²ªÁÖ¸ñÒó¸ñº²¿¹ÏËά»¯ÁÆ·¨ÐÂÊÊÓ¦Ö¢»ñFDAÅú×¼ ¼õ»º·Î¹¦ÄÜϽµËÙ¶È

·¢²¼Ê±¼ä£º2020-03-11 19:20:05 À´Ô´£º
  • ÕâÊÇά¼ÓÌØ®£¨Äá´ïÄá²¼£©»ñµÃFDAÅú×¼µÄµÚÈýÏîÊÊÓ¦Ö¢¡£Î¬¼ÓÌØ®ÓÚ2014ÄêÊ״λñÅúÓÃÓÚÖÎÁÆÌØ·¢ÐÔ·ÎÏËά»¯£¨IPF£©
  • ÔÚ IIIÆÚINBUILDÁÙ´²ÊÔÑéÈ«²¿Ñо¿ÈËȺÖУ¬¶Ô»¼ÕßÓÃÁ¦·Î»îÁ¿£¨FVC£©µÄÆÀ¹À½á¹ûÏÔʾ£¬Î¬¼ÓÌØÏà±È°²Î¿¼Áʹ»¼Õߵķι¦ÄÜϽµ·ù¶È¼õÉÙÁË57%[1]
  • ·ÎÏËά»¯³ÖÐø¶ñ»¯µÄÂýÐÔÏËά»¯¼äÖÊÐԷμ²²¡£¨ILD£©º­¸ÇÁË´óÁ¿¼²²¡£¬ÕâЩ¼²²¡¿ÉÄܵ¼ÖÂÑÏÖØµÄ·Î²¿ÎÊÌâÒÔ¼°·Î×éÖ¯²»¿ÉÄæ×ªµÄñ£ºÛÐγÉ[2], [3]

ÉϺ£2020Äê3ÔÂ11ÈÕ /ÃÀͨÉç/ --²ªÁÖ¸ñÒó¸ñº²Ðû²¼£¬ÃÀ¹úʳƷҩƷ¼à¶½¹ÜÀí¾Ö£¨FDA£©ÓÚ3ÔÂ9ÈÕÅú׼ά¼ÓÌØ®£¨Äá´ïÄá²¼£©×÷Ϊ¾ßÓнøÐÐÐÔ±íÐ͵ÄÂýÐÔÏËά»¯ÐÔ¼äÖÊÐԷμ²²¡£¨ILDs£©»¼ÕßµÄÊ׸öÖÎÁÆÒ©Îï¡£Ðí¶à·Î²¿¼²²¡¶¼¿ÉÄÜ·¢Õ¹Îª¾ßÓнøÐÐÐÔ±íÐ͵ÄÂýÐÔÏËά»¯ÐÔILD£¬ÆäÖаüÀ¨Î´·ÖÀàµÄILD¡¢×ÔÉíÃâÒßÐÔILD¡¢ÂýÐÔ¹ýÃôÐÔ·ÎÑס¢½á½Ú²¡¡¢¼¡Ñס¢¸ÉÔï×ÛºÏÕ÷¡¢Ãº¹¤³¾·ÎºÍÌØ·¢ÐÔ¼äÖÊÐÔ·ÎÑ×£¨ÀýÈçÌØ·¢ÐÔ·ÇÌØÒìÐÔ¼äÖÊÐÔ·ÎÑ×£©µÈ¡£

ά¼ÓÌØ®£¨Äá´ïÄá²¼£©ÊÇÒ»ÖÖС·Ö×ÓÀÒ°±ËἤøÒÖÖÆ¼Á£¬¿Éͬʱ×è¶Ï3ÖÖÉú³¤Òò×ÓÊÜÌ壬°üÀ¨Ñª¹ÜÄÚÆ¤Éú³¤Òò×ÓÊÜÌ塢ѪС°åÔ´ÐÔÉú³¤Òò×ÓÊÜÌå¡¢ÒÔ¼°³ÉÏËάϸ°ûÉú³¤Òò×ÓÊÜÌ壬ÓÐЧÒÖÖÆÏËά»¯¹ý³ÌÖеÄÐźÅͨ·¡£Ä¿Ç°£¬Î¬¼ÓÌØ®Òѱ»Åú×¼ÓÃÓÚÌØ·¢ÐÔ·ÎÏËά»¯£¨IPF£©µÄÖÎÁÆÒÔ¼°ÏµÍ³ÐÔÓ²»¯²¡Ïà¹ØÐÔ¼äÖÊÐԷμ²²¡£¨SSc-ILD£©µÄÖÎÁÆ¡£2019Äê10Ô£¬Î¬¼ÓÌØ®±»ÃÀ¹úFDAÊÚÓèÍ»ÆÆÐÔÁÆ·¨È϶¨£¬ÖÎÁƾßÓнøÐÐÐÔ±íÐ͵ÄÂýÐÔÏËά»¯ÐÔ¼äÖÊÐԷμ²²¡£¨¼´PF-ILD£©¡£

FDAµÄÅú×¼ÊÇ»ùÓÚIIIÆÚINBUILDÁÙ´²ÊÔÑéµÄ½á¹û¡£ÕâÊÇILDÁìÓòÊ׸ö»ùÓÚ»¼Õß¼²²¡ÁÙ´²±íÐÍ¡¢¶ø²»ÊÇ×î³õÁÙ´²Õï¶Ï¶Ô»¼Õß½øÐзÖ×éµÄIIIÆÚÁÙ´²ÊÔÑé¡£ÔÚÕâ´ÎÊÔÑéÖУ¬Î¬¼ÓÌØ®µÄ°²È«ÐÔºÍÄÍÊÜÐÔÓë֮ǰÔÚÌØ·¢ÐÔ·ÎÏËά»¯£¨IPF£©Ñо¿Öй۲쵽µÄ½á¹ûÒ»Ö¡£

