Miehlke Stephan, Hruz Petr, Vieth Michael, Bussmann Christian, von Arnim Ulrike, Bajbouj Monther, Schlag Christoph, Madisch Ahmed, Fibbe Christiane, Wittenburg Henning, Allescher Hans Dieter, Reinshagen Max, Schubert Stefan, Tack Jan, Müller Michaela, Krummenerl Patrick, Arts Joris, Mueller Ralph, Dilger Karin, Greinwald Roland, Straumann Alex
Centre for Digestive Diseases Eppendorf, Hamburg, Germany.
Department of Gastroenterology & Hepatology, University Hospital, Basel, Switzerland.
Gut. 2016 Mar;65(3):390-9. doi: 10.1136/gutjnl-2014-308815. Epub 2015 Mar 19.
To investigate the efficacy and safety of two different budesonide formulations (effervescent tablet for orodispersible use (BET) and viscous suspension (BVS)) with different daily dosages for short-term treatment of eosinophilic oesophagitis (EoE).
Adults with active EoE (n=76) randomly received 14 days' treatment with either BET 2×1 mg/day (BET1, n=19) or BET 2×2 mg/day (BET2, n=19), or BVS 2×5 mL (0.4 mg/mL)/day (BVS, n=19) or placebo (n=19) in a double-blind, double-dummy fashion, with a 2-week follow-up. Primary end point was histological remission (mean of <16 eosinophils/mm(2 )hpf). Secondary end points included endoscopy score, dysphagia score, drug safety and patient's preference for drug formulation.
Histological remission occurred in 100%, 94.7% and 94.7% of budesonide (BET1, BET2, BVS, respectively) and in 0% of placebo recipients (p<0.0001). The improvement in total endoscopic intensity score was significantly higher in the three budesonide groups compared with placebo. Dysphagia improved in all groups at the end of treatment; however, improvement of dysphagia persisted only in those treated with BET1 (p=0.0196 vs placebo). There were no serious adverse events. Local fungal infection (stained fungi) occurred in two patients of each budesonide group (10.5%). The effervescent tablet was preferred by 80% of patients.
BET or BVS was highly effective and safe for short-term treatment of EoE. The 1 mg (twice daily) dosage was equally effective as the 2 mg twice daily dosage. The majority of patients preferred the effervescent tablet formulation.
NCT02280616; EudraCT number, 2009-016692-29.
研究两种不同布地奈德制剂（口腔崩解泡腾片（BET）和粘性混悬液（BVS））不同日剂量用于短期治疗嗜酸性粒细胞性食管炎（EoE）的疗效和安全性。
76例活动性EoE成人患者以双盲、双模拟方式随机接受14天治疗，分别为BET 2×1mg/天（BET1组，n = 19）或BET 2×2mg/天（BET2组，n = 19），或BVS 2×5mL（0.4mg/mL）/天（BVS组，n = 19）或安慰剂（n = 19），并进行为期2周的随访。主要终点为组织学缓解（平均每高倍视野<16个嗜酸性粒细胞/mm²）。次要终点包括内镜评分、吞咽困难评分、药物安全性及患者对药物剂型的偏好。
布地奈德组（分别为BET1、BET2、BVS）组织学缓解率分别为100%、94.7%和94.7%，安慰剂组为0%（p<0.0001）。与安慰剂相比，三个布地奈德组的内镜总强度评分改善更显著。治疗结束时所有组吞咽困难均有改善；然而，仅BET1治疗组吞咽困难的改善持续存在（与安慰剂相比，p = 0.0196）。无严重不良事件发生。各布地奈德组均有2例患者发生局部真菌感染（真菌染色阳性）（10.5%）。80%的患者更喜欢泡腾片。
BET或BVS用于EoE短期治疗高效且安全。1mg（每日两次）剂量与2mg每日两次剂量疗效相当。大多数患者更喜欢泡腾片剂型。
NCT02280616；欧盟临床试验注册号，2009 - 016692 - 29。
