益生菌治疗溃疡性结肠炎与猪毛滴虫卵:随机、双盲、安慰剂对照临床试验(PROCTO 试验)。

Michelle V Prosberg, Sofie I Halkjær, Bobby Lo, Christina Bremerskov-Köser, Johan F K F Ilvemark, Jakob B Seidelin, Malene F Kristiansen, Anja Kort, Thomas Kallemose, Peter Bager, Flemming Bendtsen, Inge Nordgaard-Lassen, Hanne S Kapel, Helene Kringel, Christian M O Kapel, Andreas M Petersen
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引用次数: 0

摘要

背景与目的证明在中度溃疡性结肠炎患者中,每两周服用 7500 颗鼠毛线虫卵 24 周可减少肠道炎症:方法:对中度活动性溃疡性结肠炎(梅奥评分 6-10 分)患者进行单中心、随机、双盲、安慰剂对照的 2b 期临床试验,与安慰剂相比,每两周服用 7500 颗鼠毛线虫卵 24 周。主要结果临床缓解。次要结果24周时的临床反应、完全无皮质类固醇临床缓解、内镜缓解、12周和24周时的症状缓解以及随时间变化的部分梅奥评分:119名患者随机接受了沙眼衣原体卵母细胞治疗(60人)和安慰剂治疗(59人)。在第24周时,30%的沙眼衣原体卵巢治疗者与34%的安慰剂治疗者实现了临床缓解(RR=0.89;CI:0.52-1.50;P=0.80,ITT)。在所有临床反应亚组中,临床反应均无差异。然而,在试验期间不需要使用皮质类固醇治疗的患者中,在对第12周症状缓解(p=0.01)以及第14周和第18周部分梅奥评分(pConclusions:与安慰剂相比,金黄色葡萄球菌卵巢囊在第24周实现溃疡性结肠炎临床缓解或实现临床梅奥评分降低、完全无皮质类固醇临床缓解或内镜缓解方面并无优势。不过,沙眼衣原体卵巢囊肿治疗在第 12 周时可诱导症状暂时缓解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Probiotic Treatment of Ulcerative Colitis with Trichuris Suis Ova: A Randomised, Double-blinded, Placebo-controlled Clinical Trial [the PROCTO Trial].

Background and aims: To demonstrate that administration of 7500 Trichuris suis ova [TSO] every second week over 24 weeks would reduce the intestinal inflammation in moderate ulcerative colitis.

Methods: A single-centre, randomised, double-blinded, placebo-controlled, phase 2b clinical trial of 7500 Trichuris suis ova every 2 weeks for 24 weeks compared with placebo in moderate activity of ulcerative colitis [Mayo score 6-10] were performed. Primary outcome: clinical remission; secondary outcomes: clinical response at 24 weeks, complete corticosteroid-free clinical remission, endoscopic remission, symptomatic remission at 12 and 24 weeks, and partial Mayo score over time.

Results: In all, 119 patients were randomised to Trichuris suis ova [n = 60] or placebo [n = 59]. At Week 24, clinical remission was achieved in 30% of Trichuris suis ova-treated vs 34% of placebo-treated (risk ratio [RR] = 0.89; 95% confidence interval [CI]: 0.52-1.50; p = 0.80, intention to treat). No difference was found in clinical response in any of the clinical response subgroups. However, in patients who did not need treatment with corticosteroids during the trial, a temporary effect of TSO was seen in the analysis of symptomatic remission at Week 12 [p = 0.01] and the partial Mayo score at Week 14 and Week 18 [p < 0.05 and p = 0.02].

Conclusions: Compared with placebo, Trichuris suis ova administration was not superior in achieving clinical remission at Week 24 in ulcerative colitis or in achieving clinical Mayo score reduction, complete corticosteroid-free clinical remission, or endoscopic remission. However, Trichuris suis ova treatment induced symptomatic temporary remission at Week 12.

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