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伏诺拉生和阿莫西林双联疗法与质子泵抑制剂标准三联疗法根除幽门螺杆菌的比较:一项随机对照试验

Comparison of Vonoprazan and Amoxicillin Dual Therapy with Standard Triple Therapy with Proton Pump Inhibitor for Helicobacter Pylori eradication: A Randomized Control Trial.

作者信息

Zuberi Bader Faiyaz, Ali Faiza Sadaqat, Rasheed Tazeen, Bader Nimrah, Hussain Sana Muhammad, Saleem Anoshia

机构信息

Bader Faiyaz Zuberi FCPS, Meritorious Professor, Department of Medicine/Gastroenterology, Dow Medical College, Dow University of Health Sciences, Karachi, Pakistan.

Faiza Sadaqat Ali FCPS, Senior Registrar, Department of Medicine/Gastroenterology, Dow Medical College, Dow University of Health Sciences, Karachi, Pakistan.

出版信息

Pak J Med Sci. 2022 Mar-Apr;38(4Part-II):965-969. doi: 10.12669/pjms.38.4.5436.

DOI:10.12669/pjms.38.4.5436
PMID:35634610
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9121978/
Abstract

OBJECTIVES

To compare the efficacy of Vonoprazan based dual treatment versus PPI based treatment for the eradication of Helicobacter pylori infection.

METHODS

A randomized controlled trial was conducted in Department of Medicine/Gastroenterology Ruth KM Pfau Civil Hospital, DMC during the period of 22 June to 21 September 2021. Sample size was calculated as 96 in each Group. All patients of age 18-75 years with Helicobacter Pylori Infection were inducted and randomly allocated to two groups. Group-A: were given Capsule Amoxicillin 1 gm; Tablet Clarithromycin 500 mg; Capsule Omeprazole 20 mg all medications were given twice daily for two weeks. Group-B were given Capsule Amoxicillin 1 gm; Tablet Vonoprazan 20 mg (Vonozon, m/s Getz Pharma, Pakistan) twice daily for two weeks. Confirmation of Hp eradication was done by stool Hp antigen test four weeks after completion of treatment. Nine and four patients were lost to follow-up in Group-A & B respectively. Analysis was conducted on 87 patients in Group-A and 92 patients in Group-B.

RESULTS

Out of eighty-seven patients in Group-A and ninety-two patients in Group-B, 73 (83.9%) patients in Group-A and 86 (93.5%) patients in Group-B had negative H pylori result respectively after treatment ( = .042). Significantly higher frequencies of adverse events were observed in Group-A as compared to Group-B in nausea/vomiting ( = .035) and bloating ( = .045).

CONCLUSION

VA-dual provides an acceptable eradication rate with fewer adverse events.

摘要

目的

比较基于沃克帕唑的双重疗法与基于质子泵抑制剂(PPI)的疗法在根除幽门螺杆菌感染方面的疗效。

方法

2021年6月22日至9月21日期间,在达卡医学院鲁思·KM·普法乌市民医院内科/胃肠病科进行了一项随机对照试验。计算得出每组样本量为96例。纳入所有年龄在18 - 75岁、患有幽门螺杆菌感染的患者,并将其随机分为两组。A组:给予阿莫西林胶囊1克、克拉霉素片500毫克、奥美拉唑胶囊20毫克,所有药物均每日服用两次,持续两周。B组:给予阿莫西林胶囊1克、沃克帕唑片20毫克(Vonozon,Getz Pharma公司,巴基斯坦),每日服用两次,持续两周。治疗结束四周后,通过粪便幽门螺杆菌抗原检测确认幽门螺杆菌的根除情况。A组和B组分别有9例和4例患者失访。对A组的87例患者和B组的92例患者进行了分析。

结果

A组的87例患者和B组的92例患者中,治疗后A组有73例(83.9%)患者幽门螺杆菌检测结果为阴性,B组有86例(93.5%)患者幽门螺杆菌检测结果为阴性(P = 0.042)。与B组相比,A组在恶心/呕吐(P = 0.035)和腹胀(P = 0.045)方面不良事件的发生率显著更高。

结论

基于沃克帕唑的双重疗法提供了可接受的根除率,且不良事件较少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db02/9121978/2d2f453fdd64/PJMS-38-965-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db02/9121978/2d2f453fdd64/PJMS-38-965-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db02/9121978/2d2f453fdd64/PJMS-38-965-g001.jpg

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