渚濊タ缇庡潶鐗囦汉浣撶敓鐗╃瓑鏁堟€х爺绌跺垎鏋
鍙戝竷鏃堕棿锛
2023-05-17
鏉ユ簮锛
涓€銆?/strong>鑳屾櫙
涔宠吅鐧岀殑鍙戠梾鐜囧崰濂虫€ф伓鎬ц偪鐦ょ殑棣栦綅锛屾牴鎹?018骞村浗闄呯檶鐥囩爺绌舵満鏋勮皟鏌ユ樉绀猴紝鍏ㄧ悆涔宠吅鐧岀殑鍙戠梾鐜囬珮杈?4.2%[1]銆備钩鑵虹檶鐨勮礋鎷呭湪鍏ㄧ悆鑼冨洿鍐呬笉鏂鍔狅紝鑰屼腑鍥戒篃姝ｅ湪缁忓巻鐧岀棁杞瀷锛屽コ鎬т钩鑵虹檶鐨勭柧鐥呰礋鎷呰秺鏉ヨ秺閲嶏紝涓旀浜＄巼棰囬珮銆侟/span>
涔宠吅鐧岀殑娌荤枟鏂规鍖呮嫭鎵嬫湳銆佹斁鍖栫枟銆佸唴鍒嗘硨娌荤枟鍙婇澏鍚戞不鐤楃瓑[2]銆傞櫎甯歌鎵嬫湳鍙婃斁鍖栫枟娌荤枟澶栵紝鍐呭垎娉屾不鐤楀凡琚編鍥藉浗绔嬬患鍚堢檶鐥囩綉缁滄寚鍗楁帹鑽愮敤浜庡婵€绱犳晱鎰熺殑涔宠吅鐧孅sup>[3]锛屽叾鑳藉鏈夋晥闄嶄綆鑲跨槫鍒嗘湡锛屽鍔犳墜鏈満浼氬強淇濅钩鏈轰細锛屾彁楂樻偅鑰呯煭鏈熺敓瀛樼巼锛屼笖姣掑壇浣滃皬锛屾偅鑰呴鍚庡ソ锛屽挨鍏堕€傜敤浜庤€佸勾灞€閮ㄦ櫄鏈熶钩鑵虹檶鎮ｈ€匋sup>[4-5]銆傜洰鍓嶅浜庣粷缁忓悗涔宠吅鐧屾偅鑰呭湪涓村簥杩涜鎶楅泴婵€绱犳不鐤楄嵂鐗╀富瑕佹槸绗?浠ｈ姵棣欓叾鎶戝埗鍓傦紝鍖呮嫭鏉ユ洸鍝椼€侀樋閭ｆ洸鍜屼緷瑗跨編鍧︺€侟/span>
渚濊タ缇庡潶锛坋xemestane锛夛紝鍟嗗搧鍚嶄负Aromasin锛屾槸鐢辨剰澶у埄Pharmacia & Upjoin鍏徃鐮旂┒寮€鍙戠殑绗笁浠ｈ姵棣欓叾鎶戝埗鍓傘€侟/strong>浜?999骞?鏈堝湪鑻卞浗棣栨琚壒鍑嗕笂甯傦紝骞堕檰缁湪缇庡浗銆佸痉鍥姐€佺憺澹€佸姞鎷垮ぇ鍜屽寳娆у浗瀹朵笂甯傦紝涓村簥涓婁富瑕佺敤浜庣粷缁忓悗濡囧コ鏅氭湡涔宠吅鐧岀殑娌荤枟锛屼綔鐢ㄦ満鍒朵负涓庤姵棣欏寲閰剁殑搴曠墿缁撳悎浣嶇偣涓嶅彲閫嗙殑缁撳悎锛屼娇鑺抽鍖栭叾澶辨椿浠庤€岄檷浣庤娴嗕腑闆屾縺绱犳按骞冲凡杈惧埌娌荤枟涔宠吅鐧岀殑鐩殑[6]銆侟/span>
鏈枃灏嗙粨鍚堢浉鍏虫寚瀵煎師鍒欏拰鏂囩尞鐮旂┒锛岃缁嗛槓杩颁緷瑗跨編鍧︾墖浜轰綋鐢熺墿绛夋晥鎬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锛氫緷瑗跨編鍧︾墖
鑻辨枃鍚嶇О锛欵xemestane Tablets
