Abstract：
BACKGROUND: Helicobacter pylori (H. pylori) is strongly associated with peptic ulcer disease and gastric cancer. We evaluated two triple therapy regimens comprising esomeprazole, high dose bismuth, and different doses of amoxicillin for first-line H. pylori eradication.
METHODS: Two hundred patients with dyspepsia and naive H. pylori infection were randomly assigned into two groups (n = 100). Both groups were treated for 14 days similarly with esomeprazole (40 mg, twice daily) and bismuth subcitrate (240 mg, three times daily), but the dose of amoxicillin was varied between Groups A (750 mg) and B (1000 mg) three times daily. Treatment compliance and side effect were evaluated following the therapies and after 8 weeks, a negative test of stool H. pylori antigen confirmed eradication.
RESULTS: The two groups were comparable with respect to sex and age. According to intention to treat analysis, eradication rates were 80% (95% CI: 77.2%-82.8%) and 90% (95% CI: 84.1%-95.9%) in A and B groups, respectively (p = 0.22). Per-protocol eradication rates were 87% (95% CI: 80.4%-93.6%) and 92.8% (95% CI: 87.7%-97.9%), respectively (p = 0.23). Severe adverse effects were 3% and 2%, respectively (p = 0.34).
CONCLUSIONS: High dose esomeprazole, amoxicillin and bismuth achieved 92.8% cure rates per protocol in a country with a high background rate of resistance. Additional studies are needed to ascertain whether this therapy can be further improved. Until then, it can be recommended as a first-line H. pylori eradication in north of Iran.
METHODS: Two hundred patients with dyspepsia and naive H. pylori infection were randomly assigned into two groups (n = 100). Both groups were treated for 14 days similarly with esomeprazole (40 mg, twice daily) and bismuth subcitrate (240 mg, three times daily), but the dose of amoxicillin was varied between Groups A (750 mg) and B (1000 mg) three times daily. Treatment compliance and side effect were evaluated following the therapies and after 8 weeks, a negative test of stool H. pylori antigen confirmed eradication.
RESULTS: The two groups were comparable with respect to sex and age. According to intention to treat analysis, eradication rates were 80% (95% CI: 77.2%-82.8%) and 90% (95% CI: 84.1%-95.9%) in A and B groups, respectively (p = 0.22). Per-protocol eradication rates were 87% (95% CI: 80.4%-93.6%) and 92.8% (95% CI: 87.7%-97.9%), respectively (p = 0.23). Severe adverse effects were 3% and 2%, respectively (p = 0.34).
CONCLUSIONS: High dose esomeprazole, amoxicillin and bismuth achieved 92.8% cure rates per protocol in a country with a high background rate of resistance. Additional studies are needed to ascertain whether this therapy can be further improved. Until then, it can be recommended as a first-line H. pylori eradication in north of Iran.
摘要：
背景：幽门螺杆菌(H.pylori）与消化性溃疡和胃癌密切相关。我们评估了两种三联疗法，包括埃索美拉唑，高剂量铋,和不同剂量的阿莫西林用于一线根除幽门螺杆菌。
方法：将200名消化不良和单纯幽门螺杆菌感染的患者随机分为两组（n=100）。两组均接受埃索美拉唑（40mg，每天两次）和次柠檬酸铋（240毫克，每天三次)，但阿莫西林的剂量在A组(750mg)和B组(1000mg)之间每天3次不同.治疗后和8周后评估治疗依从性和副作用，粪便幽门螺杆菌抗原检测阴性证实根除。
结果：两组在性别和年龄方面具有可比性。根据意向治疗分析，A组和B组根除率分别为80%(95%CI:77.2%-82.8%)和90%(95%CI:84.1%-95.9%),分别(p=0.22)。按方案根除率为87％（95％CI：80.4％-93.6％）和92.8％（95％CI：87.7％-97.9％），分别(p=0.23)。严重不良反应分别为3%和2%,分别(p=0.34)。
结论：高剂量埃索美拉唑，在一个背景耐药率较高的国家，阿莫西林和铋每方案的治愈率为92.8％。需要进一步的研究来确定这种疗法是否可以进一步改善。在那之前,它可以被推荐为在伊朗北部一线根除幽门螺杆菌。
方法：将200名消化不良和单纯幽门螺杆菌感染的患者随机分为两组（n=100）。两组均接受埃索美拉唑（40mg，每天两次）和次柠檬酸铋（240毫克，每天三次)，但阿莫西林的剂量在A组(750mg)和B组(1000mg)之间每天3次不同.治疗后和8周后评估治疗依从性和副作用，粪便幽门螺杆菌抗原检测阴性证实根除。
结果：两组在性别和年龄方面具有可比性。根据意向治疗分析，A组和B组根除率分别为80%(95%CI:77.2%-82.8%)和90%(95%CI:84.1%-95.9%),分别(p=0.22)。按方案根除率为87％（95％CI：80.4％-93.6％）和92.8％（95％CI：87.7％-97.9％），分别(p=0.23)。严重不良反应分别为3%和2%,分别(p=0.34)。
结论：高剂量埃索美拉唑，在一个背景耐药率较高的国家，阿莫西林和铋每方案的治愈率为92.8％。需要进一步的研究来确定这种疗法是否可以进一步改善。在那之前,它可以被推荐为在伊朗北部一线根除幽门螺杆菌。
