不同剂量伏诺拉生用于幽门螺杆菌感染一线治疗的前瞻性队列研究

Different doses of vonoprazan as the first-line treatment of Helicobacter pylori infection:A prospective cohort study

目的评估低剂量及标准剂量伏诺拉生四联方案治疗幽门螺杆菌(Hp)的效果、安全性、经济学效益及患者依从性。方法选择2023年3—8月在我院确诊Hp感染的531例患者,按所受治疗药物不同分为艾司奥美拉唑(Ebid)组(口服艾司奥美拉唑20 mg,2次/d),标准剂量伏诺拉生(Vbid)组(口服伏诺拉生20 mg,2次/d)及低剂量伏诺拉生(Vqd)组(口服用伏诺拉生20 mg,1次/d),各组患者Hp四联治疗的其余3种药物相同(口服阿莫西林1000 mg,克拉霉素500 mg,枸橼酸铋钾600 mg,均2次/d),疗程14 d。所有患者停药4周后检查Hp根除率[按意向(ITT)分析及按方案(PP)分析]、症状好转情况、不良事件发生情况及患者依从性,对各组方案进行成本-效果分析(行ITT及PP分析)。结果三组患者Hp根除率在ITT及PP分析中均有差异显著(χ_(ITT)^(2)=6.351,P ITT<0.05;χ_(PP)^(2)=7.376,P PP<0.05),且Vbid组根除率均明显优于Ebid组(χ_(ITT)^(2)=6.077,P ITT<0.016;χ_(PP)^(2)=6.821,P PP<0.016)。三组方案均获得较高的症状好转率,但组间无显著差异(P>0.05)。各组发生的不良事件均较轻微,其中Vqd组不良事件发生率显著低于Ebid组(χ^(2)=6.058,P<0.016)。三组患者依从率无显著差异(P>0.05),但均超过95%。ITT及PP分析Vqd组的成本-效果比均低于Vbid、Ebid组。结论低剂量伏诺拉生四联方案与标准剂量疗效相当(两者均优于艾司奥美拉唑四联方案),但具有更好的安全性及成本效益,值得在临床Hp根除治疗中推广。

Objective To investigate the efficacy,safety,compliance,and economic benefits of low-dose or standard-dose vonoprazan quadruple therapy for the eradication of Helicobacter pylori(Hp).Methods A total of 531 patients who were diagnosed with Hp infection in our hospital from March to August 2023 were enrolled and divided into esomeprazole(Ebid)group(oral administration of esomeprazole 20 mg twice a day),standard vonoprazan(Vbid)group(oral administration of vonoprazan 20 mg twice a day),and low-dose vonoprazan(Vqd)group(oral administration of vonoprazan 20 mg once a day),and the remaining three drugs of Hp quadruple therapy were the same for the three groups(oral administration of amoxicillin 1000 mg,cla-rithromycin 500 mg,and bismuth potassium citrate 600 mg,twice a day),with a course of treatment of 14 days.All patients were examined for Hp eradication rate(based on the intention-to-treat[ITT]analysis and the per-protocol[PP]analysis),symptom improvement,adverse events,and patient compliance after 4 weeks of drug withdrawal,and a cost-effectiveness analysis was pe-rformed for the regimens in each group(including the ITT and PP analyses).Results There was a significant difference in Hp eradication rate between the three groups in the ITT and PP analyses(χ_(ITT)^(2)=6.351,P ITT<0.05;χ_(PP)^(2)=7.376,P PP<0.05),and the Vbid group had a significantly better Hp eradication rate than the Ebid group(χ_(ITT)^(2)=6.077,P ITT<0.016;χ_(PP)^(2)=6.821,P PP<0.016).The regimens in all three groups achieved a relatively high symptom improvement rate,with no significant difference between the three groups(P>0.05).All three groups had mild adverse events,and the Vqd group had a significantly lower incidence rate of adverse events than the Ebid group(χ^(2)=6.058,P<0.016).There was no significant difference in compliance rate between the three groups(P>0.05),with a compliance rate of>95%in all three groups.The Vqd group had a lower cost-effectiveness ratio than the Vbid and Ebid groups in both ITT and PP analyses.Conclusion The low-dose vonoprazan quadruple regimen has comparable efficacy to the standard-dose regimen,and both regimens have better efficacy than esomeprazole quadruple regimen.The low-dose vonoprazan quadruple regimen has better safety and cost-effectiveness and thus holds promise for clinical application in Hp eradication therapy.