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在不丹资源有限地区,奥美拉唑、四环素和每日 4 次阿莫西林给药在幽门螺杆菌根除中的疗效:一项前瞻性随机试验(BHUTAN 研究)。

Efficacy of Omeprazole, Tetracycline, and 4 Times Daily Dosing of Amoxicillin in Helicobacter pylori Eradication in Limited Resource Area in Bhutan: A Prospective Randomized Trial (BHUTAN Study).

机构信息

Gastroenterology Unit, Department of Medicine, Faculty of Medicine, Thammasat University Hospital, Pathumthani, Thailand.

Department of Medicine, Chulabhorn International College of Medicine (CICM) at Thammasat University, Pathumthani, Pathumthani, Thailand.

出版信息

Asian Pac J Cancer Prev. 2020 Apr 1;21(4):1109-1114. doi: 10.31557/APJCP.2020.21.4.1109.

DOI:10.31557/APJCP.2020.21.4.1109
PMID:32334478
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7445957/
Abstract

UNLABELLED

Backgrourd: H. pylori-associated gastric cancer is the first cancer-related death in Bhutan. Effective regimen for H. pylori eradication is essential to reduce risk of developing gastric cancer. Clarithromycin is not widely used in this limited resource country. Aim of this study was to evaluate proper regimen and prevalence of antibiotic resistance pattern for H. pylori eradication in Bhutan.

METHODS

Five hundred and forty-six patients underwent gastroscopy during GASTROCAMP between October 2014 and April 2015 in Bhutan and 77 patients were enrolled. Four gastric biopsies were obtained for rapid urease test, histopathology, H. pylori culture with Epsilometer test. All H. pylori-positive patients were randomized to receive either 7-day or 14-day of 500 mg amoxicillin four times daily, 500 mg tetracycline four times daily, and 20 mg omeprazole twice daily.

RESULTS

Seventy-seven subjects were enrolled (54 females, 23 males, mean age = 45.4 years). Of 77 patients, 52 (67.5%) received 7-day regimen while 25 (32.5%) had 14-day regimen. Prevalence of H. pylori was 38.2%. Antibiotic resistance was 80.0% for metronidazole, 11.1% for levofloxacin and no resistance seen in amoxicillin, tetracycline and clarithromycin. Overall eradication rates of 7-day and 14-day regimens were 51.9% and 80.0%, p = 0.02. Female and age ≥40 years had significantly higher eradication rate when receiving 14-day compared to 7-day regimen (94.1% vs. 45.9%, OR = 18.82; 95% CI 2.26-157.02, p = 0.0007 and 86.7% vs. 50.0%, OR = 6.50; 95% CI 1.25-33.91, p = 0.02, respectively).

CONCLUSIONS

Fourteen-day regimen might be an acceptable regimen for H. pylori eradication in limited resource area such as Bhutan. Female and age ≥40 years should receive longer duration of treatment. This 14-day regimen could at least reduce the risk of developing H. pylori-associated diseases especially peptic ulcer with complications and gastric cancer which lead to many deaths in Bhutan.
.

摘要

目的

评估在资源有限的国家中,幽门螺杆菌(H. pylori)根除的适当方案和抗生素耐药模式的流行率。

方法

2014 年 10 月至 2015 年 4 月期间,在不丹的 GASTROCAMP 期间,546 名患者接受了胃镜检查,其中 77 名患者入选。采集 4 份胃活检标本进行快速尿素酶试验、组织病理学检查和埃斯皮勒测试进行 H. pylori 培养。所有 H. pylori 阳性患者均随机接受 7 天或 14 天的治疗,方案为每日 4 次 500mg 阿莫西林、每日 4 次 500mg 四环素和每日 2 次 20mg 奥美拉唑。

结果

77 名患者入选(54 名女性,23 名男性,平均年龄=45.4 岁)。在 77 名患者中,52 名(67.5%)接受了 7 天的治疗方案,25 名(32.5%)接受了 14 天的治疗方案。H. pylori 的流行率为 38.2%。抗生素耐药性方面,甲硝唑耐药率为 80.0%,左氧氟沙星耐药率为 11.1%,阿莫西林、四环素和克拉霉素均无耐药性。7 天和 14 天治疗方案的总体根除率分别为 51.9%和 80.0%,p=0.02。女性和年龄≥40 岁患者接受 14 天方案的根除率显著高于 7 天方案(94.1% vs. 45.9%,OR=18.82;95%CI 2.26-157.02,p=0.0007 和 86.7% vs. 50.0%,OR=6.50;95%CI 1.25-33.91,p=0.02)。

结论

在资源有限的地区,如不丹,14 天方案可能是一种可接受的 H. pylori 根除方案。女性和年龄≥40 岁的患者应接受更长时间的治疗。这种 14 天的方案至少可以降低发展为幽门螺杆菌相关疾病的风险,特别是在不丹,这些疾病可导致许多死亡,包括消化性溃疡伴并发症和胃癌。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4347/7445957/0d12be48c373/APJCP-21-1109-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4347/7445957/364aeed7f4be/APJCP-21-1109-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4347/7445957/0d12be48c373/APJCP-21-1109-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4347/7445957/364aeed7f4be/APJCP-21-1109-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4347/7445957/0d12be48c373/APJCP-21-1109-g002.jpg

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