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<div id="content"> FDA 鎵瑰噯 ZYKADIA 娌荤枟 ALK+ 闈炲皬缁嗚優鑲虹檶 Novartis 鍏徃 Zykadia(TM)锛坈eritinib, LDK-378锛夋不鐤 ALK 閰皑閰告縺閰跺彈浣撻槼鎬э紙ALK+锛夎浆绉绘€ч潪灏忕粏鑳炶偤鐧岋紙NSCLC锛夋偅鑰咃紙鍏嬪攽鏇垮凹娌荤枟鏃惰繘灞曟垨鏃犳硶鑰愬彈锛夎幏寰椾簡 FDA 鎵瑰噯銆傚 163 渚嬪厠鍞戞浛灏兼不鐤楁椂鐤剧梾杩涘睍鎴栦笉鑳借€愬彈鍏舵不鐤楃殑杞Щ鎬 ALK+ NSCLC 鎮ｈ€呭疄鏂界殑鍏抽敭鎬х爺绌朵腑锛屽娌绘偅鑰呯殑鎬荤紦瑙ｇ巼鏄 54.6%锛岀紦瑙ｆ寔缁椂闂翠腑浣嶆暟鏄 7.4 涓湀銆傚彂鐢熺巼鑷冲皯涓 25% 鐨勪笉鑹簨浠跺寘鎷吂娉汇€佹伓蹇冦€佽浆姘ㄩ叾鍗囬珮銆佸憰鍚愩€佽吂鐥涖€佺柌鍔炽€侀娆插噺閫€鍙婁究绉樸€侫LK 鎶戝埗鍓 Zykadia 浜 2013 骞 3 鏈堣幏寰椾簡 FDA 绐佺牬鎬х枟娉曡瀹氾紙瑙 2013 骞 3 鏈 18 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級銆傚凡鍚戞鐩熼€掍氦浜嗙洃绠＄敵璇凤紝鍏朵粬鍦板尯鐨勭敵鎶ヤ篃鍦ㄥ噯澶囦箣涓€俍ykadia 娌荤枟澶嶆不鍜岄娌 ALK+ NSCLC 鎮ｈ€呯殑 II 鏈熷拰 III 鏈熻瘯楠屾鍦ㄨ繘琛屼箣涓紙ClinicalTrials.gov 鏍囪瘑鍙 NCT01685060銆丯CT01685138銆丯CT01828099 鍜 NCT01828112锛夛紙Novartis 鏂伴椈绋匡級銆 JUBILANT BIOSYS 鍏徃閴村畾鍑洪拡瀵圭獊鍙 EGFR 鐨勫寲鍚堢墿 JIEM-0186 鍜 JIEM-0235 鏄 Jubilant Biosys 鍏徃閴村畾鍑虹殑鍚屼竴绯诲垪鍖栧鍝佷腑鐨勪袱涓皬鍒嗗瓙锛屼綔鐢ㄦ槸琛ㄧ毊缁嗚優鐢熼暱鍥犲瓙鍙椾綋 (EGFR) 鎶戝埗鍓傦紝瀵 EGFR-娲诲寲鍜岃€愯嵂绐佸彉鍏锋湁娲绘€с€侸IEM-0186 瀵归噹鐢熷瀷鍜 L858R/T790M 绐佸彉 EGFR 鐨 IC50 鍊煎垎鍒负 0.036 鍜 0.0106銆傝繕瑙傚療鍒板叿鏈夋縺閰堕€夋嫨鎬э紝0.5 mcM 鏃朵粎瀵 97 绉嶆縺閰朵腑鐨 12 绉嶈〃鐜板嚭 > 70% 鎶戝埗鍔涖€侸IEM-0186 瀵规惡甯﹂噹鐢熷瀷 EGFR锛?gt; 200 鍊嶏級缁嗚優琛ㄧ幇鍑洪€夋嫨鎬э紝骞跺彲璇卞 