月経重積出血および子宮異常出血の管理のための新規子宮内膜チップを用いた高周波子宮内膜焼灼術：前向き研究

Radiofrequency endometrial ablation with a novel endometrial tip for the management of heavy menstrual bleeding and abnormal uterine bleeding: a prospective study.

• Eun-Ju Lee
• Hyun Kang
• Hyoung Joon Kwon
• Yun Jae Chung
• Ji-Hye Kim
• Sang Hoon Lee

抄録

月経時重症出血（HMB）または子宮異常出血（AUB）の管理のための新しい子宮内膜チップを用いた高周波焼灼術システム（RFA-EMT）の安全性と有効性を評価すること。本試験は、内科的治療が奏効しなかった月経重積出血（HMB）または子宮異常出血（AUB）を有する閉経前女性38名を対象としたプロスペクティブ試験です。子宮鏡検査と掻爬生検は手術の直前に実施した。手技のタイミングは、初期増殖期（周期4～10日目）に行われた。RFA-EMT手技は、喉頭マスク気道を用いた全身麻酔下の患者を用いて、一人の外科医によって実施された。一次転帰は出血の減少で、無月経、低月経、月経困難症として報告され、ヘモグロビン値と絵図血液評価表（PBAC）スコアを測定した。副次的転帰は、有害事象、数値評価尺度（NRS）スコアによる月経困難症、経膣超音波検査で評価された初期増殖期の子宮内膜肥厚であった。経膣超音波検査で評価したが、術前および術後の合併症はなかった。3ヵ月後の無月経率は97.4％、6ヵ月後の低月経率は100％であった。ヘモグロビン値は3ヵ月後に有意に上昇し、PBACスコア、NRSスコア、子宮内膜肥厚は3ヵ月後に有意に低下した。これらの傾向は術後6ヶ月間維持された。RFA-EMTは新しい手技であり，内科的治療が失敗したHMBまたはAUBを有する女性に安全かつ効果的である．

To evaluate the safety and efficacy of a radiofrequency ablation system with a novel endometrial tip (RFA-EMT) for the management of heavy menstrual bleeding (HMB) or abnormal uterine bleeding (AUB). This is a prospective study including a total of 38 premenopausal women with heavy menstrual bleeding (HMB) or abnormal uterine bleeding (AUB) that failed to respond to medical therapy. Hysteroscopic evaluation and curettage biopsy were performed just before the procedure. The procedure was timed to occur during the early proliferative phase (cycle days 4-10). RFA-EMT procedures were performed by a single surgeon with the patient under general anesthesia with a laryngeal mask airway. Primary outcome was reduction in bleeding, reported as amenorrhea, hypomenorrhea, and eumenorrhea, which were measured hemoglobin level and pictorial blood assessment chart (PBAC) score. Secondary outcomes were adverse events, dysmenorrhea with numeric rating scale (NRS) score, and endometrial thickening in the early proliferative phase, as assessed by transvaginal ultrasonography. There were no peri- or post-procedural complications. Combined amenorrhea, hypomenorrhea, and eumenorrhea rates at 3 and 6 months were 97.4% and 100%, respectively. The hemoglobin level was significantly increased, and the PBAC score, NRS score, and endometrial thickening were significantly decreased after 3 months. These trends were maintained for 6 months after the procedure. RFA-EMT, a new technique, is safe and effective for women with HMB or AUB for which medical therapy has failed.