ÃÜЪ¸ùÖݰ²°¢²®ÊÐÃÜЪ¸ù´óѧ·Î²¿ÓëÖØÖ¢¼à»¤Ò½Ñ§½ÌÊÚ¡¢INBUILDÁÙ´²ÊÔÑéǣͷÑо¿ÕßKevin Flaherty²©Ê¿Ëµ£º¡°¾ßÓнøÐÐÐÔ±íÐ͵ÄÂýÐÔÏËά»¯ÐÔ¼äÖÊÐԷμ²²¡»áµ¼ÖºôÎüµÀÖ¢×´ºÍ·Î¹¦Äܶñ»¯¡£ÕâÏîÅú׼ΪÖÚ¶à´ËÀ༲²¡»¼ÕßÌṩÁËÊ׸öÖÎÁÆÑ¡Ôñ¡£¡±

¼äÖÊÐԷμ²²¡£¨ILD£©º­¸Ç200¶àÖÖ¼²²¡£¬ËüÃDZ»¹éÀàΪº±¼û¼²²¡£¬¿Éµ¼Ö·ÎÏËά»¯£¬·Î×éÖ¯²»¿ÉÄæµÄ°ÌºÛ»á¶Ô·Î¹¦ÄܲúÉú¸ºÃæÓ°Ïì¡£[2], [3]¹À¼ÆÓÐ18£¥ÖÁ32£¥µÄILD»¼Õß»á³öÏÖ·ÎÏËά»¯³ÖÐø¶ñ»¯µÄÎÊÌâ¡£[4]

²ªÁÖ¸ñÒó¸ñº²Ò½Ñ§Óë×¢²áÊÂÎñ¸ß¼¶¸±×ܲÃThomas Seck²©Ê¿Ëµ£º¡°×÷Ϊ¼äÖÊÐԷμ²²¡£¨ILD£©Ñо¿ÁìÓòµÄÁìÏÈÕߣ¬ÎÒÃÇÖÂÁ¦ÓÚ¸üºÃµØÀí½âÈçºÎÖÎÁÆÕâЩ»ÙÃðÐÔ¼²²¡¡£½ñÌìÔÚÃÀ¹úµÄ»ñÅú±êÖ¾×ÅILDÑо¿ÁìÓòÈ¡µÃÁËÖØ´ó½øÕ¹£¬Ò²ÊǸöÖØÒªÀï³Ì±®¡£´Ë´ÎÐÂÊÊÓ¦Ö¢µÄ»ñÅú¾àÀëά¼ÓÌØ®»ñÅúÓÃÓÚÖÎÁÆÏµÍ³ÐÔÓ²»¯²¡Ïà¹Ø¼äÖÊÐԷμ²²¡£¨SSc-ILD£©µÄÊÊÓ¦Ö¢£¬½ö½ö¹ýÈ¥6¸öÔµÄʱ¼ä¡£¡±

·ÎÏËά»¯»ù½ð»áÊ×ϯҽѧ¹ÙGreg Cosgrove²©Ê¿Ëµ£º¡°¾ßÓнøÐÐÐÔ±íÐ͵ÄÂýÐÔÏËά»¯ÐÔ¼äÖÊÐԷμ²²¡»¼Õß¿ÉÄÜ»á³öÏÖÓëÆäËûºôÎüϵͳ¼²²¡ÏàËÆµÄÖ¢×´£¬Õâ¿ÉÄÜ»áÑÓ³Ù¶Ô»¼ÕßµÄ׼ȷÕï¶Ï¡£´Ë´ÎÄá´ïÄá²¼ÐÂÊÊÓ¦Ö¢µÄ»ñÅúΪҽÉú¼°»¼ÕßÌṩÁËеÄÖÎÁÆÑ¡Ôñ£¬¿ÉÒÔ°ïÖú¼õ»ºÕâЩ»¼Õ߷ι¦ÄܵÄϽµËÙ¶È¡£¡±

Reference

[1] Flaherty K, et al. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases N Eng J Med. Published 29 September, 2019. NEJM.org. DOI: 10.1056/NEJMoa1908681

[2] British Lung Foundation. What is pulmonary fibrosis? Available at:https://www.blf.org.uk/support-for-you/pulmonary-fibrosis/what-is-pulmonary-fibrosis[Accessed September 2019].

[3] Cottin V, Hirani NA, Hotchkin DL, et al. Presentation, diagnosis and clinical course of the spectrum of progressive-fibrosing interstitial lung diseases. Eur Respir Rev 2018;27(150):pii:180076.

[4] Wijsenbeek M, et al. Non-IPF progressive fibrosing interstitial lung diseases: the patient journey. Poster presented at the American Thoracic Society International Conference, San Diego, CA, USA, 18 23 May 201


Ïà¹ØÈÈ´ÊËÑË÷£º
¹ØÓÚÎÒÃÇ ÁªÏµÎÒÃÇ ÈËÔ±²éѯ ÃâÔðÉùÃ÷ ÓÑÇéÁ´½Ó ¹óÖÝÍøLOGO ¹ã¸æ¿¯Àý ±¾Õ¾ÓòÃû °Ù¶ÈÐÂÎÅ