Vonoprazan
證據等級: L2 | 預測適應症: 10 個
## 藥師評估報告
Vonoprazan：從糜爛性食道炎到活動性消化性潰瘍
一句話總結
Vonoprazan 原本用於治療糜爛性食道炎、胃潰瘍、十二指腸潰瘍及幽門螺旋桿菌根除。 TxGNN 模型預測它可能對**活動性消化性潰瘍 (active peptic ulcer disease)** 有效， 目前有 **2 個臨床試驗**和 **16 篇文獻**支持這個方向。
快速總覽
| 項目 | 內容 |
|---|---|
| 原適應症 | 糜爛性食道炎、胃潰瘍、十二指腸潰瘍、幽門螺旋桿菌根除輔助 |
| 預測新適應症 | gastric ulcer (disease)、active peptic ulcer disease、esophagitis (disease)、peptic ulcer perforation、gastrojejunal ulcer、peptic esophagitis、hiatus hernia (disease)、achlorhydria、cascade stomach、gastric dilatation |
| TxGNN 預測分數 | 99.97% |
| 證據等級 | L2 |
| 台灣上市 | 已上市 |
| 許可證數 | 1 張 |
| 建議決策 | Strong Proceed |
預測適應症詳細分析
1. active peptic ulcer disease L2 99.97% 主要分析
為什麼這個預測合理？
Vonoprazan 是首創的鉀離子競爭性酸阻斷劑（P-CAB），與傳統質子幫浦抑制劑（PPI）相比，具有以下優勢：
- 抑制 H+,K+-ATPase 的效力約為 Lansoprazole 的 350 倍
- 不需酸性活化，起效更快
- 在酸性環境中穩定，持續時間更長
- 不受 CYP2C19 基因多型性影響
這些特性使其在活動性消化性潰瘍的治療中具有明顯優勢。
臨床試驗
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT03116841 | PHASE4 | COMPLETED | 3 | Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated Wit... |
| NCT03214952 | N/A | COMPLETED | 3183 | Drug Use Surveillance of Takecab Tablets for "Gastric Ulcer, Duodenal Ulcer, and... |
相關文獻
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 26369775 | 2016 | Article | Clinical pharmacokinetics | The First-in-Class Potassium-Competitive Acid Blocker, Vonoprazan Fumarate: Phar... |
| 36660052 | 2023 | Article | JGH open : an open access jour | Management of Helicobacter pylori infection. |
| 38345252 | 2024 | Article | The American journal of gastro | Comparative Efficacy of P-CAB vs Proton Pump Inhibitors for Grade C/D Esophagiti... |
| 38976448 | 2025 | Article | The American journal of gastro | Randomized, Double-Blind, Active-Controlled Phase 3 Study to Evaluate Efficacy a... |
| 28988197 | 2018 | Article | Gut | Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised,... |
| 41415806 | 2025 | Article | Frontiers in microbiology | Therapeutic advances and future directions in Helicobacter pylori eradication. |
| 39156336 | 2024 | Article | Cureus | A Comprehensive Review on the Efficacy and Safety of Vonoprazan in the Managemen... |
| 32998241 | 2020 | Article | Pharmaceuticals (Basel, Switze | The Potential Benefits of Vonoprazan as Helicobacter pylori Infection Therapy. |
| 37066678 | 2023 | Article | Alimentary pharmacology & ther | A translational pharmacokinetic/pharmacodynamic approach supports optimal vonopr... |
| 41472371 | 2025 | Article | Journal of gastroenterology an | Antibiotic Resistance in Helicobacter pylori in the Asia-Pacific Region: A Call ... |
| 22512618 | 2012 | Article | Journal of medicinal chemistry | Discovery of a novel pyrrole derivative 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsul... |
| 37625445 | 2023 | Article | Drug research | Lupeol: A Triterpenoid Isolated from the Stem Bark of Hymenocardia Acida (tul.) ... |
| 41241208 | 2026 | Article | Journal of ethnopharmacology | In vivo and in silico assays demonstrate that the hydroalcoholic extract of Aloy... |
| 28267236 | 2017 | Article | Digestive endoscopy : official | Effect of vonoprazan on the treatment of artificial gastric ulcers after endosco... |
