Yang Xue-Er, Zhang Sheng-Jun, Liu Yuan, Yao Shuo-Yi, Zhang Su-Xin, Liu Xiao-Ming, Liang Lun-Xi, Wang Fen
Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha 410013, Hunan Province, China.
Hunan Key Laboratory of Nonresolving Inflammation and Cancer, The Third Xiangya Hospital, Central South University, Changsha 410006, Hunan Province, China.
World J Gastroenterol. 2025 Apr 7;31(13):100863. doi: 10.3748/wjg.v31.i13.100863.
Effective acid suppression significantly enhances the eradication rate of ().
To assess the efficacy and safety of high-dose dual therapy (HDDT) utilizing various highly potent antisecretory medications, thereby providing additional clinical guidance for eradication.
The study population comprised untreated patients from three medical centers in central China. From February 10, 2024 to March 31, 2024, 439 subjects were randomly allocated to either the esomeprazole-amoxicillin (EA) or esomeprazole-amoxicillin-clarithromycin-bismuth (B-quadruple) group. Subsequently, from April 1, 2024 to May 10, 2024, 367 subjects were randomly assigned to either the vonoprazan-amoxicillin (VA) or vonoprazan-amoxicillin-clarithromycin (VAC) group. The study recorded treatment efficacy, adverse events, compliance, symptom alleviation, and associated costs.
EA-dual demonstrated non-inferiority to B-quadruple regimen in modified intention-to-treat (mITT) and per-protocol (PP) analyses ( < 0.025). However, the eradication rate of EA was lower than that of the B-quadruple group [70.59% 83.49%, 92.86% 98.38%, 93.94% 98.38%, intention-to-treat (ITT), mITT, PP respectively, < 0.05]. In ITT, mITT, and PP analyses, VA-dual was non-inferior to VAC treatment (84.15% 83.15%, 96.25% 92.73%, 96.75% 93.75%, < 0.025). No significant differences were observed in adverse events, compliance, and symptom relief between groups. VA exhibited the lowest cost. Antibiotic use within 2 years, poor compliance, and suburban residence were associated with reduced eradication efficacy ( < 0.05).
The HDDT based on vonoprazan demonstrated non-inferiority to the VAC triple regimen, suggesting its potential as a recommended first-line treatment for eradication. While B-quadruple therapy showed better eradication rate than EA therapy, the latter proved non-inferior in mITT and PP analyses. Notably, antibiotic use within the preceding two years, adherence to treatment protocols, and patient residence emerged as critical factors influencing eradication success.
有效的抑酸显著提高了（）的根除率。
评估使用各种高效抗分泌药物的高剂量双联疗法（HDDT）的疗效和安全性，从而为（）的根除提供额外的临床指导。
研究人群包括来自中国中部三个医疗中心的未经治疗的（）患者。从2024年2月10日至2024年3月31日，439名受试者被随机分配到埃索美拉唑 - 阿莫西林（EA）组或埃索美拉唑 - 阿莫西林 - 克拉霉素 - 铋（B - 四联）组。随后，从2024年4月1日至2024年5月10日，367名受试者被随机分配到沃克拉唑 - 阿莫西林（VA）组或沃克拉唑 - 阿莫西林 - 克拉霉素（VAC）组。该研究记录了治疗效果、不良事件、依从性、症状缓解情况及相关费用。
在改良意向性分析（mITT）和符合方案分析（PP）中，EA双联疗法显示出不劣于B四联疗法（<0.025）。然而，EA的根除率低于B四联组[意向性分析（ITT）、mITT、PP时分别为70.59%对83.49%，92.86%对98.38%，93.94%对98.38%，P<0.05]。在ITT、mITT和PP分析中，VA双联疗法不劣于VAC治疗（84.15%对83.15%，96.25%对92.73%，96.75%对93.75%，P<0.025）。各组之间在不良事件、依从性和症状缓解方面未观察到显著差异。VA的成本最低。两年内使用过抗生素、依从性差和居住在郊区与根除效果降低相关（P<0.05）。
基于沃克拉唑的HDDT显示出不劣于VAC三联疗法，表明其作为（）根除推荐一线治疗的潜力。虽然B四联疗法的根除率高于EA疗法，但后者在mITT和PP分析中被证明不劣。值得注意的是，前两年内使用抗生素、遵守治疗方案以及患者居住地点是影响根除成功的关键因素。
