涓欐垔閰搁挔缂撻噴鐗囦汉浣撶敓鐗╃瓑鏁堟€х爺绌跺垎鏋

鍙戝竷鏃堕棿锛

2023-05-22

鏉ユ簮锛

涓€銆?/strong>鑳屾櫙

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鐩墠鍥藉唴澶栧浜庣櫕鐥殑娌荤枟涓昏浠ヨ嵂鐗╂不鐤椾负涓汇€侟/strong>鐧棲鎮ｈ€呯粡杩囨瑙勭殑鎶楃櫕鐥嵂鐗╂不鐤楋紝绾?0%鐨勬偅鑰呭叾鍙戜綔鏄彲浠ュ緱鍒版帶鍒剁殑锛屽叾涓?0%~60%鐨勬偅鑰呯粡杩?~5骞寸殑娌荤枟鏄彲浠ョ棅鎰堢殑锛屾偅鑰呭彲浠ュ拰姝ｅ父浜轰竴鏍峰湴宸ヤ綔鍜岀敓娲汇€傚洜姝わ紝鍚堢悊銆佹瑙勭殑鎶楃櫕鐥嵂鐗╂不鐤楁槸鍏抽敭銆侟/span>

涓欐垔閰搁挔鏄敱闆呭煿鍏徃寮€鍙戠殑绯栧師鍚堥叾婵€閰?3瀹舵棌鎶戝埗鍓傚拰GABAT鎶戝埗鍓傦紝涓昏浣滅敤浜嶨ABAA鍙椾綋锛?gamma;-姘ㄥ熀涓侀吀A鍨嬪彈浣擄級銆丯MDA鍙椾綋锛圢-鐢插熀-D-澶╁啲姘ㄩ吀鍙椾綋锛夈€侟/strong>鏈€鏃╀簬1974骞?鏈?7鏃ヨ幏PMDA锛堝尰鑽搧鍖荤枟鏈哄櫒缁煎悎鏈烘瀯锛夋壒鍑嗗湪鏃ユ湰棣栨涓婂競锛?978骞磋繘鍏ュ姞鎷垮ぇ锛?982骞寸粡NMPA锛堝浗瀹惰嵂鍝佺洃鐫ｇ鐞嗗眬锛夋壒鍑嗚繘鍏ヤ腑鍥藉競鍦猴紱1996骞磋幏FDA锛堢編鍥介鍝佽嵂鍝佺洃鐫ｇ鐞嗗眬锛夋壒鍑嗗湪缇庡浗涓婂競锛?000骞寸粡EMA锛堟娲茶嵂鍝佺鐞嗗眬锛夋壒鍑嗗湪娆ф床涓婂競銆備綔涓轰竴绉嶅箍璋辩櫕鐥嵂鐗╋紝涓欐垔閰搁挔鍑犱箮閫傜敤浜庢墍鏈夌被鍨嬬殑鐧棲鍜屽彂浣滐紝鏄复搴婃不鐤楃櫕鐥殑涓€绾跨敤鑽€侟/span>

鏈枃灏嗙粨鍚堢浉鍏虫寚瀵煎師鍒欏拰鏂囩尞鐮旂┒锛岃缁嗛槓杩颁笝鎴婇吀閽犵紦閲婄墖锛堚厾锛変汉浣撶敓鐗╃瓑鏁堟€ц瘯楠岀殑涓€鑸€冭檻锛屽鏈搧浜轰綋鐢熺墿绛夋晥鎬х爺绌剁殑鑻ュ共鍏抽敭璁捐杩涜鎺㈣锛屾棬鍦ㄤ负姝ょ被浜у搧鐨勪豢鍒跺拰娉ㄥ唽鐢虫姤鎻愪緵鍙傝€冦€侟/span>

浜屻€?/strong>鍝佺鍩烘湰鎯呭喌

閫氱敤鍚嶇О锛氫笝鎴婇吀閽犵紦閲婄墖锛堚厾锛堻/span>

鑻辨枃鍚嶇О锛歋odium Valproate Sustained-release Tablets锛堚厾锛堻/span>

鍖栧缁撴瀯寮廃/strong>锛欬/span>

瑙勬牸锛氭瘡鐗囧惈0.333g涓欐垔閰搁挔鍙?.145g涓欐垔閰革紙鐩稿綋浜?.5g涓欐垔閰搁挔锛夈€侟/span>

閫傚簲鐥囷細

1.鐧棲

鏃㈠彲浣滀负鍗曡嵂娌荤枟锛屼篃鍙綔涓烘坊鍔犳不鐤楋細

锛?锛夌敤浜庢不鐤楀叏闈㈡€х櫕鐥細鍖呮嫭澶辩鍙戜綔銆佽倢闃垫寷鍙戜綔銆佸己鐩撮樀鎸涘彂浣溿€佸け寮犲姏鍙戜綔鍙婃贩鍚堝瀷鍙戜綔锛岀壒娈婄被鍨嬬患鍚堝緛锛圵est,Lennox-Gastaut缁煎悎寰侊級绛夈€侟/span>

