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.
首款治療女性產(chǎn)后抑郁的藥物于周二獲得聯(lián)邦政府審批,這一舉動(dòng)可能會(huì)為一批治療常見妊娠并發(fā)癥等使人衰弱的疾病的藥物審批鋪平道路。
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.
這種藥可以在48小時(shí)內(nèi)迅速見效,與當(dāng)前可用的抗抑郁藥相比,它的效果有明顯改進(jìn)。目前的抗抑郁藥即使有點(diǎn)成效,可能也得二至四周見效。
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.
專家表示,母親的關(guān)懷、親情和養(yǎng)育對(duì)孩子的健康發(fā)展是至關(guān)重要的,而對(duì)于那些因抑郁癥而無法關(guān)懷、養(yǎng)育孩子或是與其建立情感紐帶的母親而言,這種新療法會(huì)直接為其緩解痛苦。而在美國,孕中或孕后的女性有多達(dá)1/7的人有抑郁的經(jīng)歷。
“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.
“產(chǎn)后抑郁癥是一種很嚴(yán)重的疾病,甚至嚴(yán)重到可能會(huì)危及生命,”食藥局藥物評(píng)估研究中心精神病藥物研究分部的代理主管蒂芙尼•法爾基奧內(nèi)博士在一份聲明中說道。
“This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”
“這份許可標(biāo)志著一款治療產(chǎn)后抑郁癥的藥物首次獲得專門審批,這也為人們提供了一種重要的新療法。”
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這款新藥將以Zulresso的名稱推向市場(chǎng),但目前它還有局限性。這種藥需要在60多個(gè)小時(shí)里進(jìn)行注射,在此期間,新產(chǎn)婦必須留在一家有執(zhí)照的醫(yī)療中心,在醫(yī)生的監(jiān)督下接受治療,因?yàn)樗赡軙?huì)像接受臨床試驗(yàn)的幾個(gè)病人那樣有眩暈或昏厥的癥狀。