Nepafenac
證據等級: L5 | 預測適應症: 10 個
## 藥師評估報告
Nepafenac 藥師筆記
一句話總結
Nepafenac 是一種眼用非類固醇抗發炎藥（NSAID）前驅物，TxGNN 預測其對眼科疾病有治療潛力，此預測獲得超過 40 項臨床試驗的強力支持，主要集中在白內障手術後發炎和黃斑水腫的預防與治療。
快速總覽
| 項目 | 內容 |
|---|---|
| 藥物名稱 | Nepafenac（納衛視） |
| DrugBank ID | DB06802 |
| 台灣商品名 | 納衛視點眼懸液劑 0.1% |
| 原核准適應症 | 白內障手術相關的術後疼痛及發炎 |
| 預測新適應症 | eye disease、optic papillitis、hypotrichosis simplex of the scalp、seborrheic keratosis、von Hippel anomaly、congenital hypotrichosis milia、mcpherson robertson cammarano syndrome、lagophthalmos、vulvar inverted follicular keratosis、vitreous detachment |
| 最高預測分數 | 0.9985（眼科疾病） |
| 證據等級 | L1（多個 RCT） |
預測適應症詳細分析
1. eye disease L1 99.85% 主要分析
為什麼這個預測合理？
### 藥理機轉分析
Nepafenac 是 amfenac 的前驅藥物，透過抑制環氧化酶（COX）來減少前列腺素合成。其機轉與預測適應症的關聯：
- 眼科疾病（TxGNN Score: 0.9985）
- Nepafenac 已是眼科常用 NSAID
- 可穿透角膜後在眼內轉化為活性代謝物
- 抑制前列腺素 E2（PGE2）合成
- 減少術後發炎、瞳孔縮小和黃斑水腫
- 預測高度合理，且已有廣泛臨床證據
臨床試驗
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT03597867 | PHASE3 | COMPLETED | 104 | Vitreous pge2 Level Changes After Topical Administration of Diclofenac 0.1%, Nep... |
| NCT01426854 | PHASE3 | COMPLETED | 260 | Clinical Evaluation of Safety and Efficacy of Nepafenac Ophthalmic Suspension, 0... |
| NCT00348582 | PHASE4 | COMPLETED | N/A | Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery |
| NCT00900887 | PHASE2 | COMPLETED | 84 | Efficacy of Topic Antiinflammatory Therapy Treatment in Center Point Thickness S... |
| NCT05847049 | N/A | COMPLETED | 16 | Influence of Combined Eplerenone , Intravitreal Aflibercept and Topical Nepafena... |
| NCT00347204 | PHASE4 | COMPLETED | 40 | Double Masked Evaluation of Acular LS Versus Nevanac for Postoperative Pain Cont... |
| NCT00865540 | PHASE4 | UNKNOWN | 30 | Effect of Anti-inflammatory Topical Prednisolone Acetate 1%, Nepafenac of 0.1% a... |
| NCT00782717 | PHASE2 | COMPLETED | 263 | A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following C... |
| NCT03851172 | PHASE2 | UNKNOWN | 75 | Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis Duri... |
| NCT00801905 | PHASE2 | TERMINATED | 50 | Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photoco... |
| NCT00405730 | PHASE3 | COMPLETED | 227 | Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye D... |
| NCT01657266 | PHASE2 | COMPLETED | 160 | Phase 2 Randomized, Double-blind Clinical Trial to Evaluate Efficacy and Safety ... |
| NCT01001806 | PHASE4 | COMPLETED | 126 | A Comparison of Peak Aqueous Penetration of Acuvail, Xibrom, and Nevanac in Pati... |
| NCT01847638 | NA | COMPLETED | 50 | Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevr... |
| NCT03918590 | PHASE4 | UNKNOWN | 60 | Pain Control Following Intravitreal Injection Using Topical Nepefanac 0.3% or Pr... |
| NCT03025945 | NA | COMPLETED | 662 | Pseudophakic Cystoid Macular Edema Prevention and Risk Factors; Prospective Stud... |
| NCT03499873 | PHASE3 | COMPLETED | 448 | A Randomized, Multicenter, Double Masked, Placebo Controlled, Parallel Group, Bi... |
| NCT00780780 | PHASE3 | COMPLETED | 40 | A Randomized Parallel, Masked to Evaluate the Efficacy of Triamcinolone Associat... |
| NCT00494494 | PHASE4 | COMPLETED | 82 | Effect of Nepafenac on Post-operative Cystoid Macular Edema Following Uncomplica... |
| NCT01021761 | PHASE4 | COMPLETED | 126 | A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevana... |
| NCT02084576 | PHASE4 | COMPLETED | 40 | Comparison of Ketorolac Tromethamine 0.4% and Nepafenac 0.1% for the Prevention ... |
| NCT02752646 | NA | COMPLETED | 200 | Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5% |
| NCT01109173 | PHASE3 | COMPLETED | 2120 | Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and ... |
| NCT02506348 | NA | UNKNOWN | 30 | Comparison of Diclofenac vs. Nepafenac Ophthalmic Drops: Patient Comfort |
