Pravastatin
證據等級: L5 | 預測適應症: 9 個
## 藥師評估報告
Pravastatin (普伐他汀) - 藥師評估報告
一句話總結
普伐他汀是一種HMG-CoA還原酶抑制劑(他汀類藥物),TxGNN預測其可用於同合子家族性高膽固醇血症和HIV感染相關血脂異常,兩者均有臨床試驗和文獻證據支持,且部分已接近核准適應症範圍。
快速總覽
| 項目 | 內容 |
|---|---|
| 藥物名稱 | Pravastatin (普伐他汀) |
| DrugBank ID | DB00175 |
| 台灣品牌名 | 帕瓦斯德定鈉鹽、Mevalotin等 |
| 原核准適應症 | 高血脂症、心血管疾病預防、移植後高脂血症 |
| 預測新適應症 | homozygous familial hypercholesterolemia、obsolete familial combined hyperlipidemia、HIV infectious disease、neurodevelopmental disorder with ataxic gait, absent speech, and decreased cortical white matter、feline acquired immunodeficiency syndrome、simian immunodeficiency virus infection、hyperlipoproteinemia、familial hypercholesterolemia、hypoalphalipoproteinemia |
| 最高證據等級 | L1-L2 (多個RCT支持) |
| 臨床試驗數 | 4項以上 |
| 文獻支持 | 豐富 (>13篇) |
預測適應症詳細分析
1. homozygous familial hypercholesterolemia L2 99.95% 主要分析
為什麼這個預測合理？
### 同合子家族性高膽固醇血症預測分析 (TxGNN Score: 0.9995, Rank: 1691)
- 他汀類藥物機制: Pravastatin抑制HMG-CoA還原酶,減少肝臟膽固醇合成
- 家族性高膽固醇血症治療: 已核准用於家族性高膽固醇血症(heterozygous)
- 同合子型挑戰: hoFH患者LDL受體功能嚴重缺陷,單一他汀療效有限但仍為基礎治療
- 合併治療策略: 通常需與PCSK9抑制劑、ezetimibe、LDL血漿分離術合併
臨床試驗
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT03510715 | PHASE3 | COMPLETED | 18 | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Childre... |
相關文獻
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 28437620 | 2017 | Article | Endocrine practice : official | AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCR... |
| 12269853 | 2002 | Article | Drugs | Rosuvastatin. |
| 14727947 | 2003 | Article | American journal of cardiovasc | Ezetimibe. |
| 28685504 | 2017 | Article | The Cochrane database of syste | Statins for children with familial hypercholesterolemia. |
| 31696945 | 2019 | Article | The Cochrane database of syste | Statins for children with familial hypercholesterolemia. |
| 15531000 | 2004 | Article | Clinical therapeutics | Rosuvastatin in the management of hyperlipidemia. |
| 31358055 | 2019 | Article | Stem cell research & therapy | Low-density lipoprotein receptor-deficient hepatocytes differentiated from induc... |
| 9793596 | 1998 | Article | The Annals of pharmacotherapy | Atorvastatin in the treatment of primary hypercholesterolemia and mixed dyslipid... |
| 9129869 | 1997 | Article | Drugs | Atorvastatin. A review of its pharmacology and therapeutic potential in the mana... |
| 14647533 | 2003 | Article | Cardiovascular drug reviews | Ezetimibe: a first-in-class, novel cholesterol absorption inhibitor. |
| 28416195 | 2017 | Article | The lancet. HIV | Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia... |
| 15067249 | 2003 | Article | Annales d'endocrinologie | [Ezetimibe: from pharmacology to clinical trials]. |
| 34425670 | 2021 | Article | Iranian biomedical journal | A Novel Splice Site Variant in the LDLRAP1 Gene Causes Familial Hypercholesterol... |
2. HIV infectious disease L1 99.74%
臨床試驗（16 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT00982189 | NA | COMPLETED | 37 | Cardiovascular Disease Risk Reduction for Persons With HIV Infection: a Polypill... |
| NCT00227500 | PHASE4 | COMPLETED | 40 | A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipida... |
| NCT00017758 | PHASE1 | COMPLETED | 56 | The Effect of Efavirenz and Nelfinavir on the Pharmacokinetics of Hydroxymethylg... |
