背景:子宫平滑肌瘤是女性最常见的良性肿瘤之一。高强度聚焦超声(HIFU)已广泛应用于子宫肌瘤的治疗。然而,HIFU方法手术持续时间长,患者耐受性差,这需要改进。本研究旨在探讨在接受HIFU和超声引导经皮无水乙醇注射的子宫肌瘤患者中添加催产素的有效性和安全性。
方法:这是一项随机对照试验。将60例子宫肌瘤患者随机分为研究组和对照组。对照组患者采用HIFU联合超声引导下经皮无水乙醇注射治疗,研究组在对照组的治疗措施基础上给予缩宫素注射液。通过使用肿瘤的体积消融率和介入放射学协会(SIR)实践指南评估治疗的有效性和安全性。分别。
结果:最后,60例患者(研究组30例,对照组30例)全部完成治疗。2组平滑肌瘤体积消融率比较差异无统计学意义(94.48%±2.07%vs.94.91%±2.53%,P=0.36),面包屑灰色时间(150.70±57.51vs.165.77±77.13s,P=0.37),总治疗能量(556,835.0±202,583vs.512,610.0±158,004J,P=0.19),和总治疗时间(116.70±28.61vs.107.40±23.22分钟,P=0.14)。催产素组的疼痛评分明显大于对照组(4.53±1.55vs.3.60±1.19,P=0.008)。在治疗后3个月和1年,两组间残余坏死性平滑肌瘤体积无统计学差异.
结论:子宫肌瘤患者HIFU联合超声引导下乙醇瘤内注射加用缩宫素并不能提高治疗效果。
背景:中国临床试验注册中心:ChiCTR2200058584。
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: The add-on use of oxytocin in uterine leiomyomas patients undergoing HIFU and ultrasound-guided intratumoral ethanol injection could not improve treatment effect.
BACKGROUND: Chinese Clinical
Trial Registry identifier: ChiCTR2200058584.