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655403370  \3,082 ¿ø/1Á¤(2024.10.01) (ÇöÀç¾à°¡) \3,082 ¿ø/1Á¤(2017.02.01) (º¯°æÀü¾à°¡) 
                         
                        
						     
						     
                         
                      
                     
                       
                     
                     
                    
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b : Ç÷¾×Åõ¼® ÀÏ¿¡ Åõ¿©µÈ´Ù¸é, Ç÷¾×Åõ¼® °úÁ¤ ÈÄ¿¡ ÀÌ ¾àÀ» Åõ¿©ÇÑ´Ù.
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   37%
   
   45%
   
   
  
   ALT > 10 x ULN ¹× >2 x ±âÀú°ª
   
   2%
   
   4%
   
   2%
   
   11%
   
   
  
   ALT > 5.0 x ULN
   
   11%
   
   16%
   
   12%
   
   24%
   
   
  
   ¾ËºÎ¹Î < 2.5g/dL
   
   <1%
   
   <1%
   
   0
   
   2%
   
   
  
   ÃѺô¸®·çºó > 2.5 x ULN
   
   2%
   
   2%
   
   3%
   
   2%
   
   
  
   ¸®ÆÄÁ¦ ¡Ã 2.1 x ULN
   
   7%
   
   6%
   
   7%
   
   7%
   
   
  
   Å©·¹¾ÆÆ¼´Ñ > 3.0 x ULN
   
   0
   
   0
   
   0
   
   0
   
   
  
   È®ÀÎµÈ Å©·¹¾ÆÆ¼´ÑÁõ°¡ ¡Ã 0.5 mg/dL
   
   1%
   
   1%
   
   2%
   
   1%
   
   
  
   °íÇ÷´ç, Àý½Ä > 250mg/dL
   
   2%
   
   1%
   
   3%
   
   1%
   
   
  
   ´ç´¢e 
   
   4%
   
   3%
   
   4%
   
   6%
   
   
  
   Ç÷´¢f 
   
   9%
   
   10%
   
   9%
   
   6%
   
   
  
   Ç÷¼ÒÆÇ < 50,000/mm3 
   
   <1%
   
   <1%
   
   <1%
   
   <1%
   
   
 
