中国实用妇科与产科杂志2024,Vol.40Issue(9):948-952,5.DOI:10.19538/j.fk2024090120
聚焦超声消融手术治疗子宫良性疾病不良事件发生率多中心大样本调查
A large multicenter survey of adverse events and complications of focused ultrasound ablation surgery in the treatment of benign uterine diseases
摘要
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.关键词
聚焦超声消融手术/子宫良性疾病/不良事件/严重不良事件Key words
FUAS/uterine benign diseases/adverse events/serious adverse events分类
医药卫生引用本文复制引用
何敏,郭海春,熊黎,宋轶钦,林振江,邓凯贤,戴宇,梁栋,陶华,王茂怀,彭玲玲,王洋洋,黄国华,官孝萍,蒋静,黄勇,王李刚,曾有挺,韩蓓,张晓霏,黎克全,张炼,龚春梅,张颖,王倩,周敏,豆于雅,朱小刚,石丽叶..聚焦超声消融手术治疗子宫良性疾病不良事件发生率多中心大样本调查[J].中国实用妇科与产科杂志,2024,40(9):948-952,5.基金项目
超声医学工程国家重点实验室开放课题(2023KFKT002) (2023KFKT002)
湖南省妇幼保健院"锐新"培育项目(2021RX28) (2021RX28)