本综述的目的是分析和总结磁共振引导下聚焦超声(MRgFUS)治疗子宫肌瘤(UFs)后最常见的不良事件(AE)和并发症,并建立其发生的危险因素。
我们在不同的数据库中搜索了评估MRgFUS在UF中治疗结果包含不良事件和/或并发症的原始研究研究(PubMed/MEDLINE,Scopus,COCHRANE)至2022年3月。评论,社论,意见或信件,案例研究,会议论文和摘要被排除在分析之外。系统的文献检索确定了446篇文章,其中43个进行了分析。
根据现有证据,MRgFUS治疗中严重并发症的总体发生率相对较低.在43项分析研究中,有11项未报告不良事件/并发症。所分析材料中所有AE的平均发生率为24.67%。最常见的AE包括疼痛,皮肤烧伤,尿路感染和坐骨神经利用。主要AE,如皮肤溃疡或深静脉血栓形成,在分析材料中,0.41%的病例发生。
MRgFUS在UF治疗中似乎是安全的。AE的发生,尤其是主要的,与其他方法相比相对较低。新设备和用户的更多体验似乎降低了AE率。AE报告缺乏统一和数据缺失是这一领域的主要问题。更有前景,需要采用统一报告和长期随访的随机研究来确定长期安全性.
The aim of this review was to analyze and summarize the most common adverse events (AEs) and complications after magnetic resonance-guided focused ultrasound (MRgFUS) therapy in uterine fibroids (UFs) and to establish the risk factors of their occurrence.
We searched for original research studies evaluating MRgFUS therapy in UFs with outcomes containing AEs and/or complications in different databases (PubMed/MEDLINE, SCOPUS, COCHRANE) until March 2022. Reviews, editorials, opinions or letters, case studies, conference papers and abstracts were excluded from the analysis. The systematic literature search identified 446 articles, 43 of which were analyzed.
According to available evidence, the overall incidence of serious complications in MRgFUS therapy is relatively low. No AEs/complications were reported in 11 out of 43 analyzed studies. The mean occurrence of all AEs in the analyzed material was 24.67%. The most commonly described AEs included pain, skin burns, urinary tract infections and sciatic neuropraxia. Major AEs, such as skin ulcerations or deep vein thrombosis, occurred in 0.41% of cases in the analyzed material.
MRgFUS seems to be safe in UF therapy. The occurrence of AEs, especially major ones, is relatively low in comparison with other methods. The new devices and more experience of their users seem to reduce AE rate. The lack of unification in AE reporting and missing data are the main issues in this area. More prospective, randomized studies with unified reporting and long follow-up are needed to determine the safety in a long-term perspective.