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首页> 外文期刊>World Journal of Gastroenterology >Triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H. pylori eradication: a comparative three-armed randomized clinical trial.
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Triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H. pylori eradication: a comparative three-armed randomized clinical trial.

机译：根除幽门螺杆菌的三重，标准四重和基于氨苄青霉素-舒巴坦的四重疗法：一项比较性的三臂随机临床试验。

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AIM: To compare the effectiveness of triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H. pylori eradication in a comparative three-armed randomized clinical trial. METHODS: A total of 360 H. pylori-positive patients suffering from dyspepsia and aging 24-79 years with a median age of 42 years were enrolled in the study and randomly allocated into the following three groups: group A (n = 120) received a standard 1-wk triple therapy (20 mg omeprazole b.i.d., 1000 mg amoxicillin b.i.d., 500 mg clarithromycin b.i.d.); group B (n = 120) received a 10-d standard quadruple therapy (20 mg omeprazole b.i.d., 1000 mg amoxicillin b.i.d., 240 mg colloidal bismuth subcitrate b.i.d., and 500 mg metronidazole b.i.d.); group C (n = 120) received the new protocol, i.e. 375 mg sultamicillin (225 mg ampicillin plus 150 mg sulbactam) b.i.d. (before breakfast and dinner), instead of amoxicillin in the standard quadruple therapy for the same duration. Chi-square test with the consideration ofP<0.05 as significant was used to compare the eradication rates by intention-to-treat and per-protocol analyses in the three groups. RESULTS: The per-protocol eradication rate was 91.81% (101 patients from a total of 110) in group A, 85.84% (97 patients from a total of 113) in group B, and 92.85% (104 patients from a total of 112) in group C. The intention-to-treat eradication rate was 84.17% in group A, 80.83% in group B, and 86.67% in group C. The new protocol yielded the highest eradication rates by both per-protocol and intention-to-treat analyses followed by the standard triple and quadruple regimens, respectively. However, the differences were not statistically significant between the three groups. CONCLUSION: The results of this study provide further support for the equivalence of triple and quadruple therapies in terms of effectiveness, compliance and side-effect profile when administered as first-line treatment for H. pylori infection. Moreover, the new protocol using ampicillin-sulbactam instead of amoxicillin in the quadruple regimen is a suitable first-line alternative to be used in regions with amoxicillin-resistant H. pylori strains.
机译：目的：在一项比较的三臂随机临床试验中，比较三联，标准四联和基于氨苄青霉素-舒巴坦的四联疗法对幽门螺杆菌根除的有效性。方法：总共360名患有消化不良和24-79岁的消化不良，年龄中位数为42岁的幽门螺杆菌阳性患者被纳入研究，并随机分为以下三组：A组（n = 120）标准的1周三联疗法（奥美拉唑20 mg，阿莫西林1000 mg，克拉霉素500 mg）； B组（n = 120）接受10天标准四联疗法（奥美拉唑b.i.d. 20 mg，阿莫西林b.i.d. 1000 mg，次柠檬酸铋胶体b.i.d. 240 mg和甲硝唑b.i.d. 500 mg）; C组（n = 120）接受了新的方案，即375 mg舒他西林（225 mg氨苄西林加150 mg舒巴坦）出生。 （在早餐和晚餐之前），而不是在同一疗程的标准四联疗法中使用阿莫西林。通过P <0.05为显着性的卡方检验，通过意向性治疗和按方案分析比较了三组的根除率。结果：A组的按协议根除率为91.81％（总共110例中的101例），B组为85.84％（总共113例中的97例），以及92.85％（总共112例中的104例） C组）。A组的意图治疗根除率是84.17％，B组是80.83％，C组是86.67％。新方案在按方案和意图实现方面均达到了最高的根除率治疗分析，然后分别进行标准的三重和四重方案治疗。但是，三组之间的差异在统计上并不显着。结论：这项研究的结果为幽门螺杆菌感染的一线治疗提供了三联和四联疗法等效性，有效性，依从性和副作用方面的进一步支持。此外，在四联方案中使用氨苄西林-舒巴坦代替阿莫西林的新方案是适用于具有阿莫西林耐药性幽门螺杆菌菌株的地区的一线替代方案。

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