L858R/T790M 绐佸彉 EGFR 闈炲皬缁嗚優鑲虹檶 (NSCLC) NCI-H1975 缁嗚優鍑嬩骸銆侼CI-H1975 鑲跨槫寮傜绉绘鐗╂ā鍨嬩腑锛孞IEM-0186 鎶戝埗浜 EGFR 鑷７閰稿寲锛屾晥搴斾笌鏆撮湶閲忕浉鍏炽€傚湪杩欑妯″瀷涓紝娌荤枟 10 澶╄偪鐦ゆ槑鏄剧缉灏忥紝瀵逛綋閲嶆棤褰卞搷銆傛湭瑙佸閲庣敓鍨 EGFR 瑁稿皬榧犵毊鑲ゅ唴 pEGFR 姘村钩鏈変綔鐢ㄣ€傚甫鏈 EGFR-娲诲寲绐佸彉鐨勪汉鑲鸿吅鐧 HCC827 鑲跨槫寮傜绉绘鐗╃殑灏忛紶涓紝涓庡巹娲涙浛灏兼不鐤楃浉姣旓紝JIEM-0186 娌荤枟 10 澶╃殑鑲跨槫娑堥€€涓庡叾鐩歌繎鎴栨洿澶氥€侸IEM-0235 鍦 NCI-H1975 鑲跨槫寮傜绉绘鐗╂ā鍨嬩腑涔熸湁娲绘€э紝琛ㄧ幇鍑鸿壇濂界殑鐞嗗寲鎬ц川鍜岃嵂鍔ㄥ鎬ц川锛屼絾骞舵湭褰㈡垚 GSH 鍔犲悎鐗 (Sivanandhan, D. et al. 105th Annu Meet Am Assoc Cancer Res (AACR) (April 5-9, San Diego) 2014, Abst LB-232)銆 OXPHOS 鎶戝埗鍓傦細涓€绫绘柊鍨嬭偪鐦ゆ不鐤楄嵂鎬ユ€ч珦鏍风櫧琛€鐥呭拰寮ユ极鎬уぇ B 缁嗚優娣嬪反鐦よ偪鐦わ紝浠ュ強娌荤枟鍚庣殑娈嬪瓨鑲跨槫锛屽瓨娲婚兘鏈夎禆浜庢哀鍖栫７閰稿寲锛圤XPHOS锛夈€傚洜姝わ紝鎶戝埗杩欑被鑲跨槫涓殑绾跨矑浣撳鍚堢墿 I 鏄潯鐙壒鐨勬不鐤楅€斿緞銆傜編鍥藉痉宸炲ぇ瀛﹀畨寰锋．鐧岀棁涓績鐮旂┒浜哄憳寮€鍙戜簡涓€绯诲垪鏂板瀷楂樻晥澶嶅悎浣 I OXPHOS 鎶戝埗鍓 (IC50 < 10 nM)锛屽寘鎷 IACS-10759銆侷ACS-1131 鐨勪紭鍖栭€犲氨浜 IACS-10759锛屽湪灏忛紶銆佸ぇ榧犮€佺姮鍜岄锜圭尨绉嶈〃鐜板嚭鑹ソ鐨勮嵂鍔ㄥ鎬ц川锛屽彛鏈嶇敓鐗╁埄鐢ㄥ害鏋佷匠 (> 90%)锛屾竻闄ょ巼閫備腑锛屽崐琛版湡闀裤€俬ERG 鍔熻兘娴嬪畾涓紝IACS-10759 鐨 Qpatch IC50 鍊 > 30 mcM銆傛椿浣撳唴鐮旂┒涓 IACS-10759 娌荤枟璇卞彂浜嗙硸閰佃В缂洪櫡 NB-1 鑲跨槫寮傜绉绘鐗╃殑娑堥€€锛孖ACS-10759 (5 mg/kg p.o. q.d.) 浣胯偪鐦や綋绉槑鏄剧缉灏忥紝浣嗗浣撻噸鏈〃鐜板嚭浠讳綍浣滅敤銆侷ACS-10759 瀵瑰悇绯 AML 缁嗚優閮芥湁鐤楁晥锛孍C50 鍊间粙浜 1 鈥 8 nM銆傚甫鏈 AML 寮傜绉绘鐗╃殑鍔ㄧ墿涓紝IACS-10759 (15 mg/kg p.o. q.d.) 