Li Qianqian, Liu Xiaofeng, Shao Lichun, Bao Xiaohua, Bai Cheng, Ge Junchen, Su Dongshuai, Xu Wenda, Jiang Ran, Mu Zhenbin, Dai Hong, Piao Bingguo, Zhang Yufeng, Liang Haijun, Yan Ying, Zhang Cheng, Xu Xiangbo, Chen Jiang, Wang Jing, Zhang Jian, Zhang Jie, Zhang Yibo, Wang Jing, Yang Qingyu, Li Xiaoqin, Zhang Xiaoyu, Hou Yumei, Jiang Ruosi, Jin Huafeng, Qi Xingshun, Wang Huishan
Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China.
Department of Gastroenterology, The 960th Hospital of the Chinese People's Liberation Army, Jinan, China.
Front Pharmacol. 2025 May 30;16:1529977. doi: 10.3389/fphar.2025.1529977. eCollection 2025.
Acute radiation-induced intestinal injury (ARII) usually occurs after pelvic radiotherapy. Glucocorticoids are potentially effective for the treatment of ARII due to their anti-inflammatory properties, but the currently available evidence is insufficient. Herein, we have designed a multicenter randomized controlled trial (RCT) to explore the efficacy and safety of glucocorticoids for the treatment of ARII.
Overall, 60 patients with ARII will be enrolled. Eligible patients will be stratified according to the grade of ARII and randomly assigned at a ratio of 1:1 to the routine treatment alone and in combination with local glucocorticoids groups. The primary endpoints include the recovery and improvement of ARII. The secondary endpoints include the recurrence and aggravation of ARII and adverse events of glucocorticoids.
This RCT will provide high-quality evidence to clarify the role of local glucocorticoids for the treatment of ARII.
ClinicalTrials.gov, identifier NCT06410443.
急性放射性肠损伤（ARII）通常发生在盆腔放疗后。糖皮质激素因其抗炎特性可能对ARII治疗有效，但目前可得证据不足。在此，我们设计了一项多中心随机对照试验（RCT）以探讨糖皮质激素治疗ARII的疗效和安全性。
总共将纳入60例ARII患者。符合条件的患者将根据ARII分级进行分层，并以1:1的比例随机分配至单纯常规治疗组和联合局部糖皮质激素组。主要终点包括ARII的恢复和改善。次要终点包括ARII的复发和加重以及糖皮质激素的不良事件。
该RCT将提供高质量证据以阐明局部糖皮质激素在ARII治疗中的作用。
ClinicalTrials.gov，标识符NCT06410443。
Zotero 插件