摘要
目的 探讨聚焦超声消融手术(FUAS)治疗子宫良性疾病不良事件的发生率.方法 收集2019年1月至2023年12月在全国24家医院接受FUAS治疗的27 524例子宫良性疾病患者的治疗信息进行分析.其中,子宫肌瘤患者17 519例,子宫腺肌病患者8676例,剖宫产瘢痕妊娠患者1077例,胎盘植入性疾病252例.根据放射介入学会的不良事件分级系统,将不良事件及并发症分为:A级(无需治疗,无后遗症)、B级(简单处理、观察,无后遗症)、C级(需要治疗,住院时间＜48h)和D级(需要采取重要治疗,护理程度升级,延长住院时间＞48h)、E级(永久性后遗症)、F级(死亡).结果 FUAS治疗后的A级不良事件发生率为13.51％(3718例)、B级不良事件发生率为0.33％(91例)、C级不良事件发生率为0.19％(52例)、D级不良事件发生率为0.07％(20例),无E级及F级不良事件发生.将C、D、E和F级不良事件定义为严重不良事件,其发生率为0.26％(72例,仅有C、D级,无E、F级).严重不良事件包括:下肢感应痛及运动异常占0.19％(51例);深Ⅱ度及Ⅲ度皮肤损伤占0.04％(11例);异常阴道排液及流血占0.02％(5例);肠道损伤占0.01％(2例);急性肾功能损伤占0.01％(3例).2019-2023年年度严重不良事件年发生率分别为0.04％、0.50％、0.14％、0.33％和0.24％.结论 基于多中心大样本的真实世界数据,FUAS治疗子宫良性疾病是安全的.
Abstract
Objective To retrospectively analyze the ad-verse events and complications of focused ultrasound ab-lation surgery(FUAS)in the treatment of benign uterine diseases.Methods From January 2019 to December 2023,27 524 patients with benign uterine diseases were treated with FUAS in 24 centers nationwide.Among them,there were 17 519 patients with uterine fibroids,8676 patients with adenomyosis,1077 patients with cesarean scar pregnancy,and 252 patients with placental accreta spectrum.According to the classification system of the Society of Interventional Radi-ology(SIR),these adverse events were classified as Class A(no therapy,no consequences),Class B(nominal therapy,ob-servation,no consequences),Class C(required therapy,minor hospitalization),Class D(major therapy,unplanned in-crease in level of care,prolonged hospitalization),Class E(permanent adverse sequelae),Class F(Death).Results Af-ter FUAS,Class A adverse events were seen in 13.51％(3718)of patients,Class B adverse events were seen in 0.33％(91)of patients,Class C adverse events were seen in 0.19％(52)of patients,and Class D adverse events were seen in 0.07％(20)of patients,no Class E and F adverse events occurred.The incidence of severe adverse events(Class C&D)was 0.26％(72).Serious adverse events observed included lower limb sensory and motor abnormalities 0.19％(51),deep second and third degree of skin bums 0.04％(11),abnormal vaginal discharge and bleeding 0.02％(5),intestinal inju-ries 0.01％(3),and acute renal injury 0.01％(2).Between 2019 and 2023,the annual incidence rates of severe adverse events were 0.04％、0.50％、0.14％、0.33％and 0.24％,respectively.Conclusion Based on the results from real-word data of multiple centers with large subjects,we concluded that FUAS treatment is safe for the treatment of gynecological and obstetric diseases.
基金项目
超声医学工程国家重点实验室开放课题(2023KFKT002)
湖南省妇幼保健院"锐新"培育项目(2021RX28)
国家科技期刊平台
NSTL
万方数据