ά¼ÓÌØÔÚÅ·ÖÞ»ñÅú£¬ÓÃÓÚÖÎÁƺ±¼û·Î²¿¼²²¡

• »ñÅú»ùÓÚSENSCIS®Ñо¿£¬¸ÃÑо¿ÏÔʾÄá´ïÄá²¼¿É¼õ»ºÏµÍ³ÐÔÓ²»¯²¡Ïà¹Ø¼äÖÊÐԷμ²²¡£¨SSc-ILD£©»¼Õߵķι¦ÄÜϽµ¹
• 2019Äê9Ô»ñµÃFDAÅú×¼ºó£¬Äá´ïÄá²¼Æù½ñΪֹÒÑÔÚ15¸ö¹ú¼Ò»ñÅúÓÃÓÚÖÎÁÆϵͳÐÔÓ²»¯²¡Ïà¹Ø¼äÖÊÐԷμ²²¡£¨SSc-ILD£©¡£
• Äá´ïÄá²¼×÷ΪÊ׸öÒ²ÊÇΨһ»ñÅúÓÃÓÚÖÎÁÆSSc-ILDµÄÁÆ·¨£¬¶ÔÓÚÕâÒ»¸ß¶Èδ¾¡ÐèÇóÁìÓòÀ´ËµÊÇÒ»ÏîÍ»ÆÆ¡£

µÂ¹úÒó¸ñº²2020Äê4ÔÂ22ÈÕ /ÃÀͨÉç/ -- ²ªÁÖ¸ñÒó¸ñº²½ñÈÕÐû²¼£¬Å·ÃËίԱ»áÒÑÅú×¼Äá´ïÄá²¼ÓÃÓÚÖÎÁƳÉÈËϵͳÐÔÓ²»¯²¡Ïà¹Ø¼äÖÊÐԷμ²²¡£¨SSc-ILD£©¡£²»ñÅúÇ°£¬ÈËÓÃҩƷίԱ»áÓÚ2020Äê2ÔÂ27ÈÕ²ÉÄÉÁËÄá´ïÄá²¼ÖÎÁÆSSc-ILDµÄ¿Ï¶¨Òâ¼û¡£

ϵͳÐÔÓ²»¯²¡£¨SSc£©ÓÖ³ÆӲƤ²¡£¬ÊÇÒ»ÖÖ»ÙÈÝÐÔ¡¢Ö²ÐÐÔºÍDZÔÚÖÂËÀÐԵĺ±¼û×ÔÉíÃâÒßÐÔ¼²²¡¡£^3£¬4£¬5Æä»áÒýÆð¸÷ÖÖÆ÷¹ÙµÄñ£ºÛÐγɣ¨ÏËά»¯£©£¬°üÀ¨·Î¡¢ÐÄÔà¡¢Ïû»¯µÀºÍÉöÔ࣬ÇÒ¿ÉÄܳöÏÖΣ¼°ÉúÃüµÄ²¢·¢Ö¢¡£·Î²¿ÊÜÀÛʱ£¬¿ÉÒýÆð¼äÖÊÐԷμ²²¡£¨ILD£©£¬³ÆΪϵͳÐÔÓ²»¯²¡Ïà¹Ø¼äÖÊÐԷμ²²¡£¨SSc-ILD£©¡£^1£¬6¼äÖÊÐԷμ²²¡£¨ILD£©ÊÇӲƤ²¡£¨SSc£©»¼ÕßËÀÍöµÄ×îÖ÷ÒªÔ­Òò£¬Ô¼Õ¼ËÀÍöÈËÊýµÄ35%¡£⁷

