伏诺拉生与阿莫西林二联方案根除幽门螺杆菌的真实世界研究

Real-world research of vonoprazan and amoxicillin dual therapy for Helicobacter pylori eradication

目的 探讨常规剂量伏诺拉生联合常规剂量阿莫西林二联方案用于幽门螺杆菌(HP)感染初次治疗患者的疗效、安全性及经济性。方法 采用前瞻性队列研究方法,根据纳排标准纳入2021年7月至2022年7月在成都新华医院消化内科门诊诊断为HP感染且初次接受治疗的患者,根据患者用药意愿分别接受伏诺拉生+阿莫西林二联方案(即VA组,富马酸伏诺拉生片20 mg,每天1次+阿莫西林胶囊1.0 g,每天2次,疗程14 d)和经典的含铋剂四联方案(即LJAF组,雷贝拉唑肠溶片20 mg,每天2次+胶体果胶铋胶囊200 mg,每天2次+阿莫西林胶囊1.0 g,每天2次+呋喃唑酮片100 mg,每天2次,疗程14 d)。治疗结束4周后,采用意向治疗(ITT)、改良的意向治疗(MITT)、按方案治疗(PP)分析,比较两组患者的HP清除率;记录其不良反应发生情况,并进行经济性评价。结果 VA组58例患者中,55例完成试验,2例失访,1例因皮疹退出;LJAF组62例患者中,57例完成试验,3例失访,2例因皮疹退出。ITT、MITT、PP分析结果显示,VA组患者的HP根除率分别为86.2%、89.3%、90.9%,LJAF组患者的HP根除率分别为87.1%、91.5%、94.7%,组间比较差异均无统计学意义(P>0.05)。VA组、LJAF组患者的不良反应发生率分别为6.9%、14.5%,组间比较差异亦无统计学意义(P>0.05)。最小成本分析结果显示,VA组患者的治疗总成本为340.9元,低于LJAF组的373.5元。结论 常规剂量伏诺拉生联合常规剂量阿莫西林二联方案用于HP感染初次治疗患者的疗效和安全性与经典的含铋剂四联方案相当,且总成本更低。

OBJECTIVE To explore the efficacy,safety and economics of a dual therapy consisting of conventional dose of vonoprazan combined with conventional dose of amoxicillin in patients with primary treatment of Helicobacter pylori(HP)infection.METHODS Using a prospective cohort study,the patients diagnosed with HP infection and receiving initial treatment in Chengdu Xinhua Hospital from July 2021 to July 2022 were collected according to inclusion and exclusion criteria.The patients were given vonoprazan/amoxicillin dual therapy(i.e.VA group,Vonoprazan fumarate tablets 20 mg,once a day+Amoxicillin capsules 1.0 g,twice a day,14 days)and bismuth-containing quadruple therapy(i.e.LJAF group,Rabeprazole sodium enteric-coated tablets 20 mg,twice a day+Colloidal bismuth pectin capsules 200 mg,twice a day+Amoxicillin capsules 1.0 g,twice a day+Furazolidone tablets 100 mg,twice a day,for 14 days)according to the patient’s medication willingness.Four weeks after the end of the treatment,HP eradication rates of the two groups were compared by using intention-to-treat(ITT),modified intention-to-treat(MITT)and per-protocol(PP)analysis.The occurrence of adverse drug reactions(ADR)was recorded,and an economic evaluation was performed for them.RESULTS Among the 58 patients in VA group,55 completed the trial,2 were lost to follow-up and one withdrew due to rash;among the 62 patients in LJAF group,57 completed the trial,3 were lost to follow-up and 2 withdrew due to rash.Results of ITT,MITT and PP analysis showed that HP eradication rates of VA group were 86.2%,89.3%and 90.9%,and those of LJAF group were 87.1%,91.5%and 94.7%,respectively;there was no statistical significance among different groups(P>0.05).The incidences of ADR in VA group and LJAF group were 6.9%and 14.5%,which were not significantly different(P>0.05).The result of cost minimization analysis showed that the treatment cost of VA group was 340.9 yuan,which was lower than 373.5 yuan of LJAF group.CONCLUSIONS In patients with primary treatment of HP infection,the efficacy and safety of dual therapy of conventional dose of vonoprazan combined with conventional dose of amoxicillin is equivalent to the bismuth-containing quadruplex therapy with low cost.