鍖栧缁撴瀯寮廃/strong>锛欬/span>
瑙勬牸锛?5 mg銆侟/span>
閫傚簲鐥囷細
1.鐢ㄤ簬缁忎粬鑾様鑺緟鍔╂不鐤?-3骞村悗锛岀粷缁忓悗闆屾縺绱犲彈浣撻槼鎬х殑濡囧コ鐨勬棭鏈熸蹈娑︽€т钩鑵虹檶鐨勮緟鍔╂不鐤楋紝鐩磋嚦瀹屾垚鎬诲叡5骞寸殑杈呭姪鍐呭垎娉屾不鐤椼€侟/span>
2.鐢ㄤ簬缁忎粬鑾様鑺不鐤楀悗锛屽叾鐥呮儏浠嶆湁杩涘睍鐨勮嚜鐒舵垨浜哄伐缁濈粡鍚庡濂崇殑鏅氭湡涔宠吅鐧屻€侟/span>
鐢ㄦ硶鐢ㄩ噺锛欬/strong>
1.娌荤枟鏃╂湡鍜屾櫄鏈熶钩鑵虹檶鎮ｈ€呯殑鎺ㄨ崘鍓傞噺涓?5 mg锛屾瘡鏃ヤ竴娆★紝姣忔涓€鐗囷紝寤鸿椁愬悗鏈嶇敤銆侟/span>
2.鏅氭湡涔宠吅鐧屾偅鑰呭簲鎸佺画鏈嶇敤鏈搧鐩磋嚦鑲跨槫杩涘睍銆侟/span>
3.鍚堝苟浣跨敤缁嗚優鑹茬礌P-450(CYP)3A4鐨勫己璇卞鍓備細闄嶄綆渚濊タ缇庡潶鏆撮湶閲忋€傛偅鑰呭悓鏃舵帴鍙桟YP3A4寮鸿瀵煎墏锛屽鍒╃骞炽€佽嫰濡ヨ嫳鏃讹紝鏈搧鐨勬帹鑽愬墏閲忎负50 mg锛屾瘡鏃ヤ竴娆★紝椁愬悗鏈嶇敤銆侟/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[7]
2銆佹憾鍑烘儏鍐袋/strong>
渚濊タ缇庡潶涓築CS IV绫昏嵂鐗╋紝婧跺嚭鍜屾笚閫忓潎涓哄叾鍦ㄤ綋鍐呭惛鏀剁殑闄愰€熸楠わ紝鍙傝€冧緷瑗跨編鍧︾墖鏃ユ湰浠垮埗鑽殑婧跺嚭[8]锛屼緷瑗跨編鍧︾墖婧跺嚭鏃犳槑鏄緋H渚濊禆鍨嬬壒寰侊紝鍚勪粙璐ㄤ腑婧跺嚭缁撴灉濡備笅锛堟湭澧炲姞琛ㄩ潰娲绘€у墏锛夛細
鍥涖€?/strong>鐢熺墿绛夋晥鎬ц瘎浠饵/strong>
渚濊タ缇庡潶鐗囬€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?008骞?5鏈堥甯冧簡銆婁緷瑗跨編鍧︾墖鐢熺墿绛夋晥鎬х爺绌舵妧鏈釜鑽寚瀵煎師鍒欙紙缁堢锛夈€婞sup>[9]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銆佺爺绌剁被鍨婞/strong>
FDA涓嵂鎸囧鍘熷垯閽堝渚濊タ缇庡潶鐗囩殑鐢熺墿绛夋晥鎬х爺绌跺缓璁噰鐢ㄥ崟鍓傞噺銆佸弻浜ゅ弶璁捐锛屽悓鏃跺紑灞曠┖鑵瑰拰椁愬悗缁欒嵂鐨勪汉浣撶敓鐗╃瓑鏁堟€х爺绌躲€侟/span>
