雷贝拉唑联合阿莫西林高剂量二联疗法与铋剂四联疗法根除幽门螺杆菌感染有效性和安全性的比较研究

Efficacy and Safety of Rabeprazole Plus Amoxicillin High-dose Dual Therapy and Bismuth-containing Quadruple Therapy in Eradicating Helicobacter pylori Infection:A Comparison Study

背景:幽门螺杆菌(Hp)感染与胃癌发生密切相关。根除Hp对于胃癌预防非常关键。目的:比较雷贝拉唑联合阿莫西林高剂量二联疗法(HDDT)与铋剂四联疗法根除Hp感染的有效性和安全性。方法:连续纳入2021年7月—2022年7月在上海市嘉定区中心医院就诊、首次^(13)C-尿素呼气试验阳性且符合入组标准的患者,随机分为2组,分别接受HDDT(A组)和铋剂四联疗法(B组)治疗,疗程14 d。A组:雷贝拉唑20 mg bid+阿莫西林1000 mg tid;B组:雷贝拉唑10 mg bid+阿莫西林1000 mg bid+克拉霉素500 mg bid+枸橼酸铋钾220 mg bid。治疗过程中记录不良事件发生情况。治疗结束4周后复查^(13)C-尿素呼气试验。结果:共859例Hp阳性患者入组(A组417例,B组442例),实际完成试验833例(A组409例,B组424例)。A组Hp根除率按符合方案(PP)和意向治疗(ITT)分析分别为96.1%和94.2%,B组分别为91.5%和87.8%,组间差异均无统计学意义(P均>0.05)。A组药物相关不良反应发生率显著低于B组(5.0%对8.8%,P<0.05)。结论:雷贝拉唑联合阿莫西林HDDT和铋剂四联疗法均能获得满意的Hp根除效果,HDDT不良反应发生率低于铋剂四联疗法。

Background:Helicobacter pylori(Hp)infection is closely related to the risk of gastric cancer.Eradication of Hp is crucial for gastric cancer prevention.Aims:To compare the efficacy and safety of rabeprazole plus amoxicillin high-dose dual therapy(HDDT)and bismuth-containing quadruple therapy in eradicating Hp infection.Methods:^(13)C-urea breath test positive naive patients who fulfilled the inclusion criteria were enrolled consecutively from July 2021 to July 2022 at the Shanghai Jiading District Central Hospital.Patients were randomly allocated into two groups receiving HDDT(rabeprazole 20 mg bid+amoxicillin 1000 mg tid;Group A)and bismuth-containing quadruple therapy(rabeprazole 10 mg bid+amoxicillin 1000 mg bid+clarithromycin 500 mg bid+bismuth potassium citrate 220 mg bid;Group B),respectively,for 14 days.Adverse events were recorded.^(13)C-urea breath test was re-examined 4 weeks after eradication therapy.Results:A total of 859 patients were enrolled initially in this study(417 in Group A and 442 in Group B),and 833 completed the trial(409 in Group A and 424 in Group B).In per-protocol(PP)analysis,the eradication rates of Hp in Group A and Group B were 96.1%and 91.5%,respectively;while in intention-to-treat(ITT)analysis,the eradication rates were 94.2%and 87.8%,respectively(all P>0.05).The incidence of drug-related adverse reactions in Group A was significantly lower than that in Group B(5.0%vs.8.8%,P<0.05).Conclusions:Both rabeprazole plus amoxicillin HDDT and bismuth-containing quadruple therapy can achieve optimal eradication rate of Hp infection,and HDDT causes fewer adverse reactions.