Tioconazole
證據等級: L5 | 預測適應症: 3 個
## 藥師評估報告
Tioconazole (治可那唑) - 藥師評估報告
一句話總結
Tioconazole 是一種咪唑類抗黴菌藥物，TxGNN 預測其用於外陰陰道炎獲得豐富臨床試驗與文獻支持，實際上這已是其核准適應症的延伸應用。
快速總覽
| 項目 | 內容 |
|---|---|
| 藥物名稱 | Tioconazole (治可那唑) |
| DrugBank ID | DB01007 |
| 原適應症 | 感受性黴菌引起之局部感染症 |
| 預測新適應症 | vulvovaginal candidiasis、vulvovaginitis、vulvitis |
| TxGNN 分數 | 0.992 (排名 13,733) |
| 證據等級 | 2 項臨床試驗、20+ 篇相關文獻 |
| 台灣上市狀態 | 有效許可證（妥舒乳膏等） |
預測適應症詳細分析
1. vulvovaginitis L1 99.23% 主要分析
為什麼這個預測合理？
### 機轉分析
Tioconazole 是廣效咪唑類抗黴菌藥物，其作用機轉為抑制真菌細胞膜麥角固醇合成。預測用於外陰陰道炎完全符合其藥理特性：
- 抗念珠菌活性：對 Candida albicans 及其他念珠菌屬具高度活性
- 抗滴蟲活性：對 Trichomonas vaginalis 也有一定效果
- 局部應用優勢：陰道製劑可達到高局部濃度，全身吸收少
臨床試驗
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT03839875 | PHASE4 | COMPLETED | 116 | A National, Multi-central, Open-label, Single-arm, Phase IV Study to Evaluate Ef... |
| NCT06056947 | PHASE3 | COMPLETED | 577 | Phase III Study to Evaluate Efficacy and Safety of Different Formulations of Fen... |
相關文獻
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 3510114 | 1986 | Article | Drugs | Tioconazole. A review of its antimicrobial activity and therapeutic use in super... |
| 40464716 | 2025 | Article | Expert review of anti-infectiv | The future of non-invasive azole antifungal treatment options for the management... |
| 10470518 | 1999 | Article | Comprehensive therapy | Vulvovaginitis in healthy women. |
| 34550113 | 2021 | Article | The Medical letter on drugs an | Ibrexafungerp (Brexafemme) for vulvovaginal candidiasis. |
| 6873744 | 1983 | Article | Gynakologische Rundschau | Open comparison of the efficacy, toleration and safety of tioconazole cream and ... |
| 3524439 | 1986 | Article | Antimicrobial agents and chemo | Single-dose tioconazole compared with 3-day clotrimazole treatment in vulvovagin... |
| 6347833 | 1983 | Article | Gynakologische Rundschau | Double-blind comparison of the efficacy, tolerance and safety of tioconazole and... |
| 6347834 | 1983 | Article | Gynakologische Rundschau | Open comparison of the efficacy, toleration and safety of tioconazole and econaz... |
| 30553009 | 2019 | Article | International journal of pharm | Chitosan-hydroxypropyl methylcellulose tioconazole films: A promising alternativ... |
| 4025721 | 1985 | Article | The Alabama journal of medical | The clinical and cytological assessment of tioconazole in vulvo-vaginal candidia... |
| 34286728 | 2021 | Article | Analytical methods : advancing | Quantitative and specific detection of viable pathogens on a portable microfluid... |
| 6873745 | 1983 | Article | Gynakologische Rundschau | Open comparison of the efficacy, toleration and safety of tioconazole cream used... |
| 6873743 | 1983 | Article | Gynakologische Rundschau | Open studies of the efficacy, tolerance, systemic absorption and vaginal persist... |
| 10990271 | 2000 | Article | Microbial drug resistance (Lar | Cross-Resistance of clinical isolates of Candida albicans and Candida glabrata t... |
| 3895961 | 1985 | Article | American journal of obstetrics | Is more than one application of an antifungal necessary in the treatment of acut... |
| 6094282 | 1984 | Article | The Journal of international m | Topical tioconazole versus systemic ketoconazole treatment of vaginal candidiasi... |
| 3216880 | 1988 | Article | Mycoses | Tioconazole in the treatment of vaginal candidosis. |
| 3984688 | 1985 | Article | Acta obstetricia et gynecologi | Treatment of vaginal candidosis with tioconazole 2% vaginal cream. |
| 6873747 | 1983 | Article | Gynakologische Rundschau | Tioconazole in the treatment of vaginal candidiasis. An international clinical r... |
| 6683696 | 1983 | Article | Gynakologische Rundschau | Tioconazole, a new broad-spectrum antifungal agent: preclinical studies related ... |
2. vulvitis L1 99.20%
臨床試驗（2 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT03839875 | PHASE4 | COMPLETED | 116 | A National, Multi-central, Open-label, Single-arm, Phase IV Study to Evaluate Ef... |
| NCT06056947 | PHASE3 | COMPLETED | 577 | Phase III Study to Evaluate Efficacy and Safety of Different Formulations of Fen... |
