Kitamura Hiroshi, Ando Naokatsu, Mizushima Daisuke, Shiojiri Daisuke, Nakamoto Takato, Takano Misao, Gatanaga Hiroyuki
AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.
AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.
J Infect Chemother. 2025 Mar;31(3):102608. doi: 10.1016/j.jiac.2025.102608. Epub 2025 Jan 6.
This study investigated the efficacy and safety of electrocautery ablation for high-grade squamous intraepithelial lesions (HSILs) in men who have sex with men (MSM) including people with human immunodeficiency virus, using comprehensive biopsy with high-resolution anoscopy (HRA).
This single-arm, open-label pilot study included 20 MSM with HSIL who were treated with electrocautery ablation. The participants were recruited from the National Center for Global Health and Medicine and followed up using HRA with a comprehensive biopsy approach at 3- and 6-months post-ablation. A comprehensive biopsy was defined as at least 1 biopsy taken from each of the 6 segments of the anal canal regardless of any abnormal findings. The primary endpoint was the local HSIL cure rate at 6 months. Secondary endpoints included the total cure rate, recurrence rates, and adverse events.
The median age of the 20 participants was 45 years, and 90 % were HIV-positive. The local cure rates were 40 % at 3 months and 50 % at 6 months. The total cure rates were 35 % and 40 % at 3 and 6 months, respectively. Ectopic recurrence occurred in 27.8 % of the participants. Most adverse events were mild and self-limiting.
Electrocautery ablation was a moderately effective and safe treatment for HSIL among MSM in Japan. However, the recurrence rates were high, indicating that conducting biopsies on normal-appearing lesions did not sufficiently prevent ectopic recurrence. Further research with larger sample sizes and longer follow-up periods is warranted to improve outcomes. This trial was registered in the Japan Registry of Clinical Trials: Clinical Trial Plan Number: jRCTs032210649.
本研究使用高分辨率肛门镜检查（HRA）结合全面活检，调查了电灼消融术对男男性行为者（MSM）包括感染人类免疫缺陷病毒者的高级别鳞状上皮内病变（HSIL）的疗效和安全性。
这项单臂、开放标签的试点研究纳入了20名接受电灼消融术治疗的HSIL男性同性恋者。参与者从国立全球健康与医学中心招募，并在消融术后3个月和6个月采用HRA结合全面活检的方法进行随访。全面活检定义为无论有无异常发现，均从肛管的6个节段各取至少1份活检样本。主要终点是6个月时局部HSIL治愈率。次要终点包括总治愈率、复发率和不良事件。
20名参与者的中位年龄为45岁，90%为HIV阳性。3个月时局部治愈率为40%，6个月时为50%。3个月和6个月时的总治愈率分别为35%和40%。27.8%的参与者发生异位复发。大多数不良事件为轻度且具有自限性。
在日本，电灼消融术是治疗男男性行为者HSIL的一种中等有效且安全的方法。然而，复发率较高，这表明对外观正常的病变进行活检并不能充分预防异位复发。有必要进行更大样本量和更长随访期的进一步研究以改善治疗效果。本试验已在日本临床试验注册中心注册：临床试验计划编号：jRCTs032210649。
