A Comparison of Two Regimens of Topical Corticosteroids in the Treatment of Patients with Bullous Pemphigoid: A Multicenter Randomized Study
A Comparison of Two Regimens of Topical Corticosteroids in the Treatment of Patients with Bullous Pemphigoid: A Multicenter Randomized Study
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DOI：
10.1038/jid.2008.412
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发表时间：
2009-07-01
影响因子：
6.5
通讯作者：
Bernard, Philippe
中科院分区：
文献类型：
--
作者：
Joly, Pascal;Roujeau, Jean-Claude;Bernard, Philippe
超强效外用皮质类固醇（CS）已被证明可以提高大疱性类天疱疮（BP）患者的生存率。我们评估了使用较低剂量局部CS和较短持续时间的温和方案是否可以更好地改善BP患者的结局。312例BP患者被纳入一项多中心随机对照试验，并根据BP程度分为中度（n = 134）或广泛（n = 178）。患者被随机分配到标准方案（丙酸氯倍他索乳膏，最初每天40 g，CS逐渐减少12个月）或温和方案（每天10- 30 g），CS逐渐减少4个月。与标准方案150/150（100%; P = 0.005）相比，轻度方案156/159（98%）的血压控制率非劣效。无事件生存率，即死亡和危及生命的不良事件的综合结局在两个治疗组之间没有差异（P = 0.77）。然而，通过年龄和Karnofsky评分的考克斯模型调整后，在中度BP患者中观察到轻度方案的强烈有益效果，相对于标准方案，死亡或危及生命的不良事件的风险几乎降低了两倍（风险比= 0.54; 95%置信区间，0.30-0.97; P = 0.039）。这种温和的方案允许CS的累积剂量减少70%，并改善BP患者的结局。
Superpotent topical corticosteroids (CS) have been demonstrated to improve bullous pemphigoid (BP) patients' survival. We assessed whether a mild regimen using lower doses of topical CS and a shorter duration could improve the outcome of BP patients even more. Three-hundred and twelve BP patients were included in a multicenter randomized controlled trial and stratified depending on the extent of BP as moderate (n = 134) or extensive (n = 178). Patients were randomly assigned to the standard regimen (clobetasol propionate cream, 40 g per day initially, with CS tapering over 12 months) or the mild regimen (10-30g per day), with CS tapering over 4 months. A noninferior rate of BP control was obtained with the mild regimen 156/159 (98%) as compared with the standard regimen 150/150 (100%; P = 0.005). Event-free survival, that is, the combined outcome of deaths and life-threatening adverse events did not differ between the two treatment groups (P = 0.77). However, upon adjusting through the Cox model for age and Karnofsky score, a strong beneficial effect of the mild regimen was observed in patients with moderate BP, with an almost twofold decrease in the risk of death or life-threatening adverse events relative to the standard regimen (hazard ratio = 0.54; 95% confidence interval, 0.30-0.97; P = 0.039). This mild regimen allows a 70% reduction of the cumulative doses of CS and improves BP patients' outcome.