Gefitinib
證據等級: L5 | 預測適應症: 10 個
## 藥師評估報告
Gefitinib (吉非替尼) - 藥師評估報告
一句話總結
吉非替尼是一種 EGFR 酪胺酸激酶抑制劑，TxGNN 預測其對多種纖維瘤樣病變和肺部良性腫瘤有潛在療效，這些預測基於 EGFR 訊號傳導在細胞增殖中的角色，但目前缺乏臨床證據支持。
快速總覽
| 項目 | 內容 |
|---|---|
| 藥物學名 | Gefitinib |
| 台灣商品名 | 基扶能膜衣錠 250 毫克、艾瑞莎 (IRESSA) |
| DrugBank ID | DB00317 |
| 原核准適應症 | EGFR-TK 突變陽性非小細胞肺癌 (NSCLC) |
| 預測新適應症 | fibromatosis, gingival、fibroma of lung、inclusion body myopathy with early-onset Paget disease with or without frontotemporal dementia、hamartoma of lung、lung hilum carcinoma、lung benign neoplasm、Leukomelanoderma-infantilism-intellectual disability-hypodontia-hypotrichosis syndrome、lung germ cell tumor、pulmonary sulcus neoplasm、junctional epidermolysis bullosa |
| 最高證據等級 | L4 (前臨床/病例報告) |
| 台灣上市狀態 | 有效許可證 |
預測適應症詳細分析
1. fibromatosis, gingival L5 99.89% 主要分析
為什麼這個預測合理？
吉非替尼透過抑制 EGFR 酪胺酸激酶活性來阻斷細胞增殖訊號，其預測適應症可從以下角度理解：
- 牙齦纖維瘤 (TxGNN Score: 0.999, Rank: 2960)：
- EGFR 訊號傳導與纖維母細胞增殖相關
- 部分牙齦纖維瘤可能由 EGFR 過度活化驅動
- 值得注意的是，EGFR-TKI 本身可能導致口腔黏膜炎
- 肺纖維瘤 / 肺錯構瘤 (TxGNN Score: 0.999, Ranks: 3554, 3683)：
- 這些為肺部良性腫瘤
- 考量到 gefitinib 的肺部組織分佈特性，預測有其合理性
- 但良性腫瘤通常不需 TKI 治療
- 額顳葉失智伴包涵體肌病 (TxGNN Score: 0.999, Rank: 3649)：
- 此預測較難解釋
- 可能與神經保護作用相關的探索性研究有關
臨床試驗
目前無針對此特定適應症的臨床試驗登記。
2. fibroma of lung 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。
3. inclusion body myopathy with early-onset Paget disease with or without frontotemporal dementia L4 99.86%
相關文獻（20 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 26595641 | 2015 | Article | Lancet (London, England) | Frontotemporal dementia. |
| 28410663 | 2017 | Article | Neurologic clinics | Frontotemporal Dementia. |
| 35182511 | 2022 | Article | The Lancet. Neurology | Advances and controversies in frontotemporal dementia: diagnosis, biomarkers, an... |
| 21810890 | 2011 | Article | Brain : a journal of neurology | Sensitivity of revised diagnostic criteria for the behavioural variant of fronto... |
| 35678399 | 2022 | Article | Continuum (Minneapolis, Minn.) | Behavioral Variant Frontotemporal Dementia. |
| 32439025 | 2020 | Article | The Psychiatric clinics of Nor | Frontotemporal Dementia: Neuropathology, Genetics, Neuroimaging, and Treatments. |
| 34747778 | 2021 | Article | Neurology India | Frontotemporal Dementia - Current Concepts. |
| 38687620 | 2024 | Article | Expert opinion on investigatio | Frontotemporal dementia: from genetics to therapeutic approaches. |
| 35039149 | 2022 | Article | Trends in pharmacological scie | Progranulin as a therapeutic target in neurodegenerative diseases. |
| 38802173 | 2024 | Article | International review of neurob | Amyotrophic lateral sclerosis; clinical features, differential diagnosis and pat... |
| 31727221 | 2019 | Article | Handbook of clinical neurology | Frontotemporal dementia. |
| 31753137 | 2019 | Article | Handbook of clinical neurology | Frontotemporal dementia. |
| 23611342 | 2013 | Article | International review of psychi | Frontotemporal dementia and psychiatry. |
