Dong Peiwen, Lin Lin, Sun Kaidi, Tang Feng, Li Qian, Zhou Xinxu, Liu Fuli, Yang Zhilin, Li Jiao, Jiang Lin, Zhao Ping, Sun Xiaobin, Wang Qiong
The Third People's Hospital of Chengdu, The Affiliated Hospital of Southwest Jiaotong University, Chengdu, Sichuan, China.
BMC Gastroenterol. 2025 May 26;25(1):406. doi: 10.1186/s12876-025-03981-1.
The aim of this study was to explore the accuracy of the diagnosis of gastro-esophageal reflux disease (GERD) through tegoprazan treatment trials, and to analyze factors that may influence test accuracy.
This was a single-blind, single-arm 2 weeks tegoprazan treatment trials from March 2023 to April 2024. Patients with 'typical' reflux or heartburn as their most troublesome symptom who were considered likely to have GERD were recruited.: Patients were submitted to endoscopy and/or esophageal pH monitoring. After the recording patient used tegoprazan for 2 weeks. This was defined as positive for tegoprazan therapy if the scores for symptoms have decreased to 50%, 75% and 100% of the baseline after 1 and 2 weeks. Calculate different sensitivity, specificity and Youden index for each criterion.
This represents a mid-term report from the study, with 98 and 91 fully evaluable at one and two weeks. The Youden index indicated that a symptom relief of > 75% after one week offers greater diagnostic value with sensitivity and specificity of 77.5% and 51.9%. Multivariate regression analysis indicated that lower BMI, preference for coffee, endoscopic mucosal erosion, ineffective esophageal peristalsis and positive SAP are independent risk factors predicting the efficacy of P-CAB treatment.
The P-CAB test (tegoprazan) presents a promising tool for the diagnosis of GERD. A one-week treatment with a criterion of 75% reduction in symptom scores from baseline may be the most cost-effective approach.
chictr.org.cn registration number ChiCTR2200065994.
本研究旨在通过替戈拉赞治疗试验探讨胃食管反流病（GERD）诊断的准确性，并分析可能影响检测准确性的因素。
这是一项从2023年3月至2024年4月进行的为期2周的单盲、单臂替戈拉赞治疗试验。招募以“典型”反流或烧心为最困扰症状且被认为可能患有GERD的患者。患者接受内镜检查和/或食管pH监测。记录后患者使用替戈拉赞2周。如果症状评分在1周和2周后降至基线的50%、75%和100%，则定义为替戈拉赞治疗阳性。计算每个标准的不同敏感性、特异性和尤登指数。
这是该研究的中期报告，在1周和2周时有98例和91例可进行全面评估。尤登指数表明，1周后症状缓解>75%具有更大的诊断价值，敏感性和特异性分别为77.5%和51.9%。多因素回归分析表明，较低的体重指数、对咖啡的偏好、内镜下黏膜糜烂、食管蠕动无效和阳性SAP是预测P-CAB治疗疗效的独立危险因素。
P-CAB试验（替戈拉赞）是一种有前景的GERD诊断工具。以症状评分较基线降低75%为标准进行为期1周的治疗可能是最具成本效益的方法。
chictr.org.cn注册号ChiCTR2200065994。
