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子宫肌瘤:子宫动脉栓塞术与腹式子宫切除术治疗的比较——一项前瞻性、随机对照临床试验

Uterine fibroids: uterine artery embolization versus abdominal hysterectomy for treatment--a prospective, randomized, and controlled clinical trial.

作者信息

Pinto Isabel, Chimeno Paloma, Romo Alicia, Paúl Laura, Haya Javier, de la Cal Miguel A, Bajo José

机构信息

Department of Radiology, University Hospital of Getafe, Carretera de Toledo, Km 12,500, 28905 Getafe-Madrid, Spain.

出版信息

Radiology. 2003 Feb;226(2):425-31. doi: 10.1148/radiol.2262011716.

Abstract

PURPOSE

To evaluate the effectiveness of uterine artery embolization (UAE) in the management of bleeding in patients with uterine fibroids and to compare UAE with hysterectomy, particularly with regard to length of hospital stay and associated complications (ie, safety).

MATERIALS AND METHODS

A prospective clinical trial was performed with patients who were randomly assigned to one of two groups: patients who were offered the option of undergoing either UAE or hysterectomy (group 1) and patients who were not informed of the alternative treatment-that is, UAE (group 2). The primary variables that were considered for evaluation of the effectiveness, efficiency, and safety of the two procedures were, respectively, bleeding cessation, total length of hospital stay, and resulting complications. The lengths of hospital stay in the two study arms were compared on an intent-to-treat basis. Owing to crossover between the treatment arms, however, effectiveness and safety were evaluated on the basis of the actual treatment received.

RESULTS

The clinical success rate for the patients who underwent UAE, which was based on the cessation of bleeding, was 86% (31 of 36 patients). The mean hospital stay for group 1 was 4.14 days shorter than that for group 2 (P <.001). Ten (25%) of the 40 patients who underwent UAE experienced minor complications, in contrast to four (20%) of the 20 who underwent hysterectomy and experienced major complications.

CONCLUSION

Compared with hysterectomy, UAE is safe and effective for treatment of bleeding fibroids, necessitates a shorter hospital stay, and results in fewer major complications.

摘要

目的

评估子宫动脉栓塞术(UAE)治疗子宫肌瘤患者出血的有效性,并将UAE与子宫切除术进行比较,特别是在住院时间和相关并发症(即安全性)方面。

材料与方法

对患者进行了一项前瞻性临床试验,这些患者被随机分配到两组中的一组:可选择接受UAE或子宫切除术的患者(第1组)和未被告知有替代治疗方法(即UAE)的患者(第2组)。评估这两种手术有效性、效率和安全性时分别考虑的主要变量为出血停止情况、住院总时长和由此产生的并发症。两组研究对象的住院时长按意向性分析原则进行比较。然而,由于治疗组之间存在交叉情况,有效性和安全性是根据实际接受的治疗进行评估的。

结果

接受UAE治疗的患者基于出血停止情况的临床成功率为86%(36例患者中的31例)。第1组的平均住院时间比第2组短4.14天(P<.001)。接受UAE治疗的40例患者中有10例(25%)出现轻微并发症,相比之下,接受子宫切除术的20例患者中有4例(20%)出现严重并发症。

结论

与子宫切除术相比,UAE治疗肌瘤出血安全有效,住院时间更短,严重并发症更少。

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