Fakheri Hafez, Bakhshi Zeinab, Bari Zohreh, Alhooei Saman
Professor, Department of Gastroenterology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.
Student of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.
Middle East J Dig Dis. 2016 Jan;8(1):51-6. doi: 10.15171/mejdd.2016.07.
BACKGROUND Several large clinical trials and meta-analyses have shown about 20% failure to eradicate Helicobacter pylori (H.pylori), necessitating investigations for second-line treatments. The aim of this study was to evaluate the effects of clarithromycin-containing quadruple regimen after nitroimidazole-containing quadruple therapy failure. METHODS Thirty two patients who had failed 10-day H.pylori treatment with omeprazole, amoxicillin, bismuth subcitrate, and metronidazole (OABM) regimen and 31 patients who had failed 10-day treatment with omeprazole, amoxicillin, bismuth subcitrate, and furazolidone (OAMF) regimen entered the study. They all received omeprazole (20 mg), amoxicillin (1 gr), bismuth subcitrate (240 mg) and clarithromycin (500 mg) twice a day for 10 days. Eight weeks after treatment, H. pylori eradication was assessed by (14)C-urea breath test. RESULTS Totally 61 patients completed the study. According to intention to treat (ITT) analysis, eradication rates by second-line OABC regimen were 84.37% (95% CI= 71.7-96.9%) in OABM group and 77.41% (95% CI= 62.71-92.11%) in OABF group (p=0.756). Per-protocol (pp) eradication rates were 87.09% (95% CI= 75.2-98.8%) and 82.75% (95% CI= 79.4-96%), respectively (p=0.638). Also the cumulative eradication rates by OABC regimen were 80.9% (95% CI= 71.2-90.6%) and 85% (95% CI= 75.9-94%) according to ITT and PP analyses, respectively. Severe side effects were reported in 3.1% of the patients. CONCLUSION Regarding ideal eradication rate (>80%) and very low adverse effects, it seems that clarithromycin-containing quadruple therapy can be an encouraging regimen after nitroimidazole-containing regimen failure.
多项大型临床试验和荟萃分析表明,根除幽门螺杆菌(H.pylori)的失败率约为20%,因此有必要对二线治疗进行研究。本研究旨在评估含硝基咪唑的四联疗法失败后含克拉霉素的四联疗法的效果。方法:32例接受奥美拉唑、阿莫西林、枸橼酸铋钾和甲硝唑(OABM)方案10天幽门螺杆菌治疗失败的患者和31例接受奥美拉唑、阿莫西林、枸橼酸铋钾和呋喃唑酮(OAMF)方案10天治疗失败的患者进入本研究。他们均接受奥美拉唑(20mg)、阿莫西林(1g)、枸橼酸铋钾(240mg)和克拉霉素(500mg),每日2次,共10天。治疗8周后,通过¹⁴C-尿素呼气试验评估幽门螺杆菌根除情况。结果:共有61例患者完成研究。根据意向性分析(ITT),二线OABC方案在OABM组的根除率为84.37%(95%CI=71.7-96.9%),在OABF组为77.41%(95%CI=62.71-92.11%)(p=0.756)。符合方案(PP)根除率分别为87.09%(95%CI=75.2-98.8%)和82.75%(95%CI=79.4-96%)(p=0.638)。根据ITT和PP分析,OABC方案的累积根除率分别为80.9%(95%CI=71.2-90.6%)和85%(95%CI=75.9-94%)。3.1%的患者报告有严重副作用。结论:考虑到理想的根除率(>80%)和极低的不良反应,含克拉霉素的四联疗法在含硝基咪唑方案失败后似乎是一种令人鼓舞的方案。