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esomeprazole

✓ Approved

Nanodaru · ATP4A · 小分子

什么是 esomeprazole？

esomeprazole 是一种小分子，由Nanodaru研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。

药物档案

公司Nanodaru
药物类别小分子
分子靶点ATP4A
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Nanodaru

作用机制

分子靶点

esomeprazole 作用于 1 个分子靶点：

ATP4AATPase H+/K+ transporting subunit alpha (ATP6A)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

esomeprazole 针对 3 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Gastrointestinal disordersDuodenal ulcer✓ Approved
Gastrointestinal disordersGastric ulcer✓ Approved
Gastrointestinal disordersGastrooesophageal reflux disease✓ Approved

相关研究文献

PubMedFrontiers in microbiology2026-09-08

Beyond acid suppression: the multifaceted role of proton pump inhibitors in Helicobacter pylori eradication.

Sroczyńska Paulina P, Krzyżek Paweł P

Gastric acid is essential for digestion, host defense, and maintenance of gastrointestinal homeostasis; however, its excessive or inappropriate secretion contributes to the development and progression of several acid-related disorders. Proton pump inhibitors (PPIs) have remained the cornerstone of acid-suppressive therapies for more than four decades owing to their potent blockade of gastric H+/K+-ATPases. This review provides a comprehensive overview of the pharmacological properties, clinical applications, and current limitations of the most widely used PPIs, including omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, and rabeprazole. Particular emphasis is placed on their role in the management of Helicobacter pylori infection, a strong risk factor for the development of severe gastric diseases and one of the most clinically important indications for PPI-based antibiotic therapy. Beyond elevating intragastric pH to enhance antibiotic stability and efficacy, accumulating evidence indicates that PPIs exert direct antibacterial activity against H. pylori and may act synergistically with selected antibiotics. The review also discusses emerging evidence for interindividual variability in PPI metabolism, drug-drug interactions, and concerns regarding long-term adverse effects of the current treatments. Finally, it highlights potassium-competitive acid blockers (P-CABs), a newer class of acid-suppressive agents that provide sustained acid inhibition and represent a promising alternative to PPI-based regimens for H. pylori eradication.

PMID 42708030
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PubMedFrontiers in pharmacology2026-09-03

Differential fracture risk among proton pump inhibitors in older adults: evidence network and pharmacovigilance validation.

Piao Hui-Ling HL, Wu Zeng-Hao ZH, Zhou Ling-Yun LY, Lai Chang-Hong CH et al.

Proton pump inhibitors (PPIs) are the first-line therapy for acid-related disorders, with particularly high rates of chronic use in adults aged ≥65 years. Nearly all existing studies treat PPIs as a uniform drug class, overlooking potential heterogeneity in fracture risk across individual agents. This study aimed to evaluate the relative fracture risk of individual PPIs in elderly adults, using a complementary dual-method approach of network meta-analysis (NMA) and disproportionality analysis. First, we performed a NMA to compare the relative risk of any-site fracture associated with individual PPIs. Second, we performed a complementary disproportionality analysis using data from the US FDA Adverse Event Reporting System (FAERS) database, with additional analysis of osteoporosis/osteopenia events defined by the Standardised Medical Dictionary for Regulatory Activities (MedDRA) Standardised Query (SMQ). The NMA included 9 eligible studies, enrolling a total of 257,445 participants. Compared with non-PPI users, omeprazole (OR 1.51, 95%CI 1.36-1.67), rabeprazole (OR 1.47, 95%CI 1.22-1.78), pantoprazole (OR 1.44, 95%CI 1.28-1.62), and lansoprazole (OR 1.32, 95%CI 1.14-1.53) were associated with a significantly increased risk of any-site fracture. In contrast, esomeprazole showed no significant association with overall fracture risk (OR 1.16, 95%CI 0.97-1.38). Pairwise comparisons from the NMA showed that esomeprazole had a lower relative fracture risk compared with other individual PPIs. In the FAERS analysis, we identified 16,908 PPI-related fracture adverse events. Consistent with NMA findings, omeprazole exhibited a significant fracture risk signal (ROR 1.25, 95%CI 1.03-1.51), while esomeprazole showed no significant signal for overall fracture (ROR 0.89, 95%CI 0.66-1.20). However, esomeprazole presented a strong positive risk signal in the narrow-scope MedDRA SMQ analysis for Osteoporosis/Osteopenia (ROR 2.44, 95%CI 1.41-4.20). Long-term PPI use is associated with increased fracture risk in elderly adults, with significant heterogeneity in bone safety profiles across individual PPI agents. Although esomeprazole was not significantly associated with fracture risk in NMA or FAERS fracture analyses, it showed a strong narrow-scope osteoporosis/osteopenia SMQ signal. This discordance indicates that absence of a fracture signal should not imply skeletal safety. These findings provide evidence-based guidance for individualized PPI prescribing in elderly patients, with careful benefit-risk assessment for those requiring extended-duration PPI regimens.

