A comparison of oral and topical corticosteroids in patients with bullous pemphigoid
A comparison of oral and topical corticosteroids in patients with bullous pemphigoid
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DOI：
10.1056/nejmoa011592
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发表时间：
2002-01-31
影响因子：
158.5
通讯作者：
Bernard, P
中科院分区：
文献类型：
--
作者：
Joly, P;Roujeau, JC;Bernard, P
背景：大疱性类天疱疮是老年人最常见的自身免疫性水疱性皮肤病。由于老年人对口服皮质类固醇的标准方案的耐受性较低，我们研究了高效外用皮质类固醇是否可以降低死亡率，同时控制diseases.Methods：共341例大疱性类天疱疮患者参加了一项随机，多中心试验和分层，根据其疾病的严重程度（中度或广泛）。患者被随机分配接受局部丙酸氯倍他索乳膏（40 g/天）或口服泼尼松（中度疾病患者每天每公斤体重0.5 mg，广泛疾病患者每天每公斤体重1 mg）。结果：在188例大疱性类天疱疮患者中，外用糖皮质激素上级口服泼尼松（P=0.02）。局部皮质类固醇组的一年生存率为76%，口服泼尼松组为58%。局部皮质类固醇组93例患者中有92例（99%）和口服泼尼松组95例患者中有86例（91%，P=0.02）在3周内疾病得到控制。局部皮质类固醇组93例患者中有27例（29%）发生严重并发症，口服泼尼松组95例患者中有51例（54%，P=0.006）。在153例中度大疱性类天疱疮患者中，局部皮质类固醇组和口服泼尼松组在总生存率、三周控制率或严重并发症发生率方面无显著差异。结论：局部皮质类固醇治疗对中度和重度大疱性类天疱疮均有效，且上级优于口服皮质类固醇治疗。（新英格兰医学杂志2002;346：321-7。）版权所有（C）2002马萨诸塞州医学会。
Background: Bullous pemphigoid is the most common autoimmune blistering skin disease of the elderly. Because elderly people have low tolerance for standard regimens of oral corticosteroids, we studied whether highly potent topical corticosteroids could decrease mortality while controlling disease.Methods: A total of 341 patients with bullous pemphigoid were enrolled in a randomized, multicenter trial and stratified according to the severity of their disease (moderate or extensive). Patients were randomly assigned to receive either topical clobetasol propionate cream (40 g per day) or oral prednisone (0.5 mg per kilogram of body weight per day for those with moderate disease and 1 mg per kilogram per day for those with extensive disease). The primary end point was overall survival.Results: Among the 188 patients with extensive bullous pemphigoid, topical corticosteroids were superior to oral prednisone (P=0.02). The one-year survival rate was 76 percent in the topical-corticosteroid group and 58 percent in the oral-prednisone group. Disease was controlled at three weeks in 92 of the 93 patients in the topical-corticosteroid group (99 percent) and 86 of the 95 patients in the oral-prednisone group (91 percent, P=0.02). Severe complications occurred in 27 of the 93 patients in the topical-corticosteroid group (29 percent) and in 51 of the 95 patients in the oral-prednisone group (54 percent, P=0.006). Among the 153 patients with moderate bullous pemphigoid, there were no significant differences between the topical-corticosteroid group and the oral-prednisone group in terms of overall survival, the rate of control at three weeks, or the incidence of severe complications.Conclusions: Topical corticosteroid therapy is effective for both moderate and severe bullous pemphigoid and is superior to oral corticosteroid therapy for extensive disease. (N Engl J Med 2002;346:321-7.) Copyright (C) 2002 Massachusetts Medical Society.