相關文獻（20 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 3510114 | 1986 | Article | Drugs | Tioconazole. A review of its antimicrobial activity and therapeutic use in super... |
| 40464716 | 2025 | Article | Expert review of anti-infectiv | The future of non-invasive azole antifungal treatment options for the management... |
| 10470518 | 1999 | Article | Comprehensive therapy | Vulvovaginitis in healthy women. |
| 34550113 | 2021 | Article | The Medical letter on drugs an | Ibrexafungerp (Brexafemme) for vulvovaginal candidiasis. |
| 6873744 | 1983 | Article | Gynakologische Rundschau | Open comparison of the efficacy, toleration and safety of tioconazole cream and ... |
| 3524439 | 1986 | Article | Antimicrobial agents and chemo | Single-dose tioconazole compared with 3-day clotrimazole treatment in vulvovagin... |
| 6347833 | 1983 | Article | Gynakologische Rundschau | Double-blind comparison of the efficacy, tolerance and safety of tioconazole and... |
| 6347834 | 1983 | Article | Gynakologische Rundschau | Open comparison of the efficacy, toleration and safety of tioconazole and econaz... |
| 30553009 | 2019 | Article | International journal of pharm | Chitosan-hydroxypropyl methylcellulose tioconazole films: A promising alternativ... |
| 4025721 | 1985 | Article | The Alabama journal of medical | The clinical and cytological assessment of tioconazole in vulvo-vaginal candidia... |
| 6873745 | 1983 | Article | Gynakologische Rundschau | Open comparison of the efficacy, toleration and safety of tioconazole cream used... |
| 6873743 | 1983 | Article | Gynakologische Rundschau | Open studies of the efficacy, tolerance, systemic absorption and vaginal persist... |
| 10990271 | 2000 | Article | Microbial drug resistance (Lar | Cross-Resistance of clinical isolates of Candida albicans and Candida glabrata t... |
| 3895961 | 1985 | Article | American journal of obstetrics | Is more than one application of an antifungal necessary in the treatment of acut... |
| 3216880 | 1988 | Article | Mycoses | Tioconazole in the treatment of vaginal candidosis. |
| 6094282 | 1984 | Article | The Journal of international m | Topical tioconazole versus systemic ketoconazole treatment of vaginal candidiasi... |
| 3984688 | 1985 | Article | Acta obstetricia et gynecologi | Treatment of vaginal candidosis with tioconazole 2% vaginal cream. |
| 1951575 | 1991 | Article | American journal of obstetrics | The in vitro activity of terconazole against yeasts: its topical long-acting the... |
| 6873747 | 1983 | Article | Gynakologische Rundschau | Tioconazole in the treatment of vaginal candidiasis. An international clinical r... |
| 6683696 | 1983 | Article | Gynakologische Rundschau | Tioconazole, a new broad-spectrum antifungal agent: preclinical studies related ... |
3. postmenopausal atrophic vaginitis L5 99.19%
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。
台灣上市情形
Tioconazole 在台灣有外用製劑許可證：
| 許可證字號 | 品名 | 劑型 | 適應症 |
|---|---|---|---|
| 有效許可證 | 妥舒乳膏 1% | 乳膏劑 | 感受性黴菌引起之局部感染 |
注意：台灣目前無陰道專用製劑，如需用於外陰陰道炎，需使用現有外用乳膏。
安全性考量
藥物交互作用
Tioconazole 為局部用藥，全身吸收極少，藥物交互作用風險低。
常見不良反應
- 局部刺激感、搔癢（發生率約 5-30%）
- 燒灼感
- 紅疹
使用注意事項
- 月經期間應避免使用陰道製劑
- 可能損壞乳膠保險套與子宮帽
- 如 3 天後症狀未改善應就醫
結論
預測適應症評估
| 適應症 | TxGNN 分數 | 臨床試驗 | 文獻 | 建議 |
|---|---|---|---|---|
| 外陰陰道炎 | 0.992 | 2 項 | 20+ 篇 | 建議（證據充足） |
臨床建議
- 念珠菌性外陰陰道炎：Tioconazole 是有效的治療選擇
- 國際上有單劑量 6.5% 陰道軟膏製劑
- 療效與 Clotrimazole、Miconazole 相當
- 台灣使用考量：
- 目前僅有外用乳膏劑型
- 若需治療外陰陰道炎，可考慮其他有陰道製劑的咪唑類藥物
- 優勢：
- 可單劑量治療
- 局部用藥全身副作用少
- 對多數念珠菌菌株有效
報告產生日期：2026-02-11 資料來源：TxGNN 知識圖譜預測、ClinicalTrials.gov、PubMed、台灣 FDA
相關藥物報告
- Alprostadil - 證據等級 L5
- Remdesivir - 證據等級 L5
- Travoprost - 證據等級 L5
- Nebivolol - 證據等級 L5
- Homatropine Methylbromide - 證據等級 L5
用 AI 幫我深入分析
想進一步了解這個藥物的老藥新用潛力嗎？點擊下方按鈕，直接開啟 AI 助手進行分析。
Claude：點擊後會複製提問並開啟新視窗，請按 Ctrl+V（Mac: Cmd+V）貼上
ChatGPT：點擊後直接開啟並自動帶入提問
引用本報告
如需引用本報告，請使用以下格式：
APA 格式：
TwTxGNN. (2026). Tioconazole老藥新用驗證報告. https://twtxgnn.yao.care/drugs/tioconazole/
BibTeX 格式：
@misc{twtxgnn_tioconazole,
title = {Tioconazole老藥新用驗證報告},
author = {TwTxGNN Team},
year = {2026},
url = {https://twtxgnn.yao.care/drugs/tioconazole/}
}
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
歡迎分享您對本報告的看法、補充資訊或提出問題。討論內容會同步到 GitHub Discussions。 需要 GitHub 帳號才能留言。