锛?锛夌敤浜庢不鐤楅儴鍒嗘€х櫕鐥細灞€閮ㄧ櫕鐥彂浣滐紝浼存湁鎴栦笉浼存湁鍏ㄩ潰鎬у彂浣溿€侟/span>

2.鐙傝簛鐥嘃/strong>

鐢ㄤ簬娌荤枟涓庡弻鐩告儏鎰熼殰纰嶇浉鍏崇殑韬佺媯鍙戜綔銆侟/span>

涓夈€?/strong>澶勬柟宸ヨ壓鍜岀悊鍖栨€ц川

1銆?/strong>澶勬柟缁勬垚涓庣悊鍖栨€ц川^[2]

鍥涖€?/strong>鐢熺墿绛夋晥鎬ц瘎浠饵/strong>

绐勬不鐤楁寚鏁帮紙Narrow therapeutic index锛孨TI锛夎嵂鐗╂垨绐勬不鐤楃獥鑽墿涓€鑸槸鎸囧墏閲忔垨琛€鑽祿搴︾殑寰皬鍙樺寲鍗冲彲鑳藉鑷存不鐤楀け璐ュ拰/鎴栦弗閲嶄笉鑹弽搴旓紝杩涜€屽嵄鍙婄敓鍛斤紝鎴栬€呭鑷存案涔呮垨涓ラ噸鐨勬畫鐤炬垨鍔熻兘涓уけ鐨勮嵂鐗┿€傜獎娌荤枟鎸囨暟鑽墿閫氬父鍏锋湁浠ヤ笅鐗圭偣锛氭湁鏁堝墏閲忎笌涓瘨鍓傞噺锛堟垨鏈夋晥娴撳害涓庝腑姣掓祿搴︼級鎺ヨ繎锛涜鑽祿搴︿綆浜庢湁鏁堟祿搴﹀彲鑳藉鑷存不鐤楀け璐ワ紝楂樹簬鏈夋晥娴撳害鍙兘瀵艰嚧涓ラ噸涓嶈壇鍙嶅簲锛涢渶瑕佸熀浜庤嵂鍔ㄥ鎴栬嵂鏁堝鎸囨爣杩涜娌荤枟鑽墿鐩戞祴锛涘叿鏈夎緝浣庢垨涓瓑绋嬪害鐨勪釜浣撳唴鍙樺紓锛涗复搴婂簲鐢ㄤ腑锛屽墏閲忚皟鏁村箙搴﹂€氬父杈冨皬绛夈€侟/span>

涓欐垔閰搁挔缂撻噴鐗囬€氳繃鍚告敹杩涘叆浜轰綋琛€娑插惊鐜彂鎸ユ不鐤椾綔鐢紝鏍规嵁鍘熺爺璇存槑涔?sup>[²^]锛屽凡鎶ラ亾鐨勪笝鎴婇吀琛€娴嗘按骞虫湁鏁堣寖鍥翠负40-100 μg/mL锛?00-700 μmol/L锛夛紝浣庝簬40 μg/mL鏃惰揪涓嶅埌鏈夋晥娌荤枟娴撳害锛岄珮浜?00 μg/mL鏃舵槗鍑虹幇鑽墿涓嶈壇鍙嶅簲鐢氳嚦涓瘨銆侳DA涓嬪睘鑽搧瀹¤瘎鍜岀爺绌朵腑蹇冿紙CDER锛変簬1995骞?1鏈堝彂甯冪殑閫熼噴鍙ｆ湇鍥轰綋鍒跺墏鐨勬墿澶ц妯″拰涓婂競鍚庡彉鏇存寚鍗楃殑闄勫綍涓叕甯冧簡鍖呮嫭25涓獎娌荤枟鎸囨暟鑽墿鐨勭洰褰曪紙瑙侀檮褰曪級锛屽叾涓垯鍖呮嫭涓欐垔閰稿拰鍙屼笝鎴婇吀閽犵殑澶氱鍓傚瀷锛屾晠涓欐垔閰搁挔缂撻噴鐗囦负鍏鐨勭獎娌荤枟鎸囨暟鑽墿銆侟/span>

