Leyden James J, Tanghetti Emil A, Miller Bruce, Ung Mark, Berson Diane, Lee Jeff
University of Pennsylvania Hospital, Philadelphia, USA.
Cutis. 2002 Feb;69(2 Suppl):12-9.
The efficacy and tolerability of tazarotene 0.1% gel and tretinoin 0.1% microsponge gel were evaluated in a multicenter, double-blind, randomized, parallel-group study in patients with mild-to-moderate inflammatory facial acne vulgaris. A total of 169 patients were randomized to once-daily applications of one of these topical retinoids for 12 weeks. Both agents were associated with significant reductions from baseline in the noninflammatory and inflammatory lesion counts. Tazarotene treatment was associated with a significantly greater incidence of treatment success (defined as > or = 50% global improvement [67% vs 49%; P=.03]) and significantly greater reductions in overall disease severity (36% vs 26%; P=.02) and noninflammatory lesion count (60% vs 38% at week 12; P=.02) than tretinoin microsponge treatment. Both drugs were well tolerated, with mean levels of dryness, burning, pruritus, erythema, and peeling generally being no more than trace throughout the study. There were no clinically significant between-group differences in these measures of tolerability. Two patients in each group (2%) discontinued because of treatment-related adverse events. The mean amount of medication applied by the patients was 0.28 g per application with tazarotene and 0.41 g per application with tretinoin microsponge, resulting in cost-effectiveness ratios of $81.45 per treatment success with tazarotene and $108.24 per treatment success with tretinoin microsponge. Tazarotene was observed to have greater efficacy and comparable tolerability and to be a cost-effective alternative to tretinoin 0.1% microsponge gel.
在一项针对轻度至中度炎症性寻常面部痤疮患者的多中心、双盲、随机、平行组研究中,评估了0.1%他扎罗汀凝胶和0.1%维甲酸微海绵凝胶的疗效和耐受性。共有169名患者被随机分配,每天使用其中一种外用维甲酸类药物,持续12周。两种药物均与非炎性和炎性皮损计数较基线水平显著减少有关。与维甲酸微海绵治疗相比,他扎罗汀治疗的治疗成功率显著更高(定义为整体改善≥50%[67%对49%;P = 0.03]),整体疾病严重程度显著降低(36%对26%;P = 0.02),非炎性皮损计数显著减少(第12周时为60%对38%;P = 0.02)。两种药物耐受性良好,在整个研究过程中,干燥、灼烧、瘙痒、红斑和脱屑的平均水平一般不超过轻微程度。在这些耐受性指标方面,组间无临床显著差异。每组有两名患者(2%)因治疗相关不良事件停药。患者使用他扎罗汀时每次用药的平均量为0.28 g,使用维甲酸微海绵时每次用药的平均量为0.41 g,他扎罗汀每例治疗成功的成本效益比为81.45美元,维甲酸微海绵每例治疗成功的成本效益比为108.24美元。观察到他扎罗汀具有更高的疗效、相当的耐受性,并且是替代维甲酸微海绵凝胶的具有成本效益的选择。