From the Department of Radiology, Severance Hospital, Research Institute of Radiological Science, Yonsei University College of Medicine, 50-1 Yonsei-ro Seodaemun-gu, Seoul 03722, Republic of Korea (K.H., M.D.K., J.H.K., G.M.K., S.M., J.P., H.C.K., J.Y.W., T.M.A.D., J.C., D.K.K.); Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea (S.Y.K., J.Y.); and Department of Biomedical Systems Informatics, Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Republic of Korea (H.J.S.).
Radiology. 2024 Sep;312(3):e231525. doi: 10.1148/radiol.231525.
Background There are insufficient data comparing resorbable microspheres (RMs) with permanent trisacryl gelatin microspheres (TAGMs) for uterine artery embolization (UAE). Purpose To compare therapeutic efficacy and clinical outcomes in participants with symptomatic fibroids after UAE with RMs or TAGMs. Materials and Methods This randomized controlled trial included participants undergoing UAE for symptomatic fibroids at a single institution (from May 2021 to May 2023). Participants were randomized one-to-one to undergo UAE with either RMs or TAGMs. Numeric rating scale pain scores and cumulative fentanyl consumption were assessed for 24 hours after undergoing UAE. Anti-Mullerian hormone was measured to assess effects of UAE on ovarian function. MRI was performed before and 3 months after UAE to evaluate fibroid necrosis and uterine artery recanalization. Repeated variables such as pain were analyzed using Mann-Whitney test with post hoc Bonferroni correction. Results Sixty female participants (mean age, 45.7 years ± 3.6 [SD]) completed the study, with 30 in each group. No evidence of a difference in pain scores was observed between groups ( > .99). Moreover, there was no evidence of a difference in the total fentanyl consumption at 24 hours after UAE between groups (median: RMs, 423 [IQR, 330-530] vs TAGMs, 562 [IQR, 437-780]; = .15). Serum anti-Mullerian hormone 3 months after UAE showed no evidence of a difference between groups (RMs vs TAGMs, 0.71 ng/mL ± 0.73 vs 0.49 ng/mL ± 0.45, respectively; = .09). No evidence of a difference in the rate of complete necrosis of the dominant fibroid was observed between groups (97% [29 of 30] for both groups; > .99). The rate of uterine artery recanalization was higher in RM versus TAGM groups (70% [21 of 30] vs 17% [five of 30], respectively; < .001). Conclusion UAE with RMs, compared with UAE with TAGMs, showed no evidence of a difference in terms of therapeutic effectiveness or postprocedural pain scores in participants with symptomatic fibroids. Clinical trial registration no. NCT05086770 © RSNA, 2024 See also the editorial by Spies in this issue.
在子宫动脉栓塞术（UAE）中，可吸收微球（RMs）与永久性三丙烯明胶微球（TAGMs）的疗效数据不足。目的：比较 RMs 和 TAGMs 栓塞治疗有症状子宫肌瘤患者的疗效和临床结局。材料与方法：本随机对照试验纳入了 2021 年 5 月至 2023 年 5 月在单家机构行 UAE 治疗有症状子宫肌瘤的患者。患者以 1:1 的比例随机分配至 RMs 组或 TAGMs 组行 UAE。术后 24 小时评估数字评分量表疼痛评分和芬太尼累积消耗量。测定抗苗勒管激素（AMH）以评估 UAE 对卵巢功能的影响。UAE 前后行 MRI 以评估肌瘤坏死和子宫动脉再通情况。采用 Mann-Whitney 检验分析疼痛等重复变量，并进行事后 Bonferroni 校正。结果：60 名女性患者（平均年龄 45.7 岁±3.6[标准差]）完成了本研究，每组 30 名。组间疼痛评分无差异（ >.99）。此外，组间术后 24 小时芬太尼总消耗量也无差异（中位数：RMs 组为 423[IQR，330530]，TAGMs 组为 562[IQR，437780]； =.15）。UAE 后 3 个月血清 AMH 无组间差异（RMs 组 vs TAGMs 组，分别为 0.71 ng/mL±0.73 和 0.49 ng/mL±0.45； =.09）。两组优势肌瘤完全坏死率无差异（均为 97%[30 例中的 29 例]； >.99）。RM 组子宫动脉再通率高于 TAGM 组（分别为 70%[30 例中的 21 例]和 17%[30 例中的 5 例]； <.001）。结论：与 UAE 联合使用 TAGMs 相比，UAE 联合使用 RMs 治疗有症状子宫肌瘤患者的疗效和术后疼痛评分无差异。临床试验注册号：NCT05086770 ©RSNA，2024 本期亦见 Spies 医生的述评。
