維基百科

米氮平

米氮平（英語：Mirtazapine），商品名為樂活憂（港台）/瑞美隆（中國大陸）（Remeron）[6]，是一種去甲腎上腺素和特異性5-羥色胺能抗抑鬱藥（NaSSA）[2] ，主要用來治療抑鬱症。米氮平也經常被用作抗焦慮藥、安眠藥、止吐藥和食慾促進劑。若按分子結構分類，米氮平被分類為四環類抗抑鬱藥(TeCA) ，並且為米塞林的6-氮雜類似物。[6] 米氮平也是一種外消旋混合物，包含(R)- 和 (S)-異構體。[6]

米氮平
臨床資料
商品名（英語：Drug nomenclature）瑞美隆（中國大陸）/樂活憂（港台）（Remeron）
其他名稱6-Azamianserin, Org 3770
AHFS/Drugs.comMonograph
MedlinePlusa697009
核准狀況
懷孕分級
給藥途徑口服
ATC碼
法律規範狀態
法律規範
藥物動力學數據
生物利用度50%[1][2][3][4]
血漿蛋白結合率85%[1][2][3][4]
藥物代謝肝臟（CYP1A2、CYP2D6、CYP3A4）[1][2][3][4][5]
生物半衰期20–40小時[1][2][3][4]
排泄途徑尿液 (75%)[1]
糞便 (15%)[1][2][3][4]
識別資訊
  • (±)-2-methyl-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine
CAS號61337-67-5  checkY
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard（英語：CompTox Chemicals Dashboard） (EPA)
ECHA InfoCard100.080.027 編輯維基數據鏈接
化學資訊
化學式C17H19N3
摩爾質量265.36 g·mol−1
3D模型（JSmol（英語：JSmol））
密度1.22 g/cm3
熔點114至116 °C（237至241 °F）
沸點432 °C（810 °F）
水溶性溶於甲醇和氯仿 mg/mL (20 °C)
  • n1cccc3c1N4C(c2ccccc2C3)CN(C)CC4
  • InChI=1S/C17H19N3/c1-19-9-10-20-16(12-19)15-7-3-2-5-13(15)11-14-6-4-8-18-17(14)20/h2-8,16H,9-12H2,1H3 checkY
  • Key:RONZAEMNMFQXRA-UHFFFAOYSA-N checkY

醫療用途

已批准的和適應症外使用

米氮平主要用來治療重度抑鬱症和其他精神障礙。[7][8]

然而研究發現，米氮平對以下症狀也有一定療效，所以米氮平有時候也會被以適應症外使用的形式處方給以下症狀的治療：

研究性的

有過文獻報道的使用米氮平進行過實驗性治療的症狀包括:

有效性和耐受性

2010年，NICE發佈了治療抑鬱症的指南，其中包括對抗抑鬱藥的綜述。它建議將通用SSRIs作為第一線選擇，因為它們「與其他抗抑鬱藥同樣有效並且具有有利的風險-效益比」。[40]關於米氮平，它發現：「米氮平與其他抗抑鬱藥在任何療效指標上沒有差異，儘管在達到緩解方面，米氮平似乎具有統計學但不具有臨床意義的優勢。此外，米氮平具有優於SSRIs的統計學優勢。就減少抑鬱症狀而言，這種差異在臨床上並不重要。然而，有強有力的證據表明服用米氮平的患者由於副作用而不太可能提早離開治療，儘管對於報告副作用的患者不是這種情況或因任何原因提早離開治療。「[41]]

2011年Cochrane評價將米氮平與其他抗抑鬱藥進行了比較，結果發現，雖然它對患者的起效較快（在第2周時），但在第6周時它與其他的抗抑鬱藥大致相同。[42]

一項針對抗抑鬱藥和睡眠的2012年評論發現，在許多因抑鬱引起睡眠障礙的患者中，米氮平減少了入睡所需的時間並提高了睡眠質量，但在某些人中，它會擾亂睡眠，有8％至28％的人會有不安腿綜合症，並且它在極少數情況下導致REM睡眠行為障礙。

2018年有項系統評價和網絡薈萃分析比較了12種抗抑鬱藥物的療效和耐受性，結果顯示米氮平是頭對頭研究中最有效的抗抑鬱藥之一。[43]

在第1周之後，相較於SSRI，米氮平有着更快的起效時間。[44][45]

副作用

2011年Cochrane評價發現，與其他抗抑鬱藥相比，它更容易引起體重增加和嗜睡，但它比三環類抗抑鬱藥引起震顫的可能性更小，並且比SSRIs更不可能引起噁心和性功能障礙。[42]

