美国FDA批准了SAGE Therapeutics公司开发的Zulresso（brexanolone，别孕烯醇酮）上市，用于产后抑郁症的治疗。这是有史以来药监部门第一次批准一种专门用于治疗产后抑郁症的药物。
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.
美国食品药品监督管理局今天批准 Zulresso注射用于静脉注射治疗成年妇女产后抑郁症—（PPD）。这是 FDA 批准的第一个专门用于 PPD 的药物。
"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.
“产后抑郁是一种严重的疾病，严重时会危及生命。女性可能会体验到伤害自己或伤害孩子的想法。产后抑郁也会干扰孕妇与婴儿的关系。FDA 药品评估和研究中心精神产品部门代理主任 Tiffany Farchione 医学博士（M.D.）博士说：“这是首次批准一种治疗产后抑郁症的药物，提供了一种重要的新的治疗方案。”
"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."
“由于担心严重的危险,包括在服用期间过度镇静或突然丧失意识,Zulresso 已经通过风险评估和缓解战略（ REMS ）获得批准，只有通过在经认证的卫生保健设施中的有限分销计划才能为患者提供服务，卫生保健提供者可以对患者进行仔细监控。”
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.
产后抑郁症是一种主要的抑郁症发生后，分娩，尽管症状可以开始怀孕。与其他形式的抑郁一样，抑郁的特征是对过去享受的活动的悲伤和/或兴趣丧失，以及感到快乐的能力下降（厌食症），并可能出现诸如认知障碍、无价值或负罪感、自杀念头等症状。
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.
临床试验中使用 Zulresso 治疗的患者最常见的不良反应包括嗜睡、口干、意识丧失和面色潮红。卫生保健提供者应该考虑改变治疗养生法，包括停止对 PPD 变得更糟或出现自杀想法和行为的患者的 Zulresso 。
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