a ¾ËºÎ¹Î(¸ðµç Ä¡·áÁß °ª< 2.5g/dL), È®ÀÎµÈ Å©·¹¾ÆÆ¼´Ñ Áõ°¡ ¡Ã 0.5mg/dL, ALT>10 x ULN ¹× >2 x ±âÀú°ªÀ» Á¦¿ÜÇϰí, ¸ðµç º¯¼ö¿¡ ´ëÇØ ±âÀú°ª¿¡¼ Grade 3 ¶Ç´Â Grade 4·Î ¾ÇÈµÈ Ä¡·áÁß °ª
b Àӻ󿬱¸ AI463-022 ¹× AI463-027
c AI463-026 ½ÃÇè ¹× ¶ó¹ÌºÎµò Åõ¿© Áß ¹ÙÀÌ·¯½ºÇ÷ÁõÀÇ Àç¹ßÀ» °æÇèÇÑ ÇÇÇèÀÚ¿¡¼ 52ÁÖ±îÁö ¼¼ °¡Áö ¿ë·®ÀÇ ÀÌ ¾à (0.1, 0.5 ¹× 1mg) 1ÀÏ 1ȸ¿Í Áö¼ÓÀûÀ¸·Î ¶ó¹ÌºÎµò 100mgÀ» 1ÀÏ 1ȸ·Î Åõ¿©ÇÏ´Â Á¦ 2»ó, ´Ù±¹°¡, ¹«ÀÛÀ§¹èÁ¤, ÀÌÁß¸Í°Ë ½ÃÇèÀÎ AI463-014 ½ÃÇèÀÇ ÀÌ ¾à 1 mg°ú ¶ó¹ÌºÎµò Åõ¿©±ºÀ» Æ÷ÇÔ.
d Ç÷¾×ÇÐ °Ë»ç, ÀϹÝÀû ÈÇа˻ç, ½ÅÀå ¹× °£±â´É °Ë»ç, ÃéÀåÈ¿¼Ò ¹× ´¢°Ë»ç¸¦ Æ÷ÇÔ
e Grade 3 = 3+, large, ¡Ã500 mg/dL ; Grade 4 = 4+, ÇöÀú, ÁßÁõ
f Grade 3 = 3+, large; Grade 4 = ¡Ã4+, ÇöÀú, ÁßÁõ, Ç÷´¢ ¸¹À½
ULN = upper limit of normal(Á¤»ó »óÇÑÄ¡)
ÀÌµé ¿¬±¸¿¡¼, ÀÌ ¾à Ä¡·á ȯÀÚ Áß, Ä¡·á Áß Á¤»ó»óÇÑÄ¡(ULN)ÀÇ 10¹è ÀÌ»ó°ú ±âÀú°ªº¸´Ù 2¹è ÀÌ»óÀÇ ALT»ó½ÂÀº Àü¹ÝÀûÀ¸·Î Ä¡·á¸¦ °è¼ÓÇÏ¿© ¼Ò½ÇµÇ¾ú´Ù. ÀÌµé ´ëºÎºÐÀÇ ¾ÇÈ´Â ALT»ó½Â¿¡ ¼±ÇàÇϰųª ¶Ç´Â µ¿½Ã¿¡ ¡Ã 2log10 /mLÀÇ ¹ÙÀÌ·¯½º ³óµµ°¨¼Ò¿Í °ü·ÃÀÌ ÀÖ¾ú´Ù. Ä¡·áÁß¿¡´Â ÁÖ±âÀûÀÎ °£±â´É °Ë»ç°¡ ±ÇÀåµÈ´Ù.
3) Ä¡·á Áß´Ü ÈÄ °£¿°ÀÇ ¾ÇÈ
°£¿°ÀÇ ¾ÇÈ ¶Ç´Â ALT ¾ÇÈ´Â ALT°¡ Á¤»ó»óÇÑÄ¡ÀÇ 10¹è Ãʰú ¹× ÇÇÇèÀÚÀÇ ´ëÁ¶°ª(±âÀú»óÅÂÀÇ ÃÖ¼Ò°ª ¶Ç´Â Åõ¿© Á¾·á ½Ã ÃÖÁ¾ ÃøÁ¤°ª)ÀÇ 2¹è Ãʰú·Î Á¤ÀÇÇÑ´Ù. Åõ¿©¸¦ Áß´ÜÇÑ ¸ðµç ÇÇÇèÀÚ¿¡ ´ëÇÏ¿©(ÀÌÀ¯¿Í »ó°ü¾øÀÌ), ´ÙÀ½ Ç¥¿¡ °¢ ½ÃÇè¿¡¼ Ä¡·áÁß´Ü ÈÄ ALT°¡ ¾ÇÈµÈ ÇÇÇèÀÚÀÇ ºñÀ²À» ³ªÅ¸³½´Ù. ÀÌ·¯ÇÑ ½ÃÇèµé¿¡¼, ÇÇÇèÀÚÀÇ ÇÏÀ§±º¿¡¼ ÀÓ»ó½ÃÇè°èȹ¼¿¡ Á¤ÀÇµÈ Åõ¿©¿¡ ´ëÇÑ ¹ÝÀÀÀ» º¸ÀÎ °æ¿ì¿¡ 52ÁÖ ¶Ç´Â ÀÌÈÄÀÇ Åõ¿© Áß´ÜÀÌ Çã¿ëµÇ¾ú´Ù. ÀÌ ¾àÀ» Ä¡·á¹ÝÀÀ¿¡ »ó°ü¾øÀÌ Áß´ÜÇÑ °æ¿ì¿¡´Â Ä¡·áÁßÁö ÈÄ °£¼öÄ¡ »ó½ÂÀ²ÀÌ ´õ ³ô¾ÆÁú ¼ö ÀÖ´Ù.
Ç¥ 3. 3°³ Àӻ󿬱¸¿¡¼ Ä¡·á Áß´Ü ÃßÀû±â°£ µ¿¾È °£¿°ÀÇ ¾ÇÈ(AI463-022, AI463-027, AI463-026)
 
  
     
   ALT»ó½Â > 10 x ULN ¹×> 2 x ´ëÁ¶°ªÀÎ ÇÇÇèÀÚa 
   
   
  
   ÀÌ ¾à
   
   ¶ó¹ÌºÎµò
   
   
  
   ´ºÅ¬·¹¿À½ÃµåÀúÇØÁ¦ Ä¡·á¸¦ ¹ÞÀº °æÇèÀÌ ¾øÀ½
   
     
     
   
  
   HBeAg-¾ç¼º
   
   4/174(2%)
   