| 27042904 | 2016 | Article | Continuum (Minneapolis, Minn.) | Frontotemporal Dementias. |
| 28330541 | 2017 | Article | Ugeskrift for laeger | [Frontotemporal dementia]. |
| 25998110 | 2015 | Article | The Psychiatric clinics of Nor | The frontotemporal dementias. |
| 24234354 | 2013 | Article | Seminars in neurology | Frontotemporal dementia. |
| 26613998 | 2016 | Article | Neurologic clinics | Frontotemporal Dementia. |
| 33840052 | 2021 | Article | CNS drugs | Pharmacotherapy for Frontotemporal Dementia. |
| 31779815 | 2019 | Article | International review of neurob | Parkinsonism in frontotemporal dementias. |
4. hamartoma of lung 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。
5. lung hilum carcinoma L4 99.86%
相關文獻（1 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 22688581 | 2012 | Article | General thoracic and cardiovas | Salvage surgery for a super-responder by gefitinib therapy for advanced lung can... |
6. lung benign neoplasm L4 99.85%
相關文獻（20 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 32778129 | 2020 | Article | Respiratory research | FGL1 regulates acquired resistance to Gefitinib by inhibiting apoptosis in non-s... |
| 24794908 | 2014 | Article | Profiles of drug substances, e | Gefitinib. |
| 37057810 | 2023 | Article | The Kaohsiung journal of medic | Dihydroartemisinin enhances gefitinib cytotoxicity against lung adenocarcinoma c... |
| 23140355 | 2014 | Article | Anti-cancer agents in medicina | Erlotinib and gefitinib for elderly patients with advanced non-small-cell lung c... |
| 38967523 | 2024 | Article | Cancer medicine | METTL1/FOXM1 promotes lung adenocarcinoma progression and gefitinib resistance b... |
| 36959566 | 2023 | Article | BMC cancer | CA916798 predicts poor prognosis and promotes Gefitinib resistance for lung aden... |
| 20942679 | 2010 | Article | The New England journal of med | Interstitial lung disease and gefitinib. |
| 38581057 | 2024 | Article | Journal of cardiothoracic surg | Circ_0001786 facilitates gefitinib resistance and malignant progression in non-s... |
| 12841190 | 2003 | Article | Nature reviews. Drug discovery | Gefitinib. |
| 20949670 | 2010 | Article | The New England journal of med | Interstitial lung disease and gefitinib. |
| 39315600 | 2024 | Article | Thoracic cancer | USP22 promotes gefitinib resistance and inhibits ferroptosis in non-small cell l... |
| 24832599 | 2014 | Article | Cell death & disease | Axl-altered microRNAs regulate tumorigenicity and gefitinib resistance in lung c... |
| 29185589 | 2017 | Article | Brazilian journal of medical a | Bevacizumab and gefitinib enhanced whole-brain radiation therapy for brain metas... |
| 34686504 | 2021 | Article | Annals of clinical and laborat | miR-145-5p Modulates Gefitinib Resistance by Targeting NRAS and MEST in Non-Smal... |
