The safety and efficacy of add-on use of oxytocin in uterine leiomyoma patients undergoing high-intensity focused ultrasound and ultrasound-guided intratumoral ethanol injection: a randomized controlled trial.

Abstract

Uterine leiomyoma is one of the most common benign tumors in females. High-intensity focused ultrasound (HIFU) has been widely used in the therapy of uterine leiomyomas. However, HIFU method has a prolonged duration of operation and poor patient tolerance, which need improvement. This study sought to explore the efficacy and safety of add-on use of oxytocin in uterine leiomyomas patients who received HIFU and ultrasound-guided percutaneous anhydrous ethanol injection. This is a randomized controlled trial. A total of 60 patients with uterine leiomyomas were included and randomly divided into study group and control group. The patients in the control group were treated with HIFU and ultrasound-guided percutaneous anhydrous ethanol injection, while the study group received oxytocin injection in addition to the treatment measures of the control group. The efficacy and safety of the treatments were assessed by using the volume ablation rate of the tumor and the Society of Interventional Radiology (SIR) Practice Guidelines, respectively. Finally, all of the 60 patients (30 in the study group and 30 in the control group) completed the treatments. There were no statistically significant differences between the 2 groups in terms of leiomyoma volume ablation rate (94.48%±2.07% vs. 94.91%±2.53%, P=0.36), crumb gray time (150.70±57.51 vs. 165.77±77.13 s, P=0.37), total treatment energy (556,835.0±202,583 vs. 512,610.0±158,004 J, P=0.19), and total treatment time (116.70±28.61 vs. 107.40±23.22 mins, P=0.14). The pain score of the oxytocin group was significantly greater than that in the control group (4.53±1.55 vs. 3.60±1.19, P=0.008). At 3 months and 1-year post-therapy, no statistically significant differences were observed in the residual necrotic leiomyoma volume between the 2 groups. The add-on use of oxytocin in uterine leiomyomas patients undergoing HIFU and ultrasound-guided intratumoral ethanol injection could not improve treatment effect. Chinese Clinical Trial Registry identifier: ChiCTR2200058584.