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 6 months 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.