Hydroxyurea
證據等級: L2 | 預測適應症: 10 個
## 藥師評估報告
Hydroxyurea：從血液腫瘤到女性乳腺癌
一句話總結
Hydroxyurea 原本用於治療慢性骨髓性白血病、骨髓纖維化及真性紅血球增多症。 TxGNN 模型預測它可能對**女性乳腺癌 (female breast carcinoma)** 有效， 目前有 **超過 20 篇文獻**支持這個研究方向。
快速總覽
| 項目 | 內容 |
|---|---|
| 原適應症 | 慢性骨髓性白血病、骨髓纖維化、真性紅血球增多症、卵巢癌、頭頸癌 |
| 預測新適應症 | 女性乳腺癌、primary non-gestational choriocarcinoma of ovary、sickle cell-hemoglobin E disease syndrome、sickle cell-hemoglobin c disease syndrome、hereditary persistence of fetal hemoglobin-sickle cell disease syndrome、sickle cell-hemoglobin d disease syndrome、sickle cell-beta-thalassemia disease syndrome、hereditary breast ovarian cancer syndrome、ovarian mucinous adenocarcinoma、ovarian clear cell adenocarcinoma |
| TxGNN 預測分數 | 99.97% |
| 證據等級 | L2 |
| 台灣上市 | 有效許可證 |
| 許可證數 | 多張 |
| 建議決策 | Proceed with Guardrails |
預測適應症詳細分析
1. female breast carcinoma L4 99.97% 主要分析
為什麼這個預測合理？
Hydroxyurea 是一種核糖核苷酸還原酶抑制劑，透過阻斷 DNA 合成發揮抗腫瘤作用。
它可以抑制細胞從 G1 期進入 S 期，並增加細胞對放射線的敏感性。
預測合理性分析：
- Hydroxyurea 已核准用於多種實體腫瘤（卵巢癌、頭頸癌）
- 在乳癌的高劑量化療方案中已有使用經驗
- 可作為放射增敏劑，與放射治療合併使用
- 研究顯示可與其他藥物（如 valproic acid）產生協同作用
機轉支持：
- 抑制 DNA 合成和修復
- 誘導複製壓力，增加 DNA 雙股斷裂
- 與 valproic acid 合併可抑制同源重組修復（PMID: 28837865）
- 脂質藥物複合體可提高細胞攝取率（PMID: 38211596）
臨床試驗
目前無針對此特定適應症的臨床試驗登記。
相關文獻
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 38211596 | 2024 | Article | Drug research | "In-silico Design and Development of Novel Hydroxyurea Lipid Drug Conjugates for... |
| 37777742 | 2023 | Article | Molecular cancer | EYA4 promotes breast cancer progression and metastasis through its role in repli... |
| 33631478 | 2021 | Article | Pathology, research and practi | An update on the role of long non-coding RNAs in the pathogenesis of breast canc... |
| 7914447 | 1994 | Article | Bone marrow transplantation | High-dose cyclophosphamide, thiotepa and hydroxyurea with autologous hematopoiet... |
| 32795962 | 2020 | Article | DNA repair | 2-hexyl-4-pentynoic acid, a potential therapeutic for breast carcinoma by influe... |
| 26844848 | 2016 | Article | Cancer biotherapy & radiopharm | In Vitro/In Vivo Evaluation of Radiolabeled [(99m)Tc(CO)3](+)-Hydroxyurea and Fl... |
| 1957839 | 1991 | Article | American journal of clinical o | A phase I study of a combination of allopurinol, 5-fluorouracil and leucovorin f... |
| 27504932 | 2017 | Article | Journal of cellular physiology | Chemoresistance of Lung and Breast Cancer Cells Growing Under Prolonged Periods ... |
| 30692636 | 2019 | Article | Oncogene | Nucleostemin reveals a dichotomous nature of genome maintenance in mammary tumor... |
| 34661718 | 2022 | Article | Naunyn-Schmiedeberg's archives | Hydroxyurea-loaded Fe3O4/SiO2/chitosan-g-mPEG2000 nanoparticles; pH-dependent dr... |
| 21730979 | 2011 | Article | British journal of cancer | Identification and evaluation of a potent novel ATR inhibitor, NU6027, in breast... |
| 31338966 | 2019 | Article | Journal of cellular and molecu | Berberine attenuates XRCC1-mediated base excision repair and sensitizes breast c... |
| 28585003 | 2017 | Article | Breast cancer (Tokyo, Japan) | Secondary breast carcinoma after completely remitted chronic myeloid leukemia fo... |
