Efficacy and safety of local glucocorticoids for the treatment of acute radiation-induced intestinal injury: protocol of a multicenter randomized controlled trial

被引：0

作者：

Li, Qianqian ^{[1
]}

Liu, Xiaofeng ^{[2
]}

Shao, Lichun ^{[3
]}

Bao, Xiaohua ^{[4
]}

Bai, Cheng ^{[5
]}

Ge, Junchen ^{[6
]}

Su, Dongshuai ^{[7
]}

Xu, Wenda ^{[8
]}

Jiang, Ran ^{[9
]}

Mu, Zhenbin ^{[10
]}

Dai, Hong ^{[11
]}

Piao, Bingguo ^{[12
]}

Zhang, Yufeng ^{[13
]}

Liang, Haijun ^{[14
]}

Yan, Ying ^{[15
]}

Zhang, Cheng ^{[16
]}

Xu, Xiangbo ^{[1
]}

Chen, Jiang ^{[1
]}

Wang, Jing ^{[2
,6
]}

Zhang, Jian ^{[3
]}

Zhang, Jie ^{[4
]}

Zhang, Yibo ^{[5
]}

Wang, Jing ^{[2
,6
]}

Yang, Qingyu ^{[7
]}

Li, Xiaoqin ^{[8
]}

Zhang, Xiaoyu ^{[9
]}

Hou, Yumei ^{[10
]}

Jiang, Ruosi ^{[11
]}

Jin, Huafeng ^{[12
]}

Qi, Xingshun ^{[1
]}

Wang, Huishan ^{[17
]}

机构：

[1] Gen Hosp Northern Theater Command, Dept Gastroenterol, Shenyang, Peoples R China

[2] 960th Hosp Chinese Peoples Liberat Army, Dept Gastroenterol, Jinan, Peoples R China

[3] Air Force Hosp Northern Theater Command, Dept Gastroenterol, Shenyang, Peoples R China

[4] 964th Hosp Chinese Peoples Liberat Army, Dept Gastroenterol, Changchun, Peoples R China

[5] 967th Hosp Chinese Peoples Liberat Army, Dept Gastroenterol, Dalian, Peoples R China

[6] 962nd Hosp Chinese Peoples Liberat Army, Dept Gastroenterol, Harbin, Peoples R China

[7] 963rd Hosp Chinese Peoples Liberat Army, Resp & Digest Dept, Jiamusi, Peoples R China

[8] 81th Grp Mil Hosp Chinese Peoples Liberat Army, Dept Gastroenterol, Zhangjiakou, Peoples R China

[9] 966th Hosp Chinese Peoples Liberat Army, Dept Gastroenterol, Dandong, Peoples R China

[10] 92493 Hosp Chinese Peoples Liberat Army, Dept Gastroenterol, Huludao, Peoples R China

[11] Liaoning Prov Corps Hosp Chinese Peoples Armed Pol, Dept Internal Med, Shenyang, Peoples R China

[12] 78th Grp Mil Hosp Chinese Peoples Liberat Army, Dept Gastroenterol, Mudanjiang, Peoples R China

[13] 79th Grp Mil Hosp Chinese Peoples Liberat Army, Dept Gastroenterol, Liaoyang, Peoples R China

[14] 96605 Hosp Chinese Peoples Liberat Army, Endoscopy Ctr, Tonghua, Peoples R China

[15] Gen Hosp Northern Theater Command, Dept Radiat Oncol, Shenyang, Peoples R China

[16] Gen Hosp Northern Theater Command, Dept Gen Surg, Shenyang, Peoples R China

[17] Gen Hosp Northern Theater Command, Dept Cardiovasc Surg, Shenyang, Peoples R China

来源：

FRONTIERS IN PHARMACOLOGY | 2025年 / 16卷

关键词：

glucocorticoids; enema; intestinal injury; radiotherapy; randomized controlled trial; RADIOTHERAPY; PATHOGENESIS; ENTERITIS;

D O I：

10.3389/fphar.2025.1529977

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Background and aims 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. Methods 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. Discussion This RCT will provide high-quality evidence to clarify the role of local glucocorticoids for the treatment of ARII. Clinical trial registration ClinicalTrials.gov, identifier NCT06410443.

引用

页数：7

共 20 条

[1] Clinical Features and Management of Acute and Chronic Radiation-Induced Colitis and Proctopathy [J].

Abu-Sbeih, Hamzah ;

Tang, Tenglong ;

Ali, Faisal S. ;

Ma, Weijie ;

Shatila, Malek ;

Luo, Wenyi ;

Tan, Dongfeng ;

Tang, Chad ;

Richards, David M. ;

Ge, Phillip S. ;

Thomas, Anusha S. ;

Wang, Yinghong .

CANCERS, 2023, 15 (12)

[2]

Chen WP, 2021, AM J TRANSL RES, V13, P7270

[3]

Citrin DE, 2017, NEW ENGL J MED, V377, P2200

[4] TOXICITY CRITERIA OF THE RADIATION-THERAPY ONCOLOGY GROUP (RTOG) AND THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER (EORTC) [J].

COX, JD ;

STETZ, J ;

PAJAK, TF .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 1995, 31 (05) :1341-1346

[5] Molecular mechanism of glucocorticoid resistance in inflammatory bowel disease [J].

De Iudicibus, Sara ;

Franca, Raffaella ;

Martelossi, Stefano ;

Ventura, Alessandro ;

Decorti, Giuliana .

WORLD JOURNAL OF GASTROENTEROLOGY, 2011, 17 (09) :1095-1108

[6] Inflammation and Immunity in Radiation Damage to the Gut Mucosa [J].

Francois, Agnes ;

Milliat, Fabien ;

Guipaud, Olivier ;

Benderitter, Andmarc .

BIOMED RESEARCH INTERNATIONAL, 2013, 2013

[7] How patients manage gastrointestinal symptoms after pelvic radiotherapy [J].

Gami, B ;

Harrington, K ;

Blake, P ;

Dearnaley, D ;

Tait, D ;

Davies, J ;

Norman, AR ;

Andreyev, HJN .

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2003, 18 (10) :987-994

[8] Radiation injury and the protein C pathway [J].

Hauer-Jensen, M ;

Fink, LM ;

Wang, JR .

CRITICAL CARE MEDICINE, 2004, 32 (05) :S325-S330

[9] Radiation enteropathy-pathogenesis, treatment and prevention [J].

Hauer-Jensen, Martin ;

Denham, James W. ;

Andreyev, H. Jervoise N. .

NATURE REVIEWS GASTROENTEROLOGY & HEPATOLOGY, 2014, 11 (08) :470-479

[10] Acute radiation proctitis: A sequential clinicopathologic study during pelvic radiotherapy [J].

Hovdenak, N ;

Fajardo, LF ;

Hauer-Jensen, M .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2000, 48 (04) :1111-1117

← 1 2 →