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翹ｴ翹
ﾑﾄﾑﾑ
ﾚQﾙlﾔ｣

絳ﾅEﾚg

�ﾆﾇｭaﾔ^ﾉ杦ﾉ

ZADAXIN thymosin alpha 1 (thymalfasin)ｪiｰUｰ_ｰVｰ罨@ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭPｪFｰ`ｰ}ｰﾑｰtｰ@ｰVｰ罨jｭ�ｪA�ﾆﾇｭaﾔ^ﾉ杦ﾉｭ汜ﾁｭΜA祓羂ｭ�ｭｸｭ�ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ罸ｮｭ氿ﾂﾙｽｭ¶pｭ｢ｭ痕政蒔Bﾉﾒﾚ�223ﾆlｭﾝﾎ�ｶｮｭ皴鹿Rｭ蟄煜ﾒﾙ禿ﾗｰRｰ羃gｰﾙｪ[ｰﾑﾚﾋﾔｱｭ樰ﾛ脛ﾆ�ｭ�ｭ�ｪAｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭPｭ�ｪAｭUｭｩﾔﾚｭ栁�ｪAｶTｭQﾅ悶ﾉｭﾒｭ政ｸｪB竄ﾆﾍ簽ﾙ�ｭ�ｪAﾚﾁﾉｨｭｩｭ痕PｭQｭｩﾔﾚﾔ芹ﾋﾚ{ｭﾒｭ政€ｭ｢ｭ蒔iﾅｼﾚQｶｮｪj


�ﾆﾇｭaﾔ^ﾉ杦ﾉｭ�ｭ擎`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP祓羂ｭ煆Lﾔｿﾆﾇ


ﾚﾋﾔｱﾚQﾙlﾔ｣ ﾉﾒﾚ�
ﾚﾁｰOｰﾑｪ[ｰv		 12ｭｩﾔﾚﾔ強涬とﾍ簽ﾙ�ｭ�ｭ淸ｸﾅﾏ*
ｪ@ﾎｾｭQ稱ﾉK
[1,5]		 12 ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(1.6 mg SQ BIW 6 mos.)
8 ｰvｰﾅｰZｰ{		 (83%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(25%) ｰvｰﾅｰZｰ{
ｪ@ﾎｾｭR稱ﾉK
[2,5]		 50 ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(1.6 mg SQ BIW 6 mos.)
49 ｰvｰﾅｰZｰ{		 (24%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(12%) ｰvｰﾅｰZｰ{
ﾎ既pｪ@ﾎｾｭR稱ﾉK
[3,4,5]		 51 ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(1.6 mg SQ BIW 6 mos.)
53 ﾚﾁ		 (37%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(25%) ﾚﾁ
ﾑﾛ脛ｰfｪ[ｰ^
[5]		 113 ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(1.6 mg SQ BIW 6 mos.)
110 ｰvｰﾅｰZｰ{ｭ�ｭｸｭ�ﾚﾁ		 (36%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(19%) ｰvｰﾅｰZｰ{ｭ�ｭｸｭ�ﾚﾁ

*荳ﾅﾏｭ�ｪAｭPｭQｭｩﾔﾚﾔ強涬とﾍ簽ﾙ�ｭ汜_ｭ？BV DNAｭｬｭｾｭЗBeAgﾅAﾆﾇｭ栁ﾒﾚﾏ

ﾎｸﾆ菁目ﾋﾔｱｭ�ｭ�ｪAZADAXINｭ�ﾚﾁﾉｨﾔ強PｭQｭｩﾔﾚﾃ鮓欽oｭ遲€ｭ穐Aﾚﾁﾔｿﾅ豁ｻﾚcｭ遲€ｭ｢ｭｸｪBZADAXINｭΟｾｭ尺ﾁ篌ｭ�ｪAALTｰxｪ[ｰXｰﾅｰCｰ聹lｪiｰtｰﾔｰAｪj禹ﾉ懊Iﾎﾅ遲�ｭQ艝ﾃ鮓強ｮｭ鬲遲ｸｪBALTｰtｰﾔｰAｭｻﾆｦｭｦｭ€ｭ｢ｭｸｭ催蝉豁ΜAﾉ樰@臀ﾎSｭ涬ｴﾔ溜恩じ溜ｻﾉ�ﾚ@ｭﾒｭ政鬲｢ﾔﾋｭ住ADAXINｭﾝﾎｱｭｸｭｻｭｾｭ｢ｪB