米氮平不被認為存在很多副作用的風險，這些副作用通常和其他抗抑鬱藥，例如SSRI，有關，並且當他們一起使用時可以改善某些副作用。這些不良反應包括食慾減退，體重減輕，失眠，噁心和嘔吐，腹瀉，尿瀦留，體溫升高，出汗過多，瞳孔擴張和性功能障礙。[5][46]

一般地，有些抗抑鬱藥，例如SSRI，會自相矛盾地加劇一些人的抑鬱或焦慮或自殺意念。[47]儘管米氮平具有鎮靜作用，但據信也有能力做到這一點，所以在美國和其他一些國家，它帶有黑框標籤來警告這些潛在的影響。

2000年發表的一份病例報告指出，米氮平可以抵消可樂定的作用，導致血壓升高。[48]

不良反應發生率[49]

非常常見（≥1/10）

  • 體重增加
  • 食慾增加
  • 嗜睡
  • 鎮靜作用
  • 口乾

常見（≥1/100~＜1/10）

  • 夢異常
  • 意思混亂
  • 焦慮
  • 失眠

不常見（≥1,000~<1/100）

罕見（≥1/10,000~>1/1,000）

  • 肌痙攣
  • 血清氨基轉移酶增加

頻率不詳

停藥

米氮平和其他抗抑鬱藥可能在停止服用後引發停藥綜合症。[5][50][51]建議逐漸緩慢減少劑量，以儘量減少停藥綜合症。[52]突然停止米氮平治療的後果可能包括抑鬱，焦慮，耳鳴，驚恐發作，眩暈，精神運動激動，易怒，食慾減退，失眠，腹瀉，噁心，嘔吐，流感類似過敏和瘙癢症，頭痛，有時會有輕度躁狂或躁狂症。[50][53][54][55][56]

藥物相互作用

與細胞色素（CYP）P450同工酶CYP1A2，CYP2D6和/或CYP3A4的抑制劑或誘導劑同時使用可導致米氮平的濃度改變，因為這些是負責其代謝的主要酶。[57][5]例如，已知氟西汀和帕羅西汀（這些酶的抑制劑）適度增加米氮平水平，而卡馬西平（一種誘導劑）可顯著降低米氮平水平。[57]據報道，在肝功能損害和中度腎功能損害的人群中，米氮平口服清除率降低約30％；而嚴重腎功能損害患者的口服清除率減少50％。[57]

根據製造商提供的信息，米氮平不應在任何單胺氧化酶抑制劑（MAOI）停用後兩周內開始使用；同樣，MAOI不應在停用米氮平後兩周內給藥。[58]米氮平與SSRI，SNRI或TCA聯合作為增強策略被認為是相對安全的，而且通常用於治療。[59]文拉法辛和米氮平的組合，有時被稱為「加州火箭燃料」。[60][61]已知在氟西汀和米氮平同時給藥的情況下可能發生5-羥色胺綜合症。

過量

如果服用過量，米氮平被認為是相對安全的[45]，儘管過量服用的毒性比大多數SSRIs（西酞普蘭除外）略高。[62]與三環類抗抑鬱藥不同，米氮平在最大推薦劑量的7至22倍時未顯示出明顯的心血管不良反應。[63]與三環類抗抑鬱藥相比，過量服用標準劑量30至50倍的病例報告稱藥物相對無毒。[64][65][不可靠的醫學來源？]

據報道，有12人死於米氮平過量。[66][67]米氮平的致命毒性指數（每百萬處方死亡人數）為3.1（95％CI：0.1至17.2）。這類似於用SSRIs觀察到的情況。[68][不可靠的醫學來源？]

藥理學

藥效學

參見：抗抑鬱藥和四環類抗抑鬱藥
米氮平[69]
Ki(nm) 物種 來源 參考
SERT >10,000 人類 [70][71]
NET ≥4,600 人類 [72][70]
DAT >10,000 人類 [73][74]
5-HT1A 3,330~5,010 人類 [5][74]
5-HT1B 3,534~12,600 人類 [5][71]
5-HT1D 794-5,010 人類 [5][71]
5-HT1E 728 人類 [71]
5-HT1F 583 人類 [71]
5-HT2A 6.3~69 人類 [5][71][75]
5-HT2B 200 人類 [5]
5-HT2C 8.9~39 人類 [5][71][75]
5-HT3 7.9 人類 [5]
5-HT4L >10,000 人類 [71]
5-HT5A 670 人類 [71]
5-HT6 ND ND ND
5-HT7 265 人類 [71][75]
α1A 316~1,815 人類 [71]
α2A 20 人類 [71][75]
α2B 88 人類 [71]
α2C 18 人類 [71][75]
β >10,000 人類 [71]
D1 ~4167 大鼠 [75]
D2 >5,454 人類 [71][75]
D3 5723 人類 [71][75]
D4 2,518 人類 [71]
H1 0.14~1.6 人類 [5][71][75][76]
H2 >10,000 大鼠 [76][77]
H3 83,200 人類 [77]
H4 >100,000 人類 [77]
mAch 670 人類 [5][72]
VGSC 6,905 大鼠 [71]
VDCC >10,000 大鼠 [71]