| NCT01475877 | N/A | COMPLETED | 20 | Bromday (Bromfenac Ophthalmic Solution)0.09% QD vs Nevanac (Nepafenac Ophthalmic... |
| NCT01318499 | PHASE2 | COMPLETED | 1342 | Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% Compared to Nepafen... |
| NCT00818844 | PHASE4 | COMPLETED | 40 | Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery |
| NCT01939691 | PHASE4 | TERMINATED | 9 | Macular Edema Nepafenac vs. Difluprednate Uveitis Trial |
| NCT07178639 | NA | RECRUITING | 150 | Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Pat... |
| NCT00333255 | PHASE3 | COMPLETED | 267 | Preoperative and Postoperative Nevanac 0.1% Compared to Acular LS for the Treatm... |
| NCT01331005 | PHASE2 | COMPLETED | 125 | A Phase II Evaluation of Topical Non-steroidal Anti-inflammatories in Eyes With ... |
| NCT04843839 | PHASE2 | UNKNOWN | 30 | Corneal Dystrophies Caused by SLC4A11 Mutation: A Promising New Paradigm Shift i... |
| NCT01853072 | PHASE3 | COMPLETED | 881 | Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The... |
| NCT00332774 | PHASE3 | COMPLETED | 149 | A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehic... |
| NCT02515045 | PHASE4 | COMPLETED | 59 | Comparison of Dropless Prophylaxis After Routine Phacoemulsification to Standard... |
| NCT01395069 | PHASE4 | COMPLETED | 162 | Randomized Clinical Trial Comparing Prophylactic Nepafenac 0.1% and Ketorolac 0.... |
| NCT02955641 | NA | UNKNOWN | 100 | Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridoto... |
| NCT07372014 | PHASE4 | ACTIVE_NOT_RECRUITING | 68 | A Comparative Analysis of the Effectiveness of Nepafenac Combined With a Lubrica... |
| NCT00939276 | PHASE3 | TERMINATED | 175 | Macular Edema Incidence/Severity Reduction With Nevanac |
| NCT07162818 | PHASE4 | COMPLETED | 61 | Effects of 0.1% Nepafenac on Vitreous Inflammatory Biomarkers in Rhegmatogenous ... |
| NCT01872611 | PHASE3 | COMPLETED | 819 | Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The... |
相關文獻
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 35025078 | 2022 | Article | Drugs | Treatment of Non-Infectious Corneal Injury: Review of Diagnostic Agents, Therape... |
| 29199864 | 2018 | Article | Current eye research | Intracameral Use of Nepafenac: Safety and Efficacy Study. |
| 26474497 | 2016 | Article | Experimental eye research | Distribution of topical ocular nepafenac and its active metabolite amfenac to th... |
| 34120417 | 2021 | Article | Korean journal of ophthalmolog | Comparison between 0.1% Nepafenac and 1% Prednisolone Eye Drop in Postoperative ... |
| 32672612 | 2020 | Article | Ophthalmology. Glaucoma | Safety and Efficacy of 0.1% Nepafenac versus 1% Prednisolone Acetate Eye Drops a... |
| 30284393 | 2018 | Article | Acta ophthalmologica | Postoperative management in cataract surgery: nepafenac and preservative-free di... |
| 34210237 | 2022 | Article | Clinical & experimental optome | Nepafenac in cataract surgery. |
| 25493620 | 2016 | Article | Journal of glaucoma | The Interaction of Nepafenac and Prostaglandin Analogs in Primary Open-angle Gla... |
| 16466612 | 2006 | Article | Current medical research and o | Ocular permeation and inhibition of retinal inflammation: an examination of data... |
| 24697218 | 2014 | Article | The Journal of pharmacy and ph | Effects of topical indomethacin, bromfenac and nepafenac on lipopolysaccharide-i... |
| 19897019 | 2010 | Article | Brain research bulletin | The effects of nepafenac and amfenac on retinal angiogenesis. |
| 24345317 | 2014 | Article | American journal of ophthalmol | Effect of nepafenac eye drops on intraocular pressure: a randomized prospective ... |
| 36573765 | 2023 | Article | Journal of cataract and refrac | Extreme intraocular pressure and steroid-dependent iritis. |
