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子宫动脉栓塞术与子宫切除术治疗症状性子宫肌瘤(EMMY试验):一项随机对照试验的围手术期和术后结果

Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): peri- and postprocedural results from a randomized controlled trial.

作者信息

Hehenkamp Wouter J K, Volkers Nicole A, Donderwinkel Peter F J, de Blok Sjoerd, Birnie Erwin, Ankum Willem M, Reekers Jim A

机构信息

Department of Gynecology, Academic Medical Center, Amsterdam, The Netherlands.

出版信息

Am J Obstet Gynecol. 2005 Nov;193(5):1618-29. doi: 10.1016/j.ajog.2005.05.017.

DOI:10.1016/j.ajog.2005.05.017
PMID:16260201
Abstract

OBJECTIVE

This was a randomized controlled trial to evaluate the safety of uterine artery embolization (UAE) compared with hysterectomy.

STUDY DESIGN

Twenty-eight Dutch hospitals recruited 177 patients with symptomatic uterine fibroids and menorrhagia who were eligible for hysterectomy. Patients were randomized to UAE (n = 88) or hysterectomy (n = 89). In this paper we evaluate the peri- and postprocedural complications, length of hospital stay, unscheduled visits, and readmission rates up to 6 weeks' post-intervention. Analysis was by intention to treat.

RESULTS

Bilateral UAE failure occurred in 4 patients (4.9%). Major complications occurred in 4.9% (UAE) and 2.7% (hysterectomy) of cases (P = .68). The minor complication rate from discharge until 6 weeks after was significantly higher in the UAE group than in the hysterectomy group (58.0% vs 40.0%; RR 1.45 [1.04-2.02]; P = .024). UAE patients were more often readmitted (11.1% vs 0%; P = .003). Total length of hospital stay was significantly shorter in UAE patients (mean [SD]: 2.5 [2.7] vs 5.1 [1.3], P < .001).

CONCLUSION

UAE is a procedure similar to hysterectomy with a low major complication rate and with a reduced length of hospital stay. Higher readmission rates after UAE stress the need for careful postprocedural follow-up.

摘要

目的

本研究为一项随机对照试验,旨在评估子宫动脉栓塞术(UAE)与子宫切除术相比的安全性。

研究设计

28家荷兰医院招募了177例有症状子宫肌瘤且月经过多、符合子宫切除术条件的患者。患者被随机分为接受UAE组(n = 88)或子宫切除组(n = 89)。在本文中,我们评估了围手术期和术后并发症、住院时间、非计划就诊情况以及干预后6周内的再入院率。分析采用意向性治疗法。

结果

4例患者(4.9%)双侧UAE失败。主要并发症发生率在UAE组为4.9%,子宫切除组为2.7%(P = 0.68)。从出院至6周,UAE组的轻微并发症发生率显著高于子宫切除组(58.0%对40.0%;相对危险度1.45 [1.04 - 2.02];P = 0.024)。UAE组患者更常再次入院(11.1%对0%;P = 0.003)。UAE组患者的总住院时间显著更短(均值[标准差]:2.5 [2.7]天对5.1 [1.3]天,P < 0.001)。

结论

UAE是一种与子宫切除术相似的手术,主要并发症发生率低,住院时间缩短。UAE后较高的再入院率强调了术后仔细随访的必要性。

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