米氮平有時被分類為去甲腎上腺素和特異性五羥色胺能能抗抑鬱藥（NaSSA），[5]儘管支持此分類的證據並不可靠。[78]米氮平有抗去甲腎上腺素、組胺和5-羥色胺受體的功效。[79][5]它特別是腎上腺素α 2A ，α2B，和α2C受體、組胺H1受體和5-羥色胺5-HT2A、5-HT2C和5-HT3的拮抗劑或反向激動劑。[5][79]不同於許多其他的抗抑鬱藥，它不抑制5-羥色胺、去甲腎上腺素或多巴胺的再攝取，也不抑制單胺氧化酶。[80]同多數抗抑鬱藥類似，米氮平的抗膽鹼能、阻斷鈉離子通道或阻斷鈣離子通道的效應很弱甚至沒有。然而在過量食用時，米氮平具有更好的耐受性和低毒性。米氮平是TCA或TeCA中最有效的H1受體拮抗劑，拮抗H1受體是米氮平最強的活性，它在低劑量下為選擇性H1受體拮抗劑。[5][71]

米氮平的(S)-(+)對映體負責5-羥色胺5-HT2A和5-HT2C的拮抗作用，[6](R)-(-)對映體負責對5-HT3受體的拮抗作用。雖然(R)-(-)是很強的組胺H1受體的拮抗劑，兩種對映體都參與了對組胺H1受體和腎上腺素α2受體的拮抗作用。

雖然沒有臨床意義，已經發現米氮平在高濃度的情況下是κ阿片樣受體的部分激動劑[81]（EC50=7.2nm）。

α2腎上腺素受體

作為腎上腺素α2受體的拮抗劑，其功能主要是由於抑制自受體和異受體，提高去甲腎上腺素和5-羥色胺能的神經傳遞，特別是中央 5-HT1A受體介導的中縫背核和海馬的神經遞質的傳導；因此，米氮平的分類為NaSSA。間接地增強α1受體介導的5-羥色胺細胞放電和抑制、直接阻斷5-羥色胺神經元上的異受體會增加細胞外5-羥色胺的濃度。[5][7][82][83][84]因此，米氮平被認為是5-HT1A受體的「間接激動劑 」。[83]中樞5-HT1A受體的活動增加被認為是大多數抗抑鬱藥物功效的主要原理。[85]

5-HT2和5-HT3受體

對5-HT2受體亞族的拮抗作用和對5-HT2C受體的反向激動作用似乎是米氮平治療抑鬱的機理之一。[86][87]米氮平能增加前額葉皮質中的多巴胺能，對大鼠的研究結果表明，阻斷α2受體和5-HT2C受體能對大鼠的此區域對多巴胺的釋放去抑制。[88]米氮平對5-HT2A受體的拮抗作用對焦慮、失眠和性功能有改進。[5]已證明米氮平可以降低人類和各種動物的尋藥行為。它也正在被研究對物質濫用的行為，以減少戒斷效應和提高緩解率。[89][90][91][92]

由於對5-HT3受體的拮抗作用，米氮平與批准的止吐藥昂丹司瓊有着共同的作用，它可顯著改善病人的噁心、嘔吐、腹瀉和腸易激綜合症的症狀。引用錯誤：沒有找到與<ref>對應的</ref>標籤在一些研究中，在一些研究中，也發現米氮平對5-HT3受體的阻斷可以改善焦慮並有效治療物質依賴。與物質濫用諮詢相結合，米氮平成功地減少了對冰毒依賴的個體對冰毒的使用。[93][90][91][92]與米氮平相比，SSRIs，SNRIs，MAOIs和一些TCAs增加了5-HT2A，5-HT2C和5-HT3受體的一般活性，造成負面結果和副作用，其中最突出的包括厭食、失眠和性功能障礙（喪失主動的性慾、性快感缺失）以及噁心和腹瀉等等。因此，它通常與這些藥物結合使用，以減少其副作用，並產生更強的抗抑鬱作用。[46][94]

