Metanat Hassan Ali, Valizadeh Seyed Mohammad, Fakheri Hafez, Maleki Iradj, Taghvaei Tarang, Hosseini Vahid, Bari Zohreh
Inflammatory Diseases of Upper Gastrointestinal Tract Research Center, Department of Gastroenterology, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran.
Helicobacter. 2015 Aug;20(4):299-304. doi: 10.1111/hel.12202. Epub 2015 Mar 4.
Helicobacter pylori (H. pylori) eradication has always been a concern. In our previous study, 14-day hybrid regimen showed ideal results. Based on these findings, we decided to compare the efficacy of 10- and 14-day hybrid regimens for H. pylori eradication.
Two hundred and seventy patients with peptic ulcer disease and H. pylori infection were enrolled in the study. One hundred and thirty-four patients received 10-day hybrid regimen (PACT-10): pantoprazole, 40 mg, and amoxicillin, 1 g, both twice daily for 10 days; plus clarithromycin, 500 mg, and tinidazole, 500 mg, both twice daily just during the last 5 days. One hundred and thirty-six patients received 14-day hybrid regimen (PACT-14): pantoprazole, 40 mg, and amoxicillin, 1 g, both twice a day for 14 days; plus clarithromycin, 500 mg, and tinidazole, 500 mg, both twice daily just for the last 7 days. Eight weeks after treatment, (14) C-urea breath test was performed to evaluate H. pylori eradication.
Two hundred and fifty patients (124 patients in PACT-10 and 126 patients in PACT-14 regimens) completed the study. The intention-to-treat eradication rates were 77.6% (95% confidence interval (CI): 70.6-84.6%) and 86% (95% CI: 80-92%) for the two regimens, respectively (p = .17). Per-protocol eradication rates were 83.8% (95% CI: 80-86%) and 92.8% (95% CI: 88-96%), respectively (p < .01). There were no significant intergroup differences in compliance to treatment or discontinuation of therapy due to severe side effects.
Ten-day hybrid regimen could not achieve acceptable eradication rate. However, 14-day hybrid regimen seems to be an acceptable option for H. pylori eradication in Iran.
幽门螺杆菌（H. pylori）根除一直是一个备受关注的问题。在我们之前的研究中，14天的联合治疗方案显示出理想的效果。基于这些发现，我们决定比较10天和14天联合治疗方案对幽门螺杆菌根除的疗效。
270例患有消化性溃疡疾病且感染幽门螺杆菌的患者纳入本研究。134例患者接受10天联合治疗方案（PACT-10）：泮托拉唑40毫克，阿莫西林1克，均每日两次，共10天；加克拉霉素500毫克和替硝唑500毫克，仅在最后5天每日两次。136例患者接受14天联合治疗方案（PACT-14）：泮托拉唑40毫克，阿莫西林1克，均每日两次，共14天；加克拉霉素500毫克和替硝唑500毫克，仅在最后7天每日两次。治疗8周后，进行（14）C-尿素呼气试验以评估幽门螺杆菌根除情况。
250例患者（PACT-10方案组124例，PACT-14方案组126例）完成了研究。两种方案的意向性治疗根除率分别为77.6%（95%置信区间（CI）：70.6 - 84.6%）和86%（95%CI：80 - 92%）（p = 0.17）。符合方案分析的根除率分别为83.8%（95%CI：80 - 86%）和92.8%（95%CI：88 - 96%）（p < 0.01）。在治疗依从性或因严重副作用而停药方面，两组间无显著差异。
10天联合治疗方案无法达到可接受的根除率。然而，14天联合治疗方案似乎是伊朗根除幽门螺杆菌的一个可接受的选择。