¡°ÕâÊÇSSc-ILD»¼ÕßÖÎÁƵÄÕæÕýÍ»ÆÆ£¬¡±²ªÁÖ¸ñÒó¸ñº²¸ß¼¶¸±×ܲüæÑ×Ö¢ÖÎÁÆÁìÓò¸ºÔðÈËPeter Fang˵¡£¡°·ÎÏËά»¯Ò»µ©·¢Éú¾ÍÎÞ·¨Äæת¡£Äá´ïÄá²¼×÷ΪÊ׸öÒ²ÊÇΨһ»ñÅúÓÃÓÚÖÎÁÆϵͳÐÔÓ²»¯²¡Ïà¹Ø¼äÖÊÐԷμ²²¡£¨SSc-ILD£©µÄÒ©ÎּÔÚÂú×ã¸ß¶Èδ¾¡ÐèÇó£¬Ê¹Éú»î±¥ÊÜSSc-ILDÕÛÄ¥µÄ»¼Õß´ÓÕæÕýÒâÒåÉÏ»ñÒæ¡£ÕâÏîÅú×¼ÊDzªÁÖ¸ñÒó¸ñº²³ÖÐøרע·ÎÏËά»¯»¼ÕßÖÎÁƹý³ÌÖлñµÃµÄÓÖÒ»¸öÀï³Ì±®¡£¡±

¡°Å·ÃËίԱ»áµÄ¾ö¶¨¶ÔÓÚÅ·ÖÞӲƤ²¡»¼ÕßȺÌåÀ´Ëµ£¬ÕâÎÞÒÉÊǸöºÜÊÜ»¶Ó­µÄºÃÏûÏ¢£¬¡±Å·ÖÞӲƤ²¡Ð­»áÁªºÏ»á£¨FESCA£©Ö÷ϯSue FarringtonÆÀÂÛµÀ¡£¡°µ±Ó²Æ¤²¡ÀÛ¼°·Î²¿Ê±£¬»á²úÉúÑÏÖغó¹û¡£ÓÐÁËÕâÖÖÖÎÁÆÑ¡Ôñ£¬ÎªÓ²Æ¤²¡»¼Õß¼°ÆäÇ×ÈË´øÀ´Á˾޴óµÄÏ£Íû¡£¡±

¸Ã¿Ï¶¨Òâ¼ûÊÇ»ùÓÚSENSCIS®ÊÔÑéµÄ½á¹û£¬ËüÊÇÒ»ÏîIIIÆÚ¡¢Ë«Ã¤¡¢°²Î¿¼Á¶ÔÕÕÊÔÑé¡£Ö¼ÔÚÑо¿Äá´ïÄá²¼ÔÚϵͳÐÔÓ²»¯²¡£¨SSc-ILD£©»¼ÕßÖеÄÁÆЧºÍ°²È«ÐÔ¡£¹ÆäÖ÷ÒªÖÕµãÊÇ52ÖÜÆÚ¼äÆÀ¹ÀµÄÓÃÁ¦·Î»îÁ¿£¨FVC£©ÄêϽµÂÊ¡£½á¹ûÏÔʾ£¬¸ù¾Ý52ÖÜÆÚ¼äµÄFVC²âÁ¿½á¹û£¬Ó밲ο¼ÁÏà±È£¬Äá´ïÄ᲼ʹ·Î¹¦ÄÜɥʧ¼õ»ºÁË44%£¨41 mL/Ä꣩¡£´ËÍ⣬½á¹ûÏÔʾÄá´ïÄá²¼µÄ°²È«ÐÔºÍÄÍÊÜÐÔÌØÕ÷ÓëÔÚÌØ·¢ÐÔ·ÎÏËά»¯£¨IPF£©»¼ÕßÖй۲쵽µÄÏàËÆ¡£¹

