背景:系统评价提示PPI-阿莫西林双重治疗的根除疗效与其他常用方案相似。然而,它可能会受到用药频率的影响。基础和临床研究表明,每日四次双重治疗具有可靠的病理生理基础,可取得满意的疗效。因此,我们对双联疗法和其他方案的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.
方法:将双重治疗与其他治疗方案的随机对照试验进行荟萃分析,以评估根除率,不良反应,和使用随机效应模型的依从性。
结果:每日四次双重治疗的根除率高于其他治疗方案(意向治疗分析:89.7%vs84.6%,OR:1.52,95CI1.08-2.14,p=0.02;符合方案分析:92.6%vs88.2%,OR:1.54,95CI1.01-2.34,p=0.04)。在一线治疗中,根据意向治疗分析,双重疗法的根除率高于其他方案(89.8%vs84.2%,OR:1.63,95CI1.02-2.61,p=0.04)。在符合方案分析中,双重疗法的疗效优于其他疗法(92.9%vs88.3%,OR:1.68,95%CI0.98-2.89,p=0.06),但不是很重要。在抢救治疗中,没有检测到显著差异。双重疗法的安全性明显优于其他方案(19.6%vs36.7%,p<0.01),但依从性无差异(p=0.58).
结论:PPI-阿莫西林双联疗法每日四次根除幽门螺杆菌的疗效和安全性优于目前的指南推荐方案,尤其是在一线治疗中,主要在亚洲。
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.
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).
CONCLUSIONS: 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.