Department of Endoscopy, Yokohama City University Hospital, Yokohama, Japan.
Department of Internal Medicine, Tokyo Komagome Metropolitan Hospital, Tokyo, Japan.
J Gastroenterol. 2017 Aug;52(8):955-964. doi: 10.1007/s00535-016-1302-1. Epub 2017 Jan 6.
The effect of maintenance steroid treatment (MST) in reducing the risk of relapse in patients with autoimmune pancreatitis (AIP) remains under debate. The aim of this study was to validate the effect of MST on AIP administered in accordance with the 2010 Japanese consensus guidelines.
The clinical data of patients with (n = 510) from 22 high-volume centers in Japan were studied. The primary endpoints were the relapse rates (RRs) in patients administered MST versus those not administered MST. The secondary endpoints were the optimal dose and duration of MST in terms of steroid toxicity and the predictors of relapse.
The RRs were 10.0% within 1 year, 25.8% within 3 years and 35.1% within 5 years. The RR in the steroid therapy group reached a plateau at 42.7% at 7 years. In terms of the optimal dosage, the overall RR in the MST 5 mg/day group was 26.1%, which was significantly lower than that in the group which had discontinued steroid therapy (45.2%; p = 0.023) or was receiving MST at 2.5 mg/day (43.4%, p = 0.001). The RRs in the group receiving MST at ≥5 mg/day versus the patient group receiving MST at <5 mg/day were 10.6 vs. 10.3% within 1 year, 23.5 vs. 32.9% within 3 years and 32.2 vs. 41.3% within 5 years, respectively (log-rank, p = 0.028). The best cutoff value of the total steroid dose for serious steroid toxicity was 6405 mg, with a moderate accuracy of 0.717 determined using the area under the curve. Presence of diffuse pancreatic swelling [odds ratio OR) 1.745; p = 0.008) and MST at >5 mg/day were identified as predictors of relapse (OR 0.483; p = 0.001).
The RR could continue to increase for 7 years even under MST. Based on our analysis of the side effects of steroid therapy, MST at 5 mg/day for 2 (total 4625 mg) to 3 (total 6425 mg) years might be a rational and safe therapeutic strategy in terms of keeping the RR to <30% while avoiding potential steroid toxicity.
维持类固醇治疗（MST）在降低自身免疫性胰腺炎（AIP）患者复发风险方面的效果仍存在争议。本研究旨在验证根据 2010 年日本共识指南进行的 MST 对 AIP 的治疗效果。
研究纳入了来自日本 22 个高容量中心的 510 例患者的临床数据。主要终点为接受 MST 治疗与未接受 MST 治疗的患者的复发率（RR）。次要终点为 MST 的最佳剂量和持续时间，包括类固醇毒性方面的最佳剂量和持续时间，以及复发的预测因素。
1 年内 RR 为 10.0%，3 年内 RR 为 25.8%，5 年内 RR 为 35.1%。在类固醇治疗组中，RR 在 7 年内达到 42.7%的平台期。在最佳剂量方面，MST 5mg/天组的总 RR 为 26.1%，明显低于停止类固醇治疗组（45.2%；p=0.023）或接受 MST 2.5mg/天组（43.4%；p=0.001）。接受 MST 5mg/天治疗组与接受 MST <5mg/天治疗组的 1 年内 RR 分别为 10.6%和 10.3%，3 年内 RR 分别为 23.5%和 32.9%，5 年内 RR 分别为 32.2%和 41.3%（对数秩检验，p=0.028）。严重类固醇毒性的总类固醇剂量最佳截断值为 6405mg，曲线下面积的中等准确性为 0.717。弥漫性胰腺肿胀（优势比 OR 1.745；p=0.008）和 MST >5mg/天是复发的预测因素（OR 0.483；p=0.001）。
即使在 MST 治疗下，RR 仍可能在 7 年内继续增加。基于我们对类固醇治疗副作用的分析，MST 5mg/天治疗 2（总剂量 4625mg）至 3（总剂量 6425mg）年可能是一种合理且安全的治疗策略，RR 可保持在<30%，同时避免潜在的类固醇毒性。
