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有症状的子宫肌瘤:子宫动脉栓塞术或子宫切除术治疗——栓塞术与子宫切除术(EMMY)随机临床试验结果

Symptomatic uterine fibroids: treatment with uterine artery embolization or hysterectomy--results from the randomized clinical Embolisation versus Hysterectomy (EMMY) Trial.

作者信息

Hehenkamp Wouter J K, Volkers Nicole A, Birnie Erwin, Reekers Jim A, Ankum Willem M

机构信息

Department of Gynecology, Academic Medical Centre, Meibergdreef 9, H4-205, 1105 AZ Amsterdam, the Netherlands.

出版信息

Radiology. 2008 Mar;246(3):823-32. doi: 10.1148/radiol.2463070260. Epub 2008 Jan 9.

DOI:10.1148/radiol.2463070260
PMID:18187401
Abstract

PURPOSE

To prospectively evaluate health-related quality of life (HRQOL) outcomes for uterine artery embolization (UAE) and hysterectomy up to 24 months after the intervention in terms of mental and physical health, urinary and defecatory function, and overall patient satisfaction.

MATERIALS AND METHODS

Ethics committee approval and informed consent were obtained for the Embolisation versus Hysterectomy Trial. Women (n = 177) with uterine fibroids and heavy menstrual bleeding who were scheduled to undergo hysterectomy were randomly assigned to undergo UAE (n = 88) or hysterectomy (n = 89). HRQOL was measured six times during a 24-month follow-up period with the following validated questionnaires: Medical Outcome Study Short Form 36 (SF-36) mental component summary (MCS) and physical component summary (PCS), Health Utilities Index Mark 3, EuroQol 5D, urogenital distress inventory (UDI), incontinence impact questionnaire, and defecation distress inventory (DDI). Satisfaction was assessed with a seven-point Likert scale. Repeated measurement analysis was performed for between-group analysis. Paired t tests were performed for within-group analysis. Satisfaction was analyzed with the Fisher exact test.

RESULTS

The SF-36 MCS and PCS, Health Utilities Index Mark 3, EuroQol 5D, and UDI scores were improved significantly in both groups at 6 months and afterward (P < .05). The DDI score was improved significantly in only the UAE group at 6 months and afterward (P < .05). No differences between groups were observed, with the exception of PCS scores at 6-week follow-up: Patients in the UAE group had significantly better scores than did patients in the hysterectomy group (P < .001). Improvement in PCS score at 24-month follow-up was significantly higher for patients who were employed at baseline (P = .035). At 24-month follow-up, patients in the hysterectomy group were significantly more satisfied than those in the UAE group (P = .02).

CONCLUSION

Both UAE and hysterectomy improved HRQOL. No differences were observed between groups regarding HRQOL at 24-month follow-up. On the basis of HRQOL results, the authors determined that UAE is a good alternative to hysterectomy.

摘要

目的

前瞻性评估子宫动脉栓塞术(UAE)和子宫切除术在干预后长达24个月的健康相关生活质量(HRQOL)结果,包括心理和身体健康、泌尿和排便功能以及患者总体满意度。

材料与方法

栓塞术与子宫切除术试验获得了伦理委员会批准并取得了知情同意。计划接受子宫切除术的子宫肌瘤伴月经过多的女性(n = 177)被随机分配接受UAE(n = 88)或子宫切除术(n = 89)。在24个月的随访期内,使用以下经过验证的问卷对HRQOL进行了6次测量:医学结局研究简表36(SF - 36)心理成分总结(MCS)和身体成分总结(PCS)、健康效用指数Mark 3、欧洲五维健康量表、泌尿生殖系统困扰量表(UDI)、尿失禁影响问卷和排便困扰量表(DDI)。使用七点李克特量表评估满意度。进行组间分析的重复测量分析。进行组内分析的配对t检验。使用Fisher精确检验分析满意度。

结果

两组在6个月及之后,SF - 36 MCS和PCS、健康效用指数Mark 3、欧洲五维健康量表和UDI评分均显著改善(P < 0.05)。仅UAE组在6个月及之后DDI评分显著改善(P < 0.05)。除了6周随访时的PCS评分外,未观察到组间差异:UAE组患者的评分显著高于子宫切除术组患者(P < 0.001)。基线时就业的患者在24个月随访时PCS评分的改善显著更高(P = 0.035)。在24个月随访时,子宫切除术组患者比UAE组患者显著更满意(P = 0.02)。

结论

UAE和子宫切除术均改善了HRQOL。在24个月随访时,两组在HRQOL方面未观察到差异。基于HRQOL结果,作者确定UAE是子宫切除术的良好替代方案。

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