Le Tien, Hicks Wendy, Menard Chantal, Hopkins Laura, Fung Michael Fung Kee
Division of Gynecologic Oncology, University of Ottawa, Ottawa, Ontario, Canada.
Am J Obstet Gynecol. 2006 Feb;194(2):377-80. doi: 10.1016/j.ajog.2005.08.022.
This study was undertaken to study the tolerability and efficacy of 5% imiquimod cream in the primary treatment of vulva intraepithelial neoplasia (VIN) grade 2/3.
VIN grade 2/3 patients were recruited from regional colposcopy units. Imiquimod cream was applied over the abnormal area by the patient using an escalating dose regime for total treatment duration of 16 weeks. At the end of study, repeat colposcopy and biopsy of the target lesion were performed to assess for response.
Twenty-three patients participated. Twenty patients (87%) had VIN grade 3. Nine patients (39%) had multifocal disease on colposcopy. Therapy was well tolerated with the most commonly observed side effects being irritation at the application site. Responses were evaluable in 17 patients. Complete responses were observed in 9 patients with partial responses in another 5 (relative risk 82%). The median time to response was 7 weeks.
Imiquimod cream can induce histologic regression of high-grade VIN lesions and is well tolerated using a slow dose-escalating regime.
本研究旨在探讨5%咪喹莫特乳膏对外阴上皮内瘤变（VIN）2/3级进行初始治疗时的耐受性和疗效。
从区域阴道镜检查单位招募VIN 2/3级患者。患者采用剂量递增方案将咪喹莫特乳膏涂抹于异常区域，总疗程为16周。研究结束时，对目标病变进行重复阴道镜检查和活检以评估反应。
23名患者参与研究。20名患者（87%）为VIN 3级。9名患者（39%）在阴道镜检查时患有多灶性疾病。治疗耐受性良好，最常见的副作用是涂抹部位的刺激。17名患者的反应可评估。9名患者观察到完全缓解，另外5名患者部分缓解（相对风险82%）。反应的中位时间为7周。
咪喹莫特乳膏可诱导高级别VIN病变的组织学消退，并且采用缓慢剂量递增方案时耐受性良好。
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