| NCT00039663 | PHASE1 | COMPLETED | 75 | Endothelial Dysfunction as a Risk Factor in HIV Study |
| NCT00665717 | PHASE1 | COMPLETED | 24 | The Influence of Raltegravir on Pravastatin Pharmacokinetics in Healthy Voluntee... |
| NCT00000941 | PHASE1 | COMPLETED | 56 | Evaluation of Potential Pharmacokinetic Interactions Between Protease Inhibitors... |
| NCT00006412 | PHASE3 | COMPLETED | 630 | A Prospective, Multicenter, Randomized Trial Comparing the Efficacy and Safety o... |
| NCT00221754 | PHASE2 | COMPLETED | 21 | Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral T... |
| NCT02578277 | PHASE1 | COMPLETED | 59 | Effects of BMS-955176 on the Single-dose Pharmacokinetics of Probe Substrates (C... |
| NCT01515813 | PHASE2 | WITHDRAWN | 0 | A Randomized Controlled Trial to Compare the Effects of Highly Active Antiretrov... |
| NCT00147797 | N/A | COMPLETED | 84 | Influence of Pravastatin on Carotid Artery Structure and Function in HIV-infecte... |
| NCT00630734 | PHASE4 | COMPLETED | 32 | Genetic Predictors of Pharmacokinetic Variability in the Drug-drug Interaction B... |
| NCT00843661 | PHASE4 | UNKNOWN | 60 | Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy fo... |
| NCT00117494 | PHASE4 | COMPLETED | 86 | Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Prav... |
| NCT04425902 | PHASE1 | COMPLETED | 20 | Effects of GSK3640254 on the Single-Dose Pharmacokinetics of Probe Substrates (C... |
| NCT02841774 | PHASE2 | COMPLETED | 10 | High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Liv... |
相關文獻（20 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 28252528 | 2017 | Article | AIDS (London, England) | Effects of pitavastatin and pravastatin on markers of immune activation and arte... |
| 28416195 | 2017 | Article | The lancet. HIV | Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia... |
| 18991624 | 2008 | Article | Current HIV research | Rosuvastatin, pravastatin, and atorvastatin for the treatment of hypercholestero... |
| 26148680 | 2015 | Article | BMC research notes | Effects of pravastatin, phytosterols, and combination therapy on lipid profile i... |
| 18510890 | 2008 | Article | Current HIV/AIDS reports | Pathogenesis and management of lipoatrophy. |
| 25574964 | 2014 | Article | AIDS (London, England) | Effects of atorvastatin and pravastatin on immune activation and T-cell function... |
| 16603852 | 2006 | Article | AIDS (London, England) | Effect of pravastatin on body composition and markers of cardiovascular disease ... |
| 27192322 | 2016 | Article | Expert opinion on pharmacother | Drug therapies for HIV-related metabolic disorders. |
| 22770622 | 2012 | Article | Expert opinion on pharmacother | The safety and effectiveness of statins as treatment for HIV-dyslipidemia: the e... |
| 35642121 | 2023 | Article | Current reviews in clinical an | A Systematic Review of Randomized Clinical Trials on the Efficacy and Safety of ... |
| 14727985 | 2002 | Article | American journal of cardiovasc | Management of protease inhibitor-associated hyperlipidemia. |
| 15293079 | 2004 | Article | Infection | Lipid lowering therapy with fluvastatin and pravastatin in patients with HIV inf... |
| 12875104 | 2003 | Article | AIDS reviews | HIV protease inhibitors and dyslipidemia. |
