¹Ù·½¼à¹Ü»ú¹¹
¹ú¼ÒÒ©Æ·¼à¶½ÖÎÀí¾Ö£¨NMPA£©£ºÂôÁ¦Öйú´ó½µÄÒ©Æ·ºÍÉúÎïÖÆÆ·¼à¹Ü¡£Èç¹ûÉæ¼°Ò©Æ·ÖÆÔìºÍÏúÊÛ£¬¿ÉÒÔ²éÔÄNMPAµÄ¹Ù·½ÍøÕ¾ºÍͨ¸æ¡£
¹ú¼ÒÎÀÉú½¡¿µÎ¯Ô±»á£¨NHC£©£ºÂôÁ¦Öйú´ó½ÕûÌåÎÀÉú½¡¿µÊÂÎñ¡£Ïà¹ØµÄÐÅÏ¢ºÍͨ±¨Í¨³£»áÔÚÆä¹Ù·½ÍøÕ¾ÉÏÐû²¼¡£
¸÷µØÎÀÉú½¡¿µÎ¯Ô±»á£ºµØ·½Õþ¸®µÄÎÀÉú²¿·ÖÒ²»áÐû²¼Óйز»Á¼Ñо¿»ú¹¹µÄÐÅÏ¢£¬ÌرðÊÇÔÚ±¬·¢ÁÙ´²ÊÔÑéÆÛÕ©»òÒ©Æ·ÖÆÔìÎÊÌâʱ¡£
ÈçºÎ±£»¤¸öÈËÒþ˽
ÄäÃû¾Ù±¨£ºÈç¹ûµ£?ÐĸöÈËÐÅϢй¶£¬¿ÉÒÔÑ¡ÔñÄäÃû¾Ù±¨£¬±£»¤×Ô¼ºµÄÒþ˽¡£
ÐÅϢʹÓÃÏÞÖÆ£ºÔÚʹÓûñÈ¡µÄÐÅϢʱ£¬Ó¦×ñÑÖ´¹æÂÉÔò£¬ÖÆÖ¹½«ÐÅÏ¢ÓÃÓÚ²»·¨»ò²»Æ·µÂµÄÄ¿µÄ?¡£
½ÌÓýºÍÅàѵ£ºÍ¨¹ý½ÌÓýºÍÅàѵ£¬Ìá¸ßÃñÖÚ¶ÔÐÅÏ¢Äþ¾²ºÍÒþ˽±£»¤µÄÒâʶ£¬ÖÆÖ¹ÔÚʹÓÃÐÅϢʱ·ºÆðÒþ˽й¶µÄÎÊÌâ¡£
ÓÐЧÀûÓùٷ½ÍøÕ¾
¹Ù·½ÍøÕ¾ÊDzéÕÒ²»Á¼Ñо¿ËùµØ?Ö·Ðû²¼µÄ×îÖ±½Ó;¾¶Ö®Ò»¡£ÎªÁËÓÐЧÀûÓÃÕâÐ©ÍøÕ¾£¬¿ÉÒԲο¼ÒÔϽ¨Ò飺
°´ÆÚÅÌÎÊ£ºÓÉÓÚ²»Á¼Ñо¿ËùµÄÐÅÏ¢¸üнϿ죬½¨Òé°´ÆÚ²é?ѯÏà¹ØÍøÕ¾£¬ÒÔÈ·±£»ñÈ¡×îеÄÐÅÏ¢¡£Ê¹Óø߼¶ËÑË÷¹¦Ð§£ºÐí¶à¹Ù·½ÍøÕ¾¶¼Óи߼¶ËÑË÷¹¦Ð§£¬¿ÉÒÔͨ¹ýÊäÈëÒªº¦´Ê½øÐо«×¼ÅÌÎÊ¡£ÀýÈ磬¿ÉÒÔÊäÈë¡°²»Á¼Ñо¿Ëù¡±¡¢¡°Î¥·¨ÊµÑéÊÒ¡±µÈÒªº¦´Ê£¬ÒÔ»ñÈ¡Ïà¹ØÐÅÏ¢¡£¹Ø×¢Í¨¸æºÍ֪ͨ£ºÐí¶à¹Ù·½ÍøÕ¾»áÐû²¼Í¨¸æºÍ֪ͨ£¬¹Ø×¢ÕâЩÐÅÏ¢¿ÉÒÔʵʱÁ˽ⲻÁ¼Ñо¿ËùµÄ¶¯Ì¬¡£
ÐÅÏ¢Ó¦Óú͸öÈË·À»¤
ÖÆÖ¹Ê¹Óò»Á¼²úÆ·£ºÍ¨¹ý¹Ù·½ÐÅÏ¢£¬¿ÉÒÔÁ˽⵽ÄÄЩҩƷ¡¢Ò½ÁÆÆ÷еµÈ²úÆ·À´Ô´¿ÉÒÉ¡£ÔÚ¹ºÖòúƷʱ£¬¿ÉÒÔÖÆÖ¹¹ºÖÃÀ´×Ô²»Á¼Ñо¿ËùµÄ²ú?Æ·¡£
