一项双盲、安慰剂对照临床试验，以评估胸腺五肽作为特应性皮炎辅助治疗的安全性和有效性。
A double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of thymopentin as an adjunctive treatment in atopic dermatitis.
作者信息
Stiller M J, Shupack J L, Kenny C, Jondreau L, Cohen D E, Soter N A
机构信息
Ronald O. Perelman Department of Dermatology, New York University School of Medicine, NY.
出版信息
J Am Acad Dermatol. 1994 Apr;30(4):597-602. doi: 10.1016/s0190-9622(94)70068-0.
BACKGROUND
Multiple immunologic abnormalities such as impaired T-cell function, elevated serum IgE level, and increased interleukin 4 production have been demonstrated in patients with atopic dermatitis.
OBJECTIVE
As part of a 12-week, multicenter, double-blind, placebo-controlled clinical trial, we evaluated the safety and efficacy of thymopentin (Timunox) as an adjunctive treatment in patients with severe atopic dermatitis.
METHODS
Thirty-nine patients at least 2 years old with severe atopic dermatitis on a minimum of 20% of their cutaneous surface area were randomly selected to receive either thrice-weekly subcutaneous injections of thymopentin, 50 mg, or placebo. Use of triamcinolone 0.1% or hydrocortisone 1.0% cream and oral antihistamines were permitted during this trial.
RESULTS
After 12 weeks, thymopentin-treated patients had significantly greater improvement than those receiving placebo. No thymopentin-related adverse events occurred.
CONCLUSION
Thymopentin may be a safe effective adjunct to therapy in patients with severe atopic dermatitis.
背景
特应性皮炎患者已被证实存在多种免疫异常，如T细胞功能受损、血清IgE水平升高以及白细胞介素4产生增加。
目的
作为一项为期12周的多中心、双盲、安慰剂对照临床试验的一部分，我们评估了胸腺五肽（替莫克）作为重度特应性皮炎患者辅助治疗的安全性和有效性。
方法
随机选择39例至少2岁、皮肤表面积至少20%患有重度特应性皮炎的患者，接受每周三次皮下注射50mg胸腺五肽或安慰剂。试验期间允许使用0.1%曲安奈德或1.0%氢化可的松乳膏以及口服抗组胺药。
结果
12周后，胸腺五肽治疗的患者比接受安慰剂的患者有显著更大的改善。未发生与胸腺五肽相关的不良事件。
结论
胸腺五肽可能是重度特应性皮炎患者治疗的一种安全有效的辅助药物。
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