�ﾆﾇｭbﾔ^ﾉ杦ﾉ

ZADAXIN thymosin alpha 1 (thymalfasin) ｪiｰUｰ_ｰVｰ罨@ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭPｪFｰ`ｰ}ｰﾑｰtｰ@ｰVｰ罨jｭ�ｪA�ﾆﾇｭbﾔ^ﾉ杦ﾉｭ汜ﾁｭΜAｰCｰ羃^ｪ[ｰtｰFｰﾙｰ罸ｮｭ氿ﾂﾙｽｭ¶pｭ｢ｭ痕政蒔Bﾙ禿ﾗｭ�篷ｶoｭﾒｭ政ｸﾚﾋﾔｱｭ樰ﾛ脛ﾆ�ｭQﾔｶｭｮｪAｰRｰ羃gｰﾙｪ[ｰﾑﾚﾋﾔｱｭPﾔｶｭ�ｭ�ｪA121ﾆlｭ栁ﾒﾚﾝﾎ�ｶΜAZADAXINｭｮｰCｰ羃^ｪ[ｰtｰFｰﾙｰ罨Aｭ�ｭｸｭ�ｪAｰCｰ羃^ｪ[ｰtｰFｰﾙｰ罸揵ｭ∠ﾁｭｻﾚ{ｭﾒｭ政ｸｪBｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭPｭ�ｭUｪ`ｭPｭQｭｩﾔﾚｭ栁�ｪAﾙ≫�ｶTｭQﾅ妙�翹ｭﾒｭ征AｰCｰ羃^ｪ[ｰtｰFｰﾙｰ罸�ｭUｪ`ｭPｭQｭｩﾔﾚｭ栁�ｪAﾙ�ﾙｭｶTｭRﾅ悶ﾉｭﾒｭ政ｸｪB竄ﾆﾍ簽ﾙ�ｭ�ｪAﾚﾁﾉｨﾚｬｭｾｭ�ﾉｨﾔ強Uｭｩﾔﾚｭ汜_ｭ∠ﾋﾚ{ｭﾒｭ政€ｭ｢ｭ蒔iﾅｼﾚQｶｮｪj


�ﾆﾇｭbﾔ^ﾉ杦ﾉｭ�ｭ擎`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭPｭｮｰCｰ羃^ｪ[ｰtｰFｰﾙｰ聘ﾂﾙｽｭ煆Lﾔｿﾆﾇ


ﾚﾋﾔｱﾚQﾙlﾔ｣
ﾚﾋﾔｱﾚQﾙlﾔ｣ﾉﾒﾚ�
ﾚﾁｰOｰﾑｪ[ｰv*		 ﾚﾁﾉｨﾚ淸ｸﾅﾏ** ﾚﾎｱ荳ﾅﾏ***
ｪ@ﾎｾｭR稱ﾉK
[6,9]		 35 ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP + ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ� (Ta1 1.6 mg SQ BIW 6 mos. + IFN 3 MU TIW 6 mos.)

37 ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ� (IFN 3 MU TIW 6 mos.)

37 ｰvｰﾅｰZｰ{		 ｰvｰﾅｰZｰ{ALT 荳ﾅ�:
(37.1%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP + ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�
(16.2%) ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�
(2.7%) ｰvｰﾅｰZｰ{

ｰEｰBｰﾑｰX荳ﾅ�:
(37.1%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP + ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�
(18.9%) ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�
(2.7%) ｰvｰﾅｰZｰ{		 ｰvｰﾅｰZｰ{ALT 荳ﾅ�:
(19.2%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP + ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�
(9.4%) ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�
ｰCｰ^ｰﾉｰAﾎｾｭQ稱ﾉK
[7,9]		 15 ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(1.0 mg SQ qd for 4 days then BIW for 51 wks. + IFN 3 MU on day 4 then TIW for 51 wks.)		 ｰEｰBｰﾑｰX荳ﾅ�:
(73.3%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP + ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�		 ｰEｰBｰﾑｰX荳ﾅ�:
(40.0%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP + ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�
ｰCｰ^ｰﾉｰAﾎｾｭQ稱ﾉK
[8,9]		 17 Thymosin alpha 1
(1.6 mg SQ BIW 6 mos. + IFN 3 MU TIW 6 mos.)
17 ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�		 ｰvｰﾅｰZｰ{ALT 荳ﾅ�:
(70.6%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP + ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�
(35.3%) ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�		 ｰvｰﾅｰZｰ{ALT 荳ﾅ�:
(29.4%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP + ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�
(17.6%) ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�
ﾑﾛ脛ｰfｪ[ｰ^
[9]		 67 ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(1.6 mg SQ BIW 6-12 mos. + IFN 3 MU TIW 6-12 mos.)
54 ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�		 ｰvｰﾅｰZｰ{ALT 荳ﾅ�:
(44.7%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP + ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�
(22.2%) ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ� +		 ｰvｰﾅｰZｰ{ALT 荳ﾅ�:
(22.4%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP + ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ�
(9.3%) ｰCｰ羃^ｪ[ｰtｰFｰﾙｰ� ++

