背景:最近,一种基于克拉霉素耐药性的简单定制疗法已被实施为幽门螺杆菌(H.幽门螺杆菌)根除治疗。尽管如此,尽管有量身定制的治疗方法和频繁的不良事件,缺乏关于治疗期的研究。本研究旨在根据克拉霉素耐药性比较7天和14天定制治疗方案的幽门螺杆菌根除率。
方法:这个多中心,prospective,随机化,非劣效性试验纳入了幽门螺杆菌阳性患者,这些患者被随机分配到7天和14天治疗方案组,取决于23SrRNA基因点突变是否存在克拉霉素抗性。标准三联疗法(STT)(20mg雷贝拉唑,1克阿莫西林,和500毫克克拉霉素每天两次)或铋四联疗法(BQT)(20毫克雷贝拉唑每天两次,500毫克甲硝唑每日三次,120毫克铋每天四次,500mg四环素每天四次)按克拉霉素耐药性分配。评估根除率和不良事件。
结果:共有314和278名患者被纳入意向治疗(ITT)和符合方案(PP)分析,分别;然而,31例患者失访,而五名患者违反了协议。7天和14天方案在ITT中的根除率相似(7天与14天:78.3%vs.78.3%,p>0.99)和PP(87.9%与89.1%,p=0.851)分析。非劣效性得到证实(p<0.025)。根据克拉霉素耐药(克拉霉素耐药率:28.7%)进行的亚组分析显示,7天和14天STT之间的根除率没有显着差异(90.0%vs.90.1%,p>0.99)和BQT(82.5%与86.5%,p=0.757)。此外,两组的不良事件无显著差异.
结论:根据克拉霉素耐药性的7天三联和四联疗法显示出相似的根除率,与14天治疗相比。
BACKGROUND: Recently, a simple tailored therapy based on clarithromycin resistance has been implemented as Helicobacter pylori (H. pylori) eradication therapy. Nonetheless, despite the tailored therapy and frequent adverse events, studies on treatment period are lacking. This study aimed to compare the H. pylori eradication rates of 7-day and 14-day tailored therapy regimens according to clarithromycin resistance.
METHODS: This multicenter, prospective, randomized, noninferiority trial enrolled H. pylori-positive patients who were randomly assigned to 7-day and 14-day regimen groups, depending on the presence or absence of clarithromycin resistance by 23S rRNA gene point mutations. Standard triple therapy (STT) (20 mg rabeprazole, 1 g amoxicillin, and 500 mg clarithromycin twice daily) or bismuth quadruple therapy (BQT) (20 mg rabeprazole twice daily, 500 mg metronidazole thrice daily, 120 mg bismuth four times daily, and 500 mg tetracycline four times daily) was assigned by clarithromycin resistance. Eradication rates and adverse events were evaluated.
RESULTS: A total of 314 and 278 patients were included in the intention-to-treat (ITT) and per-protocol (PP) analyses, respectively; however, 31 patients were lost to follow-up, whereas five patients violated the protocol. Both the 7-day and 14-day regimens showed similar eradication rates in the ITT (7-day vs. 14-day: 78.3% vs. 78.3%, p > 0.99) and PP (87.9% vs. 89.1%, p = 0.851) analyses. Non-inferiority was confirmed (p < 0.025). A subgroup analysis according to clarithromycin resistance (clarithromycin resistance rate: 28.7%) revealed no significant difference in eradication rates between the 7-day and 14-day STT (90.0% vs. 90.1%, p > 0.99) and BQT (82.5% vs. 86.5%, p = 0.757). Furthermore, adverse events did not significantly differ between the two groups.
CONCLUSIONS: The 7-day triple and quadruple therapy according to clarithromycin resistance showed similar eradication rates, as compared to the 14-day therapy.