   13/147(9%)
   
   
  
   HBeAg-À½¼º
   
   24/302(8%)
   
   30/270(11%)
   
   
  
   ¶ó¹ÌºÎµò ÀúÇ×¼º
   
   6/52(12%)
   
   0/16
   
   
 
a ´ëÁ¶°ªÀº ±âÀú»óÅÂÀÇ ÃÖ¼Ò°ª ¶Ç´Â Åõ¿©Á¾·á½ÃÀÇ ÃÖÁ¾ÃøÁ¤°ªÀÌ´Ù. Åõ¿© Á¾·á±îÁöÀÇ Áß¾Ó ½Ã°£Àº ÀÌ ¾àÀ» Åõ¿©ÇÑ ÇÇÇèÀÚ¿¡¼´Â 23ÁÖ¿´À¸¸ç ¶ó¹ÌºÎµòÀ» Åõ¿©ÇÑ ÇÇÇèÀÚ¿¡¼´Â 10ÁÖ¿´´Ù.
4) HIV/HBV µ¿½Ã°¨¿°
AI463038 ¿¬±¸¿¡ Âü¿©ÇÑ HIV/HBV µ¿½Ã°¨¿° ÇÇÇèÀÚµé(n=51)¿¡ ´ëÇÏ¿© 24ÁÖ µ¿¾È ¼öÇàÇÑ ¸Í°Ë Ä¡·á¿¡¼ ÀÌ ¾à 1 mgÀÇ ¾ÈÀü¼º ÇÁ·ÎÆÄÀÏÀº À§¾à±º(n=17)ÀÇ ¾ÈÀü¼º ÇÁ·ÎÆÄÀϰú À¯»çÇÏ¿´°í, ÀÌ´Â ºñ-HIV(ÀÎü¸é¿ª°áÇ̹ÙÀÌ·¯½º)°¨¿° ȯÀÚ¿¡¼ ³ªÅ¸³ ¾ÈÀü¼º ÇÁ·ÎÆÄÀϰúµµ À¯»çÇÏ¿´´Ù [1. °æ°í ÂüÁ¶]
5) °£ÀÌ½Ä ¼ö¿©ÀÚ
°ø°³ ¶óº§À̸ç, °£ÀÌ½Ä ÈÄ ¼öÇàÇÑ ¿¬±¸ [9. °£ºÎÀü ȯÀÚ¿¡ ´ëÇÑ Åõ¿© ÂüÁ¶]¿¡¼, ÀÌ ¾àÀ» Åõ¿©¹ÞÀº 65¸í ÇÇÇèÀڵ鿡¼ ³ªÅ¸³ ÀÌ»ó¹ÝÀÀÀÇ ¹ß»ýºóµµ¿Í Ư¡µéÀÌ °£À̽ÄÀ» ¹ÞÀº ȯÀڵ鿡¼ ¿¹»óµÇ´Â ¹ß»ýºóµµ ¹× ÀÌ»ó¹ÝÀÀÀÇ Æ¯¼º, ±×¸®°í ÀÌ ¾àÀÇ ¾Ë·ÁÁø ¾ÈÀü¼º ÇÁ·ÎÆÄÀϰú Àϰü¼ºÀÌ ÀÖ¾ú´Ù.
6) ¼Ò¾Æ ÇÇÇèÀÚ¿¡¼ ÀÓ»ó ½ÃÇè °æÇè
ÀÓ»ó ½ÃÇèÀº ¸Å¿ì ´Ù¾çÇÑ Á¶°Ç ÇÏ¿¡¼ ½Ç½ÃµÇ¾ú±â ¶§¹®¿¡, ÀÌ ¾àÀÇ ÀÓ»ó½ÃÇè¿¡¼ °üÂûµÈ ÀÌ»ó ¹ÝÀÀ·üÀº ´Ù¸¥ ¾àÀÇ ÀÓ»ó½ÃÇè¿¡¼ÀÇ ºñÀ²°ú Á÷Á¢ÀûÀ¸·Î ºñ±³ÇÒ ¼ö ¾ø°í ½ÇÁ¦ °üÂûµÇ´Â ºñÀ²À» ¹Ý¿µÇÏÁö ¾ÊÀ» ¼ö ÀÖ´Ù.
