超声消融治疗子宫肌瘤的安全性及有效性

目的 验证超声消融技术用于子宫肌瘤治疗的安全性、有效性.方法 采用前瞻性、非随机临床研究方法,对重庆医科大学附属第一医院和解放军第三○七医院就诊的99例子宫肌瘤患者(117个肌瘤,肌瘤直径≤10 cm)进行超声消融治疗.仪器为重庆海扶(HIFU)技术有限公司研制的JC型聚焦超声肿瘤治疗系统.治疗在镇静、镇痛下进行,实时超声声像图引导超声消融治疗全过程.治疗后随访期为6个月.治疗后1个月内,行增强磁共振成像(MRI)检查,评价靶肌瘤体积消融率.治疗后3、6个月时,行增强MRI检查,评价靶肌瘤体积缩小率及靶肌瘤体积缩小超过50%的肌瘤占所有肌瘤的百分比.根据子宫肌瘤症状量表(UFS)评价有症状患者的症状评分改善10分者所占比例.依照国际介入放射治疗学会(SIR)标准评价治疗相关的不良反应.结果 (1)有效性:治疗后1个月内,靶肌瘤体积消融率平均为(76±24)%;3、6个月时,靶肌瘤平均体积分别缩小了(45±21)%和(59±26)%,与治疗前比较,差异均有统计学意义(P<0.05).治疗后6个月时,靶肌瘤体积缩小≥50%共99个肌瘤,占84.6%(99/117);UFS症状评分改善10分者占92%(66/72).(2)安全性:全部患者治疗后2 h均可以正常活动.SIR标准中重要不良反应(SIR C～D级:延长住院时间,需要重要治疗,护理等级增加)及严重不良反应(SIR E～F级:永久性后遗症或死亡)的发生率均为0;一般不良反应(SIR A～B级:观察或简单治疗,无不良后果)的发生率为35%(35/99),SIR B级不良反应包括2例声通道皮肤浅Ⅱ度烧伤和2例发热,需要对症治疗及换药处理.其余包括臀部和(或)下肢酸胀痛、阴道分泌异常、排尿困难或疼痛等,均无需治疗,为SIR A级.结论 超声消融技术用于治疗子宫肌瘤是安全、有效的,可以单独用于子宫肌瘤的治疗.

Study on the efficacy and safety of ultrasound ablation in treatment of uterine fibroids

Objective To investigate the safety and efficacy of ultrasound ablation in treatment of uterine fibroids. Methods Ninety-nine patients with 117 leiomyomas in total treated by Haifu JC focused ultrasound tumor therapeutic system were enrolled in prospective and non-randomized clinical trial in First Affiliated Hospital of Chongqing Medical University and Academy of Military Medical Sciences. Ultrasound ablation was performed guided by real-time ultrasonography under conscious sedation for single session. All patients were followed up at 6 months after treatment. On the day of treatment and after 1 month, patients were given by magnetic resonance imaging(MRI) exam to evaluate the effect of fibroids ablation. At 3 and 6months after treatment, the ratio of ablated area and volume reduction of fibroids more than 50% were evaluated by MRI exam again. The symptoms improvements were evaluated by uterine fibroid symptom (UFS) and complications were analyzed by guideline of society of international radiation (SIR). Results The average ablated area ratio of the target fibroid was (76 ± 24)%. The average reduction in fibroid volume determined by MRI at 3 and 6 months after treatment was (45 ± 21)% and (59 ± 26)%. Which were significantly decreased than those before treatment (P < 0. 05). At 6 months after treatment, 84. 6% (99/117) of patients showed more than 50% volume reduction, the rate of improved symptom score was 92%(66/72). All patients could resume normal daily activities at 2 hours after treatment. The adverse reactions of SIR C - D included delayed hospitalization, repeat treatment and increased level of nursing. E - F included permanent sequelae and death. In this study, no adverse reactions of C - F were recorded. Common complications (SIR A- B, only observation or simple management without sequelae) were 35% (35/99).Four cases with adverse reactions B of SIR were found, including 2 cases with skin burning of degree Ⅱ and 2 cases with febrile, they were administered by symptomatic therapy and changing dressing The other adverse reaction A of SIR included sorness of buttock, vaginal discharge, dysuria and painful urination, they were only suggested by follow-up. Conclusion It was efficacy and safe that ultrasound ablation as a single strategy were used in treatment of uterine fibroids.