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

作　　者：蒋逸舟 马凯 崔程 曹鑫 王晓勇 Jiang Yizhou;Ma Kai;Cui Cheng;Cao Xin;Wang Xiaoyong(Department of Gastroenterology,the Affiliated Changzhou No.2 People′s Hospital of Nanjing Medical University,Changzhou 213003,China;Graduate School of Dalian Medical University,Dalian 116044,China)

机构地区：[1]南京医科大学附属常州第二人民医院消化内科,常州213003 [2]大连医科大学研究生院,大连116044

出　　处：《中华消化杂志》2024年第6期361-367,共7页Chinese Journal of Digestion

基　　金：南京医科大学常州医学中心临床研究项目(CMCC202309);常州市卫生健康委员会重大科技项目(ZD202336);常州市“十四五”卫生健康高层次人才培养工程(2022CZBJ051)。

摘　　要：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-effect

关 键 词：幽门螺杆菌 双联疗法 伏诺拉生 小剂量阿莫西林 根除治疗 

分 类 号：R573[医药卫生—消化系统]