渚濊タ缇庡潶鐗囧湪浣撳唴琚ぇ閲忎唬璋紝鍦ㄨ娴嗕腑鍘熷舰鑽殑閲忎綆浜庢€荤粰鑽噺10%锛屾牴鎹師鐮旀棩鏈琁F鏂囦欢[7]锛屽叾缁濆鐢熺墿鍒╃敤搴︿粎鏈?.9~5.0%锛屾帹娴嬭鍝佺鍏锋湁楂樺彉寮傜殑鐗瑰緛锛堢敓鐗╁埄鐢ㄥ害浣庝笖鑽墿鍚告敹鍓嶅箍娉涗唬璋級锛屽弬鑰冪浉鍏冲悓鍝佺鐢熺墿绛夋晥鎬х爺绌舵枃鐚暟鎹?sup>[10]鍙煡锛岄鍚庡崟娆″彛鏈嶄緷瑗跨編鍧︾墖25 mg鍚庡弬姣斿埗鍓侰max鐨勪釜浣撳唴鍙樺紓绯绘暟涓?4.73%锛岀粨鏋滃涓嬶細
鍥犳锛岄拡瀵规湰鍝佺鐨勯珮鍙樺紓鐗瑰緛锛岄噰鐢ㄩ噸澶嶄氦鍙夎璁℃洿绗﹀悎绉戝璇勪环鐢熺墿绛夋晥鎬х殑鐩殑锛屽洜姝ゆ帹鑽愬紑灞曚笁鍛ㄦ湡閮ㄥ垎閲嶅/鍥涘懆鏈熷畬鍏ㄩ噸澶嶇殑浜ゅ弶璁捐杩涜鏈搧鐨勭敓鐗╃瓑鏁堟€ц瘎浠枫€侟/span>
2銆佸彈璇曡€呴€夋嫨
閫氬父BE鐮旂┒閫夋嫨鍋ュ悍浜轰綔涓哄彈璇曡€咃紝鍋ュ悍浜虹兢涓€鑸病鏈変弗閲嶇柧鐥呭拰鍩虹鐢ㄨ嵂骞叉壈锛屽叾鍧囪川鎬х浉瀵硅緝濂斤紝鍦ㄥ姣斿彈璇曞埗鍓傚拰鍙傛瘮鍒跺墏鐨勪綋鍐匬K宸紓鏃朵篃鏇翠负鏁忔劅銆傚綋鍋ュ悍鍙楄瘯鑰呭弬涓庤瘯楠屽彲鑳介潰涓村畨鍏ㄦ€ф柟闈㈢殑椋庨櫓鏃跺垯寤鸿鍏ラ€夎瘯楠岃嵂鐗╃殑鐩爣閫傚簲鐥囦汉缇ゃ€侳DA涓嵂鎸囧鍘熷垯寤鸿鍙楄瘯鑰呴€夌敤鍋ュ悍鐨勭粷缁忓悗濡囧コ锛屽洜鏈嵂鍏锋湁鑷寸暩鎬э紝涓嶅疁绾冲叆鏈夌敓鑲叉綔鍔涚殑浜虹兢銆侟/span>
涓村簥璇曢獙寮€灞曢渶璁捐鐩稿簲鐨勫叆鎺掓爣鍑嗙撼鍏ュ仴搴风殑缁濈粡鍚庡コ鎬э紝閫氬父缁濈粡鍚庡コ鎬ч渶婊¤冻鑷劧鍋滅粡≥12鏈堬紝涓斿弬涓庣瓫閫夋椂濂虫€ф縺绱犳按骞筹紙淇冮粍浣撶敓鎴愮礌銆佷績鍗垫场鐢熸垚绱犲拰闆屼簩閱囷級妫€娴嬮渶绗﹀悎缁濈粡鍚庣殑璇婃柇瑕佹眰銆侟/span>
3銆佽鏍烽噰闆咟/strong>
鏍规嵁鍘熺爺鏃ユ湰IF鏂囦欢[7]涓嵂浠ｅ姩鍔涘鐨勭浉鍏崇爺绌讹紝12鍚嶅仴搴风粷缁忓悗濡囧コ鍦ㄧ┖鑵圭姸鎬佷笅鎴栭珮鑴傞鍚庣珛鍗抽€氳繃浜ゅ弶娉曞彛鏈嶅崟鍓傞噺25 mg渚濊タ缇庡潶銆備笌绌鸿吂缁欒嵂鐩告瘮锛岃繘椋熺粰鑽娇Cmax鍜孉UC瀵规暟杞崲骞冲潎鍊煎垎鍒鍔犱簡25%鍜?9%銆侟/span>
