A pilot study evaluating high dose esomeprazole, bismuth subcitrate and amoxicillin for eradicating Helicobacter pylori infection in Iran

IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Helicobacter Pub Date : 2024-02-27 DOI:10.1111/hel.13061
Sepehr Tirgar Fakheri, Hajar Shokri-Afra, David Y. Graham, Zohreh Bari, Hafez Fakheri
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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.

Materials and 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).

Conclusion

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.

在伊朗开展的一项试点研究,对大剂量埃索美拉唑、次枸橼酸铋和阿莫西林根除幽门螺旋杆菌感染的效果进行了评估。
背景:幽门螺杆菌(H. pylori)与消化性溃疡病和胃癌密切相关。我们评估了由埃索美拉唑、大剂量铋剂和不同剂量阿莫西林组成的两种三联疗法方案,用于一线根除幽门螺杆菌:将 200 名患有消化不良且未感染幽门螺杆菌的患者随机分为两组(n = 100)。两组患者均接受为期 14 天的埃索美拉唑(40 毫克,每天两次)和次枸橼酸铋(240 毫克,每天三次)治疗,但 A 组(750 毫克)和 B 组(1000 毫克)的阿莫西林剂量不同,每天三次。治疗后对治疗依从性和副作用进行了评估,8 周后,大便幽门螺杆菌抗原检测阴性证实根除了幽门螺杆菌:结果:两组患者的性别和年龄相当。根据意向治疗分析,A 组和 B 组的根除率分别为 80%(95% CI:77.2%-82.8%)和 90%(95% CI:84.1%-95.9%)(P = 0.22)。按协议根除率分别为 87%(95% CI:80.4%-93.6%)和 92.8%(95% CI:87.7%-97.9%)(P = 0.23)。严重不良反应分别为3%和2%(P = 0.34):结论:在一个耐药性背景率较高的国家,大剂量埃索美拉唑、阿莫西林和铋剂按方案治疗的治愈率达到 92.8%。还需要进行更多的研究,以确定这种疗法能否得到进一步改进。在此之前,可以建议伊朗北部地区将其作为根除幽门螺杆菌的一线疗法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Helicobacter
Helicobacter 医学-微生物学
CiteScore
8.40
自引率
9.10%
发文量
76
审稿时长
2 months
期刊介绍: Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.
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