在日本进行的一项多中心研究——OPTIMUM研究中，使用5-氨基水杨酸维持轻度至中度溃疡性结肠炎患者的实际治疗效果。
Real life results in using 5-ASA for maintaining mild to moderate UC patients in Japan, a multi-center study, OPTIMUM Study.
作者信息
Nagahori Masakazu, Kochi Shuji, Hanai Hiroyuki, Yamamoto Takayuki, Nakamura Shiro, Omuro Soji, Watanabe Mamoru, Hibi Toshifumi
机构信息
Department of Gastroenterology, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyoku, Tokyo, 113-8519, Japan.
Division of Gastroenterology, Matsuyama Red Cross Hospital, 1 Bunkyocho, Matsuyama, Ehime, Japan.
出版信息
BMC Gastroenterol. 2017 Apr 4;17(1):47. doi: 10.1186/s12876-017-0604-y.
BACKGROUND
Efficacy of maintenance therapy in ulcerative colitis (UC) in the remission stage has been reported to depend on release profile or dosing regimen of oral 5-aminosalicylic acid (5-ASA) products used. Aim of this study is to investigate real life results in using oral 5-ASA products for maintaining mild to moderate UC patients in Japan.
METHODS
Adult UC outpatients treated with oral 5-ASA products were enrolled from 379 sites in Japan between July 2012 and July 2013, and followed for 52 weeks. Remission maintenance rate was evaluated by products and dosages. Factors affecting recurrence were also examined.
RESULTS
A total of 5695 UC patients were registered. Among the 4677 patients in whom remission maintenance was observed, remission maintenance rate at week 52 was 80.2%. As for disease duration and dosage, Pentasa® 4000 mg/day in 2 divided doses was administered to 480 (21.0%) patients in remission and 341 (46.6%) patients in active stage, and Asacol® 3600 mg/day in 3 divided doses was administered to 696 (46.4%) patients in remission and 473 (67.3%) patients in active stage. The remission maintenance rate at week 52 by dosage and frequency did not significantly differ between Pentasa® Tablets at 4000 mg/day in 2 divided doses (76.5%) and Asacol® Tablets at 3600 mg/day in 3 divided doses (76.1%, P = 0.7868). Factors affecting the risk of relapse in UC were identified. Significantly persistent remission maintenance was noted in patients in whom duration of remission maintenance until enrollment was 12 to <24 months or ≥24 months relative to the reference category of <3 months (12 to <24 months: HR 0.600 [0.486-0.740], p < 0.0001]; ≥24 months: HR 0.352 [0.289-0.431], p < 0.0001).
CONCLUSIONS
Efficacy of real life results in using oral 5-ASA products for maintaining mild to moderate UC patients was favorable. Maintaining remission for 12 months or longer after induction therapy was shown to reduce recurrence risk thereafter.
TRIAL REGISTRATION
UMIN 000008563 (the date of registration: July 30, 2012), ClinicalTrials.gov NCT01654783 (the date of registration: July 30, 2012).
背景
据报道，溃疡性结肠炎（UC）缓解期维持治疗的疗效取决于所用口服5-氨基水杨酸（5-ASA）产品的释放特性或给药方案。本研究的目的是调查在日本使用口服5-ASA产品维持轻至中度UC患者病情的实际效果。
方法
2012年7月至2013年7月期间，从日本379个地点招募了接受口服5-ASA产品治疗的成年UC门诊患者，并进行了52周的随访。通过产品和剂量评估缓解维持率。还检查了影响复发的因素。
结果
共登记了5695例UC患者。在观察到缓解维持的4677例患者中，第52周的缓解维持率为80.2%。关于病程和剂量，480例（21.0%）缓解期患者和341例（46.6%）活动期患者服用了每日4000 mg分2次服用的颇得斯安（Pentasa®）；696例（46.4%）缓解期患者和473例（67.3%）活动期患者服用了每日3600 mg分3次服用的艾迪莎（Asacol®）。每日4000 mg分2次服用的颇得斯安片（76.5%）和每日3600 mg分3次服用的艾迪莎片（76.1%）在第52周时按剂量和频率计算的缓解维持率无显著差异（P = 0.7868）。确定了影响UC复发风险的因素。与<3个月的参考类别相比，入组前缓解维持时间为12至<24个月或≥24个月的患者，显著持续缓解维持（12至<24个月：HR 0.600 [0.486 - 0.740]，p < 0.0001]；≥24个月：HR 0.352 [0.289 - 0.431]，p < 0.0001）。
结论
在日本，使用口服5-ASA产品维持轻至中度UC患者病情的实际效果良好。诱导治疗后维持缓解12个月或更长时间可降低此后的复发风险。
试验注册
UMIN 000008563（注册日期：2012年7月30日），ClinicalTrials.gov NCT01654783（注册日期：2012年7月30日）。
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