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一项关于子宫肌瘤剔除术与聚乙烯醇微球子宫动脉栓塞术的前瞻性多中心对照研究:有症状子宫肌瘤患者的长期临床结局

A prospective multicenter comparative study between myomectomy and uterine artery embolization with polyvinyl alcohol microspheres: long-term clinical outcomes in patients with symptomatic uterine fibroids.

作者信息

Siskin Gary P, Shlansky-Goldberg Richard D, Goodwin Scott C, Sterling Keith, Lipman John C, Nosher John L, Worthington-Kirsch Robert L, Chambers Theodore P

机构信息

Department of Radiology, Albany Medical College, 47 New Scotland Ave, MC-113, NY, USA.

出版信息

J Vasc Interv Radiol. 2006 Aug;17(8):1287-95. doi: 10.1097/01.RVI.0000231953.91787.AF.

DOI:10.1097/01.RVI.0000231953.91787.AF
PMID:16923975
Abstract

PURPOSE

To prospectively evaluate the safety and effectiveness of polyvinyl alcohol (PVA) microspheres in patients undergoing uterine artery embolization (UAE) to treat uterine fibroid tumors and to compare the long-term changes in health-related quality of life (QOL) after UAE with the changes seen after myomectomy.

MATERIALS AND METHODS

One hundred forty-six patients with uterine myomas were enrolled into this multicenter study, with 77 patients undergoing UAE with PVA and 69 patients undergoing myomectomy. Six-month follow-up was completed for the myomectomy, whereas 2-year follow-up was completed for the UAE group. Outcomes were assessed with the Uterine Fibroid QOL Questionnaire and based on adverse event incidence, time to return to normal activity, and changes in tumor symptom scores, QOL scores, and menorrhagia bleeding scores. For the UAE cohort, changes in total uterine volume and dominant tumor size on magnetic resonance (MR) imaging were assessed.

RESULTS

In the UAE cohort, 88.3% of patients experienced a reduction of tumor-related symptoms (increase >or=5 points from baseline measurement) at 6 months, with 75.4% of patients in the myomectomy group experiencing similar improvement. Median QOL questionnaire scores at 6 months were found to be significantly higher in patients treated with UAE (P = .041), with sustained improvement seen at 12 and 24 months. Both procedures resulted in significant reductions in 6-month menorrhagia bleeding scores, with sustained improvement in the UAE cohort at 12 and 24 months. MR imaging at 6 months revealed significant uterine and tumor volume reductions after UAE (P < .05). At least one adverse event occurred in 42% of patients in the myomectomy group, compared with 26% in the UAE group (P < .05).

CONCLUSIONS

UAE performed with PVA microspheres was associated with greater sustained improvements in symptom severity and health-related QOL and with fewer complications compared with myomectomy. Six-month MR imaging data demonstrated significant reductions in uterine and tumor volumes, although the degree of tissue infarction after UAE was not assessed with contrast medium-enhanced MR imaging.

摘要

目的

前瞻性评估聚乙烯醇(PVA)微球在接受子宫动脉栓塞术(UAE)治疗子宫肌瘤患者中的安全性和有效性,并比较UAE术后与子宫肌瘤剔除术后健康相关生活质量(QOL)的长期变化。

材料与方法

146例子宫肌瘤患者纳入这项多中心研究,其中77例患者接受PVA UAE治疗,69例患者接受子宫肌瘤剔除术。子宫肌瘤剔除术组完成6个月随访,而UAE组完成2年随访。采用子宫肌瘤QOL问卷评估结局,并基于不良事件发生率、恢复正常活动的时间以及肿瘤症状评分、QOL评分和月经过多出血评分的变化。对于UAE队列,评估磁共振(MR)成像上子宫总体积和主要肿瘤大小的变化。

结果

在UAE队列中,88.3%的患者在6个月时肿瘤相关症状减轻(较基线测量增加≥5分),子宫肌瘤剔除术组75.4%的患者有类似改善。发现接受UAE治疗的患者在6个月时QOL问卷中位数得分显著更高(P = 0.041),在12个月和24个月时持续改善。两种手术均导致6个月时月经过多出血评分显著降低,UAE队列在12个月和24个月时持续改善。6个月时的MR成像显示UAE术后子宫和肿瘤体积显著减小(P < 0.05)。子宫肌瘤剔除术组42%的患者发生至少1次不良事件,而UAE组为26%(P < 0.05)。

结论

与子宫肌瘤剔除术相比,使用PVA微球进行的UAE在症状严重程度和健康相关QOL方面有更大的持续改善,且并发症更少。6个月的MR成像数据显示子宫和肿瘤体积显著减小,尽管未用造影剂增强MR成像评估UAE术后的组织梗死程度。

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