涓庝竴鑸寲瀛﹁嵂鐗╃浉姣旓紝绐勬不鐤楁寚鏁拌嵂鐗╄繘琛岀敓鐗╃瓑鏁堟€ц瘎浠锋椂锛屽簲閲囩敤鏇翠弗鏍肩殑绛夋晥鎬у垽瀹氭爣鍑嗭紝浠ヤ繚璇佹湁鏁堟€у拰瀹夊叏鎬с€傞拡瀵圭獎娌荤枟鎸囨暟鑽墿鐨勭敓鐗╃瓑鏁堟€ц瘎浠锋柟寮忥紝CDE浜?020骞?2鏈堝彂甯冧簡銆婄獎娌荤枟鎸囨暟鑽墿鐢熺墿绛夋晥鎬х爺绌舵妧鏈寚瀵煎師鍒欍€婞sup>[3]锛屽鍥藉唴浠ヨ嵂鍔ㄥ鍙傛暟涓轰富瑕佺粓鐐规寚鏍囩殑绐勬不鐤楁寚鏁拌嵂鐗╃殑鐢熺墿绛夋晥鎬х爺绌舵彁渚涗簡鎶€鏈寚瀵笺€侳DA浜?016骞?2鏈堥甯冧簡銆婁笝鎴婇吀閽犵紦閲婄墖鐢熺墿绛夋晥鎬х爺绌舵妧鏈釜鑽寚瀵煎師鍒欙紙鑽夋锛夈€婞sup>[5]锛屽鏈搧鐢熺墿绛夋晥鎬х爺绌剁殑鍏抽敭璁捐鍋氬嚭浜嗙浉鍏崇殑鎺ㄨ崘銆侟/span>

1銆佽瘯楠岃璁＄爺绌剁被鍨婞/strong>

绐勬不鐤楁寚鏁拌嵂鐗╃殑鐢熺墿绛夋晥鎬х爺绌讹紝涓€鑸缓璁噰鐢ㄥ畬鍏ㄩ噸澶嶏紙涓ゅ埗鍓傘€佸洓鍛ㄦ湡銆佷袱搴忓垪锛変氦鍙夎璁★紝浠ュ悓鏃惰幏寰楀弬姣斿埗鍓傚拰鍙楄瘯鍒跺墏鐨勪釜浣撳唴鍙樺紓銆傚浜庡彛鏈嶈皟閲婂埗鍓傦紝寤鸿鍚屾椂杩涜绌鸿吂鍜岄鍚庣敓鐗╃瓑鏁堟€х爺绌躲€侟/span>

閫氬父閲囩敤鐨勫畬鍏ㄩ噸澶嶄氦鍙夎璁¤涓嬭〃锛欬/span>

2銆佽鏍烽噰闆咟/strong>

鏍规嵁鍘熺爺璇存槑涔?sup>[2]鍙煡锛屽彛鏈嶇粰鑽悗锛屽湪24灏忔椂鏈熼棿涓欐垔閰哥殑琛€鑽祿搴?鏃堕棿鏇茬嚎鍛堢幇“骞虫粦宄?rdquo;鐨勭幇璞★紝琛€鑽祿搴﹀湪鏈嶈嵂鍚?-14灏忔椂涔嬮棿鍛堢幇鐩稿绋冲畾鐨勫钩鍙版湡锛岃嵂鐗╃殑鍗婅“鏈熶负15-17灏忔椂銆傚師鐮旇祫鏂欎互鍙婃枃鐚爺绌朵腑鑽唬鍔ㄥ姏瀛﹀弬鏁板涓嬶細

鍥? Depakene R鏃ユ湰鍙傛瘮IF鏂囦欢鑽椂鏇茬嚎

鍥藉唴澶栧悓鍝佺鐢熺墿绛夋晥鎬х爺绌舵枃鐚殑閲囨牱鐐硅璁″涓嬶細

(1) 0銆?銆?銆?銆?銆?銆?銆?銆?銆?銆?0銆?1銆?2銆?3銆?4銆?5銆?6銆?0銆?4銆?0銆?6銆?2銆?6h^[2]

(2) 0銆?銆?銆?銆?銆?.5銆?銆?.5銆?銆?.5銆?銆?.5銆?銆?銆?0銆?2銆?5銆?4銆?6銆?8銆?2銆?4 h^[8]

