Stockfleth Eggert, Meyer Thomas, Benninghoff Bernd, Salasche Stuart, Papadopoulos Latza, Ulrich Claas, Christophers Enno
Department of Dermatology, University of Kiel, Germany.
Arch Dermatol. 2002 Nov;138(11):1498-502. doi: 10.1001/archderm.138.11.1498.
Actinic keratoses (AKs) are precancerous epidermal lesions found most frequently on areas of the skin exposed to the sun. Several case studies published recently have indicated that 5% imiquimod cream, currently licensed for the treatment of genital warts, may be an effective treatment for AK.
To assess the efficacy and safety of imiquimod for the treatment of AK.
Patients in this randomized, double-blind, vehicle-controlled study applied 5% imiquimod cream or vehicle to AK lesions 3 times per week for a maximum of 12 weeks or until lesions had resolved. In the event of an adverse reaction, application of imiquimod was reduced to 1 or 2 times per week. Rest periods were also allowed if necessary.
A specialized outpatient dermatology clinic within a state-funded hospital in Germany.
The study population was aged 45 to 85 years. Of 52 patients screened, 36 men and women with AK confirmed by histological diagnosis were enrolled. Patients were excluded from the study if they did not have a histological diagnosis for AK, if they were older than 85 years, or if they did not comply with the protocol. All patients had responded to a notice asking for volunteers.
The number and appearance of lesions were evaluated before, during, and after treatment. All adverse effects were recorded.
Lesions treated with 5% imiquimod cream were clinically cleared in 21 (84%) of 25 patients and partially cleared in 2 (8%). Clearance was histologically confirmed 2 weeks after the last application of imiquimod in all patients clinically diagnosed as lesion free. Only 10% of patients treated with imiquimod were clinically diagnosed with recurrence 1 year after treatment. No reduction in the size or number of AK lesions was observed in vehicle-treated patients. Adverse effects reported by patients treated with imiquimod included erythema, edema, induration, vesicles, erosion, ulceration, excoriation, and scabbing. However, imiquimod was well tolerated since all patients completed the 12-week treatment. Only a few, mild adverse reactions to the vehicle cream were reported.
Application of 5% imiquimod cream for 12 weeks is an effective and well-tolerated treatment for AK.
光化性角化病（AK）是一种癌前表皮病变，最常出现在暴露于阳光下的皮肤区域。最近发表的几项病例研究表明，目前已获许可用于治疗尖锐湿疣的5%咪喹莫特乳膏可能是治疗AK的有效方法。
评估咪喹莫特治疗AK的疗效和安全性。
在这项随机、双盲、赋形剂对照研究中，患者每周3次将5%咪喹莫特乳膏或赋形剂应用于AK皮损，最长持续12周或直至皮损消退。如果出现不良反应，咪喹莫特的应用频率减至每周1次或2次。必要时也允许休息。
德国一家国立医院内的专业门诊皮肤科诊所。
研究人群年龄在45至85岁之间。在52名接受筛查的患者中，36名经组织学诊断确诊为AK的男性和女性被纳入研究。如果患者没有AK的组织学诊断、年龄超过85岁或未遵守研究方案，则被排除在研究之外。所有患者均对招募志愿者的通知做出了回应。
在治疗前、治疗期间和治疗后评估皮损的数量和外观。记录所有不良反应。
25例接受5%咪喹莫特乳膏治疗的患者中，21例（84%）临床皮损清除，2例（8%）部分清除。在所有临床诊断为皮损清除的患者中，最后一次应用咪喹莫特2周后，组织学证实清除。接受咪喹莫特治疗的患者中，只有10%在治疗1年后临床诊断为复发。在接受赋形剂治疗的患者中，未观察到AK皮损大小或数量的减少。接受咪喹莫特治疗的患者报告的不良反应包括红斑、水肿、硬结、水疱、糜烂、溃疡、擦伤和结痂。然而，由于所有患者均完成了12周的治疗，咪喹莫特耐受性良好。仅报告了少数对赋形剂乳膏的轻度不良反应。
应用5%咪喹莫特乳膏12周是一种治疗AK的有效且耐受性良好的方法。