| 28837865 | 2017 | Article | DNA repair | Valproic acid sensitizes breast cancer cells to hydroxyurea through inhibiting R... |
| 30088044 | 2018 | Article | Annals of hematology | Conviction in the face of affliction: a case series of Jehovah's Witnesses with ... |
| 9060546 | 1997 | Article | Journal of clinical oncology : | TPDC-FuHu chemotherapy for the treatment of recurrent metastatic brain tumors. |
| 1733549 | 1992 | Article | Cancer chemotherapy and pharma | 5-Fluorouracil, leucovorin, hydroxyurea, and escalating doses of continuous-infu... |
| 31666201 | 2020 | Article | Nanomedicine : nanotechnology, | Zileuton™ loaded in polymer micelles effectively reduce breast cancer circulatin... |
| 28237610 | 2017 | Article | Cancer radiotherapie : journal | Visceral and bone metastases of a WHO grade 2 meningioma: A case report and revi... |
| 8603452 | 1996 | Article | Cancer chemotherapy and pharma | Impact of different fluorouracil biochemical modulators on cellular dihydropyrim... |
2. sickle cell-hemoglobin E disease syndrome L2 99.67%
臨床試驗（4 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT03763656 | PHASE1, PHASE2 | COMPLETED | 33 | A Prospective Open Label, Pharmacokinetic Study of an Oral Hydroxyurea Solution ... |
| NCT03264989 | PHASE2 | COMPLETED | 57 | A Phase 2, Multicenter, Open-Label Study to Assess PK/PD of SEG101 (Crizanlizuma... |
| NCT02709681 | N/A | COMPLETED | 628 | Hydroxyurea in Sickle Cell Disease: a Large Nation-wide Cohort Study From Italy |
| NCT04927247 | PHASE3 | TERMINATED | 72 | A Randomized, Double-blind, Placebo-controlled, Multicenter Study of a Single Do... |
相關文獻（1 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 36799926 | 2023 | Article | Blood advances | Most adults with severe HbSC disease are not treated with hydroxyurea. |
3. sickle cell-hemoglobin c disease syndrome L2 99.67%
臨床試驗（11 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT03975894 | PHASE2 | UNKNOWN | 50 | A Feasibility Trial of Serial Prophylactic Exchange Blood Transfusion in Pregnan... |
| NCT01987908 | PHASE2 | TERMINATED | 35 | A Phase 2, Exploratory, Placebo-Controlled, Multicenter, Double-Blind Evaluation... |
| NCT02640573 | PHASE2 | TERMINATED | 1 | Treatment of Adult Patients With Hemoglobin SC Disease |
| NCT03474965 | PHASE2 | COMPLETED | 117 | A Phase 2,Multicenter,Open-Label Study to Assess Appropriate Dosing and to Evalu... |
| NCT05850156 | N/A | NOT_YET_RECRUITING | 130 | Study of a Deformability Parameter of Red Blood Cell. FITRED |
| NCT07277023 | NA | COMPLETED | 49 | The Influence of micro-and Macro Vascular Dysfunction on Clinical Severity in Ad... |
| NCT03128515 | PHASE3 | COMPLETED | 187 | Optimizing Hydroxyurea Therapy in Children With Sickle Cell Anemia In Malaria En... |
| NCT03763656 | PHASE1, PHASE2 | COMPLETED | 33 | A Prospective Open Label, Pharmacokinetic Study of an Oral Hydroxyurea Solution ... |
| NCT00532883 | PHASE2 | TERMINATED | 44 | Effectiveness of Hydroxyurea and Magnesium Pidolate Alone and in Combination in ... |
