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PPI-阿莫西林四联疗法每日四次优于亚洲幽门螺杆菌根除治疗指南推荐方案:系统评价和荟萃分析。

PPI-amoxicillin dual therapy four times daily is superior to guidelines recommended regimens in the Helicobacter pylori eradication therapy within Asia: A systematic review and meta-analysis.

机构信息

Department of Gastroenterology, Peking University Third Hospital, Beijing, China.

Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China.

出版信息

Helicobacter. 2021 Aug;26(4):e12816. doi: 10.1111/hel.12816. Epub 2021 May 17.

Abstract

BACKGROUND

Systematic reviews suggested that the eradication efficacy of PPI-amoxicillin dual therapy is similar to that of other commonly used regimens. However, it might be affected by the medication frequency. Basic and clinical studies have shown that dual therapy administered four-times daily has a reliable pathophysiological basis and could achieve satisfactory efficacy. Therefore, a systematic review of RCTs of dual therapy and other regimens was conducted to clarify whether dual therapy is superior to guidelines recommended regimens.

MATERIALS AND METHODS

The RCTs comparing dual therapy with other regimens were subjected to meta-analysis to evaluate the eradication rate, adverse reactions, and compliance using a random-effects model.

RESULTS

Dual therapy administered four-times daily had a higher eradication rate than other regimens (intention-to-treat analysis: 89.7% vs 84.6%, OR: 1.52, 95%CI 1.08-2.14, p = 0.02; per-protocol analysis: 92.6% vs 88.2%, OR: 1.54, 95%CI 1.01-2.34, p = 0.04). In first-line therapy, according to intention-to-treat analysis, the eradication rate of dual therapy was higher than other regimens (89.8% vs 84.2%, OR: 1.63, 95%CI 1.02-2.61, p = 0.04). In per-protocol analysis, dual therapy showed better efficacy than others (92.9% vs 88.3%, OR: 1.68, 95% CI 0.98-2.89, p = 0.06), but not significantly. In salvage treatment, no significant difference was detected. The safety of dual therapy was significantly better than other regimens (19.6% vs 36.7%, p < 0.01), but no difference was observed in compliance (p = 0.58).

CONCLUSION

PPI-amoxicillin dual therapy administered four-times daily has better efficacy and safety in H. pylori eradication than current guidelines recommended regimens, especially in first-line therapy, and mainly in Asia.

摘要

背景

系统评价表明,PPI-阿莫西林双联疗法的根除疗效与其他常用方案相似。然而,它可能受到用药频率的影响。基础和临床研究表明,每日四次给药的双联疗法具有可靠的病理生理学基础,并能达到满意的疗效。因此,对双联疗法与其他方案的 RCT 进行了系统评价,以明确双联疗法是否优于指南推荐的方案。

材料与方法

对比较双联疗法与其他方案的 RCT 进行荟萃分析,采用随机效应模型评估根除率、不良反应和依从性。

结果

每日四次给药的双联疗法根除率高于其他方案(意向治疗分析:89.7%对 84.6%,OR:1.52,95%CI 1.08-2.14,p=0.02;按方案分析:92.6%对 88.2%,OR:1.54,95%CI 1.01-2.34,p=0.04)。在一线治疗中,根据意向治疗分析,双联疗法的根除率高于其他方案(89.8%对 84.2%,OR:1.63,95%CI 1.02-2.61,p=0.04)。在按方案分析中,双联疗法的疗效优于其他方案(92.9%对 88.3%,OR:1.68,95%CI 0.98-2.89,p=0.06),但无统计学意义。在补救治疗中,未发现显著差异。双联疗法的安全性明显优于其他方案(19.6%对 36.7%,p<0.01),但依从性无差异(p=0.58)。

结论

与目前指南推荐的方案相比,PPI-阿莫西林四联疗法(每日四次)在幽门螺杆菌根除方面具有更好的疗效和安全性,尤其是在一线治疗中,且主要在亚洲。

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