伏诺拉生二联方案根除幽门螺杆菌的疗效观察

Observation of the efficacy of Vonoprazan dual therapy in the eradication of Helicobacter pylori

目的本研究针对幽门螺杆菌(Hp)感染的患者,比较含伏诺拉生的大剂量二联方案和含质子泵抑制剂的大剂量二联方案的疗效和安全性。方法采用随机对照,前瞻性的研究方法。研究对象为2023年2月至2023年12月于兰州大学第一医院消化科门诊就诊的243例符合纳入及排除标准的幽门螺杆菌感染患者,随机分为两组,伏诺拉生大剂量二联组(VPZ-HDDT组)予以富马酸伏诺拉生片20 mg,2/天+阿莫西林750 mg,4/天,连续用药14天,PPI大剂量二联组(PPI-HDDT组)予以艾司奥美拉唑40 mg,2次/天+阿莫西林750 mg,4次/天,连续用药14天。患者服药和不良反应发生情况:在开始治疗的第7、14天通过电话或微信随访,与患者沟通并记录。复查13 C或14 C尿素呼气试验需在用药结束后至少1个月。分别采用符合方案治疗(PP)分析、改良意向治疗(mITT)和意向性治疗(ITT)来对比两组患者Hp根除率,同时比较两组依从性和不良反应发生率。结果VPZ-HDDT组和PPI-HDDT组在初次治疗患者中的PP分析根除率分别为94.0%、88.5%(P=0.209),mITT分析根除率分别为91.8%、87.5%(P=0.358),ITT分析根除率分别为86.7%、81.9%(P=0.377);在再次治疗患者中,这两组PP分析与mITT分析根除率一致,分别为87.0%、84.2%(P=0.800),ITT分析根除率分别为83.3%、76.2%(P=0.550);对于难治性Hp的病人,这两组的PP分析与mITT分析根除率也一致,分别为71.4%、50.0%(P=0.429),ITT分析的根除率分别为62.5%、50.0%(P=0.640)。在不同分层中,VPZ-HDDT组的根除率均高于PPI-HDDT组,但差异均无统计学意义。这两组的不良反应发生率及依从性均相似,差异无统计学意义。结论两种二联方案在首次治疗的患者中,都可以达到临床可接受的根除率(>85%),对于再次治疗和难治性的患者,抑酸剂选择伏诺拉生会获益更大。

Objective This paper intends to compare the efficacy and safety of high-dose dual regimens containing Vonoprazan and proton pump inhibitor in patients infected with Helicobacter pylori(H.pylori).Methods A prospective randomized controlled study was conducted.According to inclusion and exclusion criteria.,243 patients with H.pylori infection admitted to the Department of Gastroenterology,the First Hospital of Lanzhou University from February 2023 to December 2023 were enrolled as the research objects.They were randomly divided into two groups.The high-dose dual therapy containing Vonoprazan group(VPZ-HDDT group)was given Vonoprazan fumarate tablet 20mg twice daily plus amoxicillin 750 mg four times daily for 14 days and the high-dose combination group containing PPI(PPI-HDDT group)was given esomeprazole 40 mg twice daily plus amoxicillin 750 mg four times daily for 14 days.Patients were followed up and recorded by telephone or WeChat on the 7th and 14th day of starting treatment for drug intake and occurrence of adverse reactions.Patients were instructed to recheck the 13C or 14C urea breath test at least 1 month after the end of medication.Treatment by protocol(PP)analysis,modified intention to treat(mITT)and intention-to-treat(ITT)analysis were used for H.pylori eradication rates in both groups,and compliance and incidence of adverse reactions were compared between the two groups.Results The eradication rates of the VPZ-HDDT group and the PPI-HDDT group in the initial treatment were 94.0%and 88.5%(P=0.209)by PP analysis,and 91.8%and 87.5%(P=0.358)86.7%by mITT analysis,and 81.9%(P=0.377)by ITT analysis,respectively.In the retreated patients,the PP analysis and mITT analysis eradication rates in these two groups were consistent,87.0%and 84.2%(P=0.800),respectively,and 83.3%and 76.2%(P=0.550)by ITT analysis.For the refractory H.pylori patients,the PP analysis and mITT analysis eradication rates in these two groups were also consistent,71.4%and 50.0%(P=0.429),and the eradication rates of ITT analysis were 62.5%and 50.0%(P=0.640),respectively.In different stratifications,the eradication rates of the VPZ-HDDT group were higher than those of the PPI-HDDT group,but the differences were not statistically significant.The incidence of adverse reactions and compliance of the VPZ-HDDT group and the PPI-HDDT group were similar,with no statistically significant differences.Conclusion Both two combination regimens can achieve clinically acceptable eradication rates(>85%)in the first-time treatment patients.For the retreated and refractory patients,the choice of vonoprazan is more beneficial.