*ﾚﾁ紵ﾆ�
**ALT荳ﾅﾏｭ�ｪAﾚﾁﾉｨﾚΟｬｭ拶LTﾅAﾆﾇﾉﾒﾚﾏｪBｰEｰBｰﾑｰX荳ﾅﾏｭ�ｪAﾚﾁﾉｨﾚΟｬｭ皐CV RNAﾅAﾆﾇﾉﾒﾚﾏｪB
***ALT荳ﾅﾏｭ�ｪAｭUｭｩﾔﾚﾔ強涬とﾍ簽ﾙ�ｭΟｬｭ拶LTﾅAﾆﾇﾉﾒﾚﾏｪBｰEｰBｰﾑｰX荳ﾅﾏｭ�ｪAｭUｭｩﾔﾚﾔ強涬とﾍ簽ﾙ�ｭΟｬｭ皐CVRNAﾅAﾆﾇﾉﾒﾚﾏｪBﾎｾｭR稱ﾉKｭΟｬｭ尺ﾎｱ荳ﾅ�ｪAｭUｭｩﾔﾚﾉ�ﾚﾁｭﾝﾚ溜ｸﾉﾒﾚｬｭｾｭ�ﾙ€ﾚﾁｭΟｾｭ蕉vｭPｭQｭｩﾔﾚﾚﾁｭﾝﾚ溜ｸﾉﾒﾚﾝﾉ�ｭﾞｪB
+P=0.0096
++P=0.10

ﾚﾁ紵ｭ樰ﾛ脛ﾆ�ｭ�ｭ�ｪAﾚﾎｱｭ皴屡ｦﾅﾈﾉwｪiALTｪj荳ﾅﾝﾚﾋｶｯｭｵｪAﾚﾁﾉｨﾔ強Uｪ`ｭPｭQｭｩﾔﾚﾔ強瀇Wｶ･ALTｭ�ｪAｰCｰ羃^ｪ[ｰtｰFｰﾙｰ罸揵ｭ∠ﾁｭﾝﾚ溜ｸﾉﾒﾚΟｬｭ｢ｭ€ｭ�9.3%ｭ�ｭﾊｭ遲ｸｭ揵π�ｭｵｪAﾙﾂﾙｽﾚﾁｭﾝﾚ溜ｸﾉﾒﾚ�ｭ�22.4%ｭΟｬｭ｢ｭ€ﾉ�ﾚ@ｭﾒｭ政ｸｪB


ｰｶｰNｰ`ｰ胙恩�

ZADAXIN thymosin alpha 1 (thymalfasin)ｪiｰUｰ_ｰVｰ罨@ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭPｪFｰ`ｰ}ｰﾑｰtｰ@ｰVｰ罨jｭ�ｪAﾅuﾆﾇﾔｽﾉﾗﾉﾒﾚ�ｭ擎Cｰ羃tｰﾑｰGｰ羃UｪEｰｶｰNｰ`ｰ翦眺瀇恩�ｪiﾅu荳ﾅﾐﾅﾈﾙ�ｪjｭｮｭｵｭ€ｭ｢ｭ痕政蒔Bｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭPｭ�ｪAﾙｭｭ栁ﾒﾚ�ｭ擎Cｰ羃tｰﾑｰGｰ羃UｪEｰｶｰNｰ`ｰ罸瀇恩�ｭｮｭｵｭ€ｪAｭ�ｭｸﾅｧﾑﾚｭ煆\ﾆ眺ｩｭ痕�ｶ[ｭ鴕ｮﾅuﾙRﾎ淏H竢ｭﾝ羇ｭ尺ｻｭ�ｭﾇｭ鬲ｩｭ遲ｸｪA�ﾆﾇﾔﾔﾅt网ﾆ�ﾉﾒﾚ�ｭ擎Cｰ羃tｰﾑｰGｰ羃Uｭｬｭｾｭ┓aﾔ^ﾉ杦ﾉｭ瀇恩�ｭｮｭｵｭ€ｭ｢ｭ痕政蒔iﾅｼﾚQｶｮｪj