PMID 42688114
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PubMedGastroenterologia y hepatologia2026-09-03

AWaRe-aligned doxycycline-based bismuth quadruple therapy achieves high Helicobacter pylori eradication rates and supports antimicrobial stewardship.

Santiago Giovanna Casadiego GC, de Jesús Yépez Barreto Ismael I, Morales Betty P BP, Risco Fernando García Del FGD

Helicobacter pylori infects a large proportion of the global population. The World Health Organization (WHO) developed the Access, Watch and Reserve (AWaRe) classification to promote rational antibiotic use and reduce antimicrobial resistance. The aim of this study was to evaluate the efficacy of a doxycycline-based bismuth quadruple therapy aligned with this strategy, as a potential alternative for Helicobacter pylori eradication in settings with limited availability of tetracycline. A prospective observational study was conducted (October 2023-October 2024) in adults with confirmed H. pylori infection. Patients received a 14-day regimen with esomeprazole, bismuth, amoxicillin, and doxycycline. Eradication was assessed ≥4 weeks after treatment using a urea breath test or histology. A total of 138 patients were included in the ITT population and 118 in the PP/mITT populations (mean age 51.3 years; 66.1% female). Overall eradication rates were 77.5% in the ITT analysis and 90.7% in the PP/mITT analyses. In the PP/mITT populations, eradication reached 94.5% in treatment-naïve patients, 85.7% after one prior treatment failure, and 61.5% after two or more prior treatment failures. Adverse events were mild (7.6%), and 92.4% of patients reported symptomatic improvement. This AWaRe-aligned doxycycline-based quadruple therapy achieved an acceptable eradication rate in the PP/mITT populations, with good tolerability. However, the lower ITT eradication rate warrants cautious interpretation of its overall effectiveness.

PMID 42692108
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PubMedMedicine2026-08-22

Complete remission of Helicobacter pylori-negative gastric MALT lymphoma following eradication therapy: A case report.

Chen Hui H, Tang Jingtong J, Mo Lin L, Wang Xi X et al.

Gastric mucosa-associated lymphoid tissue (MALT) lymphoma is typically associated with Helicobacter pylori infection; however, approximately 10% of cases are H pylori-negative. Management guidelines differ between the European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network (NCCN) regarding first-line treatment for these patients. Here, we report a case of H pylori-negative gastric MALT lymphoma that achieved complete remission following standard eradication therapy. A woman of Asian ethnicity in her late 50s presented with a 4-month history of intermittent, left-upper-quadrant abdominal pain. The patient had no significant medical or family history of gastric cancer or lymphoma. Upper gastrointestinal endoscopy revealed irregular whitish mucosa with ill-defined borders in the distal gastric body. Biopsies demonstrated dense lymphoid infiltrates positive for CD20, CD79a, CD43, kappa light chain, focal CD23, and CD21, with a Ki-67 index of approximately 8%, consistent with extranodal marginal zone lymphoma (MALT lymphoma). H pylori testing by 13C-urea breath test (DOB 3.5; cutoff < 4.0) and Giemsa staining was negative, although the DOB value was close to the cutoff threshold. Positron emission tomography-computed tomography and endoscopic ultrasound confirmed Lugano stage IE disease confined to the mucosa and submucosa. After multidisciplinary consultation, the patient received a 14-day bismuth-containing quadruple eradication regimen consisting of bismuth potassium citrate (2.4 g) twice daily, esomeprazole (40 mg) twice daily, amoxicillin (1 g) twice daily, and clarithromycin (0.5 g) twice daily. At 2-month follow-up, the patient was asymptomatic. Positron emission tomography-computed tomography showed no abnormalities, and repeat endoscopy with biopsies demonstrated complete histological remission, which persisted at 6-month follow-up. This case adds to the growing evidence that H pylori status alone should not preclude a trial of eradication therapy in patients with localized gastric MALT lymphoma. Potential mechanisms include the role of non-H pylori helicobacters, the direct antitumor effects of antibiotics, and immunomodulation. Larger prospective studies are needed to identify predictors of response in this population.

