Department of General Gynaecology and Gynaecological Oncology, Comprehensive Cancer Center, the Center for Medical Statistics, Informatics and Intelligent Systems, Section for Clinical Biometrics, and the Division of Immunology, Allergy and Infectious Diseases, Medical University of Vienna, and the Karl Landsteiner Institute for Gynecologic Surgery and Oncology, Vienna, Austria.
Obstet Gynecol. 2012 Jul;120(1):152-9. doi: 10.1097/AOG.0b013e31825bc6e8.
Alternatives to surgical therapy are needed for the treatment of high-grade cervical intraepithelial neoplasia (CIN 2-3). We aimed to estimate the efficacy of a treatment with imiquimod, a topical immune-response modulator, in patients with CIN 2-3.
Fifty-nine patients with untreated CIN 2-3 were randomly allocated to a 16-week treatment with self-applied vaginal suppositories containing either imiquimod or placebo. The main outcome was efficacy, defined as histologic regression to CIN 1 or less after treatment. Secondary outcomes were complete histologic remission, human papillomavirus (HPV) clearance, and tolerability. Assuming a two-sided 5% significance level and a power of 80%, a sample size of 24 patients per group was calculated to detect a 35% absolute increase in CIN 2-3 regression.
Histologic regression was observed in 73% of patients in the imiquimod group compared with 39% in the placebo group (P=.009). Complete histologic remission was higher in the imiquimod group (47%) compared with the placebo group (14%) (P=.008). At baseline, all patients tested positive for high-risk HPV. Human papillomavirus clearance rates were increased in the imiquimod group (60%) compared with the placebo group (14%) (P<.001). In patients with HPV-16 infection, complete remission rates were 47% in the imiquimod group compared with 0% in the placebo group (P=.003). Microinvasive cancer was observed in three of 59 (5% [1-14%]) patients, all within the placebo group. Topical imiquimod treatment was well tolerated, and no high-grade side effects were observed.
Topical imiquimod is an efficacious and feasible treatment for patients with CIN 2-3.
需要替代手术治疗的方法来治疗高级别宫颈上皮内瘤变（CIN 2-3）。我们旨在评估咪喹莫特（一种局部免疫反应调节剂）治疗 CIN 2-3 患者的疗效。
59 例未经治疗的 CIN 2-3 患者被随机分配至接受 16 周的治疗，方法为自行阴道应用咪喹莫特或安慰剂栓剂。主要结局是疗效，定义为治疗后组织学消退至 CIN 1 或更低级别。次要结局为完全组织学缓解、人乳头瘤病毒（HPV）清除和耐受性。假设双侧 5%的显著性水平和 80%的功效，计算出每组 24 例患者的样本量，以检测 CIN 2-3 消退的绝对增加 35%。
咪喹莫特组的 73%患者出现组织学消退，而安慰剂组为 39%（P=.009）。咪喹莫特组的完全组织学缓解率（47%）高于安慰剂组（14%）（P=.008）。基线时，所有患者均检测到高危型 HPV 阳性。咪喹莫特组的 HPV 清除率（60%）高于安慰剂组（14%）（P<.001）。在 HPV-16 感染的患者中，咪喹莫特组的完全缓解率为 47%，而安慰剂组为 0%（P=.003）。在 59 例患者中，有 3 例（5%[1-14%]）观察到微浸润性癌，均在安慰剂组。局部应用咪喹莫特治疗耐受性良好，未观察到高级别不良反应。
局部应用咪喹莫特是治疗 CIN 2-3 患者的有效且可行的方法。
