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腹主动脉瘤血管内修复与开放修复的生活质量。一项随机试验的结果。

Quality of life endovascular and open AAA repair. Results of a randomised trial.

作者信息

Prinssen M, Buskens E, Blankensteijn J D

机构信息

Department of Surgery, University Medical Center Utrect, The Netherlands.

出版信息

Eur J Vasc Endovasc Surg. 2004 Feb;27(2):121-7. doi: 10.1016/j.ejvs.2003.11.006.

DOI:10.1016/j.ejvs.2003.11.006
PMID:14718892
Abstract

AIM

To compare the quality of life (QoL) in the first postoperative year after elective endovascular abdominal aortic aneurysm repair (EVAR) and open repair (OR) in a randomised study.

METHODS

In the Dutch Randomised Endovascular Aneurysm Management (DREAM) trial, patients are randomly allocated to EVAR or OR. QoL questionnaires (SF-36 and EuroQoL-5D) were sent to all patients preoperatively (PREOP) and at five time points in the first postoperative year (3W, 6W, 3M, 6M and 12M). Between November 1999 and August 2002, 153 patients (141 male; 12 female) were randomised (78 EVAR and 75 OR; one crossover from OR to EVAR). The EuroQoL-5D scores and the eight domains of the SF-36 for the two groups were compared using the Mann-Whitney test. Changes over time were analysed using the Wilcoxon sign test.

RESULTS

There were no statistically significant differences in baseline characteristics (age, gender and SVS risk factors). The preoperative QoL scores of the study group were similar to the QoL scores of the general population of the same age. After 3W the OR group showed a significant decrease on the EuroQol-5D (p=0.022) and in six of the eight SF-36 domains. The EVAR group also showed a significant decrease on the EuroQol-5D (p=0.004) and in 5 of the 8 domains of the SF-36. At 6W the EuroQol-5D had recovered to baseline in the OR group and the decreased domains of the SF-36 had partially recovered. In the EVAR group the EuroQol-5D and three of the five decreased SF-36 domains, had returned to baseline. From 6M on, the OR group reported a significantly higher score on the EuroQoL-5D than the EVAR group (p=0.045 (6M) and p=0.001 (12M)).

CONCLUSION

In the early postoperative period there is a small, yet significant QoL advantage for EVAR compared to OR. At 6 months and beyond, patients reported better QoL after OR than after EVAR.

摘要

目的

在一项随机研究中比较择期血管内腹主动脉瘤修复术(EVAR)和开放修复术(OR)术后第一年的生活质量(QoL)。

方法

在荷兰随机血管内动脉瘤管理(DREAM)试验中,患者被随机分配至EVAR组或OR组。术前(PREOP)以及术后第一年的五个时间点(3周、6周、3个月、6个月和12个月)向所有患者发送生活质量问卷(SF - 36和欧洲五维健康量表 - 5D)。1999年11月至2002年8月期间,153例患者(141例男性;12例女性)被随机分组(78例接受EVAR,75例接受OR;1例从OR组交叉至EVAR组)。使用曼 - 惠特尼检验比较两组的欧洲五维健康量表 - 5D评分和SF - 36的八个维度。使用威尔科克森符号检验分析随时间的变化。

结果

基线特征(年龄、性别和血管外科学会风险因素)无统计学显著差异。研究组术前的生活质量评分与同年龄普通人群的生活质量评分相似。3周后,OR组在欧洲五维健康量表 - 5D上显著下降(p = 0.022),且在SF - 36的八个维度中的六个维度上下降。EVAR组在欧洲五维健康量表 - 5D上也显著下降(p = 0.004),且在SF - 36的八个维度中的五个维度上下降。6周时,OR组的欧洲五维健康量表 - 5D恢复至基线水平,SF - 36下降的维度部分恢复。在EVAR组,欧洲五维健康量表 - 5D以及SF - 36五个下降维度中的三个维度恢复至基线水平。从6个月起,OR组报告的欧洲五维健康量表 - 5D评分显著高于EVAR组(6个月时p = 0.045,12个月时p = 0.001)。

结论

术后早期,与OR相比,EVAR在生活质量方面有微小但显著的优势。在6个月及以后,患者报告OR术后的生活质量优于EVAR术后。

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