Tan Nian-di, Liu Xiao-Wei, Liu Cheng-Xia, Li Sheng-Bao, Chen Hong-Hui, Li Xing, Wu Hao, Liao Ai-Jun, Zhen Yan-Bo, Shen Peng-Zhen, Huo Li-Juan, Liu Hong-Ling, Shi Rui-Hua, Zhang Bing-Qiang, Zhang Zhen-Yu, Wang Jian-Ning, Zhan Qiang, Deng Hong, Shu Xu, Tuo Bi-Guang, Wang Qi-Zhi, Du Shi-Yu, Qi Ling-Zhi, Zhang Guo-Xin, Peng Qiong, Wang Bang-Mao, Ye Bin, Chen Min-Hu, Xiao Ying-Lian
Department of Gastroenterology, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, China.
Department of Gastroenterology, Xiangya Hospital Central South University, Changsha, Hunan Province, China.
J Gastroenterol Hepatol. 2022 Nov;37(11):2060-2066. doi: 10.1111/jgh.16000. Epub 2022 Sep 16.
Considering the limitation of varying acid suppression of proton pump inhibitors, this study was aimed to assess the efficacy, safety, and dose-effect relationship of keverprazan, a novel potassium-competitive acid blocker, in the treatment of duodenal ulcer (DU) compared with lansoprazole.
A randomized, double-blind, double-dummy, multicenter, low-dose, high-dose, and positive-drug parallel-controlled study was conducted to verify the non-inferiority of keverprazan (20 or 30 mg) to lansoprazole of 30 mg once daily for 4 to 6 weeks and dose-effect relationship of keverprazan in the treatment of patients with active DU confirmed by endoscopy.
Of the 180 subjects randomized, including 55 cases in the keverprazan_20 mg group, 61 cases in the keverprazan_30 mg group, and 64 cases in the lansoprazole_30 mg group, 168 subjects (93.33%) completed the study. The proportions of healed DU subjects in the keverprazan_20 mg, keverprazan_30 mg, and lansoprazole_30 mg groups were respectively 87.27%, 90.16%, and 79.69% at week 4 (P = 0.4595) and were respectively 96.36%, 98.36%, and 92.19% at week 6 (P = 0.2577). The incidence of adverse events in the keverprazan_20 mg group was lower than that in the lansoprazole_30 mg (P = 0.0285) and keverprazan_30 mg groups (P = 0.0398).
Keverprazan was effective and non-inferior to lansoprazole in healing DU. Based on the comparable efficacy and safety data, keverprazan of 20 mg once daily is recommended for the follow-up study of acid-related disorders. (Trial registration number: ChiCTR2100043455.).
鉴于质子泵抑制剂抑酸效果存在差异的局限性，本研究旨在评估新型钾离子竞争性酸阻滞剂凯普拉唑治疗十二指肠溃疡（DU）的疗效、安全性及剂量效应关系，并与兰索拉唑进行比较。
开展一项随机、双盲、双模拟、多中心、低剂量、高剂量及阳性药物平行对照研究，以验证凯普拉唑（20或30毫克）相对于每日一次30毫克兰索拉唑治疗4至6周的非劣效性，以及凯普拉唑治疗经内镜确诊的活动性DU患者的剂量效应关系。
随机分组的180名受试者中，凯普拉唑20毫克组55例，凯普拉唑30毫克组61例，兰索拉唑30毫克组64例，168名受试者（93.33%）完成了研究。在第4周时，凯普拉唑20毫克组、凯普拉唑30毫克组和兰索拉唑30毫克组DU愈合受试者的比例分别为87.27%、90.16%和79.69%（P = 0.4595），在第6周时分别为96.36%、98.36%和92.19%（P = 0.2577）。凯普拉唑20毫克组不良事件发生率低于兰索拉唑30毫克组（P = 0.0285）和凯普拉唑30毫克组（P = 0.0398）。
凯普拉唑治疗DU有效且不劣于兰索拉唑。基于疗效和安全性数据相当，建议每日一次20毫克凯普拉唑用于酸相关性疾病的后续研究。（试验注册号：ChiCTR2100043455。）
