高剂量二联疗法根除幽门螺杆菌的疗效及安全性分析

Efficacy and safety of high-dose dual therapy in eradicating Helicobacter pylori

背景我国幽门螺杆菌(Helicobacter pylori,H.pylori)感染率居高不下,而高剂量二联疗法(high-dose dual therapy,HDDT)已被逐步应用于临床,并取得较为满意的治疗效果,这与高强度抑酸及抗生素充分发挥作用有关,但基于国产集采药物的相关研究较少.目的探讨基于国产集采药物的高剂量二联疗法根除H.pylori感染的疗效及安全性.方法连续性纳入316例H.pylori感染的初治患者,随机分为2组:HDDT组(艾司奥美拉唑肠溶胶囊20 mg qid,阿莫西林750 mg qid,共14 d)和含铋剂常规四联疗法(Bismuth-containing quadruple therapy,BQT)组(艾司奥美拉唑肠溶胶囊20 mg bid,枸橼酸铋钾胶囊220 mg bid,阿莫西林1000 mg bid,呋喃唑酮片100 mg bid,共14 d),主要观察指标为H.pylori根除率,次要观察指标为两组方案的安全性及患者依从性.结果意向性治疗分析显示HDDT组与BQT组H.pylori根除率分别为88.0%和87.3%,改良意向性治疗分析两组H.pylori根除率分别为91.4%和92.0%,符合方案(PP)分析两组H.pylori根除率分别为93.3%和93.9%,组间比较均无统计学差异.HDDT组总体不良事件发生率显著低于BQT组(P=0.001).两组患者的依从性无统计学差异.结论基于国产集采药物的HDDT的H.pylori根除率与BQT相似,不良事件发生率更低,是临床值得选择的治疗方案.

BACKGROUND The infection rate of Helicobacter pylori(H.pylori)in China remains high,and high-dose dual therapy(HDDT)has been progressively applied in clinical practice and has achieved satisfactory treatment outcomes.This is related to the strong acid inhibition and the full effectiveness of antibiotics.However,there is limited research available on domestically procured drugs.AIM To evaluate the efficacy and safety of high-dose dual therapy based on domestically procured drugs for eradicating H.pylori.METHODS A total of 316 patients with newly diagnosed H.pylori infection were consecutively enrolled and randomly divided into two groups:HDDT group(esomeprazole enteric-coated capsules 20 mg qid and amoxicillin 750 mg qid for a total of 14 d)and bismuth-containing quadruple therapy(BQT)(esomeprazole enteric-coated capsules 20 mg bid,potassium citrate bismuth capsules 220 mg bid,amoxicillin 1000 mg bid,and furazolidone 100 mg bid for a total of 14 d).The primary observation index was the H.pylori eradication rate,and the secondary observation indexes were the safety of and patient compliance to the two treatment regimens.RESULTS Intention-to-treat(ITT)analysis showed that the H.pylori eradication rates in the HDDT and BQT groups were 88.0%and 87.3%,respectively.Modified ITT(MITT)analysis showed H.pylori eradication rates of 91.4%and 92.0%in the two groups,and per-protocol(PP)analysis showed H.pylori eradication rates of 93.3%and 93.9%in the two groups,with no significant difference between the groups(P>0.05).The incidence of adverse events in the HDDT group was significantly lower than that of the BQT group(P=0.001).There was no significant difference in treatment compliance between the two groups(P>0.05).CONCLUSION HDDT based on domestically procured drugs has a similar eradication rate of H.pylori to BQT,but with a lower incidence of adverse events,making it a good treatment option worth considering in clinical practice.