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随机对照试验比较腹主动脉瘤开放修复与腔内修复的生活质量。

Quality of life from a randomized trial of open and endovascular repair for abdominal aortic aneurysm.

机构信息

Division of Vascular Surgery, Department of Surgery, VU Medical Centre, Amsterdam.

St George's Vascular Institute, St George's Healthcare NHS Trust, London, UK.

出版信息

Br J Surg. 2016 Jul;103(8):995-1002. doi: 10.1002/bjs.10130. Epub 2016 Apr 5.

Abstract

BACKGROUND

Long-term survival is similar after open or endovascular repair of abdominal aortic aneurysm. Few data exist on the effect of either procedure on long-term health-related quality of life (HRQoL) and health status.

METHODS

Patients enrolled in a multicentre randomized clinical trial (DREAM trial; 2000-2003) in Europe of open repair versus endovascular repair (EVAR) of abdominal aortic aneurysm were asked to complete questionnaires on health status and HRQoL. HRQoL scores were assessed at baseline and at 13 time points thereafter, using generic tools, the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36®) and EuroQol 5D (EQ-5D™). Physical (PCS) and mental component summary scores were also calculated. Follow-up was 5 years.

RESULTS

Some 332 of 351 patients enrolled in the trial returned questionnaires. More than 70 per cent of questionnaires were returned at each time point. Both surgical interventions had a short-term negative effect on HRQoL and health status. This was less severe in the EVAR group than in the open repair group. In the longer term the physical domains of SF-36® favoured open repair: mean difference in PCS score between open repair and EVAR -1·98 (95 per cent c.i. -3·56 to -0·41). EQ-5D™ descriptive and EQ-5D™ visual analogue scale scores for open repair were also superior to those for EVAR after the initial 6-week interval: mean difference -0·06 (-0·10 to -0·02) and -4·09 (-6·91 to -1·27) respectively.

CONCLUSION

In this study EVAR appeared to be associated with less severe disruption to HRQoL and health status in the short term. However, during longer-term follow-up to 5 years, patients receiving open repair appeared to have improved quality of life and health status.

摘要

背景

开放式或血管内修复腹主动脉瘤后的长期存活率相似。关于这两种手术方式对长期健康相关生活质量(HRQoL)和健康状况的影响,数据很少。

方法

参与欧洲多中心随机临床试验(DREAM 试验;2000-2003 年)的患者被要求完成关于健康状况和 HRQoL 的问卷。使用通用工具,即医疗结局研究 36 项简明健康调查(SF-36®)和欧洲五维健康量表(EQ-5D™),在基线和之后的 13 个时间点评估 HRQoL 评分。还计算了身体(PCS)和心理成分综合评分。随访时间为 5 年。

结果

在该试验中,351 名入组患者中有 332 名返回了问卷。每个时间点的问卷返回率都超过 70%。两种手术干预都对 HRQoL 和健康状况有短期的负面影响。血管内修复组的影响比开放式修复组要小。从长远来看,SF-36®的身体领域有利于开放式修复:开放式修复与血管内修复之间的 PCS 评分平均差异为-1.98(95%置信区间-3.56 至-0.41)。开放式修复的 EQ-5D™描述性评分和 EQ-5D™视觉模拟评分也优于血管内修复后的初始 6 周间隔:平均差异分别为-0.06(-0.10 至-0.02)和-4.09(-6.91 至-1.27)。

结论

在这项研究中,血管内修复在短期内似乎与 HRQoL 和健康状况的破坏程度较轻相关。然而,在长达 5 年的随访期间,接受开放式修复的患者似乎改善了生活质量和健康状况。

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