杈惧崱浠栦紵璇存槑涔︼紙瀹屾暣鐗堬級
1
閫傚簲璇佸拰鐢ㄩ�?/p>
DAKLINZA
鏄�傜敤涓轰笌绱㈤潪甯冮煢浣跨敤涓烘湁鎱㈡�т笝鍨嬭倽鐐庣梾姣?/p>
(HCV)
鍩哄洜鍨?/p>
3
鎰熸煋鎮ｈ�呯殑娌?/p>
鐤?/p>
[
瑙佸墏閲忓拰缁欒嵂鏂规硶
(2)
鍜屼复搴婄爺绌?/p>
(14)]
銆?/p>
浣跨敤鐨勯檺鍒讹細
鈼忓湪
HCV
鍩哄洜鍨?/p>
3-
鎰熸煋鏈夌‖鍖栨偅鑰呮帴鍙?/p>
DAKLINZA
涓庣储闈炲竷闊﹁仈鐢ㄥ叡
12
鍛紝鎸佺画鐥呮瘨
瀛﹀弽搴?/p>
(SVR)
鐜囧噺浣庛�?/p>
[
瑙佷复搴婄爺绌?/p>
(14)].
2
鍓傞噺鍜岀粰鑽柟娉?/p>
2.1
鎺ㄨ崘鍓傞噺
DAKLINZA
鐨勬帹鑽愬墏閲忔槸
60
mg
锛屽彛鏈嶏紝姣忓ぉ
1
娆′笌绱㈤潪甯冮煢鑱旂敤鍏?/p>
12
鍛ㄣ�?/p>
DAKLINZA
鍙?/p>
鏈夋垨鏃犻鐗╂湇鐢ㄣ�?/p>
灏氭湭纭畾瀵规湁纭寲鎮ｈ�?/p>
DAKLINZA
鍜岀储闈炲竷闊︾殑鏈�浣虫椂闂?/p>
[
瑙佷复搴婄爺绌?/p>
(14)]
銆?/p>
瀵圭储闈炲竷闊︾壒寮傛�ф帹鑽愬墏閲忥紝鍙傝�冪浉鍏冲鏂硅祫鏂欍�?/p>
2.2
鐢变簬鑽墿鐩镐簰浣滅敤鍓傞噺淇グ
瀵逛笌
DAKLINZA
鍏卞悓缁欒嵂鍓嶅叾浠栬嵂鐗╁弬鑰冭嵂鐗╃浉浜掍綔鐢ㄥ拰绂佸繉璇佽妭銆?/p>
缁嗚優鑹茬礌
P450
閰?/p>
3A(CYP3A
鐨勫己鎶戝埗鍓傦細鍑忎綆
DAKLINZA
鍓傞噺鑷?/p>
30 mg
姣忓ぉ
1
娆″綋涓庡己
CYP3A
鎶戝埗鍓傚叡鍚岀粰鑽椂鐢?/p>
30 mg
鐗?/p>
[
瑙佽嵂鐗╃浉浜掍綔鐢?/p>
(7)]
銆?/p>
涓害
CYP3A
璇卞鍓傦細褰撳叡鍚岀粰鑽笌涓害
CYP3A
璇卞鍓傚鍔?/p>
DAKLINZA
鐨勫墏閲忚嚦
90 mg
姣?/p>
澶?/p>
1
娆″埄鐢ㄩ�傚綋鐨勭墖缁勫悎
(
涓夌墖
30
mg
鐗囨垨涓�鐗?/p>
60
mg
鍜屼竴鐗?/p>
30
mg
鐗?/p>
)
[
瑙佽嵂鐗╃浉浜掍綔鐢?/p>
(7)]
銆?/p>
寮?/p>
CYP3A
璇卞鍓傦細
DAKLINZA
鏄蹇屼笌寮?/p>
CYP3A
璇卞鍓傝仈鐢?/p>
[
瑙佺蹇岃瘉
(4)]
銆?/p>
寤鸿瀵逛笉鑹弽搴斾笉鍑忎綆
DAKLINZA
鍓傞噺銆?/p>
2.3
娌荤枟鐨勭粓姝?/p>
涓�渚嬫帴鍙?/p>
DAKLINZA
涓庣储闈炲竷闊︽偅鑰呭姘镐箙鍦扮粓姝㈢储闈炲竷闊︼紝
鐒跺悗
DAKLINZA
涔熷簲琚粓姝€�?/p>
4
绂佸繉璇?/p>
鈼?nbsp;DAKLINZA
鏄蹇屼笌寮虹儓鍦拌瀵?/p>
CYP3A
鑽墿鑱旂敤鍜岋紝浠庤�岋紝鍙兘瀵艰嚧
DAKLINZA
鐨勮緝
浣庢毚闇插拰涓уけ鐤楁晥銆?/p>
绂佸繉鑽墿鍖呮嫭锛?/p>
浣嗕笉闄愪簬鍦ㄨ〃
1
涓垪涓?/p>
[
瑙佽嵂鐗╃浉浜掍綔鐢?/p>
(7)
鍜屼复搴婅嵂鐞?/p>
瀛?/p>
(12.3)]
5
璀﹀憡鍜屾敞鎰忎簨椤?/p>
5.1
鐢变簬鑽墿鐩镐簰浣滅敤涓嶈壇鍙嶅簲鎴栦抚澶辩梾姣掑鍙嶅簲鐨勯闄?/p>
DAKLINZA
鍜屽叾浠栬嵂鐗╃殑鍚屾椂浣跨敤鍙兘瀵艰嚧宸茬煡鎴栨綔鍦ㄥ湴鏄捐憲鑽墿鐩镐簰浣滅敤锛屽叾涓湁浜?/p>
鍙兘瀵艰嚧浠ヤ笅
[
瑙佺蹇岃瘉
(4)
鍜岃嵂鐗╃浉浜掍綔鐢?/p>
(7)]
锛?/p>