大剂量雷贝拉唑钠肠溶胶囊联合含铋剂四联疗法根除幽门螺杆菌的临床效果观察

A randomized controlled trial of double-dose and standard dose rabeprazole enteric-coated capsules quadruple regimens for helicobacter pylori eradication and symptom relief

目的比较2017年最新共识中幽门螺杆菌(Helicobacter pylori,Hp)感染治疗采用10 mg和20 mg两种不同剂量雷贝拉唑钠肠溶胶囊为基础的含铋四联14 d疗法对提高Hp根除率和症状缓解率,并记录不良反应发生率。方法纳入Hp阳性的胃溃疡或十二指肠溃疡的患者随机分组,接受包含不同剂量雷贝拉唑钠肠溶胶囊的四联疗法:试验组:雷贝拉唑钠肠溶胶囊20 mg+克拉霉素片500 mg+阿莫西林胶囊1 000 mg+枸橼酸铋钾片220 mg,bid,疗程14 d;对照组:雷贝拉唑钠肠溶胶囊10 mg+克拉霉素片500 mg+阿莫西林胶囊1 000 mg+枸橼酸铋钾片220 mg,bid,疗程14 d。停药4周后复查^(13)C-呼气试验。观察指标包括:Hp根除率、症状缓解率、不良反应发生的情况。结果本试验共纳入100例患者,其中试验组50例,对照组50例。按照各自的治疗方案治疗后,试验组Hp根除率为90.0%,对照组Hp根除率为82.0%;症状缓解方面,试验组的上腹痛症状缓解率为93.3%,明显高于对照组82.8%,其余腹胀、反酸、烧灼感等症状及不良反应无明显差异。结论遵循Hp感染治疗2017版最新共识,应用20 mg大剂量雷贝拉唑钠肠溶胶囊的含铋四联14 d疗法,较标准10 mg剂量雷贝拉唑四联疗法,可以获得更高的Hp根除率及疼痛缓解率,且并无增加不良反应的风险,值得推广应用。

Objective To compare the efficacy and tolerability of a 14-day double-dose rabeprazole sodium enteric-coated capsules -based quadruple regimen composed of bismuth with a standard-dose rabeprazole quadruple regimen in eradicating Helieobaeter pylori infection and relieving symptoms. And the adverse reaction is recorded. Methods Patients with H. pylori-positive duodenal ulcer disease as well as gastric ulcer were randomly assigned to receive rabeprazole sodium enteric-coated capsules-based quadrupleregimens at different doses： bismuth potassium citrate 220 nag, clarithromyein 500 mg, amoxicillin 1 000 rng, plus either rabeprazole sodium enteric-coated capsules 20 rng bid （experimental group） or 10 rng bid （control group）, all twice daily for 14 days. H. pylori status was determined by 13C-urea breath test after 4 weeks of medication with drawal. Symptomatic relief status and adverse reaction were also determined, Results A total of 100 patients were included into this clinical trial with 50 patients in experimental group and 50 patients in the control group. H. pylori eradication rate （90.0% vs. 82.0%） and pain relieving rate （93.3% vs. 82.8%） of experimental group were significantly higher than those of control group. There was no significantly difference in reliving of flatulence, acid regulation or burning and adverse reaction. Conclusion The 14-day double- dose rabeprazole containing bismuth quadruple regimen achieved both better eradication rate and pain relieving rate than standard-dose rabeprazole quadruple regimens for H. pylori eradication without increased rate of adverse reaction.