鍗″乏鍙屽宸寸紦閲婄墖浜轰綋鐢熺墿绛夋晥鎬х爺绌跺垎鏋
鍙戝竷鏃堕棿锛
2023-06-01
鏉ユ簮锛
涓€銆?/strong>鑳屾櫙
鍗℃瘮澶氬反锛圕arbidopa锛変负澶栧懆宸︽棆鑺抽姘ㄥ熀閰歌劚缇ч叾鎶戝埗鍓傦紝涓嶈兘閫氳繃琛€鑴戝睆闅滆€岃繘鍏ヨ剳锛屾晠鍜屽乏鏃嬪宸达紙Levodopa锛夊悎鐢ㄦ椂锛屽彲鎶戝埗澶栧懆鐨勫乏鏃嬪宸磋浆鍖栦负澶氬反鑳猴紝闄嶄綆澶栧懆澶氬反鑳虹殑鐢熸垚锛屽噺灏戝壇浣滅敤锛屽悓鏃朵娇杩涘叆涓灑绁炵粡绯荤粺鐨勫乏鏃嬪宸村鍔狅紝浣垮惊鐜涓乏鏃嬪宸村惈閲忓楂橈紝鍥犺€屽彲浣胯緝澶氱殑宸︽棆澶氬反鍒拌揪榛戣川-绾圭姸浣撹€屽彂鎸ヤ綔鐢紝浠庤€屾彁楂樺乏鏃嬪宸寸殑鐤楁晥锛屽欢闀垮崐琛版湡锛屽噺杞诲乏鏃嬪宸村湪澶栧懆鐨勪笉鑹弽搴斻€侟/span>
鏈枃灏嗙粨鍚堢浉鍏虫寚瀵煎師鍒欏拰鏂囩尞鐮旂┒锛岃缁嗛槓杩板崱宸﹀弻澶氬反缂撻噴鐗囦汉浣撶敓鐗╃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
l瀵逛互鍓嶇敤杩囧乏鏃嬪宸?鑴辩晶閰舵姂鍒跺墏澶嶆柟鍒跺墏鎴栧崟鐢ㄥ乏鏃嬪宸存不鐤楁湁鍓傛湯鎭跺寲锛?ldquo;娓愬急”鐜拌薄锛夛紝宄板墏閲忚繍鍔ㄩ殰纰嶃€佽繍鍔ㄤ笉鑳界瓑鐗瑰緛鐨勮繍鍔ㄥけ璋冿紝鎴栨湁绫讳技鐭椂闂磋繍鍔ㄩ殰纰嶇幇璞$殑鎮h€咃紝鍙噺灏?ldquo;鍏?rdquo;鐨勬椂闂淬€侟/span>
1銆佺悊鍖栨€ц川
2銆佹憾鍑烘儏鍐袋/strong>
鈻插崱宸﹀弻澶氬反缂撻噴鐗囨憾鍑烘洸绾军/span>
浠庢憾鍑烘洸绾垮強婧跺嚭鏁版嵁鍙煡锛屽湪pH1.0浠嬭川涓紝鍦?灏忔椂涔嬪墠锛孧ylan浠垮埗鑽腑鍗℃瘮澶氬反鍜屽乏鏃嬪宸寸殑婧跺嚭閫熷害鍧囨槑鏄炬參浜庡弬姣斿埗鍓傦紝浣哅ylan浠垮埗鑽粛鐒朵笌鍘熺爺浜у搧鎴愬姛寤虹珛浜嗙敓鐗╃瓑鏁堛€傜粡鍒嗘瀽锛孧ylan浠垮埗鑽殑杈呮枡涓紝浣跨敤缇熶笝鐢茬氦缁寸礌鏇挎崲浜嗗師鐮斾骇鍝佷腑鐨勮仛涔欓吀涔欑儻閰?宸磋眴閰稿叡鑱氱墿锛屽悗鑰呬负鍘熺爺鍘傚晢榛樻矙涓滃埗鑽壒渚涜緟鏂欙紝鐩墠鍦ㄥ競闈笂闅句互鑾峰緱锛孧ylan浠垮埗鑽殑缂撻噴楠ㄦ灦涓矘鍚堝墏绉嶇被鐨勬敼鍙樹娇寰楀叾pH1.0鐨勬憾鍑虹壒寰佷笌鍙傛瘮鍒跺墏褰㈡垚杈冨ぇ宸紓锛屽洜姝H1.0浠嬭川涓烘湰鍝佹憾鍑哄叿鏈夋槑鏄惧尯鍒嗗姏鐨勬憾鍑烘潯浠躲€侟/span>
