Vonoprazan-amoxicillin dual therapy for Helicobacter pylori eradication in Chinese population: A prospective, multicenter, randomized, two-stage study

被引：5

作者：

Huang, Xue-Ping ^{[1
,2
]}

Liu, Yi-Juan ^{[3
]}

Lin, Shao-Wei ^{[4
]}

Shao, Yan-Feng ^{[5
]}

Qiu, Feng ^{[6
]}

Qiu, Qing-Wu ^{[7
]}

Xu, Zhang-Kun ^{[8
]}

Chen, Jin-Xian ^{[9
]}

Chen, Liang-Huo ^{[10
]}

Lin, Zhen-Qun ^{[11
]}

Dai, Wen-Hua ^{[12
]}

Zhang, Ming-Qing ^{[13
]}

Jiang, Qi ^{[14
]}

Xiao, Zhong-Qin ^{[15
]}

Cheng, Xian-Xing ^{[16
]}

Zhang, Xiang-Fei ^{[17
]}

You, Wen-Bin ^{[18
]}

Chen, Wei ^{[18
]}

Li, Long-Qin ^{[19
]}

Lin, Wei-Xing ^{[20
]}

Wang, Yong-Fu ^{[21
]}

Lai, Fu-Jin ^{[22
]}

Chen, Long-Qun ^{[23
]}

Huang, Zhong-Hua ^{[24
]}

Zheng, Wen-Qi ^{[25
]}

Wei, Jin-Qi ^{[26
]}

Lin, Zhi-Hui ^{[1
,2
]}

机构：

[1] Fujian Med Univ, Shengli Clin Med Coll, Dept Gastroenterol, 134 Dongjie, Fuzhou 350000, Fujian Province, Peoples R China

[2] Fujian Prov Hosp, Dept Gastroenterol, Fuzhou 350001, Fujian Province, Peoples R China

[3] Fujian Med Univ, Affiliated Hosp 1, Dept Gastroenterol, Fuzhou, Fujian Province, Peoples R China

[4] Fujian Med Univ, Sch Publ Hlth, Fuzhou 350000, Fujian Province, Peoples R China

[5] Third Peoples Hosp Fujian Prov, Dept Gastroenterol, Fuzhou 350000, Fujian Province, Peoples R China

[6] North Brance Fujian Prov Geriatr Hosp, Fujian Prov Hosp, Dept Gastroenterol, Fuzhou 350000, Fujian Province, Peoples R China

[7] Xiaoao Hosp, Dept Gastroenterol, Fuzhou 350000, Fujian Province, Peoples R China

[8] Fujian Energy Grp, Dept Gastroenterol, Gen Hosp, Fuzhou 350000, Fujian Province, Peoples R China

[9] Second Hosp Zhangzhou, Dept Gastroenterol, Zhangzhou 363000, Fujian Province, Peoples R China

[10] Anxi Country Hosp, Dept Gastroenterol, Quanzhou 362000, Fujian Province, Peoples R China

[11] Zhangzhou Municipal Hosp TCM, Dept Gastroenterol, Zhangzhou 363000, Fujian Province, Peoples R China

[12] Zhangpu Hosp, Dept Gastroenterol, Zhangzhou 363000, Fujian Province, Peoples R China

[13] Xiamen Univ, Affiliated Dongnan Hosp, Dept Gastroenterol, Zhangzhou 363000, Fujian Province, Peoples R China

[14] First Hosp Nanping City, Dept Gastroenterol, Nanping 353000, Fujian Province, Peoples R China

[15] Fujian Nanping Second Hosp, Dept Gastroenterol, Nanping 353000, Fujian Province, Peoples R China

[16] Wuyishan Municipal Hosp, Dept Gastroenterol, Nanping 353000, Fujian Province, Peoples R China

[17] Fuzhou Changle Dist Hosp, Dept Gastroenterol, Fuzhou 350000, Fujian Province, Peoples R China

[18] Changle City Second Hosp, Dept Gastroenterol, Fuzhou 350000, Fujian Province, Peoples R China

[19] Jinjiang Municipal Hosp, Dept Gastroenterol, Quanzhou 362000, Fujian Province, Peoples R China

[20] Fujian Univ Tradit Chinese Med, Fuding Hosp, Dept Gastroenterol, Ningde 352000, Fujian Province, Peoples R China

[21] Liancheng Hosp, Dept Gastroenterol, Longyan 364000, Fujian Province, Peoples R China

[22] Xiapu Cty Hosp, Dept Gastroenterol, Ningde 352000, Fujian Province, Peoples R China

[23] Jinjiang Second Hosp, Dept Gastroenterol, Quanzhou 362000, Fujian Province, Peoples R China

[24] First Hosp Putian City, Dept Gastroenterol, Putian 351100, Fujian Province, Peoples R China

[25] Putian Fude Hosp, Dept Gastroenterol, Putian 351100, Fujian Province, Peoples R China

[26] Sun Yat sen Univ, Affiliated Hosp 5, Dept Gastroenterol, Zhuhai 519000, Guangdong Provi, Peoples R China

来源：

WORLD JOURNAL OF GASTROENTEROLOGY | 2024年 / 30卷 / 27期

关键词：

Helicobacter pylori; Vonoprazan; Amoxicillin; Dual therapy; Bismuth quadruple therapy;

D O I：

10.3748/wjg.v30.i27.3304

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

BACKGROUND The efficacy of Vonoprazan-amoxicillin dual therapy (VAT) in the treatment of Helicobacter pylori (H. pylori) is controversial. AIM To evaluate the efficacy of VAT in the Chinese population. METHODS This prospective, multicenter, randomized, open-label, and two-stage study was conducted at 23 centers in Fujian, China (May 2021-April 2022). H. pylori-infected patients were randomized to bismuth quadruple therapy (BQT), BQT-Vonoprazan (BQT-V), seven-day VAT (VAT-7), ten-day VAT (VAT-10), and fourteen-day VAT (VAT-14) groups. The primary endpoint was the H. pylori eradication rate. The secondary endpoint was the frequency of adverse events. This study was registered with the Chinese Clinical Trial Registry, ChiCTR2100045778. RESULTS In the first stage, VAT-7 and BQT-V groups were selected for early termination because less than 23 among 28 cases were eradicated. In the second stage, the eradication rates for BQT, VAT-10, and VA-14 were 80.2% [95% confidence interval (95%CI): 71.4%-86.8%], 93.2% (86.6%-96.7%), 92.2% (85.3%-96.0%) in the intention-to-treat (ITT) analysis, and 80.9% (95%CI: 71.7%-87.5%), 94.0% (87.5%-97.2%), and 93.9% (87.4%-97.2%) in the per-protocol analysis. The ITT analysis showed a higher eradication rate in the VAT-10 and VAT-14 groups than in the BQT group (P = 0.022 and P = 0.046, respectively). The incidence of adverse events in the VAT-10 and VAT-14 groups was lower than in the BQT group (25.27% and 13.73% vs 37.62%, respectively; P < 0.001). CONCLUSION VAT with a duration of 10 or 14 days achieves a higher eradication rate than the BQT, with a more tolerable safety profile in H. pylori-infected patients in Fujian.

引用

页数：11

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