娌荤枟鍔ㄧ墿 100% 瀛樻椿锛屾渶闀胯揪 60 澶╋紝涓庤祴褰㈠墏鎴 Ara-C (100 mg/kg 2 x q.w. i.p.) 娌荤枟鍔ㄧ墿鐩告瘮浣撻噸鏃犳槑鏄惧彉鍖栥€傛璁″垝瀹炴柦鏀寔 IND 鐨勫畨鍏ㄦ€х爺绌讹紙Marszalek, J.R. et al 105th Annu Meet Am Assoc Cancer Res (AACR) (April 5-9, San Diego) 2014, Abst 949锛夈€ GENENTECH 鍏徃鐨 LDH-A 鎶戝埗鍓傞拡瀵硅偪鐦ょ硸閰佃В Genentech 鍏徃瀹炴柦浜嗛珮閫氶噺绛涢€変互閴村畾鍑哄彛鏈嶆湁鐢熺墿娲绘€х殑涔抽吀鑴辨阿閰 A (LDH-A) 鎶戝埗鍓傦紝缁撴灉鎵惧埌浜嗕竴绉嶅叿鏈夊熀浜庣粏鑳炴椿鎬х殑鍖栧悎鐗┿€傚姝ゅ厛瀵肩墿鐨勪紭鍖栭€犲氨浜 GNE-140锛屽涔抽吀鑴辨阿閰剁殑閫夋嫨鎬ч珮锛圠DH-A IC50 = 0.005 mcM锛孡DH-B IC50 = 0.009 mcM锛孡DH-C IC50 = 0.009 mcM锛夈€傝鍖栧悎鐗╅檷浣庝簡涔抽吀鐩愭按骞筹紝鍑忓皯浜 MiaPaCa-2 鑳拌吅鐧岀粏鑳炲娈栵紝鍏朵腑浠ｈ阿鐗╃殑璋冭妭涓庣硸閰佃В銆佺７閰告垔绯栭€氳矾鍙婃牳鑻烽吀鍚堟垚鏈夊叧銆侴NE-140 瀵瑰悇绯昏偪鐦ょ粏鑳為兘鏈夋椿鎬э紱瀵 GNE-140 涓嶆晱鎰熺殑缁嗚優绯诲垯琛ㄧ幇鍑 LDH-A 鎶戝埗鐨勮瘉鎹紝鑰屾棤钁¤悇绯栨憚鍙栧噺灏戙€傚叿鏈夎幏寰楄€愯嵂鎬х殑缁嗚優锛屾哀鍖栫７閰稿寲姘村钩鍗囬珮銆傛椿浣撳唴鐮旂┒涔熻瀵熷埌 LDHA 娲绘€х殑璋冭妭 (O'Brien, T. et al 105th Annu Meet Am Assoc Cancer Res (AACR) (April 5-9, San Diego) 2014, Abst 964)銆瀵硅繎 500 涓甫鏈 GNE-140 鐨勮偪鐦ょ粏鑳炵郴杩涜绛涢€夛紝鍙戠幇澶ф 15% 澶╃敓瀵规鍖栧悎鐗╂晱鎰熴€傛晱鎰熸€т笌绯栭叺瑙ｅ熀鍥犺〃杈惧鍔犵浉鍏筹紝鑰屼笌姘у寲纾烽吀鍖栧熀鍥犺〃杈惧憟璐熺浉鍏炽€傞暱鏈熺粰浜 GNE-140 娌荤枟锛岀硸閰佃В缁嗚優閫氳繃澧炲姞姘у寲纾烽吀鍖栬€岃幏寰楄€愯嵂鎬э紝鍏舵満鍒朵緷璧栦簬 AMP 娲诲寲铔嬬櫧婵€閰讹紙AMPK锛夊簲婵€搴旂瓟閫氳矾銆傞澏鏍囦负 AMPK 鐨勫伐鍏峰寲鍚堢墿銆佷笅娓告縺閰舵垨姘у寲纾烽吀鍖栧崗鍚屼綔鐢紝闃叉鑾峰緱瀵 GNE-140 鐨勮€愯嵂鎬с€傝繖椤瑰伐浣滄寚鍑 LDH-A 