PMID 42629740
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PubMedArquivos de gastroenterologia2026-08-19

REAL-WORLD EFFECTIVENESS OF HIGH-DOSE DUAL THERAPY VS OPTIMIZED CLARITHROMYCIN TRIPLE THERAPY FOR HELICOBACTER PYLORI: A PROSPECTIVE COHORT STUDY WITH TEST-OF-CURE SENSITIVITY ANALYSES.

Ugarte Lastra Alejandro A, Advincula Solis David E DE, Ramos Mamani Harold H, Cedrón Cheng Hugo Guillermo HG et al.

Helicobacter pylori eradication rates have declined globally due to rising antibiotic resistance, challenging the effectiveness of standard triple therapy. High-dose dual therapy has emerged as a simplified alternative supported by pharmacodynamic rationale. We aimed to compare the real-world effectiveness, adherence, and safety of high-dose dual therapy versus optimized clarithromycin-based triple therapy in routine gastroenterology practice. We conducted a prospective, multicenter observational cohort study in adult patients with confirmed H. pylori infection treated with either high-dose dual therapy (amoxicillin 1 g three times daily plus esomeprazole 40 mg three times daily for 14 days) or optimized clarithromycin-based triple therapy (amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and esomeprazole 40 mg twice daily for 14 days) according to physician decision. Eradication was assessed by carbon-14 urea breath test ≥4 weeks after therapy. Comparative effectiveness was estimated with effect measures, 95% confidence intervals (CI), and predefined sensitivity analyses for incomplete test-of-cure follow-up. Among 218 treated patients, 104 completed post-treatment breath testing. Eradication rates were 80.4% with high-dose dual therapy and 81.3% with triple therapy (absolute difference -0.9%; 95%CI -16.3 to 14.5; P=0.91). Moderate-to-high adherence was observed in 51.5% vs 67.6%, respectively (P=0.19). Adverse events were more frequent with high-dose dual therapy (70.8% vs 58.9%), although the difference was not statistically significant. Mainly gastrointestinal intolerance and taste disturbance. Sensitivity analyses across plausible missing-outcome scenarios showed stable comparative results. In prospective real-world practice, high-dose dual therapy achieved eradication effectiveness comparable to optimized triple therapy, with favorable tolerability. These findings support high-dose dual therapy as a pragmatic and clinically attractive alternative in settings with evolving resistance and adherence constraints.

PMID 42615755
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PubMedPsychiatry research2026-08-15

Drug-associated bipolar disorder: A disproportionality analysis of the FAERS database.

Du Pengqiang P, Chen Xiaoyu X, Zhang Wenjin W, Zhou Yujie Y et al.

Drug-induced bipolar disorder (BD) is easily neglected clinically. We mined the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to screen high BD-risk drugs and assess BD risk warnings in drug labels. Data were extracted from the FAERS database spanning the first quarter of 2004 to the third quarter of 2025. Preferred terms (PTs) related to BD, including 'bipolar disorder', were identified using the Medical Dictionary for Regulatory Activities (MedDRA v27.1). Generic drug names were standardized via the DrugBank database. Sex-stratified and BD subtype-stratified disproportionality analyses were performed. A total of 23,607,454 adverse event reports were analyzed, with 17,620 cases linked to BD. Varenicline (537 cases) was associated with the highest number of BD reports. Based on disproportionality analysis, the top five medications with the highest reporting odds ratios (RORs), proportional reporting ratio (PRR), empirical bayes geometric mean (EBGM) and information component (IC) were pizotifen, tafenoquine, flupenthixol, naltrexone, and pemoline. Among the top 50 medications, 44 (88%) lacked any mention of BD risk in their prescribing information. Time-to-onset analysis revealed that 51% of cases (n = 993) occurred within 0-30 days of drug exposure. Signals differed markedly by sex: varenicline showed higher male risk, while esomeprazole and oxycodone carried mild female-specific risks. Naltrexone strongly associated with BD-I and oxcarbazepine with BD-II, with elevated subtype-specific RORs limited by small subtype samples. Most high BD-signal drugs lack label warnings. Drug-induced BD presents distinct sex and subtype-specific risks, requiring gender- and subtype-personalized clinical monitoring.

PMID 42603523
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