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Gut: journal of the British Society of Gastroenterology v.66 no.3, 2017년, pp.487 - 494   SCI SCIE
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Randomised controlled trial of long-term maintenance corticosteroid therapy in patients with autoimmune pancreatitis

Masamune, Atsushi (Division of Gastroenterology, Tohoku University Graduate School of Medicine, , Sendai, Japan ) ; Nishimori, Isao (Nishimori Clinic, , Kochi, Japan ) ; Kikuta, Kazuhiro (Division of Gastroenterology, Tohoku University Graduate School of Medicine, , Sendai, Japan ) ; Tsuji, Ichiro (Division of Epidemiology, Department of Health Informatics and Public Health, Tohoku University School of Public Health, Graduate School of Medicine, , Sendai, Japan ) ; Mizuno, Nobumasa (Department of Gastroenterology, Aichi Cancer Center Hospital, , Nagoya, Japan ) ; Iiyama, Tatsuo (Integrated Center for Advanced Medical Technologies (ICAM-Tech), Kochi Medical School, , Kochi, Japan ) ; Kanno, Atsushi (Division of Gastroenterology, Tohoku University Graduate School of Medicine, , Sendai, Japan ) ; Tachibana, Yuichi (Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, , Fukuoka, Japan ) ; Ito, Tetsuhide (Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, , Fukuoka, Japan ) ; Kamisawa, Terumi (Department of Internal Medicine, Tokyo Metropolitan Komagome Hospital, , Tokyo ) ; Uchida, Kazushige ; Hamano, Hideaki ; Yasuda, Hiroaki ; Sakagami, Junichi ; Mitoro, Akira ; Taguchi, Masashi ; Kihara, Yasuyuki ; Sugimoto, Hiroyuki ; Hirooka, Yoshiki ; Yamamoto, Satoshi ; Inui, Kazuo ; Inatomi, Osamu ; Andoh, Akira ; Nakahara, Kazuyuki ; Miyakawa, Hiroyuki ; Hamada, Shin ; Kawa, Shigeyuki ; Okazaki, Kazuichi ; Shimosegawa, Tooru ;
  • 초록  

    Objective 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. Design 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initial oral prednisolone (PSL) treatment, maintenance therapy with PSL at 5–7.5 mg/day was continued for 3 years or withdrawn at 26 weeks.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. Results 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. Conclusions Maintenance corticosteroid therapy for 3 years may decrease relapses in patients with AIP compared with those who discontinued the therapy at 26 weeks. Trial registration number UMIN000001818; Results.


  • 주제어

    PANCREATIC DISEASE .   AUTOIMMUNE DISEASE.  

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