Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Nishimori Clinic, Kochi, Japan.
Gut. 2017 Mar;66(3):487-494. doi: 10.1136/gutjnl-2016-312049. Epub 2016 Aug 19.
Corticosteroid has been established as the standard therapy for autoimmune pancreatitis (AIP), but the requirement for maintenance corticosteroid therapy is controversial. We conducted a randomised controlled trial to clarify the efficacy of maintenance corticosteroid therapy in patients with AIP.
We conducted a multicentre, tertiary setting, randomised controlled trial. After the induction of remission with the initial oral prednisolone (PSL) treatment, maintenance therapy with PSL at 5-7.5 mg/day was continued for 3 years or withdrawn at 26 weeks. The primary endpoint was relapse-free survival over 3 years and the secondary endpoint was serious corticosteroid-related complications. All analyses were performed on an intention-to-treat basis.
Between April 2009 and March 2012, 49 patients with AIP were randomly assigned to the maintenance therapy group (n=30) or the cessation group (n=19). Baseline characteristics were not different between the two groups. Relapses occurred within 3 years in 11 out of 19 (57.9%) patients assigned to the cessation group, and in 7 of 30 (23.3%) patients in the maintenance therapy group. The relapse rate over 3 years was significantly lower in the maintenance therapy group than that in the cessation group (p=0.011). The relapse-free survival was significantly longer in the maintenance therapy group than that in the cessation group (p=0.007). No serious corticosteroid-related complications requiring discontinuation of PSL were observed.
Maintenance corticosteroid therapy for 3 years may decrease relapses in patients with AIP compared with those who discontinued the therapy at 26 weeks.
UMIN000001818; Results.
皮质类固醇已被确立为自身免疫性胰腺炎(AIP)的标准治疗方法,但维持皮质类固醇治疗的需求仍存在争议。我们进行了一项随机对照试验,以明确 AIP 患者维持皮质类固醇治疗的疗效。
我们进行了一项多中心、三级设置的随机对照试验。在初始口服泼尼松龙(PSL)治疗诱导缓解后,继续使用 5-7.5mg/天的 PSL 进行维持治疗 3 年或在 26 周时停药。主要终点是 3 年内无复发的生存率,次要终点是严重的皮质类固醇相关并发症。所有分析均基于意向治疗进行。
2009 年 4 月至 2012 年 3 月,49 例 AIP 患者被随机分为维持治疗组(n=30)或停药组(n=19)。两组的基线特征无差异。停药组中有 19 例(57.9%)患者在 3 年内复发,维持治疗组中有 30 例(23.3%)患者复发。维持治疗组 3 年内的复发率明显低于停药组(p=0.011)。维持治疗组的无复发生存率明显长于停药组(p=0.007)。未观察到因严重皮质类固醇相关并发症而需要停用 PSL 的情况。
与在 26 周停药的患者相比,AIP 患者接受 3 年维持皮质类固醇治疗可能会降低复发率。
UMIN000001818;结果。