Zagari Rocco Maurizio, Bianchi-Porro Gabriele, Fiocca Roberto, Gasbarrini Giovanni, Roda Enrico, Bazzoli Franco
Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, Italy.
Gut. 2007 Apr;56(4):475-9. doi: 10.1136/gut.2006.102269. Epub 2006 Oct 6.
Triple therapy is recommended for Helicobacter pylori eradication, yet consensus on the duration of treatment is lacking.
To compare the efficacy and safety of 1- and 2-week regimens of omeprazole, amoxicillin and clarithromycin in a large, multicentre, double-blind and randomised study.
A total of 909 H pylori-positive patients with duodenal ulcer, enrolled in 81 endoscopy units in Italy, were randomised to receive omeprazole, amoxicillin and clarithromycin for either 1 week (OAC1W) or 2 weeks (OAC2W) or omeprazole and amoxicillin for 2 weeks. H pylori eradication was assessed by histological examination and carbon-13 urea breath test 4 weeks after treatment.
Both the intention-to-treat (ITT; n = 907) and per protocol (PP; n = 661) analyses showed no significant differences between the eradication rates of OAC1W (ITT 79.7%; PP 83.6%) and OAC2W (ITT 81.7%; PP 84.9%; ITT p = 0.53; PP p = 0.71). Both triple omeprazole, amoxicillin and clarithromycin regimens gave significantly higher eradication rates compared with omeprazole and amoxicillin treatment (ITT 44.6%; PP 42.8%; p<0.001). Poor compliance was reported in 18.6%, 17.3% and 15.1% (p = 0.51) of patients for OAC2W, OAC1W and omeprazole and amoxicillin, respectively. Adverse events occurred in 9.9% and 9.6% (p = 0.88) of patients for OAC2W and OAC1W, respectively, and in 5.9% for omeprazole and amoxicillin (p = 0.11).
1-week and 2-week triple treatments for H pylori eradication are similar in terms of efficacy, safety and patient compliance.
三联疗法被推荐用于根除幽门螺杆菌，但治疗疗程的共识尚缺。
在一项大型、多中心、双盲随机研究中比较奥美拉唑、阿莫西林和克拉霉素1周与2周治疗方案的疗效和安全性。
意大利81个内镜检查单位共纳入909例幽门螺杆菌阳性十二指肠溃疡患者，随机接受奥美拉唑、阿莫西林和克拉霉素治疗1周（OAC1W）或2周（OAC2W），或奥美拉唑和阿莫西林治疗2周。治疗4周后通过组织学检查和碳-13尿素呼气试验评估幽门螺杆菌根除情况。
意向性分析（ITT；n = 907）和符合方案分析（PP；n = 661）均显示，OAC1W组（ITT 79.7%；PP 83.6%）和OAC2W组（ITT 81.7%；PP 84.9%；ITT p = 0.53；PP p = 0.71）的根除率无显著差异。与奥美拉唑和阿莫西林治疗相比（ITT 44.6%；PP 42.8%；p<0.001），两种三联疗法（奥美拉唑、阿莫西林和克拉霉素）的根除率均显著更高。OAC2W组、OAC1W组和奥美拉唑与阿莫西林组患者的依从性差分别为18.6%、17.3%和15.1%（p = 0.51）。OAC2W组和OAC1W组分别有9.9%和9.6%的患者发生不良事件（p = 0.88），奥美拉唑与阿莫西林组为5.9%（p = 0.11）。
在疗效、安全性和患者依从性方面，1周和2周的三联疗法根除幽门螺杆菌相似。