2¼¼¿¡¼ 18¼¼ÀÇ ¼Ò¾Æ ȯÀÚ¿¡¼ ÀÌ ¾àÀÇ ¾ÈÀü¼ºÀº ¸¸¼º HBV °¨¿°ÀÌ Àִ ȯÀÚ¸¦ ´ë»óÀ¸·Î ÁøÇà ÁßÀÎ µÎ °³ÀÇ ÀÓ»ó½ÃÇè(2»ó ¾àµ¿ÇÐ ½ÃÇè[AI463028]°ú 3»ó ÀÓ»ó½ÃÇè[AI463189])¿¡ ±Ù°ÅÇÑ´Ù. ÀÌ ÀÓ»ó½ÃÇèÀº ÀÌ ¾àÀ¸·Î Áß°£ Áö¼Ó±â°£ 99ÁÖ µ¿¾È Ä¡·á ¹ÞÀº 195¸íÀÇ HBeAg-¾ç¼º ÇÇÇèÀÚ¿¡¼ÀÇ °æÇèÀ» ¹Ý¿µÇÑ´Ù. ÀÌ ¾àÀ¸·Î Ä¡·á¹ÞÀº ¼Ò¾Æ ÇÇÇèÀڵ鿡¼ °üÂûµÈ ÀÌ»ó ¹ÝÀÀÀº ¼ºÀο¡¼ ÀÌ ¾àÀ¸·Î ¼öÇàÇÑ ÀÓ»ó½ÃÇè¿¡¼ °üÂûµÈ ÀÌ»ó¹ÝÀÀ°ú Àϰü¼ºÀÌ ÀÖ¾ú´Ù. ¼Ò¾Æ ÇÇÇèÀÚÀÇ 1% Ãʰú¿¡¼ º¸°íµÈ ¾à¹° À¯ÇØ ¹ÝÀÀÀº º¹Åë, ¹ßÁø, ¸ÀÀÌ ¾È ÁÁÀ½(poor palatability)(Á¦Ç° ¸À ÀÌ»ó), ¿À½É, ¼³»ç, ±¸Å並 Æ÷ÇÔÇÏ¿´´Ù. ¸Å¿ì ÈçÇϰÔ(¡Ã1/10) È£Áß±¸°¨¼Ò°¡ º¸°íµÇ¾ú´Ù.
7) ½ÃÆÇ ÈÄ Á¶»ç °æÇè
(1) ÀÌ ¾àÀÇ ½ÃÆÇ ÈÄ Á¶»ç¿¡¼ º¸°íµÈ ÀÌ»ó¹ÝÀÀ µéÀº ´ÙÀ½°ú °°´Ù. À̵é ÀÌ»ó¹ÝÀÀµéÀº Àüü Å©±â¸¦ ¾Ë ¼ö ¾ø´Â ¸ðÁý´Ü¿¡¼ ÀÚ¹ßÀûÀ¸·Î º¸°íµÈ °ÍÀ̱⠶§¹®¿¡, ±× ºóµµ¸¦ È®½ÇÈ÷ Æò°¡Çϰųª ÀÌ ¾à º¹¿ë°úÀÇ Àΰú°ü°è¸¦ È®¸³ÇÏ´Â °ÍÀº °¡´ÉÇÏÁö ¾Ê´Ù.
¨ç ¸é¿ª°è ºÎÀÛ¿ë : ¾Æ³ªÇʶô½Ã½º¾ç ¹ÝÀÀ(Anaphylatoid reaction)
¨è ´ë»ç ¹× ¿µ¾çÀå¾Ö : À¯»êÁõ
¨é °£´ãÁó¼º Àå¾Ö : ¾Æ¹Ì³ë±âÀüÀÌÈ¿¼Ò Áõ°¡
¨ê ÇǺΠ¹× ÇÇÇÏÁ¶Á÷ ºÎÀÛ¿ë : Å»¸ð, ¹ßÁø
(2) ±¹³» ½ÃÆÇ ÈÄ Á¶»ç°á°ú