| 24345529 | 2014 | Article | Journal of cataract and refrac | Once-daily nepafenac ophthalmic suspension 0.3% to prevent and treat ocular infl... |
| 22795976 | 2012 | Article | Journal of cataract and refrac | Prophylactic nepafenac and ketorolac versus placebo in preventing postoperative ... |
| 30046541 | 2018 | Article | International journal of ophth | Comparative study of the efficacy and safety of bromfenac, nepafenac and diclofe... |
| 17259381 | 2007 | Article | Diabetes | Topical administration of nepafenac inhibits diabetes-induced retinal microvascu... |
| 35196591 | 2022 | Article | Ophthalmology. Glaucoma | Topical 0.1% Nepafenac versus 0.09% Bromfenac Eye Drops for Inflammation after L... |
| 29408555 | 2018 | Article | International journal of biolo | Nepafenac loaded silica nanoparticles dispersed in-situ gel systems: Development... |
| 19040348 | 2008 | Article | Journal of ocular pharmacology | Nepafenac dosing frequency for ocular pain and inflammation associated with cata... |
2. optic papillitis L3 99.84%
臨床試驗（1 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT01847638 | NA | COMPLETED | 50 | Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevr... |
相關文獻（1 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 14635785 | 2003 | Article | Inflammation | Inflammation-mediated retinal edema in the rabbit is inhibited by topical nepafe... |
3. hypotrichosis simplex of the scalp 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。
4. seborrheic keratosis L5 99.83%
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. von Hippel anomaly L5 99.82%
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. congenital hypotrichosis milia L5 99.82%
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. mcpherson robertson cammarano syndrome L5 99.82%
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. lagophthalmos L5 99.81%
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. vulvar inverted follicular keratosis L5 99.81%
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. vitreous detachment L2 99.81%
臨床試驗（1 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT07162818 | PHASE4 | COMPLETED | 61 | Effects of 0.1% Nepafenac on Vitreous Inflammatory Biomarkers in Rhegmatogenous ... |
相關文獻（1 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 38562362 | 2024 | Article | Cureus | Bilateral Acute Posterior Multifocal Placoid Pigment Epitheliopathy With Bacilla... |
台灣上市資訊
| 許可證字號 | 商品名 | 劑型 | 許可證持有者 | 狀態 |
|---|---|---|---|---|
| （待確認） | 納衛視點眼懸液劑 0.1% | 點眼懸液劑 | （待確認） | 有效 |
| （待確認） | Ilevro 0.3% | 點眼懸液劑 | Alcon | 有效（國際） |
核准適應症：
- 用於成人患者預防及治療白內障手術相關的術後疼痛及發炎
- 治療白內障手術引起之疼痛與發炎
安全性考量
主要警告
- 延遲傷口癒合
- 所有眼用 NSAID 可能延遲角膜傷口癒合
- 與眼用類固醇併用時風險增加
- 角膜副作用
- 長期使用可能導致角膜穿孔風險
- 需監測角膜狀態
- 過敏反應
- 對 NSAID 過敏者需謹慎
- 可能發生交叉過敏反應
- 出血傾向
- 可能增加眼內出血風險
- 手術時機需謹慎評估
藥物交互作用
- 與眼用類固醇併用可能增加角膜副作用風險
- 與全身性抗凝血劑併用需謹慎
結論與下一步
評估結論
| 預測適應症 | 證據等級 | 臨床轉譯可行性 | 建議優先順序 |
|---|---|---|---|
| 白內障術後發炎/疼痛 | L1 | 高（已核准） | 不適用 |
| 糖尿病患者黃斑水腫預防 | L1 | 高 | 強烈建議申請適應症擴增 |
| 其他眼科手術後發炎 | L2 | 高 | 建議進一步評估 |
建議
- 糖尿病患者白內障手術後黃斑水腫預防
- 多項 Phase 3 試驗已證實療效
- 台灣現行適應症未明確涵蓋此族群
- 強烈建議：考慮申請適應症擴增至「糖尿病視網膜病變患者白內障手術後黃斑水腫的預防」
- 0.3% 劑型引進
- Nepafenac 0.3% 每日一次給藥，順應性優於 0.1% 每日三次
- 建議評估是否引進 0.3% 劑型
- 臨床應用擴展
- 可考慮用於玻璃體切除術後發炎控制
- 可作為雷射視網膜光凝術後輔助用藥
後續行動
- 確認豐富的臨床試驗證據（40+ 試驗）
- 評估 0.3% 劑型引進台灣的可行性
- 與許可證持有者討論適應症擴增事宜
- 準備糖尿病患者黃斑水腫預防的適應症申請文件
報告產生日期：2026-02-11 資料來源：TxGNN 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). Nepafenac老藥新用驗證報告. https://twtxgnn.yao.care/drugs/nepafenac/
BibTeX 格式：
@misc{twtxgnn_nepafenac,
title = {Nepafenac老藥新用驗證報告},
author = {TwTxGNN Team},
year = {2026},
url = {https://twtxgnn.yao.care/drugs/nepafenac/}
}
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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