Efficacy comparison of 7-and 14-day P-CAB based bismuth-containing quadruple regimen with PPI based bismuth-containing quadruple regimen for Helicobacter pylori infection: rationale and design of an open-label, multicenter, randomized controlled trial

被引：2

作者：

Oh, Chang Kyo ^{[1
,6
]}

Lim, Hyun ^{[2
,6
]}

Seo, Seung In ^{[3
,6
]}

Lee, Sang Pyo ^{[4
,6
]}

Bang, Chang Seok ^{[5
,6
]}

Shin, Woon Geon ^{[3
,6
]}

Kim, Jin Bae ^{[1
,6
]}

Jang, Hyun Joo ^{[4
,6
]}

Baik, Gwang Ho ^{[5
,6
]}

机构：

[1] Hallym Univ, Gangnam Sacred Heart Hosp, Dept Internal Med, Coll Med, 1 Singil Ro, Seoul 07441, Peoples R China

[2] Hallym Univ, Sacred Heart Hosp, Coll Med, Dept Internal Med, 22 Gwanpyeong Ro 170 Gil, Anyang 14068, South Korea

[3] Hallym Univ, Kangdong Sacred Heart Hosp, Dept Internal Med, Coll Med, 150 Seongan Ro, Seoul 05355 ac, Peoples R China

[4] Hallym Univ, Dongtan Sacred Heart Hosp, Dept Internal Med, Coll Med, 7 Keunjaebong Gil, Hwaseong 18450, South Korea

[5] Hallym Univ, Chuncheon Sacred Heart Hosp, Dept Internal Med, Coll Med, 77 Sakju Ro, Chunchon 24253, South Korea

[6] Hallym Univ, Inst Liver & Digest Dis, 1 Hallymdaehak Gil, Chunchon 24252, South Korea

来源：

BMC GASTROENTEROLOGY | 2023年 / 23卷 / 01期

关键词：

Helicobacter pylori; Potassium-competitive acid blockers; Proton pump inhibitors; Bismuth-containing quadruple therapy; METAANALYSIS; ERADICATION; THERAPY; TRIPLE;

D O I：

10.1186/s12876-023-03100-y

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Background Owing to its strong acid inhibition, potassium-competitive acid blocker (P-CAB) based regimens for Helicobacter pylori (H. pylori) eradication are expected to offer clinical advantages over proton pump inhibitor (PPI) based regimens. This study aims to compare the efficacy and adverse effects of a 7-day and a 14-day P-CAB-based bismuth-containing quadruple regimen (PC-BMT) with those of a 14-day PPI-based bismuth-containing quadruple regimen (P-BMT) in patients with high clarithromycin resistance.Methods This randomized multicenter controlled clinical trial will be performed at five teaching hospitals in Korea. Patients with H. pylori infection who are naive to treatment will be randomized into one of three regimens: 7-day or 14-day PC-BMT (tegoprazan 50 mg BID, bismuth subcitrate 300 mg QID, metronidazole 500 mg TID, and tetracycline 500 mg QID) or 14-day P-BMT. The eradication rate, treatment-related adverse events, and drug compliance will be evaluated and compared among the three groups. Antibiotic resistance testing by culture will be conducted during the trial, and these data will be used to interpret the results. A total of 366 patients will be randomized to receive 7-day PC-BMT (n = 122), 14-day PC-BMT (n = 122), or 14-day P-BMT (n = 122). The H. pylori eradication rates in the PC-BMT and P-BMT groups will be compared using intention-to-treat and per-protocol analyses.Discussion This study will demonstrate that the 7-day or 14-day PC-BMT is well tolerated and achieve similar eradication rates to those of 14-day P-BMT. Additionally, the 7-day PC-BMT will show fewer treatment-related adverse effects and higher drug compliance, owing to its reduced treatment duration.Trial registration Korean Clinical Research Information Service registry, KCT0007444. Registered on 28 June 2022, https://cris.nih.go.kr/cris/index/index.do.

引用

页数：7

共 28 条

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