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                您當前位置:網站首頁 >> 醫藥新聞 >> 行業動態 >> FDA 批準首個產后抑郁癥治療藥物 Zulresso
               
               
              FDA 批準首個產后抑郁癥治療藥物 Zulresso
              2019-03-26 17:31:10 來源:丁香園 瀏覽:3356

              美國 FDA 網站 3 月 19 日消息,FDA 今天批準 Sage 醫療公司 Zulresso(brexanolone)注射劑用于治療成年婦女產后抑郁癥(PPD)。這也是 FDA 批準的首個專門用于治療產后抑郁癥的藥物。

              「產后抑郁癥是一種嚴重的疾病,嚴重的時候可能會危及生命。女性可能會有傷害自己或傷害孩子的想法。產后抑郁癥也會影響母嬰關系。這次批準標志著首次有專門用于治療產后抑郁癥的藥物獲得批準,同時這也提供了一個重要的新治療方案,」FDA 藥物評價和研究中心精神病學產品部門代理主任、醫學博士 Farchione 稱。「出于用藥期間對嚴重風險, 包括過度鎮靜或突然意識喪失的擔憂,Zulresso 批準時伴有一項風險評估和減災戰略(REMS), 患者只能通過限制性分配計劃從獲得認證的衛生保健機構獲得這款藥物, 而這些地點的衛生保健提供者可以仔細對病人進行監測。」

              產后抑郁癥是一種在分娩后發生的嚴重抑郁癥,但癥狀可以在懷孕期間開始。與其他形式的抑郁癥一樣,它的特征是悲傷和/或對過去喜歡的活動失去興趣,感到快樂的能力下降(快感缺乏),并可能出現癥狀,如認知障礙,感覺沒有價值或內疚,或自殺想法。

              Zulresso 只能通過受限制的 Zulresso REMS 計劃獲得,該計劃要求藥物由得到認證的衛生保健機構的衛生保健提供者進行管理。REMS 要求患者在用藥前必須參加該計劃。Zulresso 使用時需要進行總計超過 60 個小時(2.5 天)的連續靜脈輸注。由于突然失去意識存在嚴重傷害風險,所以必須對患者進行過度鎮靜和突然失去意識的監測,并進行連續的脈搏血氧儀監測(監測血液中的氧水平)。接受藥物輸液時,患者必須與他們的孩子互動。這些步驟的需要在藥物處方信息的方框警告中有說明。患者會被告知 Zulresso 治療的風險,并指示他們必須在整個 60 小時的輸液過程中,衛生保健機構需對這些影響進行監測。在治療后困倦感完全消失之前,患者不應開車、操作機器或進行其他危險活動。

              Zulresso 的有效性基于兩項臨床研究,研究中受試者接受了持續 60 小時的 Zulresso 或安慰劑靜脈注射,然后進行了四周的隨訪。一項研究的受試者為重度產后抑郁癥患者,另一項研究的受試者為中度產后抑郁癥患者。本研究的主要評價方法是抑郁評分量表測量的抑郁癥狀與基線相比的平均變化。在兩項安慰劑對照研究中,第一次輸液結束時 Zulresso 在改善抑郁癥狀方面均優于安慰劑。在 30 天隨訪期結束時也觀察到了抑郁癥的改善。?

              Zulresso 治療患者在臨床試驗中最常見的不良反應包括嗜睡、口干、意識喪失和臉紅。在產后抑郁癥惡化或出現緊急自殺想法和行為的患者中,衛生保健提供者應考慮改變治療方案,包括停止使用 Zulresso。這款藥物在審評中獲得了優先審評資格及突破性療法資格。

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