Krueger G G, Drake L A, Elias P M, Lowe N J, Guzzo C, Weinstein G D, Lew-Kaya D A, Lue J C, Sefton J, Chandraratna R A
Department of Dermatology, University of Utah Health Sciences Center, Salt Lake City, USA.
Arch Dermatol. 1998 Jan;134(1):57-60. doi: 10.1001/archderm.134.1.57.
To determine the safety and efficacy of topically applied tazarotene gel in the treatment of mild to moderate psoriatic plaques.
Two multicenter, double-blind, randomized studies of 6- and 8-week duration, with an 8-week follow-up in the second study.
Medical center outpatient dermatology services.
One hundred fifty-three adults with 2 bilateral target plaques on the trunk, legs, or arms.
Vehicle gel or 0.01% and 0.05% tazarotene gel administered twice daily to 45 patients (study A), or 0.05% and 0.1% tazarotene gel administered either once or twice daily to 108 patients (study B).
Treatment success and plaque elevation, scaling, and erythema vs time.
The 0.01% tazarotene gel showed minimal efficacy. Applications of 0.05% and 0.1% tazarotene gels administered once or twice daily, resulted in significant improvements in plaque elevation, scaling, erythema, and overall clinical severity as early as 1 week. Treatment success rates (defined as > 75% improvement from baseline) were 45% with 0.05% tazarotene gel vs 13% with vehicle gel after 6 weeks of treatment (P < .05; study A) and ranged from 48% to 63% with the various tazarotene treatment regimens after 8 weeks of treatment (study B). These improvements were evident at the 8-week follow-up. Treatment-related adverse effects were generally limited to mild or moderate local irritation and were less frequent with the treatment regimen administered once daily.
The 0.05% and 0.1% tazarotene gels demonstrated significant efficacy in the treatment of mild to moderate psoriatic plaques that persisted after cessation of treatment.
确定局部应用他扎罗汀凝胶治疗轻至中度银屑病斑块的安全性和有效性。
两项为期6周和8周的多中心、双盲、随机研究,第二项研究有8周的随访期。
医疗中心门诊皮肤科服务。
153名成年人,躯干、腿部或手臂上有2个双侧目标斑块。
对45名患者(研究A)每日两次给予赋形剂凝胶或0.01%和0.05%他扎罗汀凝胶,或对108名患者(研究B)每日一次或两次给予0.05%和0.1%他扎罗汀凝胶。
治疗成功率以及斑块隆起、脱屑和红斑随时间的变化情况。
0.01%他扎罗汀凝胶疗效甚微。每日一次或两次应用0.05%和0.1%他扎罗汀凝胶,早在1周时就能使斑块隆起、脱屑、红斑及整体临床严重程度有显著改善。治疗成功率(定义为较基线改善>75%)在治疗6周后,0.05%他扎罗汀凝胶组为45%,赋形剂凝胶组为13%(P<0.05;研究A),在治疗8周后,各种他扎罗汀治疗方案的成功率在48%至63%之间(研究B)。这些改善在8周随访时仍很明显。与治疗相关的不良反应一般仅限于轻度或中度局部刺激,每日一次给药方案的不良反应较少。
0.05%和0.1%他扎罗汀凝胶在治疗轻至中度银屑病斑块方面显示出显著疗效,且在治疗停止后仍持续有效。