鍗″乏鍙屽宸寸紦閲婄墖閫氳繃鍚告敹杩涘叆浜轰綋寰幆浠庤€屽彂鎸ョ枟鏁堬紝鏍规嵁銆婁互鑽姩瀛﹀弬鏁颁负缁堢偣璇勪环鎸囨爣鐨勫寲瀛﹁嵂鐗╀豢鍒惰嵂浜轰綋鐢熺墿绛夋晥鎬ц瘯楠屾寚瀵煎師鍒欍€嬶紝鏈搧搴斾互PK-BE鐨勬柟寮忚瘎浼板彈璇曞埗鍓備笌鍙傛瘮鍒跺墏鐨勭敓鐗╃瓑鏁堟€с€侳DA浜?012骞?9鏈堥甯冧簡銆夵a data-linktype="2" href="https://www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=55de1a75cfbc6600d8f6ab6a551258dd" title="鐐瑰嚮鏌ョ湅">鍗″乏鍙屽宸寸紦閲婄墖鐢熺墿绛夋晥鎬х爺绌舵妧鏈釜鑽寚瀵煎師鍒橖/a>锛堣崏妗堬級銆媅8]锛屾湰鏂囧皢缁撳悎涓嵂鎸囧鍘熷垯瀵规湰鍝佺敓鐗╃瓑鏁堟€х爺绌剁殑鍏抽敭璁捐鍋氬嚭鐩稿叧鐨勬帹鑽愩€侟/span>
FDA涓嵂鎸囧鍘熷垯鎺ㄨ崘涓ゅ簭鍒椼€佷袱鍛ㄦ湡浜ゅ弶璇曢獙鐨勮璁★紝寮€灞曞崟娆$粰鑽殑绌鸿吂鍙婇鍚庝汉浣撶敓鐗╃瓑鏁堟€х爺绌躲€侟/span>
鏍规嵁Accord Healthcare B.V.閫氳繃HMA锛堟鐩熶簰璁ょ▼搴忥級涓婂競鐨勫崱宸﹀弻澶氬反缂撻噴鐗囦豢鍒惰嵂鐨勫叕寮€瀹¤瘎鎶ュ憡[8]璧勬枡鍙煡锛岀┖鑵圭粰鑽姸鎬佷笅鍗℃瘮澶氬反Cmax涓綋鍐呭彉寮備负34%锛孉UC鐨勪釜浣撳唴鍙樺紓绾︿负33%~34%锛屾彁绀烘湰鍝佷腑鍗℃瘮澶氬反鎴愬垎鍏锋湁楂樺彉寮傜壒寰侊紝鍥犳鍙€氳繃涓夊懆鏈熸垨鍥涘懆鏈熼噸澶嶄氦鍙夎璁℃潵杩涜鐢熺墿绛夋晥鎬ц瘯楠岀殑璁捐銆侟/span>
鍥? Levodopa/carbidopa Accord 200/50 mg, PAR
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
鏍规嵁涓婅堪PK鍙傛暟锛孊E鐮旂┒閲囪鐐硅璁℃椂闇€鍏虫敞杈惧嘲鏃堕棿鑼冨洿浠ュ強鍗婅“鏈燂紝鍚屾椂鑰冭檻楂樿剛椁愬鍚勬垚鍒嗚嵂鍔ㄥ鐨勫奖鍝嶏紝绉戝鍦拌璁¢噰琛€鐐逛互婊¤冻鐢熺墿绛夋晥鎬х爺绌剁殑闇€瑕併€侟/span>
3銆佹娴嬬墿璐ㄥ強妫€娴嬮毦搴?/strong>
鍗″乏鍙屽宸寸紦閲婄墖涓哄乏鏃嬪宸村拰鍗℃瘮澶氬反缁勬垚鐨勫鏂瑰埗鍓傦紝鏍规嵁涓嵂鎸囧鍘熷垯[7]锛岄渶鍚屾椂妫€娴嬭娴嗕腑鐨勫乏鏃嬪宸村拰鍗℃瘮澶氬反杩涜浜轰綋鐢熺墿绛夋晥鎬х爺绌躲€侟/span>
4銆佺敓鐗╃瓑鏁堟€ц瘎浠饵/strong>