±¹³»¿¡¼ Àç½É»ç¸¦ À§ÇÏ¿© 6³âµ¿¾È ¼ºÀÎ(16¼¼ ÀÌ»ó) 3,367¸íÀ» ´ë»óÀ¸·Î ½Ç½ÃÇÑ ½ÃÆÇÈÄ »ç¿ë¼ºÀûÁ¶»ç°á°ú ÀÌ»ó¹ÝÀÀÀÇ ¹ßÇöÀ²Àº Àΰú°ü°è¿Í »ó°ü¾øÀÌ 7.57%(255/3,367¸í, 380°Ç)·Î º¸°íµÇ¾ú´Ù. ÀÌ Áß ÀÌ ¾à°ú Àΰú°ü°è¸¦ ¹èÁ¦ÇÒ ¼ö ¾ø´Â À¯ÇØ»ç·Ê ¹ßÇöÀ²Àº 1.60%(54/3,367¸í, 67°Ç)·Î ÇǷΰ¡ 0.30%(10/3,367¸í, 10°Ç)·Î °¡Àå ¸¹¾Ò°í, ±× ´ÙÀ½Àº »óº¹ºÎÅë 0.24%(8/3,367¸í, 8°Ç), °¡½¿¾²¸² 0.21%(7/3,367¸í, 8°Ç), ¼ÒȺҷ® 0.18%(6/3,367¸í, 6°Ç), ¿À½É 0.12%(4/3,367¸í, 4°Ç) µîÀÇ ¼øÀ¸·Î ³ªÅ¸³µ´Ù.
¶ÇÇÑ Áß´ëÇÑ À¯ÇØ»ç·ÊÀÇ ¹ßÇöÀ²Àº Àΰú°ü°è¿Í »ó°ü¾øÀÌ 0.27%(9/3,367¸í, 19°Ç)·Î °£½Å»ý¹° 0.15%(5/3,367¸í, 5°Ç), º¹°³»ÃâÇ÷, º¹¼ö °¢ 0.03%(1/3,367¸í, 2°Ç), ¹®¸Æ¾Ð Ç×Áø À§º´Áõ, º¹Åë, À§Àå°üÃâÇ÷, ´ã°ü¿°, °£¼º³úÁõ, ºñÁß°ÝÆíÀ§, ÆÐÇ÷Áõ, ´«²¨Ç®ÇǺÎÁúȯ, À§Ç÷°üÁ¾, ¸¸¼º ºÎºñµ¿¿° °¢ 0.03%(1/3,367¸í, 1°Ç)À¸·Î º¸°íµÇ¾úÀ¸¸ç, ¿¹»óÇÏÁö ¸øÇÑ À¯ÇØ»ç·ÊÀÇ ¹ßÇöÀ²Àº Àΰú°ü°è¿Í »ó°ü¾øÀÌ 5.58%(188/3,367¸í, 253°Ç)·Î °¡½¿¾²¸² 0.65%(22/3,367¸í, 23°Ç), °¨±â 0.62%(21/3,367¸í, 21°Ç), »óº¹ºÎÅë 0.30%(10/3,367¸í, 10°Ç), ±âħ, °£½Å»ý¹° °¢ 0.24%(8/3,367¸í, 8°Ç), °¡·Á¿òÁõ 0.21%(7/3,367¸í, 7°Ç), °¡½¿ÅëÁõ 0.18%(6/3,367¸í, 6°Ç), º¯ºñ, º¹Åë, Ç㸮ÅëÁõ °¢ 0.15%(5/3,367¸í, 5°Ç), º¹ºÎºÒÄè°¨, Ä๰ °¢ 0.12%(4/3,367¸í, 4°Ç) µîÀÇ ¼øÀ¸·Î º¸°íµÇ¾ú´Ù.
      
