Arnreiter Christina, Oppelt Peter
Department of Gynecology, Obstetrics and Gynecologic Endocrinology, Kepler University Hospital, Johannes Kepler University, Linz, Austria (all authors).
Department of Gynecology, Obstetrics and Gynecologic Endocrinology, Kepler University Hospital, Johannes Kepler University, Linz, Austria (all authors).
J Minim Invasive Gynecol. 2021 Aug;28(8):1462-1469. doi: 10.1016/j.jmig.2021.04.009. Epub 2021 Apr 21.
To evaluate the treatment success, possible side effects, and safety of radiofrequency ablation with the Sonata System.
An electronic literature search in the PubMed and Medline databases was carried out from inception to August 2020.
The review was performed in accordance with the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. Keywords such as "Sonata," "transcervical ablation," and "uterine myoma" were used to identify all relevant articles independently by both authors. Full-text articles in English that reported at least 1 of the following outcomes were included in the study: reduction in perfused/total myoma volume, effect of treatment on bleeding intensity and myoma-related symptoms, number of surgical reinterventions, adverse events, return to activities of daily life, effects on surrounding tissue, and safety during pregnancy.
TABULATION, INTEGRATION, AND RESULTS: 10 studies matching the inclusion criteria were identified and used for further analysis. A reduction in total and perfused myoma volume of 63.2% and 64.5% was achieved. One of the studies showed a 53.8 ± 50.5% (n = 48) reduction in Menstrual Pictogram Score, and another study showed a 51.1 ± 40.9% (n = 142) reduction in Pictorial Blood Loss Assessment Chart at 12 months. 87.2% (n = 190) of the patients reported a clinically meaningful reduction in menstrual blood loss after 12 months. While Symptom Severity Scores dropped by 28.8 ± 19.3, 23.3 ± 23.7, and 23.7 ± 19.4 points at 3, 6, and 12 months, respectively, Health-Related Quality of Life Scores increased to 77.5 ± 22.0, 82.8 ± 19.0, and 83.3 ± 20.5 points. One study had an 8% reintervention rate after 12 months, and another study showed a 0.7% and 5.2% rate after 12 and 24 months. After an average of 64 months after ablation, the reintervention rate was 11.8%. Time to return to activities of daily life was 2.9 ± 2.5 days. No related complications during pregnancy and delivery were reported.
Radiofrequency ablation with the Sonata System represents a minimally invasive, organ-preserving treatment option in patients with symptomatic uterine myomas, associated with clinically meaningful improvement of myoma-related symptoms.
评估使用索纳塔系统进行射频消融术的治疗成功率、可能的副作用及安全性。
对PubMed和Medline数据库进行了从建库至2020年8月的电子文献检索。
本综述按照系统评价和Meta分析的首选报告项目指南进行。两位作者分别使用“索纳塔”“经宫颈消融”和“子宫肌瘤”等关键词独立识别所有相关文章。纳入研究的英文全文文章需报告以下至少一项结果：灌注/总体肌瘤体积减小、治疗对出血强度和肌瘤相关症状的影响、再次手术干预次数、不良事件、恢复日常生活活动情况、对周围组织的影响以及孕期安全性。
制表、整合及结果：确定了10项符合纳入标准的研究并用于进一步分析。总体肌瘤体积和灌注肌瘤体积分别减少了63.2%和64.5%。一项研究显示，月经图像评分在12个月时降低了53.8±50.5%（n = 48），另一项研究显示，12个月时图像失血评估图评分降低了51.1±40.9%（n = 142）。87.2%（n = 190）的患者报告12个月后月经失血量在临床上有显著减少。症状严重程度评分在3、6和12个月时分别下降了28.8±19.3、23.3±23.7和23.7±19.4分，与健康相关的生活质量评分分别提高到77.5±22.0、82.8±19.0和83.3±20.5分。一项研究显示12个月后的再次干预率为8%，另一项研究显示12个月和24个月后的再次干预率分别为0.7%和5.2%。消融术后平均64个月时，再次干预率为11.8%。恢复日常生活活动的时间为2.9±2.5天。未报告孕期和分娩期间的相关并发症。
使用索纳塔系统进行射频消融术是有症状子宫肌瘤患者的一种微创、保留器官的治疗选择，可使肌瘤相关症状在临床上得到有意义的改善。
