Drake L A, Fallon J D, Sober A
Massachusetts General Hospital, Boston.
J Am Acad Dermatol. 1994 Oct;31(4):613-6. doi: 10.1016/s0190-9622(94)70225-x.
Atopic dermatitis is associated with severe pruritus for which effective topical treatment is lacking. As a potent H1 and H2 antagonist, the antipruritic effect of topical doxepin was first demonstrated in histamine-induced itch in nonatopic volunteers.
The current study was undertaken to compare the efficacy and safety of topical 5% doxepin cream in relieving pruritus associated with atopic dermatitis.
A total of 270 patients with atopic dermatitis who had daily moderate to severe pruritus for at least 1 week were enrolled in the double-blind, vehicle-controlled, multicenter study. Treatment was randomly assigned: 5% doxepin cream or vehicle cream was applied twice on the day of the baseline visit and four times daily for the remainder of the 7-day trial.
Relief of pruritus was achieved in 85% of doxepin-treated patients and 57% of vehicle-treated patients by day 7; a majority of these positive responses occurred during the first 24 hours. Pruritus severity scores demonstrated significantly greater improvement with topical doxepin at each study visit (p < 0.01). Visual analogue scales for pruritus severity and pruritus relief showed similar improvement in the doxepin-treated group. At each of three visits, the physician's global evaluation for relief of pruritus also showed significant improvement in the doxepin treatment group (p < 0.01). The physician's global evaluations of eczema significantly favored topical doxepin on day 7 (p < 0.01). Nineteen patients withdrew from the study because of adverse effects (doxepin, n = 16; vehicle, n = 3). The most commonly reported were localized stinging or burning (doxepin group, n = 39; vehicle group, n = 34) and drowsiness (doxepin group, n = 37; vehicle group, n = 3), all of which decreased in frequency and severity over time.
Topical doxepin is effective in reducing pruritus in patients with atopic dermatitis. It has an apparent short-term low risk of major side effects or sensitization.
特应性皮炎常伴有严重瘙痒，目前缺乏有效的局部治疗方法。作为一种强效的H1和H2拮抗剂，局部应用多塞平的止痒作用最初是在非特应性志愿者的组胺诱导性瘙痒中得到证实的。
本研究旨在比较局部应用5%多塞平乳膏缓解特应性皮炎相关瘙痒的疗效和安全性。
共有270例特应性皮炎患者纳入这项双盲、赋形剂对照、多中心研究，这些患者每日有中度至重度瘙痒症状至少1周。治疗随机分配：在基线访视日，5%多塞平乳膏或赋形剂乳膏均涂抹2次，在为期7天的试验剩余时间里，每日涂抹4次。
到第7天时，85%接受多塞平治疗的患者瘙痒症状得到缓解，而接受赋形剂治疗的患者中这一比例为57%；大多数积极反应发生在最初24小时内。在每次研究访视时，多塞平局部治疗组的瘙痒严重程度评分改善显著更大（p < 0.01）。瘙痒严重程度和瘙痒缓解的视觉模拟量表显示，多塞平治疗组有类似改善。在三次访视中的每一次，医生对瘙痒缓解的整体评估也显示多塞平治疗组有显著改善（p < 0.01）。在第7天，医生对湿疹的整体评估明显更倾向于局部应用多塞平（p < 0.01）。19例患者因不良反应退出研究（多塞平组16例；赋形剂组3例）。最常报告的不良反应是局部刺痛或烧灼感（多塞平组39例；赋形剂组34例）和嗜睡（多塞平组37例；赋形剂组3例），所有这些不良反应的频率和严重程度均随时间下降。
局部应用多塞平对减轻特应性皮炎患者的瘙痒有效。它在短期内有明显的低主要副作用或致敏风险。
