5%咪喹莫特乳膏治疗浅表性基底细胞癌：一项双盲、随机、赋形剂对照研究。
Imiquimod 5% cream for the treatment of superficial basal cell carcinoma: a double-blind, randomized, vehicle-controlled study.
作者信息
Geisse John K, Rich Phoebe, Pandya Amit, Gross Kenneth, Andres Kara, Ginkel Angie, Owens Mary
机构信息
Solano Dermatology Associates, Vallejo, California 94589, USA.
出版信息
J Am Acad Dermatol. 2002 Sep;47(3):390-8. doi: 10.1067/mjd.2002.126215.
BACKGROUND
Imiquimod 5% cream may provide an effective nonsurgical treatment for superficial basal cell carcinoma (sBCC) based on results of previous studies.
OBJECTIVE
The objective of this phase II dose-response study was to explore various dosing regimens using imiquimod 5% cream for sBCC to find the most effective frequency of dosing with tolerable side effects.
METHODS
Patients (n = 128) were dosed twice daily, once daily, 5 times a week, or 3 times a week in this 12-week, randomized, double-blind, vehicle-controlled study. At 6 weeks after treatment, the entire tumor area was clinically evaluated, excised, and examined exhaustively for histologic evidence of residual sBCC.
RESULTS
Complete response rates were 100% (10/10), 87.1% (27/31), 80.8% (21/26), and 51.7% (15/29) for patients in the twice daily, once daily, 5 times a week, and 3 times a week imiquimod groups, respectively, and 18.8% (6/32) in the vehicle group.
CONCLUSION
Imiquimod 5% cream was effective in the treatment of sBCC. Daily or 5 times a week dosing for 12 weeks demonstrated high efficacy results with acceptable safety profiles.
背景
根据先前研究结果，5%咪喹莫特乳膏可能为浅表性基底细胞癌（sBCC）提供一种有效的非手术治疗方法。
目的
本II期剂量反应研究的目的是探索使用5%咪喹莫特乳膏治疗sBCC的各种给药方案，以找到副作用可耐受的最有效给药频率。
方法
在这项为期12周的随机、双盲、赋形剂对照研究中，128例患者分别接受每日两次、每日一次、每周5次或每周3次给药。治疗6周后，对整个肿瘤区域进行临床评估，切除并进行详尽的组织学检查，以寻找残留sBCC的组织学证据。
结果
每日两次、每日一次、每周5次和每周3次咪喹莫特组患者的完全缓解率分别为100%（10/10）、87.1%（27/31）、80.8%（21/26）和51.7%（15/29），赋形剂组为18.8%（6/32）。
结论
5%咪喹莫特乳膏治疗sBCC有效。每日或每周5次给药12周显示出高效结果且安全性可接受。
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