鎶戝埗鍓傚彲涓庡叾浠栬嵂鐗╄仈鐢ㄤ互寤剁紦鑲跨槫澶嶅彂 (Boudreau, A. et al. 105th Annu Meet Am Assoc Cancer Res (AACR) (April 5-9, San Diego) 2014, Abst 1423)銆 IO-125 瓒呭垎瀛愬ゥ娌欏埄閾傜被浼肩墿鎶楃檶鐤楁晥鏀瑰杽 Invictus Oncology 鍏徃鐨勭爺绌朵汉鍛樺睍绀轰簡涓€绉嶅熀浜庡寲瀛︾殑瓒呭垎瀛愬钩鍙版妧鏈紝鐢ㄤ互瀵瑰己鏁堥搨鍓傚寲鐤楄嵂濂ユ矙鍒╅搨绫讳技鐗╄繘琛屽伐绋嬫敼閫犮€ 绾崇背缁撴瀯鎻愰珮浜嗘笚閫忔€э紝骞舵湁淇濈暀鏁堝簲锛屾晠鑳芥敼鍠勮嵂鍔ㄥ鍙婂鑲跨槫鐨勭敓鐗╁垎甯冦€傚湪瓒呭垎瀛愭不鐤楁柊鑽 IO-125 涓紝涓€绉嶇嫭鐗圭殑閾 (II) 鍊熷姪鍗曠緹閰搁敭涓庤儐鍥洪唶楠ㄦ灦杩炴帴锛孨-Pt 閰嶄綅鐜浣挎按鍚堥€熷害鍔犲揩锛屼粠鑰屾彁鍗囦簡鏁堢巼銆傛湰鍝佽璁＄殑鏄互 pH 渚濊禆鏂瑰紡閲婃斁浜屾皑鍩虹幆宸辩兎-閾傦紝鍔ㄦ€佸厜鏁ｅ皠鍜岀數瀛愭樉寰暅娴嬪畾琛ㄦ槑鍏跺彲鑷垜缁勮鍒扮粺涓€澶у皬鍜屽垎甯冪殑绾崇背灏哄害瓒呭垎瀛愯瀹氱粨鏋勪腑銆傜敤 HPLC 娴嬪畾鏈搧鐞嗗寲鐗圭偣锛屾樉绀哄叾绾害绾︿负 99%銆傜敤灏忛紶涔宠吅 4T1 鍜屼汉涔宠吅鑵虹檶 MDA-MB-231 涓夐槾缁嗚優绯绘鏌ワ紝IO-125 鎽勫彇鐜囨槸娓哥濂ユ矙鍒╅搨鐨 10鈥?0 鍊嶃€傚埄鐢ㄦ偅鑰呬钩鑵烘爣鏈埗鎴愮殑鍘熷彂鎬х粨鐩磋偁涔宠吅鐧岀郴妫€鏌ワ紝IO-125 鐨 IC50 鍊 (30 mM) 鏄庢樉浣庝簬濂ユ矙鍒╅搨 (140 mM)銆傛€讳箣锛屽熀浜 IO-125 鐨勮秴鍒嗗瓙娌荤枟鑽寮€鍙戜笅涓€浠ｆ柊鍨嬮搨鍩哄己鏁堟姉鐧岃嵂鏄剧ず鍑哄墠鏅 (Roy, M. et al.105th Annu Meet Am Assoc Cancer Res (AACR) (April 5-9, San Diego) 2014, Abst 4483)銆 BC-001 瀵逛钩鑵哄拰鑲剧粏鑳炵檶寮傜绉绘鐗╂ā鍨嬫湁鏁 BioCycive 鍏徃鍜屾礇鏉夌煻鍗楀姞宸炲ぇ瀛︾殑鐮旂┒浜哄憳瀹炴柦浜嗕竴椤逛复搴婂墠鐮旂┒璇勪环 BC-001 鐨勬椿鎬э紝杩欑鐜簩纭簩閰搶鍡殑鏂板瀷浜岃仛鐗╅拡瀵圭殑鏄鍚戞€у崗鍚屾縺鍔ㄥ墏 p300锛屽彲鎶戝埗 HIF-1 伪锛屾嫙鐢ㄤ簬娌荤枟鐧岀棁銆侫549 缁嗚優涓紝BC-001 鍙珮鏁堜笅璋冨绉嶇己姘ц瀵煎熀鍥犵殑琛ㄨ揪銆侭C-001 寮烘晥鍑忓皯浜嗗悇绯荤檶缁嗚優鐨勭敓闀匡紝EC50 鍊煎湪绾虫懇灏旇寖鍥村唴銆備钩鑵虹檶鍜岃偩缁嗚優鐧屾ā鍨嬩腑锛孊C-001 (1 mg/kg) 涓庡鐓у墏鐩告瘮鎶戝埗浜嗚偪鐦ょ敓闀裤€備互 BC-001 (1 mg/kg) 娌荤枟 45 澶╋紝鏈灏忛紶浜х敓鎬ユ€ф瘨鎬э紙Dubey, R. et al. 105th Annu Meet Am Assoc Cancer Res (AACR) (April 5-9, San Diego) 2014, Abst 1014锛夈€ FDA 鎵瑰噯鍙稿Ε鏄斿崟鎶楁不鐤楀涓績宸ㄦ穻宸寸粨澧炵敓 FDA 鎵瑰噯浜 Janssen Biotech 鍏徃鐨勭粨鍚堢櫧浠嬬礌-6 (IL-6) 鐨勫祵鍚堝崟鍏嬮殕鎶椾綋鍙稿Ε鏄斿崟鎶楋紙siltuximab锛孲ylvant[TM]锛夛紝鐢ㄤ簬娌荤枟鏈劅鏌 HIV 鎴栦汉鐤辩柟鐥呮瘨-8 鐨勫涓績宸ㄦ穻宸寸粨澧炵敓鎮ｈ€呫€傚法娣嬪反缁撳鐢熸槸涓€绉嶇綍瑙佺殑娣嬪反澧炵敓鎬х柧鐥咃紝浼氳繃搴︿骇鐢 IL-6銆傛壒鍑嗘牴鎹殑鏄竴椤 II 鏈熻瘯楠岋紝浼拌 79 渚嬪法娣嬪反缁撳鐢熸偅鑰呮帴鍙楁渶浣虫敮鎸佹不鐤楋紝澶栧姞瀹夋叞鍓傛垨姣 3 鍛ㄩ潤鑴変竴娆 11 mg/kg 鍙稿Ε鏄斿崟鎶楋紙ClinicalTrials.gov 鏍囪瘑鍙 NCT01024036锛夈€傚徃濡ユ様鍗曟姉缁勪笁鍒嗕箣涓€浠ヤ笂鍙楄瘯鑰呯殑鑲跨槫鍜岀棁鐘剁紦瑙ｆ寔缁秴杩 18 鍛ㄣ€傚畨鎱板墏缁勬不鐤楀け璐ヤ腑浣嶆椂闂存槸 134 澶╋紝浣嗘不鐤楃粍鏈揪鍒扮粺璁″鎰忎箟銆傚徃濡ユ様鍗曟姉鍜屽畨鎱板墏缁勮传琛€鎮ｈ€呯殑琛€绾㈣泲鐧藉垎鍒鍔 61%锛?.5 g/dL锛夊拰0%銆侸anssen 鍏徃鍦 2013 骞 9 鏈堥€掍氦浜 BLA 鍜 MAA 鐢虫姤锛堣2013 骞 9 鏈 4 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級銆侳DA 瀵硅繖涓€鐢宠閲囧彇浜嗕紭鍏堣瘎瀹★紝涔嬪墠鎺堜簣鍙稿Ε鏄斿崟鎶楃綍鐢ㄨ嵂璧勬牸锛圝anssen Biotech 鏂伴椈绋匡紱FDA 鏂伴椈绋匡級銆 F-17727 浣撳唴琛ㄧ幇鍑烘姉蹇冭倢绾ょ淮棰ゅ姩浣滅敤銆傚績鎴块ⅳ鍔紙AF锛夋槸蹇冭剰鐨勪竴绉嶅績鐜囦笉榻愶紝蹇冭“鏃跺叾鍙戠敓鐜囧崌楂樸€侫F 涓庡績鎴垮唴瀵艰嚧蹇冭剰鏀剁缉闅滅鐨勫紓甯告湁鍏炽€傜洰鍓嶅嚑绉嶆姉蹇冪巼涓嶉綈鑽殑涓嶈冻鏄己涔忓績鎴跨壒寮傛€с€侾ierre Fabre 妫€楠岀殑鍋囪鏄敤鏂板瀷鎶戝埗鍓 F-17727 闃绘柇閽剧數娴 Ikur锛堝績鎴跨壒鏈夊苟鐢 K(v)1.5 閫氶亾鎵胯浇锛夊彲棰勯槻 AF銆傚湥鍦颁簹鍝ユ鍦ㄤ妇鍔炵殑"2014 