美國FDA批准了SAGE Therapeutics公司開發的Zulresso（brexanolone，別孕烯醇酮）上市，用於產後抑鬱症的治療。這是有史以來藥監部門第一次批准一種專門用於治療產後抑鬱症的藥物。
The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.
美國食品藥品監督管理局今天批准 Zulresso注射用於靜脈注射治療成年婦女產後抑鬱症—（PPD）。這是 FDA 批准的第一個專門用於 PPD 的藥物。
"Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.
“產後抑鬱是一種嚴重的疾病，嚴重時會危及生命。女性可能會體驗到傷害自己或傷害孩子的想法。產後抑鬱也會干擾孕婦與嬰兒的關係。FDA 藥品評估和研究中心精神產品部門代理主任 Tiffany Farchione 醫學博士（M.D.）博士說：“這是首次批准一種治療產後抑鬱症的藥物，提供了一種重要的新的治療方案。”
"Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient."
“由於擔心嚴重的危險,包括在服用期間過度鎮靜或突然喪失意識,Zulresso 已經通過風險評估和緩解戰略（ REMS ）獲得批准，只有通過在經認證的衛生保健設施中的有限分銷計劃才能為患者提供服務，衛生保健提供者可以對患者進行仔細監控。”
PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy. As with other forms of depression, it is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure (anhedonia) and may present with symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation.
產後抑鬱症是一種主要的抑鬱症發生後，分娩，儘管症狀可以開始懷孕。與其他形式的抑鬱一樣，抑鬱的特徵是對過去享受的活動的悲傷和/或興趣喪失，以及感到快樂的能力下降（厭食症），並可能出現諸如認知障礙、無價值或負罪感、自殺念頭等症狀。
The most common adverse reactions reported by patients treated with Zulresso in clinical trials include sleepiness, dry mouth, loss of consciousness and flushing. Health care providers should consider changing the therapeutic regimen, including discontinuing Zulresso in patients whose PPD becomes worse or who experience emergent suicidal thoughts and behaviors.
臨床試驗中使用 Zulresso 治療的患者最常見的不良反應包括嗜睡、口乾、意識喪失和麵色潮紅。衛生保健提供者應該考慮改變治療養生法，包括停止對 PPD 變得更糟或出現自殺想法和行為的患者的 Zulresso 。
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