聚焦超声消融治疗子宫良性疾病不良反应分析

Adverse effect analysis of focused ultrasound ablation in the treatment of benign uterine diseases

目的探讨聚焦超声消融治疗子宫良性疾病的不良反应。方法收集2010年11月至2019年4月在遂宁市中心医院接受聚焦超声消融治疗的7614例子宫良性疾病患者,分析术中和术后的各种不良反应及其发生率,以及严重不良反应的年发生率,并对比分析不同病种严重不良反应差异。结果聚焦超声消融术中的主要不良反应为治疗区痛5261例(69.0964%)、骶尾部痛3816例(50.1182%)、皮肤烫痛2777例(36.4723%)、放射痛805例(10.5726%)、腹股沟痛501例(6.5800%)、臀部皱褶处疼痛251例(3.2966%)、其他部位疼痛234例(3.0733%)。疼痛评分均低于4分,通过调整镇痛镇静给药时间、降低治疗强度、调整治疗层面及辐照位置后均能耐受并顺利完成治疗。术后观察到的不良反应事件共3320例。根据国际放射介入学会不良反应分级:A级不良反应3069例(40.3073%),B级213例(2.7975%),C级16例(0.2101%),D级22例(0.2889%),无D级以上严重不良反应发生。A^B级仅需观察、简单处理,均在短时间内恢复;C级和D级需短时间住院处理或护理,均痊愈。2011年C级和D级不良反应发生率为1.51%,2018年降至0.085%。子宫肌瘤、子宫腺肌病、腹壁切口子宫内膜异位症术后C级和D级不良反应发生率比较,差异无统计学意义(P>0.05)。结论聚焦超声消融治疗子宫良性疾病的严重不良反应发生率较低,可以安全有效地用于子宫良性疾病的治疗。

Objective To retrospectively analyze the adverse effects of focused ultrasound ablation in management of benign uterine diseases.Methods From November 2010 to April 2019,7 614 cases of benign uterine diseases were treated with focused ultrasound ablation in Suining Central Hospital.The adverse effects and their occurrence rates and the annual occurrence rates of severe adverse effects during and after the treatment were analyzed,and the difference in the severe adverse effects was compared among various diseases.Results The major adverse effects during the focused ultrasound ablation included the pain in the treated area in 5 261 cases(69.0964%),sacrococcygeal pain in 3 816 cases(50.1182%),burning on skin in 2777 cases(36.4723%),radiation pain in 805 cases(10.5726%),inguinal pain in 501 cases(6.5800%),pain at buttock wrinkles in 251 cases(3.2966%),and pain in other parts in 234 cases(3.0733%).However,the pain score was less than 4 and all patients completed focused ultrasound ablation treatment after the doctors adjusted the time of sedative and analgesic administration,reduced the intensity of treatment,extended treatment intervals,or changed sonication point.After focused ultrasound ablation treatment,3320 adverse events were observed.According to the classification system of Society of Interventional Radiology,the events comprised 3069(40.3073%),213(2.7975%),16(0.2101%)and 22(0.2889%)cases of Class A,B,C and D,respectively,and no complications at Class D or above occurred.Class A and B events subsided within 3 days without specific treatment,and patients who suffered Class C adverse effects recovered after short-term treatment or nursing in hospital.The adverse effect rate of Class C and D reduced from 1.51% in 2011 to 0.085% in 2018.There was no significant difference in the occurrence rates of Class C and D events(P> 0.05) after focused ultrasound ablation treatment for uterine fibroids,adenomyosis,and abdominal wall endometri os is.Conclusion Focused ultrasound ablation treatment for benign uterine diseases is safe and effective,with low occurrence of severe adverse events.