度他雄胺 Dutasteride

INT-dutasteride-001 3 個適應症被研究

B 2 U 1

適應症與證據等級

良性攝護腺肥大 (BPH) / 下泌尿道症狀 (LUTS) Benign Prostatic Hyperplasia

B 🟡 B 初步證據附警語發布 ⚠️ 中度市場風險

→

雄性禿（雄激素性脫髮） Androgenetic Alopecia

B 🟡 B 初步證據附警語發布 ⚠️ 中度市場風險

→

柔沛後遺症（5α-還原酶抑制劑後症候群／PFS） Post Finasteride Syndrome

U ⚫ U 未驗證證據分歧 ⚠️ 中度市場風險

→

法規與權威立場 (L4)

L4a · US FDA

立場：supportive

AVODART is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of the need for BPH-related surgery. AVODART is not approved for the prevention of prostate cancer.

來源 ↗

L4b · EU EFSA

立場：not_addressed

L4c · UK NHS

立場：cautious

Dutasteride. Indications and dose — Benign prostatic hyperplasia. By mouth. For adult: 500 micrograms once daily, review treatment at 3–6 months and then every 6–12 months. ... Contra-indications: Women; children. ... Cautions: Patients should be assessed for prostate cancer before treatment and at regular intervals afterwards — dutasteride reduces serum prostate specific antigen (PSA) concentr…

來源 ↗

L4d · TW TFDA / 衛福部

立場：cautious

Dutasteride（適尿通 Avodart 0.5mg 軟膠囊）為醫師處方用藥，核可適應症為良性攝護腺肥大（BPH），仿單載明可能引起性功能障礙（性慾減退、勃起功能障礙、射精異常）及男性乳房異常變化等不良反應，部分症狀於停藥後仍可能持續。

來源 ↗

L4e · WHO

立場：not_addressed

Finasteride and dutasteride: prostate cancer (WHO Drug Information / WHO Pharmaceuticals Newsletter signal communication)

來源 ↗