     
   
        
  
  
    
   
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  ¡Û CECIL TEXTBOOK of MEDICINE.23th. GOLDMAN, AUSIELLO. Chapter152. Chronic Hepatitis.  
  ¡Û AASLD(Ameican Association for the Study of Liver Disease) Sep, 2009. GUIDELINE TITLE : Chronic Hepatitis B 
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[2009.10.19 Áø·á½É»çÆò°¡À§¿øÈ¸] 
Á¦ÇȽº ¾àÁ¦³»¼ºÀ¸·Î Çñ¼¼¶óÁ¤ Åõ¿© Áß º¯°æ Åõ¿©µÈ ¹Ù¶óÅ©·çµåÁ¤1mgÀÇ ¿ä¾ç±Þ¿©¿¡ ´ëÇÏ¿© 
 
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  ¡Û CECIL TEXTBOOK of MEDICINE.23th. GOLDMAN, AUSIELLO. Chapter152. Chronic Hepatitis.  
  ¡Û AASLD(Ameican Association for the Study of Liver Disease) Sep, 2009. GUIDELINE TITLE : Chronic Hepatitis B 
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   - ±×·¯³ª, Á¦ÃâµÈ °Ë»ç°á°ú ÂüÁ¶ ÇöÇà ÀÎÁ¤±âÁØ»ó HBV-DNA(-)µÇ¾ú´Ù°¡ 2ȸ ÀÌ»ó HBV-DNA(+)ÀÌ È®ÀεǴ ¹ÙÀÌ·¯½º µ¹ÆÄÇö»óÀ¸·Î º¸±â ¾î·Á¿ï »Ó ¾Æ´Ï¶ó, YMDD mutant °Ë»ç¸¦ ½Ç½ÃÇÏÁö ¾ÊÀº °æ¿ì·Î¼ ¡®07.9/29ºÎÅÍ ±³Ã¼ Åõ¿©ÇÑ ¹Ù¶óÅ©·çµå 1mgÀº ÀÎÁ¤±âÁØ¿¡ ÀǰŠ¿ä¾ç±Þ¿©·Î ÀÎÁ¤ÇÏÁö ¾Æ´ÏÇÔ. 
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¡Û AASLD(AmeicanAssociation for the Study of Liver Disease) Feb, 2007.
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¡Û ´ëÇѰ£ÇÐȸ ¹× ´ëÇѼÒȱâÇÐȸÀǰß
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¡Ø  Ÿ ¾àÁ¦·Î ±³Ã¼ÇÏ´Â °ÍÀº °ü·ÃÇÐȸ Àǰߵî ÂüÁ¶ÇÒ ¶§ °¡´ÉÇÒ °ÍÀ¸·Î ÆÇ´ÜµÇ³ª, ¾àÁ¦°£ÀÇ ±³Â÷³»¼º µîÀÌ ¿ì·ÁµÇ¹Ç·Î ±³Ã¼Åõ¿©´Â ½ÅÁßÈ÷ °áÁ¤ÇÏ¿©¾ßÇÒ °ÍÀÓ.
¡Ø ¹ÝÀÀÀÌ ¾ø´Â °æ¿ì¶õ ÀÏÂ÷Ä¡·á ½ÇÆÐ¸¦ ¶æÇÔ(2007³â ´ëÇѰ£ÇÐȸ °¡À̵å¶óÀÎ ¡¸¸¸¼º BÇü°£¿°ÀÇ Ä¡·á¡¹ÂüÁ¶, Ç×¹ÙÀÌ·¯½ºÁ¦¸¦ Àû¾îµµ 6°³¿ù Åõ¿© ÈÄ Ç÷û HBV DNA°¡ Ä¡·á Àü¿¡ ºñÇØ 1/100 ¹Ì¸¸À¸·Î °¨¼ÒÇÏÁö ¾ÊÀº°æ¿ì)
- µû¶ó¼, ·¹º¸ºñ¸£ Åõ¿© ÁßHBV-DNA¿Í SGOT/SGPT ¼öÄ¡°¡ Àß Á¶ÀýµÇ°í ÀÖ¾úÀ¸³ª SGPT ¼öÄ¡°¡ 1~2°³¿ù ¸¸¿¡44¿¡¼ 67·Î »ó½ÂÇÏ¿´´Ù ÇÏ¿© ¹Ù¶óÅ©·çµå·Î ±³Ã¼Åõ¿© ÇÑ µ¿»ç·Ê´Â ±³Ã¼Åõ¿© ÇÒ ¸¸ÇÑ Å¸´çÇÑ»çÀ¯°¡ ¾Æ´Ï¹Ç·Î, ¹Ù¶óÅ©·çµåÁ¤Àº ÀÎÁ¤ÇÏÁö ¾Æ´ÏÇÔ.
- ¶ÇÇÑ, µ¿ ¾àÁ¦µéÀº °¢ ÀÎÁ¤±âÁØ¿¡¼ ¡®HBV-DNA (+) ¹× SGOT/SGPT 80´ÜÀ§ ÀÌ»ó¡¯ÀÌ ¸í½ÃµÇ¾îÀÖ´Â ¹Ù, SGOT/SGPT´Â ÀϹÝÀûÀ¸·Î °£¼Õ»óÀÇ Ç¥ÁöÀÚ·Î »ç¿ëµÇ³ª ´Ù¸¥ ¹ÙÀÌ·¯½º¿¡ ÀÇÇÑ °¨¿° µîÀÇ»óȲ¿¡¼µµ Áõ°¡ÇÏ´Â µî Á¦ÇÑÀÌ ÀÖÀ¸¹Ç·Î ±³Ã¼ Åõ¿©½Ã¿¡´Â ¡®SGOT/SGPT 80´ÜÀ§ ÀÌ»ó¡¯Á¶°ÇÀ» Àû¿ëÇÏÁö¾Ê±â·Î ÇÔ.
[2008.10.20 Áø·á½É»çÆò°¡À§¿øÈ¸]
 