鎹瘡鏃ョ粡娴庢柊闂绘姤閬掽sup>[11]锛岃繎骞存潵锛屽師鐮旀伅瀹佸湪涓浗甯傚満闀挎湡澶勪簬鏂緵鐨勭姸鎬侊紝2021骞翠互鏉ユ伅瀹佷粠绾?0鍏?鐩掍竴璺笂娑ㄥ埌杩?000鍏?鐩掞紝鍥藉唴閮ㄥ垎甯曢噾妫梾鎮h€呯粡甯搁櫡鍏ユ棤鑽彲鐢ㄧ殑鐘舵€併€?019骞?鏈?0鏃ワ紝鏉窞榛樻矙涓滃埗鑽湁闄愬叕鍙告浘鍙戝嚭鍏憡绉帮細鐢变簬鎭畞鐢熶骇宸ュ巶鐨勫師鍥狅紝褰卞搷鍒板叏鐞冩伅瀹佷緵璐э紝棰勮鏈潵涓€骞村唴锛?019骞达級涓浗甯傚満灏嗕笉鑳芥甯镐緵搴斻€?021骞?0鏈?0鏃ワ紝鎭畞鐨勪腑鍥戒唬鐞嗗晢娆у姞闅嗗尰鑽儴璐熻矗浜烘帴鍙楀ぎ瑙嗛噰璁挎椂琛ㄧず锛屾伅瀹佹槸鍦ㄥ浗澶栫敓浜с€佸浗鍐呰繘琛屽垎鍖呰锛屽洜鏂板啝鐤儏鍜屽師鏉愭枡鎵€闄愶紝瀵艰嚧浜ч噺鎬ュ墽涓嬮檷銆傛伅瀹佹柇璐х殑鑳屽悗锛屽弽鏄犵殑鏄?00涓囧笗閲戞.鎮h€呬簾寰呰В鍐崇殑缂鸿嵂鍥板锛屽洜姝や豢鍒惰嵂鐨勫紑鍙戣兘鏈€澶х▼搴︾殑缂撹В鎮h€呯殑缁忔祹璐熸媴鍜岀柧鐥呭洶鎵帮紝閫犵骞垮ぇ鐨勫笗閲戞.鎮h€呫€侟/span>
鏈枃鎬荤粨浜嗗崱宸﹀弻澶氬反缂撻噴鐗囩敓鐗╃瓑鏁堟€х爺绌剁殑鐜扮姸锛岀粨鍚堢幇鏈夌浉鍏矪E鎶€鏈寚鍗楀拰鐮旂┒鐜扮姸锛屾湡鏈涗负鍗″乏鍙屽宸寸紦閲婄墖浠垮埗鑽爺鍙態E璇曢獙鐨勬妧鏈敾鍏虫彁渚涙湁浠峰€肩殑鍙傝€冦€傚湪鎶楀笗閲戞.姘忕梾鑽墿棰嗗煙锛屾垜鍙告嫢鏈夐潪甯镐赴瀵岀殑涓村簥璇曢獙鎴愬姛缁忛獙銆傛垜鍙搁噰鐢?ldquo;涓€绔欏紡”涓村簥鐮旂┒鏈嶅姟锛屽崗鍔╃敵鍔炴柟闄嗙画瀹屾垚浜嗗涓珮闅惧害鎶楀笗閲戞.姘忕梾鑽墿鐨勪复搴婄爺绌讹紝鍖呮嫭鎭╀粬鍗℃湅鍙屽宸寸墖锛堝叏鍥界嫭瀹舵姤浜э級銆佸崱宸﹀弻澶氬反缂撻噴鐗囷紙鍏ㄥ浗棣栧鎶ヤ骇锛夈€佺敳纾洪吀娌欓潪鑳虹墖锛堟湁鏈涘叏鍥介瀹惰幏鎵癸級銆佺敳纾洪吀闆锋矙鍚夊叞鐗囥€佹仼浠栧崱鏈嬬墖鍜屽宸翠笣鑲肩墖绛夊涓搧绉嶃€傞拡瀵归珮闅惧害鎶楀笗閲戞.姘忕梾鑽墿鐨勪复搴婄爺绌讹紝鎴戝徃鑷村姏浜庢彁渚涢泦鍖诲鏈嶅姟銆佸彈璇曡€呮嫑鍕熴€佷复搴婅繍钀ョ鐞嗐€佺敓鐗╂牱鏈垎鏋愩€佹暟鎹鐞嗕笌缁熻鍒嗘瀽浜庝竴浣撶殑涓村簥鐮旂┒“涓€绔欏紡”骞冲彴鏈嶅姟锛屽彲鍔╁姏鐢冲姙鑰呭畬鎴愰珮璐ㄣ€侀珮鏁堢殑鍖昏嵂鐮斿彂宸ヤ綔銆侟/span>
鍏€?/strong>鍙傝€冩枃鐚?/strong>
[1] GBD2019
[2] 闄堣姖鍚?椹缓,鍞愬,闃崇泭寰?璐烘潈婧?鍛ㄥ啗鍗?涓浗甯曢噾妫梾鐤剧梾璐熸媴鍙樺寲瓒嬪娍鍒嗘瀽鍙婇娴媅J].涓浗鎱㈡€х梾棰勯槻涓庢帶鍒?2022,30(09):649-654.
