伏诺拉生三联疗法用于幽门螺杆菌感染初治患者的临床观察

Clinical observation of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori infection

目的评价伏诺拉生三联疗法用于幽门螺杆菌(Hp)感染初治患者的疗效与安全性。方法将2022年3月-2023年8月在我院消化内科门诊就诊的198例Hp感染初治患者,按随机数字表法分为伏诺拉生三联疗法组(VAC组,98例)和铋剂四联疗法组(BQT组,100例)。VAC组患者给予富马酸伏诺拉生片20 mg+阿莫西林胶囊1 g+克拉霉素片0.5 g,均为每天2次。BQT组患者给予艾司奥美拉唑镁肠溶片20 mg,每天2次+甲硝唑片0.4 g,每天4次+四环素片0.5 g,每天3次+枸橼酸铋钾胶囊0.6 g,每天2次。两组患者的疗程均为14 d。比较意向性治疗(ITT)、改良意向性治疗(MITT)、方案治疗(PP)分析集中两组患者的Hp根除率;记录两组的不良反应发生情况及用药依从性。结果ITT、MITT、PP分析集中,VAC组患者的Hp根除率均非劣效于BQT组;VAC组患者的1~2级恶心、呕吐、食欲缺乏的发生率显著低于BQT组,依从性良好的患者比例显著高于BQT组(P<0.05)。无论体质量指数(BMI)≤25 kg/m^(2)还是>25 kg/m^(2),两组患者的Hp根除率比较,差异均无统计学意义(P>0.05)。结论伏诺拉生三联疗法用于Hp感染初治患者的疗效非劣效于铋剂四联疗法,且安全性较高,患者用药依从性良好;BMI对Hp根除率无显著影响。

OBJECTIVE To evaluate the therapeutic efficacy and safety of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori(Hp)infection.METHODS From March 2022 to August 2023,198 treatment-naive patients with Hp infection treated at the outpatient service of department of gastroenterology in our hospital were assigned to the vonoprazanbased triple therapy group(VAC group,n=98)and the bismuth-based quadruple therapy group(BQT group,n=100)using the random number table method.Patients in VAC group were given Vonoprazan fumarate tablets(20 mg)+Amoxicillin capsules(1 g)+Clarithromycin tablets(0.5 g),all twice daily.Patients in BQT group were given Esomeprazole magnesium enteric-coated tablets(20 mg,twice daily)+Metronidazole tablets(0.4 g,four times daily)+Tetracycline tablets(0.5 g,three times daily)+Bismuth potassium citrate capsules(0.6 g,twice daily).The treatment course for both groups was 14 days.The Hp eradication rates were compared between the two groups in intention-to-treat(ITT),modified intention-to-treat(MITT),and per-protocol(PP)analysis sets,while adverse reaction occurrence and medication compliance of two groups were recorded.RESULTS In the ITT,MITT and PP analyses sets,the Hp eradication rates in VAC group were non-inferior to those in BQT group.The incidences of grades 1-2 nausea,vomiting,and loss of appetite in VAC group were significantly lower than in BQT group,and the proportion of patients with good compliance was significantly higher in VAC group(P<0.05).Regardless of whether the body mass index(BMI)≤25 kg/m^(2) or>25 kg/m^(2),no statistically significant difference was observed in the Hp eradication rates between the two groups(P>0.05).CONCLUSIONS Vonoprazan-based triple therapy is non-inferior to bismuth-based quadruple therapy in the treatment of treatment-naive patients with Hp infection,with higher safety and good patient medication compliance.BMI has no significant impact on the Hp eradication rate.