       
   
  
  
   
    DUR °ü·Ã °í½Ã 
    
      
        [º´¿ë¿¬·É±Ý±â ÀǾàǰ / ÀӺαݱâ ÀǾàǰ / ºñ¿ëÈ¿°úÀû ÇÔ·® ÀǾàǰ / ¾ÈÀü¼º °ü·Ã ±Þ¿©ÁßÁö ÀǾàǰ]  
      
     
       
 
    
     
  
    
       
      
        
          
            
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    Ç׸ñ 
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    DUR (ÀǾàǰ»ç¿ëÆò°¡) 
    º´¿ë±Ý±â :
     
	 °í½ÃµÈ º´¿ë±Ý±â ³»¿ëÀº ¾ø½À´Ï´Ù.
	 
	 [»óÈ£ÀÛ¿ë/º´¿ë±Ý±â°Ë»ö]  										
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      °í½ÃµÈ ¿¬·É±Ý±â ³»¿ëÀº ¾ø½À´Ï´Ù.
      
      [¿¬·É´ë±Ý±â»ó¼¼°Ë»ö]  
       
       
        
        
     
   
  
   
    Mechanism of Action 
    
      Entecavir¿¡ ´ëÇÑ Mechanism_Of_Action Á¤º¸  By competing with the natural substrate deoxyguanosine triphosphate, entecavir functionally inhibits all three activities of the HBV polymerase (reverse transcriptase, rt): (1) base priming, (2) reverse transcription of the negative strand from the pregenomic messenger RNA, and (3) synthesis of the positive strand of HBV DNA. 
     
   
  
   
    Pharmacology 
     
      Entecavir¿¡ ´ëÇÑ Pharmacology Á¤º¸  Entecavir is a guanosine nucleoside analogue with selective activity against hepatitis B virus (HBV). It is designed to selectively inhibit the Hepatitis B virus, blocking all three steps in the replication process. Entecavir is more efficient than an older Hepatitis B drug, lamivudine. 
     
   
  
   
    Metabolism 
    
      Entecavir¿¡ ´ëÇÑ Metabolism Á¤º¸  # Phase_1_Metabolizing_Enzyme:Not Available 
     
   
  
   
    Absorption 
    
      Entecavir¿¡ ´ëÇÑ Absorption Á¤º¸  Absorption Following oral administration in healthy subjects, entecavir peak plasma concentrations occurred between 0.5 and 1.5 hours. In healthy subjects, the bioavailability of the tablet is 100% relative to the oral solution. 
     
   
  
   
    Pharmacokinetics 
    
      EntecavirÀÇ ¾à¹°µ¿·ÂÇÐÀÚ·á  
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 ÃÖ°í ³óµµ µµ´Þ ½Ã°£ : 0.5~1.5 ½Ã°£
  »ýü ÀÌ¿ë·ü : Á¤Á¦´Â °æ±¸ ¿ë¾×°ú ºñ½ÁÇÕ´Ï´Ù.
  À½½ÄÀÇ ¿µÇâ : °í Áö¹æ ½ÄÀÌ´Â AUC¸¦ °¨¼Ò½Ã۰í, Èí¼ö¸¦ Áö¿¬½Ãŵ´Ï´Ù. 
  
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 ´Ü¹é °áÇÕ :  13% 
  Vd : °ÅÀÇ Á¶Á÷¿¡ ºÐÆ÷
  
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 ½Å¹è¼³ : 62~73% ¹Ìº¯Èü 
    Åõ¼®¿¡ ÀÇÇÑ ¿µÇâ : Ç÷¾× Åõ¼®½Ã 13%, º¹¸· Åõ¼® ½Ã 0.3%
   
       
   
  
   
    Toxicity 
    
      Entecavir¿¡ ´ëÇÑ Toxicity Á¤º¸  Healthy subjects who received single entecavir doses up to 40 mg or multiple doses up to 20 mg/day for up to 14 days had no increase in or unexpected adverse events. If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. 
     