| 31482260 | 2020 | Article | Inflammopharmacology | In vivo antiulcer activity, phytochemical exploration, and molecular modelling o... |
| 41094194 | 2026 | Article | The Journal of antibiotics | Olorofim, a potential novel drug candidate against Helicobacter pylori infection... |
2. peptic ulcer perforation L2 99.97%
臨床試驗（1 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT04728516 | PHASE4 | RECRUITING | 2600 | The Effect of Vonoprazan-based Dual Eradication Therapy vs PPI Treatment on Gast... |
相關文獻（2 篇）
3. gastrojejunal ulcer L4 99.97%
相關文獻（20 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 36228734 | 2023 | Article | Gastroenterology | Vonoprazan Versus Lansoprazole for Healing and Maintenance of Healing of Erosive... |
| 33620586 | 2021 | Article | Journal of gastroenterology | Evidence-based clinical practice guidelines for peptic ulcer disease 2020. |
| 26369775 | 2016 | Article | Clinical pharmacokinetics | The First-in-Class Potassium-Competitive Acid Blocker, Vonoprazan Fumarate: Phar... |
| 35226174 | 2022 | Article | Journal of gastroenterology | Evidence-based clinical practice guidelines for gastroesophageal reflux disease ... |
| 39294424 | 2024 | Article | Digestive diseases and science | Vonoprazan vs. Proton Pump Inhibitors for Treatment and Prevention of Gastric an... |
| 26935876 | 2016 | Article | Gut | Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-... |
| 31409606 | 2020 | Article | Gut | Phase III, randomised, double-blind, multicentre study to evaluate the efficacy ... |
| 39145848 | 2024 | Article | Current gastroenterology repor | Potassium-competitive Acid Blockers: Current Clinical Use and Future Development... |
| 40388079 | 2025 | Article | Drugs | Vonoprazan: A Review in Erosive Esophagitis and Non-Erosive Gastro-Esophageal Re... |
| 38582271 | 2024 | Article | Gastroenterology | Comparison of Vonoprazan Versus Intravenous Proton Pump Inhibitor for Prevention... |
| 38388872 | 2024 | Article | Drugs | Vonoprazan: A Review in Helicobacter pylori Infection. |
| 38345252 | 2024 | Article | The American journal of gastro | Comparative Efficacy of P-CAB vs Proton Pump Inhibitors for Grade C/D Esophagiti... |
| 39466255 | 2025 | Article | The American journal of gastro | The Role of P-CABs in GERD. |
| 39269391 | 2024 | Article | Gastroenterology | AGA Clinical Practice Update on Integrating Potassium-Competitive Acid Blockers ... |
| 36660052 | 2023 | Article | JGH open : an open access jour | Management of Helicobacter pylori infection. |
| 38252210 | 2024 | Article | Digestive diseases and science | Pantoprazole and Vonoprazan Performed Well in Preventing Peptic Ulcer Recurrence... |
| 38916840 | 2024 | Article | Drugs | Zastaprazan: First Approval. |
| 35342997 | 2022 | Article | Journal of gastroenterology an | Vonoprazan non-inferior to lansoprazole in treating duodenal ulcer and eradicati... |
| 40923937 | 2025 | Article | Current opinion in gastroenter | Potassium-competitive acid blockers. |
| 36127938 | 2022 | Article | Przeglad gastroenterologiczny | Vonoprazan in the management of erosive oesophagitis and peptic ulcer-induced me... |
4. hiatus hernia (disease) L4 99.88%
