Galen Donald I, Pemueller Rodolfo Robles, Leal José Gerardo Garza, Abbott Karen R, Falls Janice L, Macer James
San Ramon Ob/Gyn, 11030 Bollinger Canyon Rd, Ste 250, San Ramon, CA 94582, USA.
Department of Obstetrics and Gynecology, Hospital Universitario Esperanza, Guatemala City, Guatemala.
JSLS. 2014 Apr-Jun;18(2):182-90. doi: 10.4293/108680813X13693422518353.
To review phase II and phase III treatments of symptomatic uterine fibroids (myomas) using laparoscopic radiofrequency volumetric thermal ablation (RFVTA).
We performed a retrospective, multicenter clinical analysis of 206 consecutive cases of ultrasound-guided laparoscopic RFVTA of symptomatic myomas conducted on an outpatient basis under two phase II studies at 2 sites (n = 69) and one phase III study at 11 sites (n = 137). Descriptive and exploratory, general trend, and matched-pair analyses were applied.
From baseline to 12 months in the phase II study, the mean transformed symptom severity scores improved from 53.9 to 8.8 (P < .001) (n = 57), health-related quality-of-life scores improved from 48.5 to 92.0 (P < .001) (n = 57), and mean uterine volume decreased from 204.4 cm(3) to 151.4 cm(3) (P = .008) (n = 58). Patients missed a median of 4 days of work (range, 2-10 days). The rate of possible device-related adverse events was 1.4% (1 of 69). In the phase III study, approximately 98% of patients were assessed at 12 months, and their transformed symptom severity scores, health-related quality-of-life scores, mean decrease in uterine volume, and mean menstrual bleeding reduction were also significant. Patients in phase III missed a median of 5 days of work (range, 1-29 days). The rate of periprocedural device-related adverse events was 3.5% (5 of 137). Despite the enrollment requirement for patients in both phases to have completed childbearing, 4 pregnancies occurred within the first year after treatment.
RFVTA does not require any uterine incisions and provides a uterine-sparing procedure with rapid recovery, significant reduction in uterine size, significant reduction or elimination of myoma symptoms, and significant improvement in quality of life.
回顾采用腹腔镜射频容积热消融术（RFVTA）治疗有症状子宫肌瘤的II期和III期治疗情况。
我们对206例连续病例进行了回顾性多中心临床分析，这些病例是在两个地点的II期研究（n = 69）和11个地点的III期研究（n = 137）中，在门诊基础上进行的超声引导下腹腔镜有症状子宫肌瘤RFVTA。应用了描述性和探索性、总体趋势以及配对分析。
在II期研究中，从基线到12个月，平均转化症状严重程度评分从53.9改善至8.8（P <.001）（n = 57），健康相关生活质量评分从48.5提高至92.0（P <.001）（n = 57），平均子宫体积从204.4 cm³降至151.4 cm³（P =.008）（n = 58）。患者平均误工4天（范围为2 - 10天）。可能与设备相关的不良事件发生率为1.4%（69例中的1例）。在III期研究中，约98%的患者在12个月时接受了评估，他们的转化症状严重程度评分、健康相关生活质量评分、子宫体积平均减小以及月经出血量平均减少也均有显著意义。III期患者平均误工5天（范围为1 - 29天）。围手术期与设备相关的不良事件发生率为3.5%（137例中的5例）。尽管两个阶段的患者入组要求均为已完成生育，但治疗后第一年内仍发生了4例妊娠。
RFVTA无需任何子宫切口，是一种保留子宫的手术，具有恢复快、子宫大小显著缩小、肌瘤症状显著减轻或消除以及生活质量显著改善的特点。
