5%咪喹莫特乳膏治疗外阴鳞状上皮内瘤样病变的疗效及安全性分析

目的探讨5%咪喹莫特乳膏治疗外阴鳞状上皮内瘤样病变（VIN）的疗效和安全性。方法对42例门诊就诊的VIN患者给予5%咪喹莫特乳膏治疗,逐渐增加用药量至每周外用4次,疗程16周,期间每2周复诊1次,观察皮损变化及不良反应情况。疗程结束后再次行组织病理检查。结果实际完成疗程者36例,其中痊愈21例,好转10例,总有效率为86.1%。VINⅠ、VINⅡ的治愈率明显高于VINⅢ,VINⅠ的有效率也高于VINⅢ。好转患者皮损面积平均缩小57.2%。在治疗过程中,没有患者疾病进展或被诊断为鳞癌。20例患者出现不同程度的不良反应,主要表现为轻、中度的局部刺激症状,无一例患者出现系统症状,减量或暂时停药2周后均恢复正常治疗。结论外用5%咪喹莫特乳膏治疗VIN安全有效,患者耐受性好。

Therapeutic effect and safety evaluation on 5% imiquimod cream in the treatment of vulva intraepithelial neoplasia

Objective To evaluate the efficacy and safety of 5% imiquimod cream in topical treatment of vulva intraepithelial neoplasia（VIN）.Methods 42 outpatients with VIN were treated with 5% imiquimod cream.An escalating dose regimen was used until reaching the maximum 4 times per week application frequency.The total treatment duration was 16 weeks.Patients were seen every 2 weeks for the change of lesions and side-effects.After completion of 16 weeks on study,repeat biopsy of the target lesion was performed to evaluate for the end of treatment histologic response.Results 36 patients completed the 16-week treatment protocol.Recovery was observed in 21 patients with improvement in another 10 patients for in a total effective rate of 86.1%.In patients whose disease was improved,the median percentage reduction of target lesion area was 57.2%.The rates of recovery in VINⅠand VINⅡand the effective rate in VINⅠwere higher significantly than that of VINⅢ（P〈0.01）.The skin eruptions had shrunk an average of 57.2 percent.There were no patients with progressive disease or cancer diagnosed during the treatment period.20 patients have experienced adverse reactions which were mainly mild or medium local reactions,all of whom can continue and complete the protocol after a short period at a lower dose or drug discontinuance.No systemic side effects were found.Conclusion 5% imiquimod cream can be used safely,effectively and conveniently in treatment of VIN.