¹ØÓÚϵͳÐÔÓ²»¯²¡Ïà¹Ø¼äÖÊÐԷμ²²¡£¨SSc-ILD£©

ϵͳÐÔÓ²»¯²¡£¨SSc£©Ò²³ÆӲƤ²¡£¬ÊÇÒ»ÖÖÓ°Ïì½áµÞ×éÖ¯ÇÒÎÞ·¨ÖÎÓúµÄº±¼ûµÄ×ÔÉíÃâÒßÐÔ¼²²¡¡£ÓÉÓÚӲƤ²¡Ó°Ïì½áµÞ×éÖ¯£¬Ö¢×´¿ÉÄܳöÏÖÔÚÉíÌåµÄÈκβ¿Î»£¬°üÀ¨Æ¤·ô¡¢¼¡È⡢Ѫ¹ÜºÍÄÚÔ࣬ʹÆäÄÑÒÔÕï¶Ï¡£³Ó²Æ¤²¡Ó°Ïìµ½·Î²¿Ê±¿ÉÒýÆð¼äÖÊÐԷμ²²¡£¨ILD£©£¬³ÆΪϵͳÐÔÓ²»¯²¡Ïà¹Ø¼äÖÊÐԷμ²²¡£¨SSc-ILD£©¡£^3,5Ô¼25%µÄӲƤ²¡»¼ÕßÔÚÈ·Õïºó3ÄêÄÚ³öÏÖÏÔÖøµÄ·Î²¿ÊÜÀÛ¡£SSc-ILDÊÇÒ»ÖÖ½øÕ¹ÐԵķβ¿¼²²¡£¬ºÜ¶à»¼ÕßÔçÆÚÎÞÖ¢×´£¬µ«Ô¤ºó½Ï²î£¬»¼ÕßÉú´æÂʵ͡£ËüÊÇӲƤ²¡£¨SSc£©»¼ÕßËÀÍöµÄ¹Ø¼üÇý¶¯ÒòËØ¡£^3,4

¹ØÓÚSENSCISÑо¿

Äá´ïÄá²¼ÓÃÓÚϵͳÐÔÓ²»¯²¡Ïà¹Ø¼äÖÊÐԷμ²²¡£¨SSc-ILD£©µÄIIIÆÚÁÙ´²Ñо¿£¨SENSCIS£©ÊÇÒ»Ï¸Ç32¸ö¹ú¼ÒºÍµØÇøµÄ¶àÖÐÐÄËæ»ú¡¢Ë«Ã¤¡¢°²Î¿¼Á¶ÔÕÕµÄÊÔÑ飬ÄÉÈë576Àý»¼Õߣ¬ÖйúÓÐ9¸öÑо¿ÖÐÐIJÎÓë¡£Ñо¿Ä¿µÄÔÚÓÚ̽¾¿Äá´ïÄá²¼ÖÎÁÆSSc-ILD»¼Õß52ÖܵÄÓÐЧÐÔ¼°°²È«ÐÔ£¬Ö÷ÒªÖÕµãΪ52ÖÜÆÚ¼äÓÃÁ¦·Î»îÁ¿£¨FVC£©ÄêϽµÂÊ¡£Ñо¿Ö¤ÊµÄá´ïÄá²¼¿É¼õ»ºSSc-ILD»¼ÕßµÄÓÃÁ¦·Î»îÁ¿£¨FVC£©ÄêϽµÂÊ£¬ÑÓ»ºSSc-ILD»¼Õߵķι¦ÄܼõÍ˺ͼ²²¡½ø³Ì¡£¸ÃÑо¿½á¹û¿¯µÇÔÚ¡¶ÐÂÓ¢¸ñÀ¼Ò½Ñ§ÔÓÖ¾¡·¡£