| 25818741 | 2014 | Article | Indian journal of cancer | The comparisons of the efficacy and toxicity between gefitinib and docetaxel for... |
| 29480364 | 2018 | Article | Cancer chemotherapy and pharma | Combination of S-1 and gefitinib increases the sensitivity to radiotherapy in lu... |
| 34861803 | 2022 | Article | Journal of chemotherapy (Flore | Circ_SETD3 regulates gefitinib sensitivity and tumor progression by miR-873-5p-d... |
| 32323848 | 2020 | Article | Oncology reports | Triptolide inhibits epithelial‑mesenchymal transition and induces apoptosis in g... |
| 39394098 | 2024 | Article | BMC cancer | FTO/m6A mediates miR-138-5p maturation and regulates gefitinib resistance of lun... |
| 31233201 | 2019 | Article | Oncology reports | let‑7 and miR‑17 promote self‑renewal and drive gefitinib resistance in non‑smal... |
7. Leukomelanoderma-infantilism-intellectual disability-hypodontia-hypotrichosis syndrome L4 99.84%
相關文獻（20 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 38288441 | 2024 | Article | Frontiers in pharmacology | Valsartan attenuates LPS-induced ALI by modulating NF-κB and MAPK pathways. |
| 39281285 | 2024 | Article | Frontiers in pharmacology | Gastrointestinal tract organoids as novel tools in drug discovery. |
| 30033041 | 2019 | Article | The lancet. Diabetes & endocri | Advances in the medical treatment of Cushing's syndrome. |
| 18931563 | 2008 | Article | Gan to kagaku ryoho. Cancer & | [Cutaneous toxicities]. |
| 34474028 | 2021 | Article | European journal of pharmacolo | Mechanisms of gefitinib-induced QT prolongation. |
| 18316005 | 2008 | Article | Mayo Clinic proceedings | Small cell lung cancer. |
| 30048162 | 2018 | Article | Expert opinion on pharmacother | New and emerging drug therapies for Cushing's disease. |
| 32349387 | 2020 | Article | Journal of clinical medicine | Cardiovascular Complications of Systemic Therapy in Non-Small-Cell Lung Cancer. |
| 14528286 | 2003 | Article | Oncogene | Small-molecule cyclin-dependent kinase modulators. |
| 37553597 | 2023 | Article | BMC cancer | BYL719 reverses gefitinib-resistance induced by PI3K/AKT activation in non-small... |
| 37258113 | 2023 | Article | International heart journal | Gefitinib Increases the Incidence of QT Prolongation in Patients with Non-Small ... |
| 34208765 | 2021 | Article | Cells | Dynamic Evaluation of Circulating miRNA Profile in EGFR-Mutated NSCLC Patients T... |
| 37269912 | 2024 | Article | Journal of ethnopharmacology | FZKA reverses gefitinib resistance by regulating EZH2/Snail/EGFR signaling pathw... |
| 19734999 | 2009 | Article | Acta oncologica (Stockholm, Sw | Cardiotoxicity induced by tyrosine kinase inhibitors. |
| 18617157 | 2008 | Article | Biochemical pharmacology | Erlotinib and gefitinib for the treatment of myelodysplastic syndrome and acute ... |
| 22076388 | 2011 | Article | Targeted oncology | Pulmonary toxicities from targeted therapies: a review. |