| 28364370 | 2017 | Article | American journal of cardiovasc | Recommendations for Managing Drug-Drug Interactions with Statins and HIV Medicat... |
| 17508476 | 2006 | Article | Collegium antropologicum | HIV-associated lipodystrophy syndrome. |
| 16218799 | 2005 | Article | AIDS research and human retrov | A randomized trial of the efficacy and safety of fenofibrate versus pravastatin ... |
| 25907504 | 2015 | Article | The American journal of cardio | A Systematic Review of the Usefulness of Statin Therapy in HIV-Infected Patients... |
| 18753120 | 2008 | Article | HIV clinical trials | Treatment of altered body composition in HIV-associated lipodystrophy: compariso... |
| 17117030 | 2006 | Article | AIDS (London, England) | Influence of pravastatin on carotid artery structure and function in dyslipidemi... |
| 10983656 | 2000 | Article | AIDS (London, England) | Efficacy and tolerability of pravastatin for the treatment of HIV-1 protease inh... |
3. neurodevelopmental disorder with ataxic gait, absent speech, and decreased cortical white matter L5 99.62%
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。
4. feline acquired immunodeficiency syndrome L5 99.55%
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. simian immunodeficiency virus infection L5 99.55%
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. familial hypercholesterolemia L1 99.34%
臨床試驗（6 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT03510715 | PHASE3 | COMPLETED | 18 | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Childre... |
| NCT02107898 | PHASE3 | COMPLETED | 216 | A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Stud... |
| NCT01890967 | PHASE2 | COMPLETED | 527 | A Phase 2 Efficacy and Safety Dose-Ranging Study of LY3015014 in Patients With P... |
| NCT00688896 | PHASE2 | COMPLETED | 155 | A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Eva... |
| NCT03510884 | PHASE3 | COMPLETED | 153 | A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label T... |
| NCT00145574 | PHASE4 | COMPLETED | 194 | Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Colese... |
相關文獻（13 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 31618540 | 2019 | Article | The New England journal of med | 20-Year Follow-up of Statins in Children with Familial Hypercholesterolemia. |
| 28437620 | 2017 | Article | Endocrine practice : official | AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCR... |
| 31696945 | 2019 | Article | The Cochrane database of syste | Statins for children with familial hypercholesterolemia. |
| 28685504 | 2017 | Article | The Cochrane database of syste | Statins for children with familial hypercholesterolemia. |
| 12891228 | 2003 | Article | Clinical pharmacology and ther | Pharmacokinetics and pharmacodynamics of pravastatin in children with familial h... |
| 12269853 | 2002 | Article | Drugs | Rosuvastatin. |
| 25054950 | 2014 | Article | The Cochrane database of syste | Statins for children with familial hypercholesterolemia. |
| 14727947 | 2003 | Article | American journal of cardiovasc | Ezetimibe. |
| 8726243 | 1996 | Article | Pediatric research | Short-term efficacy and safety of pravastatin in 72 children with familial hyper... |
| 16682304 | 2006 | Article | Journal of the American Colleg | Oxidized low-density lipoprotein in children with familial hypercholesterolemia ... |