| NCT02336373 | PHASE2 | TERMINATED | 32 | SC Youth Treatment With Hydroxyurea Effects |
| NCT03264989 | PHASE2 | COMPLETED | 57 | A Phase 2, Multicenter, Open-Label Study to Assess PK/PD of SEG101 (Crizanlizuma... |
相關文獻（19 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 36047926 | 2022 | Article | The Cochrane database of syste | Hydroxyurea (hydroxycarbamide) for sickle cell disease. |
| 39647172 | 2025 | Article | NEJM evidence | Hydroxyurea for Children and Adults with Hemoglobin SC Disease. |
| 28426137 | 2017 | Article | The Cochrane database of syste | Hydroxyurea (hydroxycarbamide) for sickle cell disease. |
| 33679049 | 2021 | Article | Journal of clinical and experi | Sickle Hepatopathy. |
| 11406036 | 2001 | Article | The Cochrane database of syste | Hydroxyurea for sickle cell disease. |
| 37439373 | 2023 | Article | Haematologica | Metabolic signatures of cardiorenal dysfunction in plasma from sickle cell patie... |
| 32499906 | 2020 | Article | Hematology reports | The curious case of hemoglobin DC disease masquerading as sickle cell anemia. |
| 39229085 | 2024 | Article | bioRxiv : the preprint server | CureSCi Metadata Catalog-finding and harmonizing studies for secondary analysis ... |
| 10959446 | 2000 | Article | Advances in pediatrics | Major changes in sickle cell disease. |
| 17724699 | 2008 | Article | American journal of hematology | Pulmonary hypertension associated with sickle cell disease: clinical and laborat... |
| 36799926 | 2023 | Article | Blood advances | Most adults with severe HbSC disease are not treated with hydroxyurea. |
| 27736922 | 2016 | Article | PloS one | Associations of Prolonged QTc in Sickle Cell Disease. |
| 26615793 | 2016 | Article | American journal of hematology | Effects of hydroxyurea treatment for patients with hemoglobin SC disease. |
| 39779438 | 2025 | Article | La Revue de medecine interne | [Extramedullary hematopoiesis, a rare complication of sickle cell disease: A six... |
| 22949140 | 2013 | Article | Pediatric blood & cancer | Hydroxyurea treatment of children with hemoglobin SC disease. |
| 18177923 | 2008 | Article | Seminars in arthritis and rheu | Characteristics and outcome of connective tissue diseases in patients with sickl... |
| 17551985 | 2007 | Article | Pediatric blood & cancer | Sickle cell disease caused by Hb S/Québec-CHORI: treatment with hydroxyurea and ... |
| 11464988 | 2001 | Article | Journal of pediatric hematolog | Hydroxyurea therapy for pediatric patients with hemoglobin SC disease. |
| 33538815 | 2021 | Article | JAMA ophthalmology | Longitudinal Assessment of Retinal Thinning in Adults With and Without Sickle Ce... |
4. hereditary persistence of fetal hemoglobin-sickle cell disease syndrome L4 99.67%
相關文獻（1 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 23342821 | 2012 | Article | Journal of the National Medica | Kikuchi-Fugimoto's disease in sickle cell disease: report of 2 cases. |
5. sickle cell-hemoglobin d disease syndrome L1 99.67%
臨床試驗（4 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT04046705 | PHASE3 | UNKNOWN | 78 | A Prospective Multicenter Trial Comparing Allogeneic Matched Related Haematopoie... |
