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他扎罗汀凝胶,一种新型维甲酸,用于银屑病的局部治疗:载体对照的安全性、有效性及治疗效果持续时间研究

Tazarotene gel, a new retinoid, for topical therapy of psoriasis: vehicle-controlled study of safety, efficacy, and duration of therapeutic effect.

作者信息

Weinstein G D, Krueger G G, Lowe N J, Duvic M, Friedman D J, Jegasothy B V, Jorizzo J L, Shmunes E, Tschen E H, Lew-Kaya D A, Lue J C, Sefton J, Gibson J R, Chandraratna R A

机构信息

Department of Dermatology, University of California Irvine, USA.

出版信息

J Am Acad Dermatol. 1997 Jul;37(1):85-92. doi: 10.1016/s0190-9622(97)70216-0.

Abstract

BACKGROUND

Topical therapy providing initial improvement and maintenance of effect after treatment of the large majority of patients with limited, mild to moderate psoriasis is not presently available. Previous topical retinoids have generally been either ineffective or too irritating for therapy of psoriasis.

OBJECTIVE

Our purpose was to evaluate a new topical retinoid, tazarotene, in the treatment of stable plaque psoriasis during treatment and posttreatment periods.

METHODS

In a double-blind manner, 324 patients were randomly selected to receive tazarotene 0.1% or 0.05% gel, or vehicle control, once daily for 12 weeks and were then followed up for 12 weeks after treatment.

RESULTS

Of the total, 318 patients could be evaluated. Tazarotene gels were superior (p < 0.05) to vehicle, often as early as treatment week 1, in all efficacy measures: plaque elevation, scaling, and erythema; treatment response; percentage treatment success (patients with > or = 50% improvement); and time to initial success. Efficacy was equivalent on target lesion sites (trunk or limbs and knees or elbows) and overall. A sustained therapeutic effect was observed for 12 weeks after treatment. Tazarotene gel was cosmetically acceptable. There was low systemic absorption, limiting toxicity to local irritation.

CONCLUSION

Once-daily tazarotene was effective and safe as a topical monotherapy for plaque psoriasis, providing rapid reduction of signs and symptoms.

摘要

背景

目前尚无局部治疗方法能使绝大多数局限性轻至中度银屑病患者在治疗后获得初始改善并维持疗效。既往局部用维甲酸类药物治疗银屑病通常要么无效,要么刺激性过大。

目的

我们的目的是评估一种新型局部用维甲酸类药物他扎罗汀在稳定期斑块状银屑病治疗期及治疗后阶段的疗效。

方法

采用双盲法,随机选择324例患者,每日一次外用0.1%或0.05%他扎罗汀凝胶或赋形剂对照,共12周,随后治疗后随访12周。

结果

总共318例患者可进行评估。在所有疗效指标方面,他扎罗汀凝胶在治疗第1周时往往就优于赋形剂对照(p < 0.05),包括斑块隆起、鳞屑和红斑;治疗反应;治疗成功率(改善≥50%的患者);以及达到初始成功的时间。在靶皮损部位(躯干或四肢以及膝部或肘部)和总体上疗效相当。治疗后观察到持续12周的治疗效果。他扎罗汀凝胶在美容方面是可接受的。全身吸收低,将毒性限制为局部刺激。

结论

每日一次外用他扎罗汀作为斑块状银屑病的局部单一疗法有效且安全,能迅速减轻体征和症状。

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