Department of Surgery, Icahn School of Medicine at Mount Sinai, New York, New York.
Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
Clin Infect Dis. 2019 Mar 19;68(7):1204-1212. doi: 10.1093/cid/ciy615.
Anal high-grade squamous intraepithelial lesions (HSILs) ablation may reduce the incidence of invasive cancer, but few data exist on treatment efficacy and natural regression without treatment.
An open-label, randomized, multisite clinical trial of human immunodeficiency virus (HIV)-infected adults aged ≥27 years with 1-3 biopsy-proven anal HSILs (index HSILs) without prior history of HSIL treatment with infrared coagulation (IRC). Participants were randomized 1:1 to HSIL ablation with IRC (treatment) or no treatment (active monitoring [AM]). Participants were followed every 3 months with high-resolution anoscopy. Treatment participants underwent anal biopsies of suspected new or recurrent HSILs. The AM participants underwent biopsies only at month 12. The primary end point was complete clearance of index HSIL at month 12.
We randomized 120 participants. Complete index HSIL clearance occurred more frequently in the treatment group than in the AM (62% vs 30%; risk difference, 32%; 95% confidence interval [CI], 13%-48%; P < .001). Complete or partial clearance (clearance of ≥1 index HSIL) occurred more commonly in the treatment group (82% vs 47%; risk difference, 35%; 95% CI, 16%-50%; P < .001). Having a single index lesion, compared with having 2-3 lesions, was significantly associated with complete clearance (relative risk, 1.96; 95% CI, 1.22-3.10). The most common adverse events related to treatment were mild or moderate anal pain and bleeding. No serious adverse events were deemed related to treatment or study participation.
IRC ablation of anal HSILs results in more clearance of HSILs than observation alone.
肛门高级别鳞状上皮内病变（HSIL）的消融治疗可能会降低浸润性癌症的发生率，但对于未经红外凝固治疗（IRC）的情况下，HSIL 的治疗效果和自然消退的数据较少。
一项针对人类免疫缺陷病毒（HIV）感染的、年龄≥27 岁的成年人的开放性标签、随机、多中心临床试验，这些患者有 1-3 次活检证实的肛门 HSIL（索引 HSIL）病史，且之前没有接受过 IRC 治疗 HSIL 的病史。参与者以 1:1 的比例随机分配到 HSIL 消融联合 IRC（治疗）或不治疗（主动监测[AM]）。参与者每 3 个月接受一次高分辨率肛门镜检查。治疗组的参与者对疑似新出现或复发的 HSIL 进行肛门活检。AM 组的参与者仅在第 12 个月进行活检。主要终点是在第 12 个月时，索引 HSIL 完全清除。
我们随机分配了 120 名参与者。治疗组的索引 HSIL 完全清除率高于 AM 组（62% vs 30%；风险差异，32%；95%置信区间[CI]，13%-48%；P <.001）。治疗组更常见完全或部分清除（至少清除 1 个索引 HSIL）（82% vs 47%；风险差异，35%；95%CI，16%-50%；P <.001）。与 2-3 个病灶相比，单个病灶与完全清除显著相关（相对风险，1.96；95%CI，1.22-3.10）。与治疗相关的最常见不良事件是轻度或中度肛门疼痛和出血。没有严重的不良事件被认为与治疗或研究参与有关。
IRC 消融治疗肛门 HSIL 比单纯观察更能清除 HSIL。