| 23841999 | 2013 | Article | Journal of hematology & oncolo | Signal transduction inhibitors in treatment of myelodysplastic syndromes. |
| 25572389 | 2015 | Article | European journal of endocrinol | Therapy of endocrine disease: response and toxicity of small-molecule tyrosine k... |
| 34207313 | 2021 | Article | Biomedicines | Natural Products, Alone or in Combination with FDA-Approved Drugs, to Treat COVI... |
| 39414535 | 2024 | Article | International journal of biolo | Integrated microbiome and metabolome analysis reveals synergistic efficacy of ba... |
8. lung germ cell tumor L3 99.84%
臨床試驗（1 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT00068497 | NA | COMPLETED | 40 | Single Agent ZD-1839 (NSC-715055, IND-61187) in Patients With Advanced Head and ... |
相關文獻（20 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 22588876 | 2012 | Article | Cancer discovery | Occupy EGFR. |
| 21485758 | 2011 | Article | Acta clinica Belgica | Epidermal growth factor receptor targeted therapies for solid tumours. |
| 38261467 | 2024 | Article | Clinical cancer research : an | Germline USP36 Mutation Confers Resistance to EGFR-TKIs by Upregulating MLLT3 Ex... |
| 16330971 | 2005 | Article | Cancer nursing | Gefitinib (Iressa, ZD1839) and tyrosine kinase inhibitors: the wave of the futur... |
| 24618893 | 2014 | Article | Cancer biology & therapy | Met in lung cancer. |
| 38656402 | 2025 | Article | Drug delivery and translationa | Wheat germ agglutinin modified mixed micelles overcome the dual barrier of mucus... |
| 14967454 | 2004 | Article | International journal of radia | Rationale and clinical basis for combining gefitinib (IRESSA, ZD1839) with radia... |
| 22042963 | 2011 | Article | Journal of clinical oncology : | Large-cell neuroendocrine carcinoma of the lung harboring EGFR mutation and resp... |
| 22579297 | 2012 | Article | Lung cancer (Amsterdam, Nether | Chemotherapy for pulmonary large cell neuroendocrine carcinoma: similar to that ... |
| 17189393 | 2006 | Article | Clinical cancer research : an | Epidermal growth factor receptor activation: how exon 19 and 21 mutations change... |
| 26561558 | 2016 | Article | Clinical cancer research : an | InsR/IGF1R Pathway Mediates Resistance to EGFR Inhibitors in Glioblastoma. |
| 36361596 | 2022 | Article | International journal of molec | MGL S3 Chimeric Enzyme Drives Apoptotic Death of EGFR-Dependent Cancer Cells thr... |
| 22236672 | 2012 | Article | Progress in neurological surge | Role of chemotherapy on brain metastasis. |
| 15560844 | 2004 | Article | BMC cancer | The in vitro effect of gefitinib ('Iressa') alone and in combination with cytoto... |
| 35896603 | 2022 | Article | Scientific reports | Optimization of the 4-anilinoquin(az)oline scaffold as epidermal growth factor r... |
| 19601750 | 2009 | Article | Anti-cancer agents in medicina | The epidermal growth factor receptor as a therapeutic target in glioblastoma mul... |