(3) 0銆?銆?銆?銆?銆?銆?銆?銆?銆?銆?0銆?1銆?2銆?3銆?4銆?5銆?6銆?8銆?0銆?4銆?8銆?2銆?6 h^[9]

(4) 0銆?.5銆?銆?銆?銆?銆?銆?銆?銆?銆?2銆?5銆?4銆?8銆?2 h^[10]

鍥犳锛孊E鐮旂┒閲囪鐐硅璁℃椂闇€鍚屾椂鍏奸【绌鸿吂鍜岄鍚庝笝鎴婇吀鐨勮揪宄版椂闂磋寖鍥翠互鍙婂崐琛版湡锛屼互婊¤冻鐢熺墿绛夋晥鎬х爺绌剁殑闇€瑕併€侟/span>

3銆佺敓鐗╃瓑鏁堟€ц瘎浠饵/strong>

鏍规嵁銆婄獎娌荤枟鎸囨暟鑽墿鐢熺墿绛夋晥鎬х爺绌舵妧鏈寚瀵煎師鍒欍€嬶紝绐勬不鐤楁寚鏁拌嵂鐗╄繘琛岀敓鐗╃瓑鏁堟€ц瘎浠锋椂锛屽簲閽堝涓昏鑽姩瀛﹀弬鏁帮紙AUC_0-t銆丄UC_0-_∞鍜孋_max锛夊垎鍒 绠楋紝骞堕噰鐢ㄤ互涓嬩笁涓瓑鏁堟€у垽瀹氭爣鍑嗗悓鏃惰繘琛岃瘎浠凤細

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锛?锛夋牴鎹寚瀵煎師鍒欒姹傦紝绐勬不鐤楁寚鏁拌嵂鐗╁湪缁撴灉鎶ュ憡鏃讹紝鍒嗗埆閽堝AUC_0-t銆丄UC_0-_∞鍜孋_max锛孅strong>闇€鎻愪緵鍙楄瘯鍒跺墏鍜屽弬姣斿埗鍓傜殑涓綋鍐呮爣鍑嗗樊S_WT鍜孲_WR锛孅strong>骞朵笌鏂囩尞鐩稿簲鏁版嵁杩涜姣旇緝锛屼互璇勪及BE璇曢獙鏄惁鐪熷疄鍙嶆槧鍙傛瘮鍒跺墏鐨勪釜浣撳唴鍙樺紓鎯呭喌锛汓/span>

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鍥? 涓欐垔閰搁挔缂撻噴鐗囷紙鈪狅級鍥藉唴鐢虫姤鎯呭喌

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浜斻€?/strong>鎬荤粨

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鍏?/strong>銆?/strong>鍙傝€冩枃鐚?/strong>

[1] 涓栫晫鍗敓缁勭粐锛岀櫕鐥紝https://www.who.int/zh/news-room/fact-sheets/detail/epilepsy

[2] 寰峰反閲戝師鐮斿湴浜у寲璇存槑涔?

[3] 銆婄獎娌荤枟鎸囨暟鑽墿鐢熺墿绛夋晥鎬х爺绌舵妧鏈寚瀵煎師鍒欍€?

[4] 銆婁笝鎴婇吀閽犵紦閲婄墖鐢熺墿绛夋晥鎬х爺绌舵妧鏈釜鑽寚瀵煎師鍒欙紙鑽夋锛夈€婞/span>

[5] Depakote ER鍘熺爺FDA璇存槑涔?

[6] Depakene R鏃ユ湰鍙傛瘮IF鏂囦欢.

[7] ANDA review.

[8] Natriumvalproaat Sandoz Chrono 500 mg,PAR.

[9] 涓欐垔閰搁挔缂撻噴鐗囧湪鍋ュ悍浜轰綋鍐呯殑鑽姩瀛︾爺绌迭/span>

[10] 楂樻晥娑茬浉鑹茶氨-璐ㄨ氨鑱旂敤娉曞揩閫熸祴瀹氫汉琛€娴嗕腑涓欐垔閰搁挔娴撳害.

[11] Ghodke-Puranik Y, Thorn CF, Lamba JK, et al. Valproic acid pathway: pharmacokinetics and pharmacodynamics. Pharmacogenet Genomics. 2013;23(4):236-241. doi:10.1097/FPC.0b013e32835ea0b2

涓冦€?/strong>闄勫綍

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