多次16周疗程的局部用咪喹莫特治疗大面积光化性角化病的安全性和有效性

Safety and Efficacy of Multiple 16-week Courses of Topical Imiquimod for the Treatment of Large Areas of Skin Involved with Actinic Keratoses.

作者信息

Del Rosso James Q, Sofen Howard, Leshin Barry, Meng Tc, Kulp James, Levy Sharon

出版信息

J Clin Aesthet Dermatol. 2009 Apr;2(4):20-8.

PMID:20729935

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2923947/

Abstract

OBJECTIVE

Safety of multiple 16-week courses of imiquimod applied to large areas (>25 cm(2)) of skin with actinic keratoses.

DESIGN

Subjects applied 1 to 6 packets two times per week for 16 weeks; if actinic keratoses were persistent at two months post-treatment, up to two additional courses could be administered within the 18-month study period.

SETTING

Multicenter, outpatient.

PARTICIPANTS

Adults with >/=4 actinic keratoses on the head, torso, and/or extremities.

MEASUREMENTS

Treatment discontinuations, adverse events, lesion counts.

RESULTS

Safety analyses included 551 subjects. At baseline, mean overall treatment area was 625+/-1114cm(2). Overall, the mean days on study was 467+/-157, and the mean exposure 215+/-133 packets with 155, 150, and 250 subjects receiving 1, 2, or 3 treatment courses, respectively. Of the 155 subjects (28.1%) who did not complete the study, 20 (3.6%) and 9 (1.6%) were discontinued for adverse events and local skin reactions, respectively. Adverse events related to study drug were reported by 40.5 percent of subjects. The local skin reactions rated as severe reported by the most subjects were erythema (31.4%), flaking/scaling/drying (23.8%), and scabbing/crusting (22.0%). For 525 subjects with analyzable lesion data, the mean baseline lesion count was 45.5+/-2.4. Overall reduction in target lesion count was 80.2 percent (p<0.0001, 95% CI 77.2-83.3%), with overall complete clearance rate of 36.4 percent and partial clearance rate (>/=75% reduction) of 68.6 percent.

CONCLUSION

Multiple 16-week courses of imiquimod to treat actinic keratoses were well tolerated and significantly decreased lesions in subjects with extensive actinic keratoses.

摘要

目的

评估多次16周疗程的咪喹莫特用于大面积（>25平方厘米）光化性角化病皮肤治疗的安全性。

设计

受试者每周两次应用1至6包药物，持续16周；如果光化性角化病在治疗后两个月仍持续存在，在18个月的研究期内最多可再给予两个疗程的治疗。

地点

多中心门诊。

参与者

头部、躯干和/或四肢有≥4处光化性角化病的成年人。

测量指标

治疗中断情况、不良事件、皮损计数。

结果

安全性分析纳入551名受试者。基线时，平均总治疗面积为625±1114平方厘米。总体而言，平均研究天数为467±157天，平均用药量为215±133包，分别有155、150和250名受试者接受1、2或3个疗程的治疗。在未完成研究的155名受试者（28.1%）中，分别有20名（3.6%）和9名（1.6%）因不良事件和局部皮肤反应而中断治疗。40.5%的受试者报告了与研究药物相关的不良事件。大多数受试者报告的严重局部皮肤反应为红斑（31.4%）、脱屑/鳞屑/干燥（23.8%）和结痂（22.0%）。对于525名有可分析皮损数据的受试者，平均基线皮损计数为45.5±2.4。目标皮损计数总体减少80.2%（p<0.0001，95%置信区间77.2 - 83.3%），总体完全清除率为36.4%，部分清除率（减少≥75%）为68.6%。