| 23907440 | 2013 | Article | Current treatment options in o | Molecular subtyping of brain metastases and implications for therapy. |
| 24136891 | 2013 | Article | Journal of the National Cancer | Statistical and practical considerations for clinical evaluation of predictive b... |
| 15376352 | 2004 | Article | The New England journal of med | EGFR mutations and sensitivity to gefitinib. |
| 28460442 | 2017 | Article | Oncotarget | EGFR mediates activation of RET in lung adenocarcinoma with neuroendocrine diffe... |
9. pulmonary sulcus neoplasm L4 99.84%
10. junctional epidermolysis bullosa L5 99.84%
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。
台灣上市資訊
有效許可證：
| 許可證字號 | 商品名 | 許可證持有者 |
|---|---|---|
| 衛署藥輸字第024308號 | 艾瑞莎膜衣錠 250 毫克 | 台灣阿斯乙利康 |
| 衛部藥製字第059XXX號 | 基扶能膜衣錠 250 毫克 | 多家學名藥廠 |
核准適應症：
- 具有 EGFR-TK 突變之局部侵犯性或轉移性非小細胞肺癌 (NSCLC) 病患之第一線治療
- 先前已接受化學治療後仍局部惡化或轉移之肺腺癌病患之第二線用藥
安全性考量
黑框警語
- 間質性肺病 (ILD)：可能發生致命性間質性肺病，發生率約 1-3%
- 出現呼吸困難、咳嗽或發燒時應立即停藥並評估
常見不良反應
| 不良反應 | 發生率 |
|---|---|
| 皮疹 | 40-50% |
| 腹瀉 | 30-40% |
| 皮膚乾燥 | 20-30% |
| 噁心 | 15-25% |
| 甲溝炎 | 10-20% |
藥物交互作用
| 交互作用藥物 | 嚴重程度 | 說明 |
|---|---|---|
| CYP3A4 誘導劑 | Major | Rifampicin 等可降低 gefitinib 濃度 |
| CYP3A4 抑制劑 | Moderate | Ketoconazole 等可增加 gefitinib 濃度 |
| Warfarin | Moderate | 可能增加出血風險 |
| PPI/H2 blocker | Moderate | 可能降低 gefitinib 吸收 |
特殊族群
- 肝功能不全：中重度肝功能不全患者需謹慎使用
- 孕婦：禁用，為 FDA 懷孕分類 D 級
藥物-食物交互作用 (DFI)
葡萄柚 🔴 Major
- 影響：葡萄柚顯著增加 Gefitinib 血中濃度和毒性
- 建議：避免葡萄柚
藥物-草藥交互作用 (DHI)
聖約翰草（貫葉連翹） 🔴 Major
- 影響：聖約翰草顯著降低 Gefitinib 血中濃度
- 建議：禁止併用
藥物-疾病注意事項 (DDSI)
資料來源：DDInter 2.0（原文內容請參閱該網站）
腎臟疾病 🟡 Moderate
- 可能有嚴重不良反應。
Stevens-Johnson Syndrome 🟢 Minor
- 需定期監測。可能危及生命。必要時應停止治療。
Gastrointestinal Diseases 🟢 Minor
- 可能有致命風險。必要時應停止治療。
Eye Diseases 🟢 Minor
- 必要時應停止治療。
Lung Diseases 🟢 Minor
- 應謹慎使用本藥物。可能有致命風險。出現症狀時應考慮停藥。
肝臟疾病 🟢 Minor
- 需定期監測。可能有嚴重不良反應。必要時應停止治療。
結論與下一步
預測評估結論
Gefitinib 的預測新適應症（纖維瘤樣病變、良性肺腫瘤、神經退化性疾病）目前缺乏臨床證據支持。雖然 EGFR 訊號傳導在細胞增殖中扮演重要角色，但：
- 良性腫瘤通常不需要使用具有顯著毒性的 TKI
- 神經退化性疾病的預測缺乏明確機轉基礎
- 現有證據等級僅停留在理論推測
證據等級總結
| 預測適應症 | TxGNN Score | 證據等級 | 評估 |
|---|---|---|---|
| 牙齦纖維瘤 | 0.999 | L5 | 僅機轉推測 |
| 肺纖維瘤 | 0.999 | L5 | 僅機轉推測 |
| 額顳葉失智伴肌病 | 0.999 | L5 | 關聯性不明 |
| 肺錯構瘤 | 0.999 | L5 | 僅機轉推測 |
| 肺門癌 | 0.999 | L4 | 有病例報告（與原適應症相近） |
建議
- 不建議優先開發預測適應症：
- 缺乏臨床前證據
- 藥物毒性與良性疾病不匹配
- 神經退化性疾病預測機轉不明
- 可能的研究方向：
- 若有新的機轉證據支持 EGFR 在纖維化疾病中的角色，可考慮前臨床研究
- 額顳葉失智與包涵體肌病的預測需更多基礎研究支持
- 現有適應症優化：
- 持續優化 NSCLC 治療方案
- 探索與其他 TKI 或免疫療法的組合策略
報告生成日期：2026-02-11 資料來源：TxGNN 知識圖譜預測、ClinicalTrials.gov、PubMed、台灣 FDA
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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). Gefitinib老藥新用驗證報告. https://twtxgnn.yao.care/drugs/gefitinib/
BibTeX 格式：
@misc{twtxgnn_gefitinib,
title = {Gefitinib老藥新用驗證報告},
author = {TwTxGNN Team},
year = {2026},
url = {https://twtxgnn.yao.care/drugs/gefitinib/}
}
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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