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?.5銆?銆?.33銆?.67銆?銆?.33銆?.67銆?銆?.5銆?銆?銆?銆?2銆?6銆?4銆?6銆?8銆?2銆?6銆?20銆?44 h锛?2涓級[11]
(2) 0銆?.25銆?.5銆?銆?.5銆?銆?銆?銆?銆?2銆?6銆?4銆?8銆?2銆?20銆?68 h锛?6涓級[12]
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€傛牴鎹師鐮旇鏄庝功鎻忚堪锛屽仴搴风粷缁忓悗濡囧コ鍙ｆ湇鏈搧鍚庯紝渚濊タ缇庡潶鐨勮娴嗘祿搴︿互澶氭寚鏁扮殑褰㈠紡涓嬮檷锛屽钩鍧囩粓鏈崐琛版湡绾?4灏忔椂銆傚洜渚濊タ缇庡潶鐗囧湪浣撳唴鐨勬毚闇查噺姘村钩杈冧綆锛?4灏忔椂鍚庤鑽祿搴︿笅闄嶈嚦鏋佷綆姘村钩锛岄€氬父浼氬鑷碆QL锛堜綆浜庢娴嬮檺搴︼級锛屽洜姝ゅ湪婊¤冻鏈娑堥櫎鐩稿簲鑷冲皯閲囬泦3-4涓牱鍝佷互纭繚鍑嗙‘浼扮畻鏈娑堥櫎鐩告枩鐜囩殑鎯呭喌涓嬶紝閲囪缁堢偣璁捐涓?4灏忔椂鍚屾牱绗﹀悎鐢熺墿绛夋晥鎬ц瘎浠风殑鐩殑銆侟/span>
4銆佸叾浠栬€冭檻
浣跨敤浜鸿倽鍒跺墏鐨勭爺绌惰〃鏄庯紝缁嗚優鑹茬礌P450 3A4锛圕YP 3A4锛夋槸鍙備笌渚濊タ缇庡潶姘у寲鐨勪富瑕佸悓宸ラ叾[9]銆傚洜姝や笌鑲濇哀鍖栭叾CYP 3A4鐨勫己鏁堟姂鍒跺墏鎴栬瀵煎墏鍚堢敤浼氬奖鍝嶈瘯楠岃嵂鐗╃殑浠ｈ阿锛屽缁廋YP 3A4閰朵唬璋㈢殑鑽墿鏈夊奖鍝嶇殑涓昏椋熺墿閫氬父濡備笅[13]锛欬/span>
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[8] 銈ㄣ偔銈汇儭銈广偪銉抽尃25mg銆孷TRS銆岻F鏂囦欢
[9] 銆婁緷瑗跨編鍧︾墖鐢熺墿绛夋晥鎬х爺绌舵妧鏈釜鑽寚瀵煎師鍒欙紙缁堢锛堻/span>
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[14] 渚濊タ缇庡潶鐗囧師鐮旇繘鍙ｈ鏄庝功.
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