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雷贝拉唑辅助治疗低剂量阿司匹林治疗患者的溃疡复发:一项多中心前瞻性研究。

Rabeprazole Coadministration Controls Ulcer Recurrence in Patients on Low-dose Aspirin Therapy: A Multicenter Prospective Study.

机构信息

Hyogo Prefectural Harima-Himeji General Medical Center, Japan.

National Hospital Organization, Hakodate National Hospital, Japan.

出版信息

Intern Med. 2023 Feb 15;62(4):495-502. doi: 10.2169/internalmedicine.9646-22. Epub 2022 Jul 29.

DOI:10.2169/internalmedicine.9646-22
PMID:35908971
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10017235/
Abstract

Objective To evaluate the efficacy and safety of rabeprazole coadministration with low-dose aspirin (LDA). Methods From 2015 to 2018, we conducted a large-scale, multicenter, prospective observational study to assess the safety and efficacy of treatment with rabeprazole (5 or 10 mg/day) in combination with LDA. Results The incidence of adverse reactions was 0.73% (11/1,513 patients), with no serious adverse reactions. We found no trend toward increases in the incidence of adverse reactions with increases in treatment duration. The cumulative recurrence rate of ulcers by Week 52 (Kaplan-Meier estimates) was 3.50% (range, 1.56-7.75%). No gastrointestinal bleeding was reported. Conclusion Rabeprazole in combination with LDA appears as safe and effective in real-world situations as in clinical trials.

摘要

目的 评估雷贝拉唑与低剂量阿司匹林(LDA)合用的疗效和安全性。

方法 2015 年至 2018 年,我们开展了一项大规模、多中心、前瞻性观察性研究,以评估雷贝拉唑(5 或 10 mg/天)联合 LDA 治疗的安全性和疗效。

结果 不良反应发生率为 0.73%(11/1513 例患者),无严重不良反应。我们发现不良反应发生率与治疗时间的延长无明显增加趋势。第 52 周(Kaplan-Meier 估计)溃疡的累积复发率为 3.50%(范围为 1.56-7.75%)。未报告胃肠道出血。

结论 雷贝拉唑联合 LDA 在真实世界中的安全性和疗效与临床试验相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e58d/10017235/8c1fd25255b2/1349-7235-62-0495-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e58d/10017235/31af54702216/1349-7235-62-0495-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e58d/10017235/8c1fd25255b2/1349-7235-62-0495-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e58d/10017235/31af54702216/1349-7235-62-0495-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e58d/10017235/8c1fd25255b2/1349-7235-62-0495-g002.jpg

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本文引用的文献

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Evidence-based clinical practice guidelines for peptic ulcer disease 2020.2020 年消化性溃疡病循证临床实践指南。
J Gastroenterol. 2021 Apr;56(4):303-322. doi: 10.1007/s00535-021-01769-0. Epub 2021 Feb 23.
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Vonoprazan prevents low-dose aspirin-associated ulcer recurrence: randomised phase 3 study.Vonoprazan 预防低剂量阿司匹林相关溃疡复发:随机 3 期研究。
Gut. 2018 Jun;67(6):1033-1041. doi: 10.1136/gutjnl-2017-314852. Epub 2017 Dec 1.
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Efficacy and safety of twice-daily rabeprazole maintenance therapy for patients with reflux esophagitis refractory to standard once-daily proton pump inhibitor: the Japan-based EXTEND study.
每日 2 次雷贝拉唑维持治疗对标准每日 1 次质子泵抑制剂治疗抵抗的反流性食管炎患者的疗效和安全性:日本 EXTEND 研究。
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4
Vonoprazan treatment improves gastrointestinal symptoms in patients with gastroesophageal reflux disease.Vonoprazan 治疗可改善胃食管反流病患者的胃肠道症状。
Kaohsiung J Med Sci. 2017 Dec;33(12):616-622. doi: 10.1016/j.kjms.2017.07.004. Epub 2017 Aug 5.
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Gastrointestinal symptom prevalence depends on disease duration and gastrointestinal region in type 2 diabetes mellitus.胃肠道症状的患病率取决于 2 型糖尿病的疾病持续时间和胃肠道部位。
World J Gastroenterol. 2017 Sep 28;23(36):6694-6704. doi: 10.3748/wjg.v23.i36.6694.
6
The effect of acotiamide on epigastric pain syndrome and postprandial distress syndrome in patients with functional dyspepsia.阿考替胺对功能性消化不良患者上腹部疼痛综合征和餐后不适综合征的影响。
J Med Invest. 2016;63(3-4):230-5. doi: 10.2152/jmi.63.230.
7
Long-term efficacy and safety of rabeprazole in patients taking low-dose aspirin with a history of peptic ulcers: a phase 2/3, randomized, parallel-group, multicenter, extension clinical trial.雷贝拉唑在有消化性溃疡病史的服用低剂量阿司匹林患者中的长期疗效和安全性:一项2/3期、随机、平行组、多中心、扩展临床试验。
J Clin Biochem Nutr. 2015 May;56(3):228-39. doi: 10.3164/jcbn.15-1. Epub 2015 Apr 8.
8
Intra-gastric pH following single oral administrations of rabeprazole and esomeprazole: double-blind cross-over comparison.单次口服雷贝拉唑和埃索美拉唑后的胃内pH值:双盲交叉比较。
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