失败发生率、死亡发生率、因人工血管失败导致的死亡发生率,及不良反应发生率方面无明显差异。

    结论:
采用双嘧达莫联合阿司匹林在可降低狭窄发生的风险,并延长无助力条件下人造血管通透时间,治疗组和对照组差异有统计学意义,但临床效果不明显。




附英文原文摘要:
 
Effect of Dipyridamole plus Aspirin on Hemodialysis Graft Patency

for the DAC Study Group 

ABSTRACT

Background: Arteriovenous graft stenosis leading to thrombosis is a major cause of complications in patients undergoing hemodialysis. Procedural interventions may restore patency but are costly. Although there is no proven pharmacologic therapy, dipyridamole may be promising because of its known vascular antiproliferative activity.

Methods: We conducted a randomized, double-blind, placebo-controlled trial of extended-release dipyridamole, at a dose of 200 mg, and aspirin, at a dose of 25 mg, given twice daily after the placement of a new arteriovenous graft until the primary outcome, loss of primary unassisted patency (i.e., patency without thrombosis or requirement for intervention), was reached. Secondary outcomes were cumulative graft failure and death. Primary and secondary outcomes were analyzed with the use of a Cox proportional-hazards regression with adjustment for prespecified covariates.

Results: At 13 centers in the United States, 649 patients were randomly assigned to receive dipyridamole plus aspirin (321 patients) or placebo (328 patients) over a period of 4.5 years, with 6 additional months of follow-up. The incidence of primary unassisted patency at 1 year was 23% (95% confidence interval [CI], 18 to 28) in the placebo group and 28% (95% CI, 23 to 34) in the dipyridamole–aspirin group, an absolute difference of 5 percentage points. Treatment with dipyridamole plus aspirin significantly prolonged the duration of primary unassisted patency (hazard ratio, 0.82; 95% CI, 0.68 to 0.98; P=0.03) and inhibited stenosis. The incidences of cumulative graft failure, death, the composite of graft failure or death, and serious adverse events (including bleeding) did not differ significantly between study groups.

Conclusions: Treatment with dipyridamole plus aspirin had a significant but modest effect in reducing the risk of stenosis and improving the duration of primary unassisted patency of newly created grafts. 

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