用于子宫动脉栓塞的可吸收微球与三聚丙烯明胶微球:随机对照试验。

IF 12.1 1区 医学 Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Radiology Pub Date : 2024-09-01 DOI:10.1148/radiol.231525
Kichang Han,So Yeon Kim,Man-Deuk Kim,Joon Ho Kwon,Gyoung Min Kim,Sungmo Moon,Juil Park,Hyung Cheol Kim,Jong Yun Won,Turki Mohammed A Dhahi,Jinyoung Choi,Dong Kyu Kim,Jinho Yang,Hye Jung Shin
{"title":"用于子宫动脉栓塞的可吸收微球与三聚丙烯明胶微球:随机对照试验。","authors":"Kichang Han,So Yeon Kim,Man-Deuk Kim,Joon Ho Kwon,Gyoung Min Kim,Sungmo Moon,Juil Park,Hyung Cheol Kim,Jong Yun Won,Turki Mohammed A Dhahi,Jinyoung Choi,Dong Kyu Kim,Jinho Yang,Hye Jung Shin","doi":"10.1148/radiol.231525","DOIUrl":null,"url":null,"abstract":"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 U 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 (P > .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]; P = .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; P = .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; P > .99). The rate of uterine artery recanalization was higher in RM versus TAGM groups (70% [21 of 30] vs 17% [five of 30], respectively; P < .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.","PeriodicalId":20896,"journal":{"name":"Radiology","volume":null,"pages":null},"PeriodicalIF":12.1000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Resorbable Microspheres versus Trisacryl Gelatin Microspheres for Uterine Artery Embolization: A Randomized Controlled Trial.\",\"authors\":\"Kichang Han,So Yeon Kim,Man-Deuk Kim,Joon Ho Kwon,Gyoung Min Kim,Sungmo Moon,Juil Park,Hyung Cheol Kim,Jong Yun Won,Turki Mohammed A Dhahi,Jinyoung Choi,Dong Kyu Kim,Jinho Yang,Hye Jung Shin\",\"doi\":\"10.1148/radiol.231525\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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 U 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 (P > .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]; P = .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; P = .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; P > .99). The rate of uterine artery recanalization was higher in RM versus TAGM groups (70% [21 of 30] vs 17% [five of 30], respectively; P < .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.\",\"PeriodicalId\":20896,\"journal\":{\"name\":\"Radiology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":12.1000,\"publicationDate\":\"2024-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Radiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1148/radiol.231525\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Radiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1148/radiol.231525","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
引用次数: 0

摘要

背景 目前尚无足够数据比较可吸收微球(RMs)与永久性三丙烯明胶微球(TAGMs)在子宫动脉栓塞术(UAE)中的应用。目的 比较使用 RMs 或 TAGMs 进行 UAE 后有症状子宫肌瘤患者的疗效和临床结局。材料和方法 该随机对照试验包括在一家机构接受超导电子显微镜治疗症状性子宫肌瘤的参与者(2021 年 5 月至 2023 年 5 月)。参试者被一对一随机分配到使用RMs或TAGMs进行UAE治疗。对接受 UAE 治疗后 24 小时内的数字评分表疼痛评分和芬太尼累积用量进行评估。对抗穆勒氏管激素进行了测量,以评估UAE对卵巢功能的影响。在做超导可视化手术前和手术后3个月进行核磁共振成像,以评估子宫肌瘤坏死和子宫动脉再通畅情况。疼痛等重复变量采用 Mann-Whitney U 检验和事后 Bonferroni 校正进行分析。结果 60 名女性参与者(平均年龄 45.7 岁 ± 3.6 [SD])完成了研究,每组 30 人。没有证据表明组间疼痛评分存在差异(P > .99)。此外,也没有证据表明各组在 UAE 后 24 小时的芬太尼总用量存在差异(中位数:RMs,423 [IQR, 330-530] vs TAGMs,562 [IQR, 437-780]; P = .15)。UAE 3 个月后的血清抗苗勒氏管激素显示,组间无差别(RMs vs TAGMs,分别为 0.71 ng/mL ± 0.73 vs 0.49 ng/mL ± 0.45;P = .09)。没有证据表明组间优势肌瘤完全坏死率存在差异(两组均为 97% [30个中的29个];P > .99)。RM组的子宫动脉再通率高于TAGM组(分别为70% [30例中的21例] vs 17% [30例中的5例];P < .001)。结论 在有症状的子宫肌瘤患者中,与使用 TAGM 的 UAE 相比,使用 RM 的 UAE 在治疗效果或术后疼痛评分方面没有证据表明存在差异。临床试验注册号NCT05086770 © RSNA, 2024 另请参阅 Spies 在本期发表的社论。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Resorbable Microspheres versus Trisacryl Gelatin Microspheres for Uterine Artery Embolization: A Randomized Controlled Trial.
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 U 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 (P > .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]; P = .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; P = .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; P > .99). The rate of uterine artery recanalization was higher in RM versus TAGM groups (70% [21 of 30] vs 17% [five of 30], respectively; P < .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.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Radiology
Radiology 医学-核医学
CiteScore
35.20
自引率
3.00%
发文量
596
审稿时长
3.6 months
期刊介绍: Published regularly since 1923 by the Radiological Society of North America (RSNA), Radiology has long been recognized as the authoritative reference for the most current, clinically relevant and highest quality research in the field of radiology. Each month the journal publishes approximately 240 pages of peer-reviewed original research, authoritative reviews, well-balanced commentary on significant articles, and expert opinion on new techniques and technologies. Radiology publishes cutting edge and impactful imaging research articles in radiology and medical imaging in order to help improve human health.
期刊最新文献
Risk Factors for Pneumothorax Following Lung Biopsy: Another Peek at Air Leak. Sex-specific Associations between Left Ventricular Remodeling at MRI and Long-term Cardiovascular Risk. The Clinical Weight of Left Ventricular Mass and Shape. Assessment of Nonmass Lesions Detected with Screening Breast US Based on Mammographic Findings. CT-guided Coaxial Lung Biopsy: Number of Cores and Association with Complications.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1