随机临床试验：咪喹莫特治疗宫颈发育不良的辅助手段。
Randomized clinical trial of imiquimod: an adjunct to treating cervical dysplasia.
机构信息
Department of Medicine, Mayo Clinic, Rochester, MN 55905, USA.
出版信息
Am J Obstet Gynecol. 2012 Jan;206(1):42.e1-7. doi: 10.1016/j.ajog.2011.06.105. Epub 2011 Jul 13.
Abstract
OBJECTIVES
Human papillomavirus (HPV) infection is a major risk factor for cervical cancer. Imiquimod is a topical medication that enhances the immune response to HPV-induced genital warts. This study evaluated cervical application of imiquimod as an adjunct to standard treatment for cervical dysplasia.
STUDY DESIGN
Fifty-six patients were randomized to standard excisional/ablative treatment vs applications of imiquimod followed by standard treatment. The primary endpoint was dysplasia recurrence within 2 years.
RESULTS
There were no differences in dysplasia recurrence between the 2 groups. Treatment was well tolerated, with side effects being mild but significantly worse in women receiving imiquimod for, chills, fatigue, fever, headache, myalgias, and vaginal discharge.
CONCLUSION
This trial does not support the hypothesis that imiquimod, as used in this trial, has an impact on recurrence of cervical dysplasia, but the adequacy of findings are limited by sample size. The trial does support the feasibility and acceptability of the use of imiquimod on the cervix.
摘要
目的
人乳头瘤病毒（HPV）感染是宫颈癌的主要危险因素。咪喹莫特是一种局部用药，可增强针对 HPV 引起的生殖器疣的免疫反应。本研究评估了咪喹莫特宫颈给药作为宫颈上皮内瘤样病变标准治疗的辅助手段。
研究设计
56 名患者被随机分为标准切除术/消融治疗与咪喹莫特应用后标准治疗组。主要终点为 2 年内的不典型增生复发。
结果
两组间不典型增生复发无差异。治疗耐受性良好，副作用轻微，但接受咪喹莫特治疗的女性副作用更明显，包括寒战、疲劳、发热、头痛、肌痛和阴道分泌物。
结论
本试验不支持咪喹莫特（如本试验中使用的那样）对宫颈不典型增生复发有影响的假设，但由于样本量有限，结果的充分性受到限制。该试验确实支持在宫颈上使用咪喹莫特的可行性和可接受性。
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