Marshburn Paul B, Matthews Michelle L, Hurst Bradley S
Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, Carolinas Medical Center, P.O. Box 32861, Charlotte, NC 28232, USA.
Obstet Gynecol Clin North Am. 2006 Mar;33(1):125-44. doi: 10.1016/j.ogc.2005.12.009.
Information is still being collected on the long-term clinical responses and appropriate patient selection for UAE. Prospective RCTs have not been performed to compare the clinical results from UAE with more conventional therapies for symptomatic uterine leiomyomata. At least three attempts at conducting such RCTs have been unsuccessful because of poor patient accrual that related to differing patient expectation and desires, clinical bias, insurance coverage, and the tendency that patients who have exhausted other treatment options may be disposed more favorably to less invasive treatments. Other comparative studies have serious limitations. For example, the retrospective study that compared outcomes after abdominal myomectomy with UAE suggested that patients who received UAE were more likely to require further invasive treatment by 3 years than were recipients of myomectomy. Lack of randomization introduced a selection bias because women in the group that underwent UAEwere older and were more likely to have had previous surgeries. A prospective study of "contemporaneous cohorts," which excluded patients who had sub-mucosal and pedunculated subserosal myomas, sought to compare quality of life measures and adverse events in patients who underwent UAE or hysterectomy. The investigators concluded that both treatments resulted in marked improvement in symptoms and quality of life scores, but complications were higher in the group that underwent hysterectomy over 1 year. In this study,however, a greater proportion of patients who underwent hysterectomy had improved pelvic pain scores. Furthermore, hysterectomy eliminates uterine bleeding and the risk for recurrence of myomas. Despite the lack of controlled studies that compared UAE with conventional surgery, and despite limited extended outcome data, UAE has gained rapid acceptance, primarily because the procedure preserves the uterus, is less invasive, and has less short-term morbidity than do most surgical options. The cost of UAE varies by region, but is comparable to the charges for hysterectomy and is less expensive than abdominal myomectomy. The evaluation before UAE may entail additional fees for diagnostic testing, such as MRI, to assess the uterine size and screen for adenomyosis. Other centers have recommended pretreatment ultrasonography, laparoscopy, hysteroscopy, endometrial biopsy, and biopsy of large fibroids to evaluate sarcoma. Generally,after UAE the recovery time and time lost from work are less; however, the potential need for subsequent surgery may be greater when compared with abdominal myomectomy. Any center that offers UAE should adhere to published clinical guidelines,maintain ongoing assessment of quality improvements measures, and observe strict criteria for obtaining procedural privileges. After McLucas advocated that gynecologists learn the skill to perform UAE for managing symptomatic myomas, the Society of Interventional Radiology responded with a precautionary commentary on the level of technical proficiency that is necessary to maintain optimum results from UAE. The complexity of pelvic arterial anatomy, the skill that is required to master modern coaxial microcatheters, and the hazards of significant patient radiation exposure were cited as reasons why sound training and demonstration of expertise be obtained before clinicians are credentialed to perform UAE.A collaboration between the gynecologist and the interventional radiologist is necessary to optimize the safety and efficacy of UAE. The primary candidates for this procedure include women who have symptomatic uterine fibroids who no longer desire fertility, but wish to avoid surgery or are poor surgical risks. The gynecologist is likely to be the primary initial consultant to patients who present with complaints of symptomatic myomas. Therefore, they must be familiar with the indications, exclusions, outcome expectations, and complications of UAE in their particular center. When hysterectomy is the only option, UAE should be considered. Appropriate diagnostic testing should aid in the exclusion of most, but not all, gynecologic cancers and pregnancy. Other contraindications include severe contrast medium allergy, renal insufficiency, and coagulopathy. MRI may be used to screen women before treatment in an attempt to detect those who have adenomyosis; patients should be aware that UAE is less effective in the presence of solitary or coexistent adenomyosis. Because some women may experience ovarian failure after UAE, additional studies to determine basal follicle-stimulating hormone and estradiol before and after the procedure may provide insight into UAE-induced follicle depletion.UAE is a unique new treatment for uterine myomas, and is no longer considered investigational for symptomatic uterine fibroids. There is international recognition that data are needed from RCTs that compare UAE with surgical alternatives. Current efforts to provide prospective objective assessment of treatment outcomes and complications after UAE will help to optimize patient selection and clinical guidelines. FIBROID should provide critical data for the assessment of safety and outcomes measures for women who receive UAE for symptomatic uterine myomas.