[3] 涓崕鍖诲浼氱缁忕梾瀛﹀垎浼氬笗閲戞.鐥呭強杩愬姩闅滅瀛︾粍,涓浗鍖诲笀鍗忎細绁炵粡鍐呯鍖诲笀鍒嗕細甯曢噾妫梾鍙婅繍鍔ㄩ殰纰嶅缁? 涓浗甯曢噾妫梾鏃╂湡杩愬姩鐥囩姸娌荤枟寰瘉鍖诲鎸囧崡[J]. 涓浗绁炵粡鍏嶇柅瀛﹀拰绁炵粡鐥呭鏉傚織, 2021,28(4):267-279.
[4] Sinemet CR鍘熺爺鑻卞浗涓婂競璇存槑涔?
[5] 銈广偪銉儨閰嶅悎閷燣50/銈广偪銉儨閰嶅悎閷燣100鍘熺爺鏃ユ湰IF鏂囦欢
[6] Carbidopa & Levodopa Extended-Release Tablets, Mylan Pharmacueticals, Inc. Bioequivalence Review(s)
[7] U.S. Food and Drug Administration. Guidance on Carbidopa锛汱evodopa. 2012.
[8] NL/H/2309/002/DC.PUBLIC ASSESSMENT REPORT
[9] Hsu, A., Yao, H. M., Gupta, S., & Modi, N. B. (2015). Comparison of the pharmacokinetics of an oral extended-release capsule formulation of carbidopa-levodopa (IPX066) with immediate-release carbidopa-levodopa (Sinemet(®)), sustained-release carbidopa-levodopa (Sinemet(®) CR), and carbidopa-levodopa-entacapone (Stalevo(®)). Journal of clinical pharmacology, 55(9), 995–1003.
[10] 鐜嬪缓,璋㈡灄,鐜嬪ぇ涓?绛?HPLC娉曟祴瀹氫汉琛€娴嗕腑宸︽棆澶氬反鍜屽崱姣斿宸存祿搴﹀強鍏惰嵂浠e姩鍔涘鐮旂┒[J].涓浗鑽澶у瀛︽姤,2004(3):239-243..
[11] 浠锋牸椋欐定20鍊嶏紝甯曢噾妫梾浜洪亣“鑽崚”锛屽崡鏂瑰懆鏈?/span>
棰勭煡鏇村鍝佺鍒嗘瀽锛岃鍜ㄨ↓↓↓