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0.05% 地奈德乳膏与1% 氢化可的松乳膏治疗儿童特应性皮炎的长期安全性及疗效比较的多中心试验

Multicenter trial for long-term safety and efficacy comparison of 0.05% desonide and 1% hydrocortisone ointments in the treatment of atopic dermatitis in pediatric patients.

作者信息

Jorizzo J, Levy M, Lucky A, Shavin J, Goldberg G, Dunlap F, Hinds A, Strelka L, Baker M, Tuley M

机构信息

Bowman Gray School of Medicine, Winston-Salem, North Carolina, USA.

出版信息

J Am Acad Dermatol. 1995 Jul;33(1):74-7. doi: 10.1016/0190-9622(95)90014-4.

DOI:10.1016/0190-9622(95)90014-4
PMID:7601950
Abstract

BACKGROUND

Desonide, a class 6 nonfluorinated topical corticosteroid, has been available for more than two decades. Hydrocortisone is widely used in the treatment of dermatoses in children.

OBJECTIVE

Our purpose was to compare the safety and efficacy of desonide ointment and 1.0% hydrocortisone ointment in children with atopic dermatitis.

METHODS

One hundred thirteen children (mean age, 4.8 years) with mild to moderate atopic dermatitis were enrolled in a multicenter, randomized, investigator-masked, parallel-group study. Treatments were applied twice daily for 5 weeks and extended to 6 months in 36 of the patients. Signs of atrophy were evaluated. Efficacy was determined by measuring global improvement, erythema, lichenification, excoriations, oozing or crusting, pruritus, and induration.

RESULTS

No differences in safety were observed between hydrocortisone and desonide. The investigator's global assessment of improvement significantly favored desonide over hydrocortisone during 3 months of treatment (p < 0.05).

CONCLUSION

Desonide ointment showed greater efficacy, produced more rapid improvement, and demonstrated an equivalent cutaneous safety profile when compared with 1% hydrocortisone ointment for up to 6 months.

摘要

背景

地奈德是一种6类非氟化外用皮质类固醇,已上市二十多年。氢化可的松广泛用于儿童皮肤病的治疗。

目的

我们的目的是比较地奈德软膏和1.0%氢化可的松软膏治疗儿童特应性皮炎的安全性和疗效。

方法

113例轻度至中度特应性皮炎儿童(平均年龄4.8岁)纳入一项多中心、随机、研究者设盲、平行组研究。治疗方案为每日两次,持续5周,36例患者延长至6个月。评估萎缩迹象。通过测量整体改善情况、红斑、苔藓化、抓痕、渗出或结痂、瘙痒和硬结来确定疗效。

结果

氢化可的松和地奈德在安全性方面未观察到差异。在治疗的3个月期间,研究者对改善情况的整体评估显示地奈德明显优于氢化可的松(p<0.05)。

结论

与1%氢化可的松软膏相比,地奈德软膏在长达6个月的时间里显示出更大的疗效,改善更快,且皮肤安全性相当。

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