关于 UAE 的长期临床反应及合适的患者选择,目前仍在收集相关信息。尚未进行前瞻性随机对照试验(RCT)来比较 UAE 与更传统的有症状子宫平滑肌瘤治疗方法的临床结果。由于患者招募情况不佳,至少三次开展此类 RCT 的尝试均未成功,这与患者不同的期望和诉求、临床偏倚、保险覆盖范围以及已用尽其他治疗选择的患者可能更倾向于接受侵入性较小治疗的趋势有关。其他比较研究存在严重局限性。例如,一项比较腹部子宫肌瘤切除术后与 UAE 结果的回顾性研究表明,接受 UAE 的患者在 3 年内比接受子宫肌瘤切除术的患者更有可能需要进一步的侵入性治疗。缺乏随机分组导致了选择偏倚,因为接受 UAE 的女性年龄更大,且更有可能曾接受过手术。一项针对“同期队列”的前瞻性研究排除了黏膜下和带蒂浆膜下肌瘤患者,旨在比较接受 UAE 或子宫切除术患者的生活质量指标和不良事件。研究人员得出结论,两种治疗方法均使症状和生活质量评分显著改善,但子宫切除组在 1 年以上的并发症发生率更高。然而,在这项研究中,接受子宫切除术的患者中有更大比例的人盆腔疼痛评分有所改善。此外,子宫切除术可消除子宫出血和肌瘤复发风险。尽管缺乏将 UAE 与传统手术进行比较的对照研究,且长期结果数据有限,但 UAE 已迅速得到认可,主要是因为该手术保留了子宫,侵入性较小,且短期发病率低于大多数手术选择。UAE 的费用因地区而异,但与子宫切除术的费用相当,且比腹部子宫肌瘤切除术便宜。UAE 术前评估可能需要额外的诊断测试费用,如 MRI,以评估子宫大小并筛查子宫腺肌病。其他中心建议进行术前超声检查、腹腔镜检查、宫腔镜检查、子宫内膜活检以及大肌瘤活检以评估肉瘤。一般来说,UAE 术后恢复时间和误工时间较短;然而,与腹部子宫肌瘤切除术相比,后续手术的潜在需求可能更大。任何提供 UAE 的中心都应遵循已发表的临床指南,持续评估质量改进措施,并遵守获得手术权限的严格标准。在 McLucas 主张妇科医生学习进行 UAE 以治疗有症状肌瘤的技能后,介入放射学会对维持 UAE 最佳效果所需的技术熟练程度发表了预防性评论。盆腔动脉解剖结构的复杂性、掌握现代同轴微导管所需的技能以及患者大量辐射暴露的风险被引述为临床医生在获得进行 UAE 的资质前需要接受良好培训和专业技能示范的原因。妇科医生和介入放射科医生之间的合作对于优化 UAE 的安全性和有效性至关重要。该手术的主要候选对象包括有症状子宫肌瘤且不再渴望生育,但希望避免手术或手术风险较高的女性。妇科医生很可能是有症状肌瘤患者的首要初始咨询医生。因此,他们必须熟悉其所在特定中心 UAE 的适应症、排除标准、预期结果和并发症。当子宫切除术是唯一选择时,应考虑 UAE。适当的诊断测试应有助于排除大多数但并非所有的妇科癌症和妊娠。其他禁忌症包括严重的造影剂过敏、肾功能不全和凝血功能障碍。MRI 可用于在治疗前对女性进行筛查,以试图检测出患有子宫腺肌病的患者;患者应知晓在存在孤立性或并存子宫腺肌病的情况下 UAE 的效果较差。由于一些女性在 UAE 后可能会出现卵巢功能衰竭,术前和术后测定基础促卵泡生成素和雌二醇的额外研究可能有助于深入了解 UAE 引起的卵泡耗竭情况。UAE 是一种针对子宫肌瘤的独特新疗法,对于有症状的子宫平滑肌瘤不再被视为试验性治疗。国际上公认需要来自比较 UAE 与手术替代方案的 RCT 数据。目前为提供 UAE 治疗后结果和并发症的前瞻性客观评估所做的努力将有助于优化患者选择和临床指南。FIBROID 研究应为接受 UAE 治疗有症状子宫平滑肌瘤的女性的安全性和结果评估提供关键数据。