骞村疄楠岀敓鐗╁澶т細"涓婃姤鍛婁簡鐮旂┒缁撴灉銆 F-17727 瀵 Ikur 鐨 IC50 鍊间负 1.8 mcM锛屽湪 HEK-293 缁嗚優涓 Ik(v)1.5 鍔ㄤ綔鐢典綅鍚庣浉鐨勬姂鍒朵綔鐢ㄥ寮猴紝鑰屼笉鏄宄板€奸儴鍒嗐€傚ぇ榧犲績鑲屾姝绘ā鍨嬩腑锛岀粰鍔ㄧ墿娉ㄥ皠閽鹃€氶亾闃绘粸鍓 F-17727锛?.5 鍜 5 mg/kg i.v.锛夋垨璧嬪舰鍓傘€傜敤鑽悗 2 鍒嗛挓鐢ㄥ績鐢靛浘璁板綍蹇冪巼涓嶉綈骞冲潎鏃剁▼锛屽崟娆′娇鐢 F-17727 鍚庤瀵熷埌蹇冨緥涓嶉綈鐨勬椂绋嬫湁鏄庢樉宸紓锛堜笌璧嬪舰鍓傜浉姣 P < 0.05锛夛紝璇佸疄浜嗗叾棰勯槻蹇冨緥涓嶉綈鍙戜綔鐨勪綔鐢ㄣ€傚鍏 AF 妯″瀷鎶ラ亾浜嗙浉浼肩粨鏋滐紝琛ㄦ槑鑷彂 AF 鍙戜綔锛團-17727 鍜岃祴褰㈠墏鍒嗗埆涓 4 vs. 165 s锛夊拰璇卞彂 AF锛堝垎鍒负 82 vs. 261 s锛夋椂绋嬩笌璧嬪舰鍓傜浉姣旀槑鏄剧缉鐭€傝繖浜涚粨鏋滆瘉瀹炰簡涓村簥鍓嶇爺绌朵腑 F-17727 浣滀负鎶楀績鑲岀氦缁撮ⅳ鍔ㄥ墏鐨勭枟鏁堬紙Junquero, D. et al Exp Biol (April 26-30, San Diego) 2014, Abst 652.17锛夈€ EMA 鎵瑰噯鍗℃牸鍒楀噣鍜屼簩鐢插弻鑳嶅鏂硅嵂 Janssen-Cilag International 鍏徃鐨 Vokanamet(R) 鏄敱閽?钁¤悇绯栧崗鍚岃浆杩愯泲鐧 2 (SGLT2) 鎶戝埗鍓 Invokana(R)锛堝崱鏍煎垪鍑€锛宑anagliflozin锛夊拰鑳板矝绱犲鏁忓墏浜岀敳鍙岃儘閫熼噴鍒跺墏缁勬垚鐨勫浐瀹氬墏閲忓鏂硅嵂锛屽凡鍦ㄦ鐩熻幏鎵广€傚崟鐢ㄤ簩鐢插弻鑳嶆垨涓庡叾浠栬嵂鐗╄仈鐢紙鍖呮嫭鑳板矝绱狅級涓嶈兘鍏呭垎鎺у埗琛€绯栫殑鎮ｈ€咃紝浠ュ強宸茬粡鍦ㄥ垎寮€鐢ㄥ崱鏍煎垪鍑€鍜屼簩鐢插弻鑳嶇殑鎮ｈ€咃紝閫傚疁浣跨敤鏈墖鍓傛不鐤楋紝姣忔棩鐢ㄨ嵂涓ゆ銆?013 骞 3 鏈堢敵鎶ヤ簡 MAA 锛堣 2013 骞 3 鏈 8 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級銆傛敮鎸佸叾鐢虫姤鐨 III 鏈熻鍒掑寘鎷簩鐢插弻鑳 + 鍗℃牸鍒楀噣涓庝簩鐢插弻鑳 + 瑗挎牸鍒楁眬鎴栨牸鍒楃編鑴茬殑姣旇緝锛堣 2013 骞 10 鏈 23 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級銆傚彟涓€椤圭爺绌惰皟鏌ヤ簡鍗℃牸鍒楀噣 + 浜岀敳鍙岃儘鍔犵敤涓€绉嶇：閰拌劜锛圕linicalTrials.gov 