| NCT06464458 | NA | RECRUITING | 30 | Optimizing the Management of Sickle Cell Patients on Hydroxyurea: The Value of T... |
| NCT03763656 | PHASE1, PHASE2 | COMPLETED | 33 | A Prospective Open Label, Pharmacokinetic Study of an Oral Hydroxyurea Solution ... |
| NCT06979492 | PHASE4 | NOT_YET_RECRUITING | 50 | Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease |
相關文獻（2 篇）
6. sickle cell-beta-thalassemia disease syndrome L2 99.67%
臨床試驗（4 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT01962415 | PHASE2 | RECRUITING | 100 | A Phase II Study of Reduced Intensity Conditioning in Pediatric Patients and You... |
| NCT04528355 | N/A | RECRUITING | 50 | A Prospective Outcomes Study of Pediatric and Adult Patients With Non-Malignant ... |
| NCT03653338 | PHASE1, PHASE2 | RECRUITING | 5 | T-Cell Depleted, Alternative Donor Transplant in Pediatric and Adult Patients Wi... |
| NCT03763656 | PHASE1, PHASE2 | COMPLETED | 33 | A Prospective Open Label, Pharmacokinetic Study of an Oral Hydroxyurea Solution ... |
相關文獻（2 篇）
7. cervical adenosarcoma L5 99.40%
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. colon mucinous adenocarcinoma L5 99.32%
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。
9. rectum mucinous adenocarcinoma L5 99.31%
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。
10. gallbladder mucinous adenocarcinoma L5 99.28%
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
| 許可證號 | 品名 | 劑型 | 核准適應症 |
|---|---|---|---|
| - | 捷可衛錠 | 錠劑 | 骨髓纖維化、真性紅血球增多症、GvHD |
| - | Hydroxyurea 膠囊 | 膠囊 | 慢性骨髓性白血病、卵巢癌、頭頸癌 |
安全性考量
- 藥物交互作用：文獻中多與其他化療藥物合併使用
- 注意事項：
- 骨髓抑制是最主要的劑量限制毒性
- 長期使用可能增加繼發性白血病風險
- 皮膚毒性（色素沉著、潰瘍）
- 巨球性貧血
- 乳癌適用考量：
- 目前多用於高劑量化療方案
- 需考量與現有標準治療的比較
安全性資訊請參考原廠仿單。
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）
Nervous System Diseases 🔴 Major
- 注意事項：Neurological symptoms such as disorientation or hallucinations have been reported very rarely during hydroxyurea therapy…
肝臟疾病 🟡 Moderate
- 應謹慎使用本藥物。需定期監測。可能需要調整劑量。
癲癇 🟡 Moderate
- 風險包括：癲癇發作。
Bone Marrow Failure Disorders 🟢 Minor
- 本藥物在此情況下禁用。需定期監測。風險包括：骨髓抑制、出血、感染、血栓、貧血。可能有嚴重不良反應。
腎臟疾病 🟢 Minor
- 注意事項：Hydroxyurea is primarily eliminated by the kidney…
結論與下一步
決策：Proceed with Guardrails
理由：
- 豐富的體外研究支持 HU 在乳癌中的活性
- 已有 Phase I/II 臨床經驗，尤其在高劑量化療方案中
- 新穎的藥物傳遞系統（如脂質複合體）可能改善療效
- 與其他藥物的協同作用提供聯合治療機會
若要推進需要：
- 評估 HU 在現代乳癌治療中的角色（與 CDK4/6 抑制劑、免疫治療的比較或聯合）
- 開發更有效的藥物傳遞系統以提高腫瘤靶向性
- 確定最適合的乳癌亞型（如三陰性乳癌）
- 設計與 valproic acid 或其他增敏劑的聯合用藥方案
相關藥物報告
- Acetazolamide - 證據等級 L2
- Vonoprazan - 證據等級 L2
- Omalizumab - 證據等級 L2
- Gemcitabine - 證據等級 L2
- Prednisone - 證據等級 L2
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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). Hydroxyurea老藥新用驗證報告. https://twtxgnn.yao.care/drugs/hydroxyurea/
BibTeX 格式：
@misc{twtxgnn_hydroxyurea,
title = {Hydroxyurea老藥新用驗證報告},
author = {TwTxGNN Team},
year = {2026},
url = {https://twtxgnn.yao.care/drugs/hydroxyurea/}
}
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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