   
  
   
    Drug Interactions 
    
      Entecavir¿¡ ´ëÇÑ Drug_Interactions Á¤º¸  Not Available 
     
   
  
   
    CYP450  Drug Interaction 
    
      [CYP450 TableÁ÷Á¢Á¶È¸]  
     
   
  
   
    Food Interaction 
    
      Entecavir¿¡ ´ëÇÑ Food Interaction Á¤º¸  Take on an empty stomach.Taking the product with a high-fat meal or a light snack reduces the maximal concentration by 44 to 46% and total exposure by 18 to 20%. 
     
   
  
   
    Drug Target 
    
      
      [Drug Target]  
     
   
  
   
    Description 
    
      Entecavir¿¡ ´ëÇÑ Description Á¤º¸  Entecavir is an oral antiviral drug used in the treatment of hepatitis B infection. It is marketed under the trade name Baraclude (BMS).Entecavir is a guanine analogue that inhibits all three steps in the viral replication process, and the manufacturer claims that it is more efficacious than previous agents used to treat hepatitis B (lamivudine and adefovir). It was approved by the U.S. Food and Drug Administration (FDA) in March 2005. 
     
   
  
   
    Dosage Form 
    
      Entecavir¿¡ ´ëÇÑ Dosage_Form Á¤º¸  Tablet	Oral 
     
   
  
   
    Drug Category 
    
      Entecavir¿¡ ´ëÇÑ Drug_Category Á¤º¸  Antiviral Agents 
     
   
  
   
    Smiles String Canonical 
    
      Entecavir¿¡ ´ëÇÑ Smiles_String_canonical Á¤º¸  NC1=NC(=O)C2=C(N1)N(C=N2)C1CC(O)C(CO)C1=C 
     
   
  
   
    Smiles String Isomeric 
    
      Entecavir¿¡ ´ëÇÑ Smiles_String_isomeric Á¤º¸  NC1=NC(=O)C2=C(N1)N(C=N2)[C@H]1C[C@H](O)[C@@H](CO)C1=C 
     
   
  
   
    InChI Identifier 
    
      Entecavir¿¡ ´ëÇÑ InChI_Identifier Á¤º¸  InChI=1/C12H15N5O3/c1-5-6(3-18)8(19)2-7(5)17-4-14-9-10(17)15-12(13)16-11(9)20/h4,6-8,18-19H,1-3H2,(H3,13,15,16,20)/t6-,7-,8-/m0/s1/f/h15H,13H2 
     
   
  
   
    Chemical IUPAC Name 
    
      Entecavir¿¡ ´ëÇÑ Chemical_IUPAC_Name Á¤º¸  2-amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-3H-purin-6-one 
     
   
    
 
    
     
  
    
       
      
        
          
            
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                ÃÖ±ÙÁ¤º¸¼öÁ¤ÀÏ 2025-07-08
               
              
                
                 º» ¼öÁ¤ÀÏ Á¤º¸´Â Çã°¡Á¤º¸ ÀÌ¿ÜÀÇ ±âŸÁ¤º¸ ¼öÁ¤ÀÏÀ» ÀǹÌÇϹǷÎ, Çã°¡Á¤º¸¼öÁ¤ÀÏÀº º»¹®¿¡ Ç¥±âµÈ ³¯Â¥¸¦ ÂüÁ¶ÇϽñ⠹ٶø´Ï´Ù.
                 
                   
             
                         
      
           
          
                
                    
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                      µå·°ÀÎÆ÷ ÀǾàÇмúÁ¤º¸´Â ½ÄǰÀǾàǰ¾ÈÀüóÀÇ Á¦Ç°Çã°¡»çÇ×, Çмú¹®Çå, Á¦¾àȸ»ç Á¦°øÁ¤º¸ µîÀ» ±Ù°Å·Î ÀÛ¼ºµÈ Âü°í Á¤º¸ÀÔ´Ï´Ù. 
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                            ¹Ýµå½Ã Á¦Á¶¡¤¼öÀÔ»ç, ÆÇ¸Å»ç, ÀÇ»ç, ¾à»ç¿¡°Ô ÃÖÁ¾ÀûÀ¸·Î È®ÀÎÇϽñ⠹ٶø´Ï´Ù. 
                          ÀüÈ: 02-3486-1061 ¤Ó À̸ÞÀÏ: webmaster@druginfo.co.kr
 
  
                  
 
               
  
  
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