½¡¿µ¼à²â£ºÈç¹û×Ô¼º»ò¼ÒÈËÒ»¾Ê¹ÓùýÉæ¼°²»Á¼Ñо¿ËùµÄ²úÆ·£¬¿ÉÒÔ½øÐÐÃÜÇеĽ¡¿µ¼à²â£¬ÊµÊ±·¢Ã÷²¢´¦Àí¿ÉÄܵĽ¡¿µÎÊÌâ¡£
¼ÓÈ뽡¿µ½ÌÓý£º½«Ëùѧµ½µÄÐÅÏ¢·ÖÏí¸øÉí±ßµÄÈË£¬Ìá¸ßÈ«Éç»á¶Ô²»Á¼Ñо¿ËùµÄ¾¯ÌèÒâʶ£¬ÅäºÏά»¤ÃñÖÚ½¡¿µ¡£
ýÌåºÍÐÂÎű¨µÀ
¹Ø×¢Ö÷Á÷ýÌ壺Ö÷Á÷ýÌåͨ³£»á±¨µÀÖØ´óÉç»áÎÊÌ⣬°üÀ¨²»Á¼Ñо¿ËùµÄÔ˶¯¡£¹Ø×¢ÑëÊÓ¡¢ÈËÃñÈÕ±¨µÈ?Ö÷Á÷ýÌåµÄ±¨µÀ¡£Ê¹ÓÃÐÂÎÅËÑË÷ÒýÇæ£º¿ÉÒÔʹÓÃÐÂÎÅËÑË÷ÒýÇæ£¬ÈçGoogleÐÂÎÅ¡¢Ð»ªÍøµÈ£¬½øÐÐÒªº¦´ÊËÑË÷£¬ÒÔ»ñÈ¡×îеÄÐÂÎű¨µÀ¡£¶©ÔÄרҵÐÂÎÅÍøÕ¾£ºÒ»Ð©×¨ÒµÐÂÎÅÍøÕ¾»áÌṩÏêϸµÄÐÂÎű¨µÀºÍÆÊÎö£¬¶©ÔÄÕâÐ©ÍøÕ¾¿ÉÒÔ»ñÈ¡¸ü¶àÐÅÏ¢¡£
ÀûÓÃÉç»á×éÖ¯ºÍרҵ»ú¹¹
Ñ¡ÔñȨÍþ×éÖ¯£ºÑ¡ÔñÄÇЩÓÐÁ¼ºÃÉùÓþºÍרҵÅä¾°µÄ×éÖ¯£¬ÒÔÈ·±£»ñÈ¡¿É¿¿µÄÐÅÏ¢¡£¹Ø×¢×îб¨?¸æ£ºÕâЩ×é֯ͨ³£»áÐû²¼×îеÄÊӲ챨¸æ£¬¹Ø×¢ËûÃǵĹٷ½ÍøÕ¾»ò¶©ÔÄËûÃǵÄÓʼþÁÐ±í£¬ÒÔ»ñÈ¡×îеÄÐÅÏ¢¡£¼ÓÈëÑÐÌÖ»áºÍ½²×ù£ºÒ»Ð©×éÖ¯»á¾Ù°ìÑÐÌÖ»áºÍ½²×ù£¬Á˽âËûÃǵÄÊÓ²ì½á¹û£¬²¢Óëר¼Ò½øÐн»Á÷¡£
ÔÚÏßÅÌÎÊÆ½Ì¨
NMPA¹Ù·½ÍøÕ¾£ºÔÚÍøÕ¾Ê×Ò³£¬ÓÐרÃŵġ°¼à¹ÜÐÅÏ¢¹ûÕæ¡±À¸Ä¿£¬Ìṩ×îеÄÒ©Æ·¡¢Ò½ÁÆÆ÷еµÈ¼à¹ÜÐÅÏ¢¡£
Õþ¸®ÃÅ»§ÍøÕ¾£ºÐí¶à¹ú¼ÒºÍµØÇøµÄÕþ¸®ÃÅ»§ÍøÕ¾ÌṩÁ˹ûÕæÍ¸Ã÷µÄÐÅÏ¢ÅÌÎÊЧÀÍ¡£ÔÚÖйú£¬¿ÉÒÔͨ¹ý¸÷¼¶ÎÀÉú½¡¿µÎ¯Ô±»áµÄÍøÕ¾ÅÌÎÊÏà¹ØÐÅÏ¢¡£
רҵÊý¾Ý¿â£ºÒ»Ð©×¨ÒµµÄÒ½ÁƺͿÆÑÐÊý¾Ý¿â£¬ÈçClinicalTrials.gov£¬¿ÉÒÔÌṩȫÇòÁÙ´²ÊÔÑéµÄÐÅÏ¢£¬°üÀ¨ÊÔÑé»ú¹¹µÄµØµãºÍºÏ¹æÇé¿ö¡£
У¶Ô£º°×ÑÒËÉ(1C0m4pJyqZtPma0S7t9ZFfz4hTykKag)


