Data of the participants.

This study aimed to investigate the efficacy and safety of using optimized parameters obtained by computer simulation for ultrasound-guided high-intensity focused ultrasound (HIFU) treatment of uterine adenomyosis in comparison with conventional parameters. We retrospectively assessed a single-institution, prospective study that was registered at Clinical Research Information Service (CRiS) of Republic of Korea (KCT0003586). Sixty-six female participants (median age: 44 years) with focal uterine adenomyosis were prospectively enrolled. All participants were treated with a HIFU system by using treatment parameters either for treating uterine fibroids (Group A, first 20 participants) or obtained via computer simulation (Group B, later 46 participants). To assess the treatment efficacy of HIFU, qualitative indices, including the clinically effective dysmenorrhea improvement index (DII), were evaluated up to 3 years after treatment, whereas quantitative indices, such as the nonperfused volume ratio and adenomyosis volume shrinkage ratio (AVSR), on MRI were evaluated up to 3 months after treatment. Quantitative/qualitative indices were compared between Groups A and B by using generalized linear mixed effect model. A safety assessment was also performed. Results showed that clinically effective DII was more frequently observed in Group B than in Group A (odds ratio, 3.69; P = 0.025), and AVSR were higher in Group B than in Group A (least-squares means, 21.61; P = 0.001). However, two participants in Group B developed skin burns at the buttock and sciatic nerve pain and required treatment. In conclusion, parameters obtained by computer simulation were more effective than the conventional parameters for treating uterine adenomyosis by using HIFU in terms of clinically effective DII and AVSR. However, care should be taken because of the risk of adverse events.

本研究旨在对比计算机仿真优化参数与常规参数，应用于超声引导高强度聚焦超声（high-intensity focused ultrasound, HIFU）治疗子宫腺肌症的疗效与安全性。本研究对一项在韩国临床研究信息服务中心（Clinical Research Information Service, CRiS）注册的前瞻性单中心研究进行了回顾性评估（登记编号：KCT0003586）。共前瞻性纳入66例局灶型子宫腺肌症女性受试者（中位年龄44岁）。所有受试者均接受HIFU系统治疗，其中前20例采用子宫肌瘤治疗参数（A组），后46例采用计算机仿真获取的治疗参数（B组）。为评估HIFU治疗疗效，本研究于治疗后最长3年内评估包括临床有效痛经改善指数（Dysmenorrhea Improvement Index, DII）在内的定性指标；于治疗后最长3个月内评估MRI相关定量指标，包括非灌注体积比与腺肌症体积缩小率（adenomyosis volume shrinkage ratio, AVSR）。采用广义线性混合效应模型对比A、B两组的定量与定性指标，并开展安全性评估。结果显示，B组临床有效DII发生率高于A组（比值比=3.69；P=0.025），且B组AVSR高于A组（最小二乘均数=21.61；P=0.001）。但B组有2例受试者出现臀部皮肤灼伤与坐骨神经痛，需接受后续治疗。综上，就临床有效DII与AVSR而言，计算机仿真获取的参数应用于HIFU治疗子宫腺肌症的疗效优于常规参数，但需警惕不良事件发生风险。