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一项评估CKD-495治疗急慢性胃炎患者疗效和安全性的2期、多中心、随机、双盲、平行组试验。

A Phase 2, Multi-Center, Randomized, Double-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients With Acute and Chronic Gastritis.

作者信息

Park Su Hyun, Lee Oh Young, Lee Yong Chan, Park Kyung Sik, Park Jong Jae, Park Moo In, Song Geun Am, Lee Dong Ho, Jung Hyunsoo, Kim Sung Kook, Kim Tae Nyeun, Choi Suck-Chei, Jee Sam Ryong, Rew Jong Sun, Lee Soo Teik, Choi Eun Kwang, Baik Gwang Ho, Park Shin Jung

机构信息

Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Republic of Korea.

Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.

出版信息

Can J Gastroenterol Hepatol. 2025 Apr 10;2025:2702089. doi: 10.1155/cjgh/2702089. eCollection 2025.

Abstract

CKD-495 is a newly developed drug extracted from Cinnamomum cassia Presl. This phase II study assessed the clinical benefits of CKD-495 in the treatment of acute and chronic gastritis. This study randomly assigned 250 patients with endoscopically-proven gastric mucosal erosion to five groups. The groups received either 75 mg or 150 mg of CKD-495, 100 mg of rebamipide, 60 mg of Artemisiae argyi folium 95% ethanol ext. (20 ⟶ 1) (Stillen; Dong-A ST Co., Ltd., Seoul, Korea), or placebo for 2 weeks, respectively. The primary endpoint was the erosion improvement rate, and the secondary endpoints were erosion cure rates, improvement rates of gastrointestinal symptoms, edema, redness, and hemorrhage. Drug-related adverse events were evaluated. The endoscopic erosion improvement rate was significantly higher in the 75 mg CKD-495 group than in the other groups in both the full analysis set (73% vs. 41%, 45%, 52%, 48% for the 75 mg CKD-495, 150 mg CKD-495, placebo, 60 mg Stillen, and 100 mg rebamipide groups, respectively) and the per-protocol set (PPS) (75% vs. 37%, 45%, 51%, 50%). The cure rate of gastric erosion was significantly higher in the 75 mg CKD-495 group than in the other groups. The improvement rates of hemorrhage erosion were significantly higher in the 150-mg CKD-495 group. No significant differences were observed in the safety profiles. No serious adverse events or drug reactions were observed. These results demonstrate that 75 mg of CKD-495 has excellent efficacy for the treatment of endoscopic and symptomatic improvements for acute and chronic gastritis. ClinicalTrials.gov identifier: NCT03437785.

摘要

CKD - 495是一种新开发的从肉桂中提取的药物。这项II期研究评估了CKD - 495治疗急慢性胃炎的临床疗效。该研究将250例经内镜证实有胃黏膜糜烂的患者随机分为五组。这些组分别接受75毫克或150毫克的CKD - 495、100毫克瑞巴派特、60毫克艾叶95%乙醇提取物(20⟶1)(Stillen;韩国首尔东国制薬株式会社)或安慰剂,为期2周。主要终点是糜烂改善率,次要终点是糜烂治愈率、胃肠道症状、水肿、发红和出血的改善率。评估了药物相关不良事件。在全分析集(75毫克CKD - 495组为73%,而75毫克CKD - 495、150毫克CKD - 495、安慰剂、60毫克Stillen和100毫克瑞巴派特组分别为41%、45%、52%、48%)和符合方案集(PPS)(75%对37%、45%、51%、50%)中,75毫克CKD - 495组的内镜糜烂改善率均显著高于其他组。75毫克CKD - 495组的胃糜烂治愈率显著高于其他组。150毫克CKD - 495组的出血性糜烂改善率显著更高。安全性方面未观察到显著差异。未观察到严重不良事件或药物反应。这些结果表明,75毫克CKD - 495在治疗急慢性胃炎内镜及症状改善方面具有优异疗效。ClinicalTrials.gov标识符:NCT03437785。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2649/12006708/4414ccbc7c81/CJGH2025-2702089.001.jpg

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