Gastrounit, Medical Division and Copenhagen IBD Center, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark.
Department of Gastroenterology and Hepatology, Copenhagen University Hospital - Gentofte and Herlev, Herlev, Denmark.
J Crohns Colitis. 2024 Nov 4;18(11):1879-1893. doi: 10.1093/ecco-jcc/jjae095.
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.
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.
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].
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.
证明每两周给予 7500 条猪鞭虫卵[TSO]，共 24 周，可减轻中度溃疡性结肠炎的肠道炎症。
进行了一项为期 24 周的单中心、随机、双盲、安慰剂对照、2b 期临床试验，比较了每两周给予 7500 条猪鞭虫卵与安慰剂治疗中度活动期溃疡性结肠炎[Mayo 评分 6-10]的疗效。主要结局：临床缓解；次要结局：24 周时的临床反应、完全无皮质类固醇的临床缓解、内镜缓解、12 周和 24 周时的症状缓解以及随时间推移的部分 Mayo 评分。
共有 119 例患者被随机分配至猪鞭虫卵[n=60]或安慰剂组[n=59]。在第 24 周，猪鞭虫卵治疗组的临床缓解率为 30%，安慰剂组为 34%（风险比[RR]为 0.89；95%置信区间[CI]为 0.52-1.50；p=0.80，意向治疗）。在任何临床反应亚组中，均未发现临床反应的差异。然而，在试验期间不需要皮质类固醇治疗的患者中，在第 12 周时观察到 TSO 的临时症状缓解作用[p=0.01]，以及第 14 周和第 18 周时的部分 Mayo 评分[p<0.05 和 p=0.02]。
与安慰剂相比，在第 24 周时，猪鞭虫卵治疗并未在溃疡性结肠炎中更有效地实现临床缓解，也未能实现临床 Mayo 评分降低、完全无皮质类固醇的临床缓解或内镜缓解。然而，猪鞭虫卵治疗在第 12 周时诱导了症状的临时缓解。