鏍囪瘑鍙 NCT01106625锛夈€傛澶栵紝涓ら」澶у瀷璇曢獙璋冩煡浜嗘澶嶆柟鑽不鐤 55 宀佷互涓婂苟鏈夊績琛€绠＄柧鐥呴闄╃殑 2 鍨嬬硸灏跨梾鎮ｈ€咃紙ClinicalTrials.gov 鏍囪瘑鍙 NCT01032629锛夛紙Janssen 鏂伴椈绋匡級銆 SUGLAT 鐗囧湪鏃ユ湰鎺ㄥ嚭娌荤枟 2 鍨嬬硸灏跨梾 Suglat(R) 鐗囷紙浼婃牸鍒楀噣 L-鑴皑閰革紝ipragliflozin L-proline锛夊浠婂凡鍦ㄦ棩鏈潰甯傦紝鐢ㄤ簬娌荤枟 2 鍨嬬硸灏跨梾锛屽墏閲忚鏍间负 25 鍜 50 mg銆傝鑽敱 Astellas Pharma 鍜 Kotobuki Pharmaceutical 涓ゅ鍏徃鑱斿悎鐮斿埗锛屽睘鏃ユ湰棣栦釜鑾锋壒娌荤枟 2 鍨嬬硸灏跨梾鐨勯挔/钁¤悇绯栧崗鍚岃浆杩愯泲鐧 2 (SGLT2) 鎶戝埗鍓傘€傛姂鍒 SGLT2 鍚庡彲鎶戝埗钁¤悇绯栫殑鍐嶆憚鍙栥€侫stellas 鍏徃璐熻矗鐢熶骇鍜岄攢鍞骇鍝侊紝骞朵笌 Kotobuki Pharmaceutical 鍜 MSD K.K. 涓ゅ鍏徃鍏卞悓鎺ㄥ箍锛堣 2013 骞 9 鏈 3 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級锛圓stellas Pharma 鍜 MSD K.K. 鏂伴椈绋匡級銆 DYAX 鍏徃鎵╁睍 KALBITOR 鐢ㄩ€旇幏 FDA 鎵瑰噯 FDA 宸茬粡鎵瑰噯浜 Dyax 鍏徃鐨 Kalbitor(R)锛堣壘鍗′粦鑲斤紝ecallantide锛夋墿灞曢€傚簲鐥囷紝杩欑琛€娴嗘縺鑲介噴鏀鹃叾鐨勮偨鎶戝埗鍓傜敤浜庢不鐤楅仐浼犳€ц绠℃€ф按鑲 (HAE) 鍙戜綔锛屽寘鎷勾婊 12 宀佺殑鎮ｈ€咃紙瑙 2010 骞 2 鏈 3 鏃ャ€婃堡妫矾閫忚嵂鐗╂柊闂汇€嬶級銆傛敮鎸佹娆¤鏄庝功鎵╁鍐呭鑾锋壒鐨勬槸浠ュ墠涓ら」宸插畬鎴愮殑 III 鏈熷畨鎱板墏瀵圭収鐮旂┒锛堢О涓 EDEMA3 鍜 EDEMA4锛夌殑缁撴灉锛屼互鍙婄爺绌 DX-88/19 鐨勭粨鏋滐紝Kalbitor 棣栨鑾锋壒鏃 DX-88/19 浠嶅湪杩涜涔嬩腑锛圕linicalTrials.gov 鏍囪瘑鍙 NCT00262080銆丯CT00457015 鍜 NCT00456508锛夈€傚骞存弧 12 宀佸効绔ユ偅鑰呯殑鐤楁晥鍜屽畨鍏ㄦ€т笌瀵规垚浜虹兢浣撶殑鐩歌繎锛圖yax 鏂伴椈绋匡級銆 LUNDBECK 鍏徃纭畾鍙€忚剳鏂板瀷 PDE2A 鎶戝埗鍓傜殑鐗圭偣 Lu-AF-64280 