ｰｶｰNｰ`ｰ胙恩�ｭｮｭｵｭ€ｭ擎`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭPｭ煆Lﾔｿﾆﾇ


ﾚﾋﾔｱ
ﾉﾒﾚ�
ｰｶｰNｰ`ｰ�
ﾚQﾙlﾔ｣		 ﾉﾒﾚ�
ﾚﾁｰOｰﾑｪ[ｰv*		 荳ﾅﾏ**
ｪ@ﾎｾｭQ稱ﾉK
ﾙｭﾚ�
ｰCｰ羃tｰﾑｰGｰ羃U
[10]		 9 ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP (900 ug/m² *** SQ BIW ｭTｶTﾉ�)
6 ﾉ��		 (69%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(10%) ﾉ��
ｪ@ﾎｾｭR稱ﾉK
ﾙｭﾚ�
ｰCｰ羃tｰﾑｰGｰ羃U
[11]		 45 Thymosin alpha 1 (900 ug/m² *** SQ BIW ｭSｶTﾉ�)
40 ｰvｰﾅｰZｰ{		 (67%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(53%) ｰvｰﾅｰZｰ{
ｪ@ﾎｾｭQ稱ﾉK
ﾙｭﾚ�
ｰCｰ羃tｰﾑｰGｰ羃U
[12]		 110 ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP (900 ug/m² *** SQ BIW ｭQｶTﾉ�)
111 ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP (900 ug/m² *** SQ BIW ｭSｶTﾉ�)
109 ｰvｰﾅｰZｰ{		 ｰvｰﾅｰZｰ{荳ﾅ�翹ｭSｭ�ｭｸｭ�ｰvｰﾅｰZｰ{ｭ栁ﾒﾚｾｭ上ﾉｭWｭ栁ﾒﾚ瀇椚ｻ糴ｭｵｭ｢ﾔｿﾅ豁ｻﾔｩｭ痕政ｸﾅｰZｰ{
ｪ@ﾎｾｭR稱ﾉK
ﾔﾔﾅt网ﾆ�
ｰCｰ羃tｰﾑｰGｰ羃U
[13]		 48 ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP (900 ug/m² *** SQ BIW ｭSｶTﾉ�)
49 ｰvｰﾅｰZｰ{		 ｭSｶTﾉ�:(71%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(43%) ｰvｰﾅｰZｰ{

ｭWｶTﾉ�:
(65%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(24%) ｰvｰﾅｰZｰ{
ｪ@ﾎｾｭR稱ﾉK
ﾔﾔﾅt网ﾆ�
ｭaﾔ^ﾉ杦ﾉ
[14,15]		 11 ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP (ﾉeｰｶｰNｰ`ｰ耿�: 900 ug/m² *** SQ ｰｶｰNｰ`ｰ罸R纜ﾎO BIW ｭQｶTﾉ�)
12 ｰvｰﾅｰZｰ{		 ｰvｰﾅｰZｰ{ｭRｭｩﾔﾚ:
(64%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(17%) ｰvｰﾅｰZｰ{

ｭUｭｩﾔﾚ:
(45%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(17%) ｰvｰﾅｰZｰ{

ｭXｪPｭQｭｩﾔﾚ:
(45%) ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP
(0%) ｰvｰﾅｰZｰ{
ｰCｰ^ｰﾉｰAｪ@ﾎｾｭR稱ﾉK
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[16]		 ｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭP (ﾉeｰｶｰNｰ`ｰ耿�: 900 ug/m² *** SQ BIW ｭRｶTﾉ�)
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*ｰｶｰNｰ`ｰ罸η遲ﾏｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭPｭﾝﾚ溜ｸﾚﾁｰOｰﾑｪ[ｰvｪBｰvｰﾅｰZｰ{ｭ�ｭｸｭ�ｰRｰ羃gｰﾙｪ[ｰﾑｭﾒｭ政ｸｰOｰﾑｪ[ｰvｭ�ｪAｰ`ｰｭｰVｰ罨EｰAｰﾑｰtｰ@ｭPｭ鬲ｵｭ�ｰｶｰNｰ`ｰ翦眺ﾝﾚ溜ｸｪB
**荳ﾅﾏｭ�ｪAﾉeﾚﾋﾔｱｭ↑Aｶ[ｭ�ﾙｭｭ｢ﾅuﾙRﾎ擎ﾔｰxｰﾑｭ�磽ｭｵｭｸﾉﾒﾚﾏ
***900 ug/m² ｭ�1.6mg