不同疗程伏诺拉生联合小剂量阿莫西林根除幽门螺杆菌的疗效分析

Efficacy of different treatment duration of vonoprazan combined with low-dose amoxicillin in Helicobacter pylori eradication

目的探究不同疗程伏诺拉生+小剂量阿莫西林双联疗法根除幽门螺杆菌(H.pylori)的有效性和安全性。方法纳入南京医科大学附属常州第二人民医院2022年12月1日至2023年11月30日H.pylori阳性的初治患者150例。采用随机数字表法分为10 d疗程组和14 d疗程组,各75例;两组均采用伏诺拉生(20 mg/次、2次/d)联合阿莫西林(0.75 g/次、3次/d)双联疗法治疗,疗程分别为10和14 d。采用意向性治疗集(ITT)和符合方案集(PP)分析比较10 d疗程组和14 d疗程组的H.pylori根除效果。基于PP分析比较两组不良反应发生率。采用成本-效果分析评估2种治疗方案的经济性,基于PP分析探索10 d疗程组根除率的影响因素。统计学方法采用独立样本t检验和卡方检验。结果ITT和PP分析中,10 d疗程组和14 d疗程组分别纳入75、75例和70、72例患者。ITT分析显示,10 d疗程组与14 d疗程组根除率分别为86.7%(65/75)、90.7%(68/75),PP分析显示两组的根除率分别为92.9%(65/70)、94.4%(68/72),差异均无统计学意义(均P>0.05)。PP分析显示,10 d疗程组和14 d疗程组的不良反应发生率分别为12.9%(9/70)和9.7%(7/72),差异无统计学意义(P>0.05)。10 d疗程组和14 d疗程组的成本-效果比分别为3.29和4.19元/%。体重影响H.pylori根除率的最佳截断值为63.5 kg,体表面积影响H.pylori根除率的最佳截断值为1.73 m^(2)。体重≤63.5 kg的患者H.pylori根除率高于体重>63.5 kg的患者[100.0%(42/42)比82.1%(23/28)],体表面积≤1.73 m^(2)的患者H.pylori根除率高于体表面积>1.73 m^(2)的患者[100.0%(45/45)比80.0%(20/25)],差异均有统计学意义(χ^(2)=5.61、6.91,P=0.018、0.009)。结论伏诺拉生+小剂量阿莫西林双联疗法10 d疗程是一种安全、有效的H.pylori初治方案,体重和体表面积是根除率的影响因素。

ObjectiveTo investigate the efficacy and safety of different treatment duration of dual therapy including vonoprazan and low-dose amoxicillin in Helicobacter pylori(H.pylori)eradication.MethodsFrom December 1,2022 to November 30,2023,a total of 150 H.pylori-infected patients who underwent primary treatment in the Affiliated Changzhou No.2 People′s Hospital of Nanjing Medical University were recruited.The patients were divided into 10-day treatment group and 14-day treatment group with 75 patients in each group by random number table method.Patients of both groups were treated with vonoprazan(20 mg each time,twice per day)combined with amoxicillin(0.75 g each time,3 times per day),and the treatment duration was 10 and 14 days,respectively.Intention-to-treat(ITT)and per-protocol(PP)analyses were used to evaluate the eradication efficacy of H.pylori of the 10-day treatment group and 14-day treatment group.PP analysis was used to compare the incidence of adverse events between the 2 groups.Cost-effectiveness analysis was performed to evaluate the economic efficiency of the 2 treatment regimens.Identified factors affecting the eradication rate in the 10-day treatment group based on the PP.Independent sample t-test and chi-square test were used for statistical analysis.ResultsIn ITT and PP analysis,a total of 75,75 patients and 70,72 patients were included in the 10-day treatment group and 14-day treatment group,respectively.The results of ITT analysis showed that the eradication rates of 10-day treatment group and 14-day treatment group were 86.7%(65/75)and 90.7%(68/75),respectively.The results of PP analysis showed that the eradication rates of the 2 groups were 92.9%(65/70)and 94.4%(68/72),respectively,and the differences were not statistically significant(both P>0.05).The results of PP analysis showed that the incidences of adverse events of the 10-day treatment group and 14-day treatment group were 12.9%(9/70)and 9.7%(7/72),respectively,and the difference was not statistically significant(P>0.05).The cost-effectiveness ratios of the 10-day treatment group and 14-day treatment group were 3.29 and 4.19 yuan/%,respectively.The optimal cut-off values were 63.5 kg for body weight and 1.73 m^(2)for body surface area to affect the H.pylori eradication rate.The H.pylori eradication rate of patients with body weight≤63.5 kg was higher than that of patients with body weight>63.5 kg(100.0%,42/42 vs.82.1%,23/28),and the H.pylori eradication rate of the patients with body surface area≤1.73 m^(2)was higher than that of patients with body surface area>1.73 m^(2)(100.0%,45/45 vs.80.3%,20/25),and the differences were statistically significant(χ^(2)=5.61 and 6.91,P=0.018 and 0.009).ConclusionsThe 10-day combination therapy of vonoprazan and low-dose amoxicillin is a safe and effective primary treatment regimen for H.pylori eradication.Body weight and body surface area are influencing factors of the eradication rate.