灞炰簬涓€绉嶉€夋嫨鎬х７閰镐簩閰叾 2A (PDE2A) 鏂板瀷鎶戝埗鍓傦紝鍙┛閫忓埌澶ц剳鍐咃紝鍏锋湁娼滃湪鎶楃簿绁炵梾鎴栨彁楂樿鐭ョ殑浣滅敤锛孒. Lundbeck 鐨勭爺绌朵汉鍛樹粙缁嶄簡鍏朵复搴婂墠鐗圭偣銆 PDE2A 浠嬪绗簩淇′娇鑵鸿嫹 3',5'-鐜崟纾烽吀 (cAMP) 鍜岄笩鑻 3',5'-楦熻嫹鍗曠７閰 (cGMP) 鐨勭伃娲汇€俢AMP 鍜 cGMP 鐨勫鍔犱笌璁ょ煡琛ㄧ幇鏀瑰杽鐩稿叧銆傜敱浜庣己涔忚兘绌胯繃琛€鑴戝睆闅滅殑閫傚疁鐮旂┒宸ュ叿锛岄樆纰嶄簡瀵 PDE2A 浣滅敤鐨勮皟鏌ャ€侺u-AF-64280 閫夋嫨鎬ф姂鍒跺叏闀块噸缁勪汉 PDE2A (Ki = 20 nM)锛屽浜 PDE9A (Ki = 1 mcM) 鍜 PDE10A (Ki = 1.8 mcM) 鏈変腑搴︽姂鍒朵綔鐢紝鑴遍澏鏁堝簲鏈夐檺銆侺u-AF-64280 琛ㄧ幇鍑鸿壇濂界殑鑴戠┛閫忔€э紝灏忛紶鍜屽ぇ榧犺剳鍐呮祿搴﹂珮杈 20 nM锛屽苟鍛堟祿搴︿緷璧栨€ц搫绉€傚湪娲讳綋鍐呯爺绌朵腑锛岀敤鑽悗 1 灏忔椂娴嬪畾锛岃鑽 (20 mg/kg) 浣挎捣椹粏鑳炲 cGMP 姘村钩鏄庢樉鍗囬珮锛? 灏忔椂鍚庢仮澶嶅埌鍩虹嚎鍊笺€傜簿绁炲垎瑁傜棁鐩稿叧璁ょ煡鍔熻兘闅滅澶ч紶妯″瀷涓紝Lu-AF-64280 浠ュ墏閲忎緷璧栨柟寮忓噺杞讳簡鐩愰吀 1-锛?-鑻熀鐜繁鍚″挴鐑凤級鐩愰吀鍝屽暥 (PCP) 璇卞彂鐨勬柊浜嬬墿鎺㈢┒缂洪櫡锛?0 mg/kg 鏃惰揪鍒扮粺璁″鎰忎箟 (P < 0.001)銆侾CP 娌荤枟鏂扮敓澶ч紶鐨勬敞鎰忓畾鍔胯浆绉讳换鍔′腑锛孡u-AF-64280 鏄庢樉鏀瑰杽浜嗗害澶栬浆鎹㈠拰搴﹀杞崲閫嗗悜琛ㄧ幇锛圥 < 0.001锛夛紝鎻愮ず棰濆彾鐨川鎵ц鍔熻兘鏀瑰杽銆侱BA/2 鍒嗚鐥囨牱灏忛紶鐨 P20-N40 鍚闂ㄦ帶妯″紡涓紝Lu-AF-64280 鏄庢樉闄嶄綆浜 T/C 姣斿€硷紝鎻愮ず淇℃伅澶勭悊鏀瑰杽銆侺u-AF-64280 骞舵湭鍑忓急灏忛紶 PCP 璇卞彂娲诲姩杩囧害锛屾湭鎶戝埗鏉′欢鍥為伩鍙嶅簲锛圧edrobe, J.P. et al Psychopharmacology (Berlin) 2014, Advanced publication锛夈€侟/p> </div> <div id="copy">浣滆€咃細涓嶈銆€鏉ユ簮锛氭堡濮嗘．璺€廃/div> <div class="sxart"> <li>涓婁竴绡囷細<a 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