Sterry W, Ruzicka T, Herrera E, Takwale A, Bichel J, Andres K, Ding L, Thissen M R T M
Department of Dermatology, University Hospital Charité, Humboldt University, Schumannstrasse 20-21, D-10117 Berlin, Germany.
Br J Dermatol. 2002 Dec;147(6):1227-36. doi: 10.1046/j.1365-2133.2002.05069.x.
Imiquimod 5% cream has been investigated for non-surgical treatment of superficial and nodular basal cell carcinoma (BCC) tumours.
Two studies were conducted to examine the effect of occlusion at low dosing frequencies on the safety and efficacy of topical imiquimod 5% cream for the treatment of superficial and nodular BCC.
Both open-label studies were conducted in Europe. Patients diagnosed with BCC were enrolled into either the superficial (93 patients) or nodular (90 patients) study, depending on the histological confirmation of the patient's tumour subtype. Patients were randomized to one of four groups to apply imiquimod 5% cream 2 or 3 days per week either with or without occlusion. Six weeks following a 6-week treatment period, the entire target tumour area was excised and histologically examined for evidence of residual tumour.
In both studies, the highest histologically complete response rate was seen in the 3 days per week with occlusion groups, with complete response rates of 87% and 65% for the superficial and nodular studies, respectively. Occlusion did not have a statistically significant effect on response rate at either dosing frequency. Response rates for superficial and nodular BCC tumours treated 3 days per week without occlusion were 76% and 50%, respectively.
In the superficial study, the complete response rate of 87% in the 3 days per week with occlusion group was similar to that of daily and 5 days per week dosing without occlusion in a previous 12-week study and one study of daily dosing without occlusion for 6 weeks. All treatment groups had acceptable safety profiles in both studies. Occlusion did not have a statistically significant effect on efficacy for either superficial or nodular BCC tumours.
5%咪喹莫特乳膏已被用于非手术治疗浅表性和结节性基底细胞癌（BCC）肿瘤。
开展两项研究，以检验低给药频率下的封包对5%咪喹莫特乳膏局部治疗浅表性和结节性BCC安全性和有效性的影响。
两项开放标签研究均在欧洲进行。根据患者肿瘤亚型的组织学确诊结果，将诊断为BCC的患者纳入浅表性研究（93例患者）或结节性研究（90例患者）。患者被随机分为四组，每周2天或3天应用5%咪喹莫特乳膏，分为有或无封包两种情况。在为期6周的治疗期结束6周后，切除整个目标肿瘤区域并进行组织学检查，以寻找残留肿瘤的证据。
在两项研究中，每周3天封包组的组织学完全缓解率最高，浅表性研究和结节性研究的完全缓解率分别为87%和65%。封包在任何一种给药频率下对缓解率均无统计学显著影响。每周3天不封包治疗的浅表性和结节性BCC肿瘤的缓解率分别为76%和50%。
在浅表性研究中，每周3天封包组87%的完全缓解率与之前一项12周研究以及一项每日给药6周不封包研究中每日和每周5天给药不封包的完全缓解率相似。在两项研究中，所有治疗组的安全性均良好。封包对浅表性或结节性BCC肿瘤的疗效均无统计学显著影响。