米氮平不具有5-羥色胺能活性，不會引起5-羥色胺能副作用或5-羥色胺綜合症。[95][78]這與其不是5-羥色胺再攝取抑制劑或MAOI，也不是5-羥色胺受體激動劑的事實一致。[78][95]沒有關於單獨使用米氮平的5-羥色胺綜合症的報道，並且未發現米氮平過量引起5-羥色胺綜合症。[95][78][96]但是，有一些案例報告米氮平與SSRIs等5-羥色胺能藥物聯合應用引起5-羥色胺綜合症，儘管這些報道非常罕見，並不一定暗示米氮平是致病因素。[78][97][98][99][100][101]在MAOI中加入米氮平不會引起5-羥色胺綜合症，並被認為是一種安全的組合。[78][95]此外，米氮平實際上可用於治療5-羥色胺綜合症，至少有一篇文章發現它可有效地解決該綜合症。[78][102][103]這是按照5-HT2A受體是導致5-羥色胺綜合症的主要受體（而5-HT1A受體似乎是保護性的）。[78][95]米氮平是一種有效的5-HT2A受體拮抗劑，而賽庚啶是一種具有這種特性的藥物，可介導5-羥色胺綜合症的恢復，並且在臨床上已成熟，可作為對抗它的解毒劑。[78][104]

H1受體

米氮平是一種非常強的H1受體反向激動劑，因此，它可以引起強大的鎮靜和催眠作用。[5]米氮平於健康志願者的單15毫克劑量已被發現導致在H1受體的80％以上的佔用並誘導強烈的嗜睡。[105]但是，經過長時間的慢性治療，H1會脫敏，並且抗組胺能的效應變得更耐受。許多患者也可能在晚上服用以避免這種影響，這似乎是對抗它們的有效策略。阻斷H1受體可以改善先前存在的患病個體的過敏、瘙癢、噁心和失眠。然而，它也可能有助於增加體重。與H1受體相反，米氮平僅對毒蕈鹼乙酰膽鹼受體僅具有低親和力，儘管在臨床實踐中有時仍會出現口乾、便秘和瞳孔散大等抗膽鹼能副作用。[106]

藥代動力學

米氮平的口服生物利用度約為50％。有85%結合到血漿蛋白。它主要在肝臟中通過去甲基化和細胞色素P450酶的羥基化代謝，其主要代謝物之一是去甲基米氮平。整體清除半衰期為20~40小時。約15％由糞便、75％由尿液排出。[107]

社會文化

通用名

Mirtazapine是該藥物的英文、法文以及INN、USAN、USP、BAN、DCF、JAN的通用名。[108][109]它的西班牙語通用名是mirtazapina、德語通用名是Mirtazapin、拉丁語通用名是mirtazapinum。[108]

品牌名稱

米氮平在全球使用相當多的商品名被出售，包括：

Adco-Mirteron、Afloyan、Amirel、Arintapin Smelt、Avanza、Azapin、Beron、Bilanz、Calixta、Ciblex、Combar、Comenter、Depreram、Divaril、Esprital、Maz、Menelat、Mepirzapine、Merdaten、Meronin、Mi Er Ning、Milivin、Minelza、Minivane、Mirastad、Mirazep、Miro、Miron、Mirrador、Mirt、Mirta、Mirtabene、Mirtadepi、Mirtagamma、Mirtagen、Mirtalan、Mirtamor、Mirtamylan、Mirtan、Mirtaneo、Mirtapax、Mirtapil、Mirtapine、Mirtaron、Mirtastad、Mirtax、Mirtaz、Mirtazap、Mirtazapin、Mirtazapina、Mirtazapine、Mirtazapinum、Mirtazelon、Mirtazon、Mirtazonal、Mirtel、Mirtimash、Mirtin、Mirtine、Mirzapine、Mirzaten、Mirzest、Mitaprex、Mitaxind、Mitocent、Mitrazin、Mizapin、Motofen、Mytra、Norset、Noxibel、Pharmataz、Promyrtil、Rapizapine、Ramure、Redepra、Reflex、Remergil、Remergon、Remeron、Remirta、Rexer、Saxib、Sinmaron、Smilon、Tazepin、Tazimed、Tetrazic、Tifona、U-Mirtaron、U-zepine、Valdren、Vastat、Velorin、Yarocen、Zania、Zapex、Zestat、Zismirt、Zispin、Zuleptan、 Zulin.

歷史

米氮平在1989年的時候由Organon合成出來並被公佈。首次被批准用於治療重性抑鬱障礙是在1994年的荷蘭。1996年，商品名為Remeron的米氮平被引入美國。[107][110]

引用

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