ÒÒ»ÇËáÄá´ïÄá²¼Èí½ºÄÒ£¨Î¬¼ÓÌØ^®£©ÖØÒªÀï³Ì±®

• 2014Äê10Ô£¬Î¬¼ÓÌØ^®»ñµÃFDAµÄÅú×¼ÓÃÓÚÖÎÁÆÌØ·¢ÐÔ·ÎÏËά»¯£¨IPF£©
• 2015Ä꣬ά¼ÓÌØ^®±»ÄÉÈë¹ú¼ÊÖ¸ÄÏ£¬²¢ÓÚ2016Äê±»ÄÉÈëÖйúIPFÕï¶ÏºÍÖÎÁÆר¼Ò¹²Ê¶
• 2017Äê9Ô£¬Î¬¼ÓÌØ^®±»¹ú¼ÒÒ©Æ·¼à¶½¹ÜÀí¾ÖÅú×¼ÔÚÖйúÉÏÊУ¬ÓÃÓÚÖÎÁÆÌØ·¢ÐÔ·ÎÏËά»¯£¨IPF£©
• 2018Äê1Ô£¬Î¬¼ÓÌØ^®½øÈëÁËÕã½­Ê¡´ó²¡Ò½±£Ä¿Â¼£¬²¢ÓÚͬÄ꿪չÁËIPF»¼ÕßÔ®ÖúÏîÄ¿
• 2019Äê3Ô£¬²ªÁÖ¸ñÒó¸ñº²ÏòÃÀ¹úʳƷҩƷ¹ÜÀí¾Ö£¨FDA£©ºÍÅ·ÖÞÒ©Æ·¹ÜÀí¾Ö£¨EMA£©µÝ½»Î¬¼ÓÌØ^®ÓÃÓÚϵͳÐÔÓ²»¯²¡Ïà¹Ø¼äÖÊÐԷμ²²¡£¨SSc-ILD£©µÄÉÏÊÐÉêÇë
• 2019Äê6Ô£¬²ªÁÖ¸ñÒó¸ñº²ÏòÖйúÒ©Æ·¼à¶½¹ÜÀí¾ÖµÝ½»ÁËά¼ÓÌØ^®ÓÃÓÚÖÎÁÆÖÎÁÆϵͳÐÔÓ²»¯²¡Ïà¹Ø¼äÖÊÐԷμ²²¡£¨SSc-ILD£©µÄ×¢²áÉêÇë
• 2019Äê9Ô£¬ÃÀ¹úʳƷҩƷ¼à¶½¹ÜÀí¾Ö£¨FDA£©Åú׼ά¼ÓÌØ^®×÷ΪÊ׸öÒ²ÊÇΨһÄܹ»¼õ»ºÏµÍ³ÐÔÓ²»¯²¡Ïà¹Ø¼äÖÊÐԷμ²²¡£¨SSc-ILD£©»¼Õ߷ι¦ÄÜϽµµÄÒ©Îï¡£
• 2019Äê10Ô£¬ÃÀ¹úʳƷҩƷ¼à¶½¹ÜÀí¾Ö£¨FDA£©ÊÚÓèά¼ÓÌØ^®ÓÃÓÚ½øÐÐÐÔÏËά»¯ÐÔ¼äÖÊÐԷμ²²¡£¨PF-ILD£©Í»ÆÆÐÔÁÆ·¨È϶¨¡£
• 2019Äê12Ô£¬²ªÁÖ¸ñÒó¸ñº²ÏòÖйúÒ©Æ·¼à¶½¹ÜÀí¾ÖµÝ½»ÁËά¼ÓÌØ^®ÓÃÓÚÖÎÁƽøÐÐÐÔÏËά»¯ÐÔ¼äÖÊÐԷμ²²¡£¨PF-ILD£©µÄ×¢²áÉêÇë¡£
• 2020Äê3Ô£¬FDAÅú׼ά¼ÓÌØ^®×÷Ϊ¾ßÓнøÐÐÐÔ±íÐ͵ÄÂýÐÔÏËά»¯ÐÔ¼äÖÊÐԷμ²²¡£¨ILDs£©»¼ÕßµÄÊ׸öÖÎÁÆÒ©Îï¡£

²Î¿¼ÎÄÏ×

¹Distler O, et al. Nintedanib for systemic sclerosis-associated interstitial lung disease. N Eng J Med 2019;380:2518 28. Available at:http://dx.doi.org/10.1056/NEJMoa1903076. Last accessedApril 2020.
²[INSERT EC APPROVAL]
³Denton CP, Khanna D. Systemic sclerosis. Lancet 2017;390:1685 99.
⁴Cottin V, et al. Interstitial lung disease associated with systemic sclerosis (SSc-ILD). Respir Res 2019;20:13.
⁵Kowal-Bielecka O, et al. Update of EULAR recommendations for the treatment of systemic sclerosis. Ann Rheum Dis 2017;76:1327 1339.
⁶Solomon JJ, et al. European Respiratory Update: Scleroderma lung disease. Eur. Respir. Rev. 2013; 22: 127, 6 19.
⁷Tyndall AJ, et al. Causes and risk factors for death in systemic sclerosis: study from the EULAR Scleroderma Trials and Research (EUSTAR) database. Ann Rheum Dis 2010;69:1809 1815.

Ïà¹ØÈÈ´ÊËÑË÷£º