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一项针对痤疮患者的外用0.05%异维A酸、5%过氧化苯甲酰凝胶和安慰剂的双盲评估。

A double-blind evaluation of topical isotretinoin 0.05%, benzoyl peroxide gel 5% and placebo in patients with acne.

作者信息

Hughes B R, Norris J F, Cunliffe W J

机构信息

Department of Dermatology, General Infirmary, Leeds.

出版信息

Clin Exp Dermatol. 1992 May;17(3):165-8. doi: 10.1111/j.1365-2230.1992.tb00196.x.

DOI:10.1111/j.1365-2230.1992.tb00196.x
PMID:1451291
Abstract

A double-blind, randomized study comparing isotretinoin gel (Isotrex), its vehicle base, and benzoyl peroxide was performed on 77 patients with mild to moderate acne vulgaris. The effect of treatment was assessed by acne grade and lesion count. The vehicle base had no effect, but both active groups produced significant improvements. Benzoyl peroxide and isotretinoin significantly reduced non-inflamed lesions at 4 (P < 0.05), 8 (P < 0.01), 12 (P < 0.01) weeks. Benzoyl peroxide had a more rapid effect on inflamed lesions, their being significant reductions at 4, 8 and 12 weeks (P < 0.01), whereas with isotretinoin there was a significant improvement at 12 weeks (P < 0.01). In addition, compared to placebo, both active treatments significantly reduced inflamed and non-inflamed lesions. Acne grade had improved significantly in the benzoyl peroxide group by 4 weeks (P < 0.01) and in the isotretinoin group by 8 weeks (P < 0.05). No significant change in haematological or biochemical parameters occurred. An irritant dermatitis occurred equally with both treatments but was well tolerated by the patients. This data confirms the clinical benefit of benzoyl peroxide in acne. The initial effect of isotretinoin on non-inflamed lesions in this study suggests that the prime mode of action is on comedone formation or separation whereas benzoyl peroxide has an effect on both comedones and inflammation.

摘要

对77例轻至中度寻常痤疮患者进行了一项双盲随机研究,比较异维A酸凝胶(Isotrex)、其赋形剂基质和过氧化苯甲酰的疗效。通过痤疮分级和皮损计数评估治疗效果。赋形剂基质无作用,但两个活性组均产生了显著改善。过氧化苯甲酰和异维A酸在第4周(P<0.05)、第8周(P<0.01)、第12周(P<0.01)时显著减少非炎性皮损。过氧化苯甲酰对炎性皮损起效更快,在第4、8和12周时显著减少(P<0.01),而异维A酸在第12周时显著改善(P<0.01)。此外,与安慰剂相比,两种活性治疗均显著减少炎性和非炎性皮损。过氧化苯甲酰组在4周时痤疮分级显著改善(P<0.01),异维A酸组在8周时显著改善(P<0.05)。血液学或生化参数无显著变化。两种治疗均出现刺激性皮炎,但患者耐受性良好。该数据证实了过氧化苯甲酰治疗痤疮的临床益处。本研究中异维A酸对非炎性皮损的初始作用表明其主要作用方式是对粉刺形成或分离的影响,而过氧化苯甲酰对粉刺和炎症均有作用。

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