Efficacy of Different Acid Suppressors in Bismuth-containing Quadruple Therapy as First-line Treatment Against Helicobacter Pylori
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 670
- 试验地点
- 1
- 主要终点
- Rate of eradication success
研究概览
简要总结
Ａretrospective study was conducted to compare the efficacy, safety, and cost-effectiveness of traditional proton pump inhibitors (PPI ) and Potassium-competitive acid blockers ( P-CAB )for clarithromycin-based bismuth-containing quadruple therapy in the management of Helicobacter pylori eradication.
详细描述
This study retrospectively enrolled participants with H. pylori infection who received bismuth quadruple regimen containing clarithromycin. The basic information, treatment results, adverse reactions and compliance of the patients were collected. According to the type of acid inhibitors, participants were divided into traditional PPI group and P-CAB group. Traditional PPI group which were divided into lansoprazole group and esomeprazole group. The eradication rate, safety, compliance of H. pylori in different treatment regimens was evaluated. Multivariate analysis was performed to identify predictors of eradication failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 18-75 years with persistent H. pylori infection.
- •Participants received clarithromycin-based bismuth-containing quadruple therapy.
排除标准
- •Patients received rescue therapy
- •Patients treated with PPI, P-CAB,bismuth and antibiotics in the previous 4 weeks
- •Patients with gastorectomy
- •Currently pregnant or lactating or other conditions unable to receive therapy
- •Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk
- •Severe neurologic or psychiatric disorders
- •Information incomplete
结局指标
主要结局
Rate of eradication success
时间窗: 1 month
Six weeks after completion of treatment, numbers of patients get H.pylori eradicated supported by negative 13C-UBT results will be investigated by an independent researcher. Then eradication rate in each group will be calculated by using intention-to-treat (ITT) analysis, modified intention to treat analysis (MITT) and per-protocol (PP) analysis. The ITT analysis includes all the patients who take at least one dose of the study medications. The MITT analysis is limited to patients who complete follow-up.The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Prevalence of adverse events
时间窗: 1 month
At the follow-up, adverse events complained by patients will be recorded by an independent researcher, meanwhile CTCAE v5.0 was used to evaluate severity of adverse events.The prevalence of adverse events was compared between the two group
Number of participants with good compliance
时间窗: 1 month
Compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good whenmore than 90% or less than 120% of the total pills were taken
次要结局
未报告次要终点
研究者
Xiuli Zuo
Director of Qilu Hospital gastroenterology department
Shandong University