伏诺拉生四联疗法治疗顽固性幽门螺杆菌感染的效果

Efficacy of Vonoprazan based quadruple therapy in refractory Helicobacter pylori infection

目的探讨伏诺拉生四联疗法治疗顽固性幽门螺杆菌(Hp)感染的效果。方法选取2021年1月至12月南通市海门区人民医院消化科经标准四联疗法根治失败的92例顽固性Hp感染患者作为研究对象,采用分段随机法分成观察组(47例)和对照组(45例)。观察组采用伏诺拉生+阿莫西林+左氧氟沙星+枸橼酸铋钾治疗;对照组采用艾司奥美拉唑+阿莫西林+左氧氟沙星+枸橼酸铋钾治疗,两组治疗时间均为14 d。停药4周后复测呼气试验,比较两组Hp根除率、消化道症状改善情况及不良反应发生情况。结果共85例(观察组44例,对照组41例)完成试验。意向性(ITT)分析:观察组Hp根除率为87.2%,对照组Hp根除为率57.8%,符合方案集(PP)分析:观察组Hp根除率为93.2%,对照组Hp根除为率63.4%。观察组的Hp根除率高于对照组,差异有统计学意义(P<0.05)。两组患者Hp除菌成功后消化道症状评分低于本组治疗前,差异有统计学意义(P<0.05)。两组的药物不良反应总发生率比较,差异无统计学意义(P>0.05)。结论伏诺拉生四联疗法对顽固性Hp感染患者具有较好的根除效果,有效改善消化道症状,无严重不良反应。

Objective To explore the efficacy of Vonoprazan based quadruple therapy in refractory Helicobacter pylori infection.Methods A total of 92 refractory Helicobacter pylori(Hp)positive patients who failed to cure with standard quadruple therapy in the Department of Gastroenterology,Nantong Haimen People's Hospital from January to December 2021 were selected as the study objects and they were divided into observation group(47 cases)and control group(45 cases)using stratified randomization.Observation group were treated with Vonoprazan,Amoxicillin,Levofloxacin,Bismuth Potassium Citrate,and control group were treated with Esomeprazole,Amoxicillin,Levofloxacin,Bismuth Potassium Citrate.The treatment course was 14 days in two groups.The 13C-urea breath was retested,and the eradication rate of Helicobacter pylori,improvement of digestive symptoms and incidence of adverse reactions were compared of the two groups after 4 weeks of withdrawal.Results A total of 85 patients(44 cases were in observation group and 41 cases were in control group)completed the experiment.According to the intention-to-treat(ITT),the Hp eradication rates were 87.2%in observation group and 57.8%in control group.According to the per-protocol(PP),the Hp eradication rates were 93.2%in observation group and 63.4%in control group.The Hp eradication rate in the observation group was higher than that in the control group,and the difference was statistically significant(P<0.05).The gastrointestinal symptom scores of the two groups after successful Hp sterilization were lower than those before treatment in the same group,and the differences were statistically significant(P<0.05).There was no statistically significant difference in the incidence of adverse drug reactions between the two groups(P>0.05).Conclusion Vonoprazan based quadruple therapy has better curative effect on eradication of refractory Helicobacter pylori infection,obviously relieve the symptom of digestive tract and has no severe adverse reactions.