相關文獻（6 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 41426852 | 2025 | Article | Cureus | Vonoprazan Therapy in Gastroesophageal Reflux Disease (GERD): Effects on the Sev... |
| 38821110 | 2024 | Article | Scandinavian journal of gastro | The presence of hiatal hernia is a significant predictor for symptomatic recurre... |
| 41231641 | 2025 | Article | International journal of surge | Gastroesophageal reflux disease: comprehensive review from medical to surgical m... |
| 34547219 | 2022 | Article | Scandinavian journal of gastro | Predictors and timing for the development of symptomatic gastroesophageal reflux... |
| 36649678 | 2023 | Article | Digestion | Examination on Factors Affecting Symptom Change after Drug Withdrawal in Patient... |
| 36716726 | 2023 | Article | Digestion | Long-Term Clinical Course after Successful Initial Treatment in Patients with Mi... |
5. achlorhydria L5 99.86%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
6. pylorospasm L5 99.85%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
7. Dieulafoy lesion L5 99.85%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
8. gastric dilatation L4 99.85%
9. cascade stomach L4 99.85%
相關文獻（1 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 36343209 | 2023 | Article | ACS nano | Endoscopy Deliverable and Mushroom-Cap-Inspired Hyperboloid-Shaped Drug-Laden Bi... |
10. hemorrhagic duodenitis L4 99.74%
相關文獻（5 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 33620586 | 2021 | Article | Journal of gastroenterology | Evidence-based clinical practice guidelines for peptic ulcer disease 2020. |
| 27891632 | 2017 | Article | Alimentary pharmacology & ther | Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in... |
| 39712905 | 2025 | Article | DEN open | Profound gastric mucosal changes and severe rebound acid hypersecretion after lo... |
| 34085115 | 2021 | Article | European journal of clinical p | Effect of a proton-pump inhibitor on intestinal microbiota in patients taking lo... |
| 31406072 | 2019 | Article | Nihon Shokakibyo Gakkai zasshi | [Refractory eosinophilic gastroenteritis with gastritis, duodenal ulcer, and col... |
台灣上市資訊
| 許可證號 | 品名 | 劑型 | 核准適應症 |
|---|---|---|---|
| 衛部藥輸字（待確認） | 福星定膜衣錠10毫克 | 膜衣錠 | 糜爛性食道炎、胃潰瘍、十二指腸潰瘍、幽門螺旋桿菌根除 |
安全性考量
藥物交互作用
Vonoprazan 的藥物交互作用相對較少，主要需注意：
| 交互作用類型 | 藥物 | 說明 |
|---|---|---|
| 禁忌併用 | Atazanavir、Rilpivirine | 降低抗病毒藥物吸收 |
| 謹慎併用 | Warfarin | 監測 INR |
| 謹慎併用 | Methotrexate | 可能增加血中濃度 |
優於 PPI 的安全性特點
- 不受 CYP2C19 基因多型性影響
- 藥效穩定，個體間差異小
- 長期使用的安全性數據持續累積中
結論與下一步
決策：Strong Proceed
理由： Vonoprazan 對活動性消化性潰瘍的預測與其核准適應症高度重疊，且有大量高品質文獻和臨床試驗支持。作為新一代抑酸劑，其在消化性潰瘍治療中的優越性已獲充分驗證。
建議：
- 此預測基本上是對現有適應症的確認和擴展
- 可直接用於臨床實踐，遵循現有用藥指引
- 持續關注長期安全性數據
- 對於 PPI 療效不佳的患者可優先考慮使用
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引用本報告
如需引用本報告，請使用以下格式：
APA 格式：
TwTxGNN. (2026). Vonoprazan老藥新用驗證報告. https://twtxgnn.yao.care/drugs/vonoprazan/
BibTeX 格式：
@misc{twtxgnn_vonoprazan,
title = {Vonoprazan老藥新用驗證報告},
author = {TwTxGNN Team},
year = {2026},
url = {https://twtxgnn.yao.care/drugs/vonoprazan/}
}
免責聲明
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
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