A comparison of oral methylprednisolone plus azathioprine or mycophenolate mofetil for the treatment of pemphigus
A comparison of oral methylprednisolone plus azathioprine or mycophenolate mofetil for the treatment of pemphigus
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DOI：
10.1001/archderm.142.11.1447
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发表时间：
2006-11-01
影响因子：
--
通讯作者：
Luger, Thomas A.
中科院分区：
文献类型：
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作者：
Beissert, Stefan;Werfel, Thomas;Luger, Thomas A.
目的：目的：探讨甲基强的松龙联合硫唑嘌呤钠或霉酚酸酯治疗天疱疮的安全性和有效性。设计：前瞻性、多中心、随机、非盲临床试验，比较2组平行的天疱疮患者（寻常型天疱疮和落叶型天疱疮）口服甲泼尼龙加硫唑嘌呤或口服甲泼尼龙加吗替麦考酚酯治疗。设置：德国的13个皮肤科。患者：我们纳入了寻常型天疱疮（n = 33）或落叶型天疱疮（n = 7）患者，这些患者的临床病变提示天疱疮，皮肤活检标本的组织学分析显示表皮内起泡，表皮内IgG的细胞间沉积，抗桥粒芯糖蛋白3和/或抗桥粒芯糖蛋白1自身抗体的免疫印迹分析结果。次要结局指标为安全性特征和缓解持续时间。在18例接受口服甲泼尼龙和硫唑嘌呤的天疱疮患者中，平均+/- SD为74 +/- 127天后达到完全缓解，而平均+/-SD为20天（95%）21例接受口服甲泼尼龙和吗替麦考酚酯治疗的患者，平均SD为91 ± 113天后完全缓解。硫唑嘌呤组使用的甲基强的松龙累积总剂量中位数为8916 mg（SD，+/-29 844 mg），而麦考酚酯组为9334 mg（SD，+/- 13 280 mg）。在6（33%）的18例硫唑嘌呤治疗，3级或4级不良反应被记录在对比4（19%）的21例患者谁收到mycophenolate mofetil.Conclusion：mycophenolate mofetil和硫唑嘌呤表现出相似的疗效，皮质类固醇节约的影响，和安全性的辅助治疗寻常型天疱疮和落叶型天疱疮。
Objective: To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine sodium or mycophenolate mofetil for the treatment of pemphigus.Design: A prospective, multicenter, randomized, non-blinded clinical trial to compare 2 parallel groups of patients with pemphigus (pemphigus vulgaris and pemphigus foliaceus) treated with oral methylprednisolone plus azathioprine or oral methylprednisolone plus mycophenolate mofetil.Settings: Thirteen departments of dermatology in Germany.Patients: We included patients with pemphigus vulgaris (n = 33) or pemphigus foliaceus (n = 7) evidenced by clinical lesions suggestive of pemphigus, intraepidermal blistering on histological analysis of skin biopsy specimens, intercellular deposition of IgG within the epidermis, and immunoblot analysis findings for antidesmoglein 3 and/or antidesmoglein 1 autoantibodies.Main Outcome Measures: The cumulative total methylprednisolone doses and rate of remission. Secondary outcome measures were safety profiles and duration of remission.Results: In 13 (72%) of 18 patients with pemphigus receiving oral methylprednisolone and azathioprine, complete remission was achieved after a mean +/- SD of 74 +/- 127 days compared with 20 (95%) of 21 patients receiving oral methylprednisolone and mycophenolate mofetil in whom complete remission occurred after a mean SD of 91 +/- 113 days. The total median cumulative methylprednisolone dose used was 8916 mg (SD, +/-29 844 mg) in the azathioprine group compared with 9334 mg (SD, +/- 13 280 mg) in the mycophenolate group. In 6 (33%) of 18 patients treated with azathioprine, grade 3 or 4 adverse effects were documented in contrast to 4 (19%) of 21 patients who received mycophenolate mofetil.Conclusion: mycophenolate mofetil and azathioprine demonstrate similar efficacy, corticosteroid-sparing effects, and safety profiles as adjuvants during treatment of pemphigus vulgaris and pemphigus foliaceus.