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甲泼尼龙联合小剂量甲氨蝶呤治疗大疱性类天疱疮——单中心回顾性分析

Methylprednisolone Plus Low-Dose Methotrexate for Bullous Pemphigoid-A Single Center Retrospective Analysis.

作者信息

Gravani Agoritsa, Gaitanis Georgios, Spyridonos Panagiota, Alexis Ioannis, Tigas Stelios, Bassukas Ioannis D

机构信息

Department of Dermatology, University General Hospital of Ioannina, 45500 Ioannina, Greece.

Department of Skin and Venereal Diseases, Faculty of Medicine, School of Health Sciences, University of Ioannina, 45110 Ioannina, Greece.

出版信息

J Clin Med. 2022 Jun 2;11(11):3193. doi: 10.3390/jcm11113193.

Abstract

Monomodal systemic glucocorticoids remain the mainstay of treatment for bullous pemphigoid (BP). In this retrospective, single-arm study, we evaluated the feasibility (efficacy and tolerability) of the combination of methylprednisolone and low-dose (up to 12.5 mg/week) methotrexate (MP + MTX) for BP. At week 12, 53/55 (96.4%) patients initiated on MP + MTX during a five-year period (potential follow up time: ≥4 years) remained on treatment. At this time-point, BP remission was achieved in all compliant patients (including = 24 cases of dipeptidyl peptidase-4 inhibitors-associated BP; 12-week remission rate: 100% [95% CI: 91.9-100.0%]; mean time to remission: 29.5 days, SEM: 2.3 days) at a mean cumulative MP dose to disease control of 678.4 mg (SEM = 49.4 mg). Eight patients relapsed during follow up (10.81 [95% CI: 5.16-21.72] relapses/100 person years, py), and seven manifested a severe adverse event (6.80 [95% CI: 3.00-14.28] severe adverse events/100 py); however, 73.4% (±7.9%) had suffered neither a relapse nor a SAE at the three-years follow up. Continuing low dose MP intake (≤8 mg/day) beyond week 12 in combination with MTX minimized the risk of a feasibility limiting event ( = 0.013). Conclusively, the combination of methylprednisolone with methotrexate is a promising, safe, and efficient modality for BP patients, which enables rapid glucocorticoid tapering.

摘要

单药全身使用糖皮质激素仍然是大疱性类天疱疮(BP)治疗的主要手段。在这项回顾性单臂研究中,我们评估了甲泼尼龙与低剂量(每周最高12.5 mg)甲氨蝶呤(MP + MTX)联合治疗BP的可行性(疗效和耐受性)。在第12周时,55例在五年期间开始使用MP + MTX治疗的患者中有53例(96.4%)仍在接受治疗(潜在随访时间:≥4年)。在这个时间点,所有依从性良好的患者均实现了BP缓解(包括24例与二肽基肽酶-4抑制剂相关的BP;12周缓解率:100% [95% CI:91.9 - 100.0%];平均缓解时间:29.5天,标准误:2.3天),达到疾病控制时MP的平均累积剂量为678.4 mg(标准误 = 49.4 mg)。8例患者在随访期间复发(10.81 [95% CI:5.16 - 21.72]次复发/100人年,人年),7例出现严重不良事件(6.80 [95% CI:3.00 - 14.28]次严重不良事件/100人年);然而,在三年随访时,73.4%(±7.9%)的患者既没有复发也没有发生严重不良事件。在第12周后继续低剂量MP摄入(≤8 mg/天)并联合MTX可将限制可行性事件的风险降至最低(P = 0.013)。总之,甲泼尼龙与甲氨蝶呤联合使用对于BP患者是一种有前景、安全且有效的治疗方式,能够快速减少糖皮质激素用量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af13/9181025/3ebdd29c9c1d/jcm-11-03193-g001.jpg

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