一项关于经肛门使用青蒿琥酯（栓剂）治疗肛门高级别鳞状上皮内病变的 I 期研究。
A phase I study of intra-anal artesunate (suppositories) to treat anal high-grade squamous intraepithelial lesions.
机构信息
Department of Surgery, Oregon Health & Science University, Portland, Oregon, United States of America.
Frantz Medical Development, Ltd, Mentor, Ohio, United States of America.
出版信息
PLoS One. 2023 Dec 15;18(12):e0295647. doi: 10.1371/journal.pone.0295647. eCollection 2023.
BACKGROUND
Ablation or surgical excision is the typical treatment of anal high-grade squamous intraepithelial lesions (HSIL). Recurrences are common due to the persistence of underlying human papillomavirus (HPV) infection. Additional well-tolerated and effective non-surgical options for HPV-associated anal disease are needed.
METHODS
This 3+3 dose escalation Phase I clinical trial evaluated the safety and tolerability of artesunate suppositories in the treatment of patients with biopsy-proven HSIL.
RESULTS
The maximal tolerated dose was 400 mg, administered in 3 cycles. All adverse events associated with the use 200- and 400-mg artesunate suppositories were Grade 1. At the 600-mg dose, patients experienced clinically significant nausea.
CONCLUSION
Artesunate suppositories are a safe treatment option for anal HSIL.
背景
消融或手术切除是治疗肛门高级别鳞状上皮内病变（HSIL）的典型方法。由于人乳头瘤病毒（HPV）感染持续存在，复发较为常见。需要额外的耐受性良好且有效的非手术选择来治疗与 HPV 相关的肛门疾病。
方法
这是一项 3+3 剂量递增的 I 期临床试验，评估了青蒿琥酯栓剂治疗活检证实为 HSIL 的患者的安全性和耐受性。
结果
最大耐受剂量为 400mg，分 3 个周期给药。所有与使用 200mg 和 400mg 青蒿琥酯栓剂相关的不良事件均为 1 级。在 600mg 剂量下，患者出现了明显的临床恶心。
结论
青蒿琥酯栓剂是治疗肛门 HSIL 的安全选择。
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