The first drug for women suffering postpartum depression received federal approval on Tuesday, a move likely to pave the way for a wave of treatments to address a debilitating condition that is the most common complication of pregnancy.
首款治疗女性产后抑郁的药物于周二获得联邦政府审批,这一举动可能会为一批治疗常见妊娠并发症等使人衰弱的疾病的药物审批铺平道路。
The drug works very quickly, within 48 hours — a significant improvement over currently available antidepressants, which can take two to four weeks to have an effect, if they work at all.
这种药可以在48小时内迅速见效,与当前可用的抗抑郁药相比,它的效果有明显改进。目前的抗抑郁药即使有点成效,可能也得二至四周见效。
Experts say the new treatment will provide immediate relief for mothers whose depression keeps them from providing their babies with the care, bonding and nurturing that is crucial for healthy development. As many as one in seven American women experience depression during or after pregnancy.
专家表示,母亲的关怀、亲情和养育对孩子的健康发展是至关重要的,而对于那些因抑郁症而无法关怀、养育孩子或是与其建立情感纽带的母亲而言,这种新疗法会直接为其缓解痛苦。而在美国,孕中或孕后的女性有多达1/7的人有抑郁的经历。
“Postpartum depression is a serious condition that, when severe, can be life-threatening,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement.
“产后抑郁症是一种很严重的疾病,甚至严重到可能会危及生命,”食药局药物评估研究中心精神病药物研究分部的代理主管蒂芙尼•法尔基奥内博士在一份声明中说道。
“This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”
“这份许可标志着一款治疗产后抑郁症的药物首次获得专门审批,这也为人们提供了一种重要的新疗法。”
There are limitations to the new drug, brexanolone, which will be marketed as Zulresso. It is delivered by infusion over 60 hours, during which a new mother must remain in a certified medical center, under supervision should she get dizzy or faint, as several patients did in clinical trials.
Brexanolone这款新药将以Zulresso的名称推向市场,但目前它还有局限性。这种药需要在60多个小时里进行注射,在此期间,新产妇必须留在一家有执照的医疗中心,在医生的监督下接受治疗,因为她可能会像接受临床试验的几个病人那样有眩晕或昏厥的症状。
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