| 1658544 | 1991 | Article | Metabolism: clinical and exper | Pravastatin in heterozygous familial hypercholesterolemia: low-density lipoprote... |
| 18611121 | 2008 | Article | Expert opinion on drug metabol | Pravastatin: an evidence-based statin? |
| 27595674 | 2016 | Article | American heart journal | Statin-associated muscle symptoms and SLCO1B1 rs4149056 genotype in patients wit... |
7. hypoalphalipoproteinemia L4 99.21%
相關文獻（3 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 21107758 | 2011 | Article | Current atherosclerosis report | What combination therapy with a statin, if any, would you recommend? |
| 12679198 | 2003 | Article | The American journal of cardio | High-density lipoprotein subpopulations in pathologic conditions. |
| 9362407 | 1997 | Article | Journal of the American Colleg | Modulation of lipoprotein(a) atherogenicity by high density lipoprotein choleste... |
8. hypercholesterolemia due to cholesterol 7alpha-hydroxylase deficiency L5 99.07%
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. cholesterol-ester transfer protein deficiency L4 99.04%
相關文獻（1 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 11741245 | 2000 | Article | AAPS pharmSci | Assessing the cost-effectiveness of pharmacogenomics. |
台灣上市資訊
有效許可證
台灣已有多項pravastatin製劑核准,核准適應症包括:
- 高血脂症: 原發性高膽固醇血症、混合型高血脂症
- 初發性預防: 高膽固醇血症無冠心病患者的心肌梗塞預防
- 再發性預防: 冠心病患者的二次預防
- 移植後高脂血症: 心臟移植後免疫抑制治療相關高脂血症
重要說明
家族性高膽固醇血症已在部分製劑核准適應症中提及。
安全性考量
已知安全性資訊
- 肌肉毒性: 罕見但可能發生橫紋肌溶解症
- 肝功能異常: 需監測肝功能指數
- 糖尿病風險: 長期使用可能輕微增加糖尿病風險
- 藥物交互作用: 與部分藥物有交互作用,但程度較其他他汀輕
HIV患者特殊考量
- CYP代謝優勢: Pravastatin不經CYP3A4代謝
- 與抗病毒藥物交互作用:
- 與蛋白酶抑制劑交互作用較少
- Lopinavir/ritonavir可能增加pravastatin血中濃度
- 監測建議: 仍需定期監測肝功能和肌酸激酶
藥物交互作用重點
- 與fibrates併用增加肌病風險
- 與免疫抑制劑(ciclosporin)交互需謹慎
- 與抗凝血劑需監測INR
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）
Cognitive Dysfunction 🟡 Moderate
- 應謹慎使用本藥物。可能有嚴重不良反應。
糖尿病 🟡 Moderate
- 應謹慎使用本藥物。需定期監測。
腎臟疾病 🟡 Moderate
- 應謹慎使用本藥物。需定期監測。可能需要降低劑量。可能有嚴重不良反應。
肝臟疾病 🟢 Minor
- 本藥物在此情況下禁用。需定期監測。
Rhabdomyolysis 🟢 Minor
- 需定期監測。可能有嚴重不良反應。
腎臟疾病 🟢 Minor
- 需定期監測。可能有嚴重不良反應。
藥物-食物交互作用 (DFI)
資料來源：DDInter 2.0（原文內容請參閱該網站）
酒精 🟡 Moderate
- 影響：產生協同作用。
- 建議：建議避免併用。
結論與下一步
整體評估
| 評估項目 | 同合子家族性高膽固醇血症 | HIV相關血脂異常 |
|---|---|---|
| 證據等級 | L2 (系統性回顧支持) | L1-L2 (多個RCT) |
| 機制合理性 | 高 (已為基礎治療) | 高 (代謝優勢) |
| 臨床可行性 | 高 (合併療法一部分) | 高 |
| 建議優先順序 | 高 | 高 |
建議
同合子家族性高膽固醇血症:
- 臨床定位: 作為hoFH多重療法的基礎治療
- 合併用藥: 需與PCSK9抑制劑、ezetimibe等合併
- 適應症擴展: 考慮在現有家族性高膽固醇血症適應症下包含hoFH
HIV相關血脂異常:
- 首選他汀之一: 因代謝特性,為HIV患者較安全的他汀選擇
- 臨床推廣: 可在抗病毒治療相關血脂異常指引中推薦
- 藥動學優勢: 特別適用於使用CYP3A4抑制劑型抗病毒藥物的患者
實務建議
- 監測計畫:
- 基線和治療期間定期監測肝功能、CK
- HIV患者注意病毒載量和CD4變化
- 劑量考量:
- HIV患者可能需較低起始劑量
- 根據降脂效果調整劑量
限制說明
- hoFH患者因LDL受體缺陷,他汀單一療法效果有限
- Pravastatin降脂效力不如其他高效他汀(如atorvastatin, rosuvastatin)
- HIV患者的心血管預後長期數據仍在累積中
報告產生日期: 2026-02-11 資料來源: TxGNN預測、ClinicalTrials.gov、PubMed、台灣食品藥物管理署
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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). Pravastatin老藥新用驗證報告. https://twtxgnn.yao.care/drugs/pravastatin/
BibTeX 格式：
@misc{twtxgnn_pravastatin,
title = {Pravastatin老藥新用驗證報告},
author = {TwTxGNN Team},
year = {2026},
url = {https://twtxgnn.yao.care/drugs/pravastatin/}
}
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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