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

作　　者：何敏 王洋洋 龚春梅 张颖 王倩 周敏[4] 豆于雅 朱小刚[6] 石丽叶 郭海春[8] 熊黎 宋轶钦[10] 林振江 邓凯贤 戴宇 梁栋[14] 陶华 王茂怀 彭玲玲 黄国华[18] 官孝萍 蒋静[20] 黄勇[21] 王李刚 曾有挺 韩蓓 张晓霏 黎克全 张炼 HE Min;WANG Yang-yang;GONG Chun-mei;ZHANG Ying;WANG Qian;ZHOU Min;DOU Yu-ya;ZHU Xiao-gang;SHI Li-ye;GUO Hai-chun;XIONG Li;SONG Yi-qin;LINZhen-jiang;DENG Kai-xian;DAI Yu;LIANG Dong;TAO Hua;WANG Mao-huai;PENG Ling-ling;HUANG Guo-hua;GUAN Xiao-ping;JIANG Jing;HUANG Yong;WANG Li-gang;ZENG You-ting;HAN Bei;ZHANGXiao-fei;LI Ke-quan;ZHANG Lian(不详;State Key Laboratory of Ultrasonic Medical Engineering,Chongqing Medical University,Chongqing 400016,China)

机构地区：[1]超声医学工程国家重点实验室,重庆400016 [2]重庆海扶医院妇科,重庆401121 [3]重庆医科大学附属第一医院放射科,重庆400016 [4]重庆医科大学附属第二医院妇科,重庆400016 [5]陆军军医大学西南医院妇科,重庆400016 [6]中南大学湘雅三医院妇科,湖南长沙410007 [7]中南大学湘雅二医院妇科,湖南长沙410007 [8]长沙市妇幼保健院妇科,湖南长沙410007 [9]湖南省妇幼保健院妇科,湖南长沙410028 [10]郴州市第一人民医院妇科,湖南郴州423033 [11]遵义医科大学附属医院妇科,贵州遵义563099 [12]南方医科大学顺德医院妇科,广东佛山528399 [13]深圳市妇幼保健院妇科,广东深圳518038 [14]佛山市第一人民医院妇科,广东佛山528000 [15]广州市妇女儿童医疗中心柳州医院妇科,广西柳州545026 [16]赣南医科大学第一附属医院妇科,江西赣州341000 [17]泰安市中心医院妇科,山东泰安271099 [18]遂宁市中心医院妇科,四川遂宁629099 [19]内江市第一人民医院妇科,四川内江641099 [20]川北医学院附属医院妇科,四川南充637100 [21]凉山彝族自治州第一人民医院妇科,四川凉山615000 [22]绵阳市中心医院妇科,四川绵阳621099 [23]自贡市第四人民医院妇科,四川自贡643000 [24]内蒙古自治区中医院妇科,内蒙古呼和浩特750306 [25]上海第一妇婴保健院,上海200040

出　　处：《中国实用妇科与产科杂志》2024年第9期948-952,共5页Chinese Journal of Practical Gynecology and Obstetrics

基　　金：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)。

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27524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17519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。Objective To retrospectively analyze the adverse events and complications of focused ultrasound ablation surgery(FUAS)in the treatment of benign uterine diseases.Methods From January 2019 to December 2023,27524 patients with benign uterine diseases were treated with FUAS in 24 centers nationwide.Among them,there were17519 patients with uterine fibroids,8676 patients with adenomyosis,1077 patients with cesarean scar pregnancy,and252 patients with placental accreta spectrum.According to the classification system of the Society of Interventional Radiology(SIR),these adverse events were classified as Class A(no therapy,no consequences),Class B(nominal therapy,observation,no consequences),Class C(required therapy,minor hospitalization),Class D(major therapy,unplanned increase in level of care,prolonged hospitalization),Class E(permanent adverse sequelae),Class F(Death).Results After 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 in0.07%(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 burns 0.04%(11),abnormal vaginal discharge and bleeding 0.02%(5),intestinal injuries 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 

分 类 号：R459.9[医药卫生—治疗学]