FDAÊÚÓè¶÷¸ñÁо»ÓÃÓÚÖÎÁÆÂýÐÔÉö²¡ÒÔ¿ìËÙͨµÀ×ʸñ
¡°ÂýÐÔÉöÔ༲²¡ÊÇÒ»ÖÖÑÏÖØÇҸ߶ÈÁ÷Ðеļ²²¡£¬È«ÇòÓнü7ÒÚ³ÉÄêÈËÊÜÓ°Ïì¡£¡±²ªÁÖ¸ñÒó¸ñº²¹«Ë¾¸±×ܲá¢ÐÄѪ¹Ü´úлÁìÓòҽѧ¸ºÔðÈËWaheed Jamal²©Ê¿ËµµÀ£¬¡°FDAµÄÕâÒ»¾ö¶¨±íÃ÷£¬¶ÔÓÚ»¼ÓÐÂýÐÔÉöÔ༲²¡¼°ÆäÏà¹ØÐÄѪ¹ÜºÍ´úл¼²²¡µÄÈËÀ´Ëµ£¬ÓÐЧµÄÖÎÁÆ·½°¸ÊǶàÃ´ÖØÒª¡£¡±
ÂýÐÔÉöÔ༲²¡»áÔö¼ÓÐÄѪ¹ÜÔÒòµ¼ÖµĹýÔçËÀÍö·çÏÕ£¬ÊÇÈ«ÇòÖ÷ÒªËÀÍöÔÒòÖ®Ò»¡£1´óÔ¼2/3µÄÂýÐÔÉöÔ༲²¡ÊÇÓÉ´úл¼²²¡ÒýÆðµÄ£¬ÈçÌÇÄò²¡£¨¼´ÌÇÄò²¡Éö²¡£©¡¢¸ßѪѹºÍ·ÊÅÖÖ¢¡£2,3,4
ÀñÀ´¹«Ë¾²úÆ·Ñз¢¸±×ܲá¢Jeff Emmick²©Ê¿Ö¸³ö£º¡°ÎÒÃÇÈÏʶµ½ÐÄÔà¡¢ÉöÔàºÍ´úлϵͳ֮¼ä´æÔÚ½ôÃÜÁªÏµ£¬ÎÒÃÇÒÑÖÂÁ¦ÓÚ¿ªÕ¹Ò»Ïî¹ã·ºµÄÁÙ´²¿ª·¢ÏîÄ¿£¬ÒÔÆÀ¹À¶÷¸ñÁо»µÄÐÄÉö´úл»ñÒæ¡£FDAµÄ¿ìËÙͨµÀ×ʸñÊÇÆÀ¹À¶÷¸ñÁо»ÖÎÁÆÂýÐÔÉöÔ༲²¡Ç±Á¦µÄÖØÒªÒ»²½¡£¡±
ÕýÔÚ½øÐеÄEMPA-KIDNEYÁÙ´²Ñо¿ÆÀ¹À¶÷¸ñÁо»ÔÚ»¼ÓÐÂýÐÔÉöÔ༲²¡£¨»¼ÓлòÕß²»»¼ÓÐÌÇÄò²¡£©µÄ³ÉÈËÖжÔÉöÔ༲²¡½øÕ¹ºÍÐÄѪ¹ÜËÀÍö·¢ÉúµÄÓ°Ïì¡£EMPA-KIDNEYÑо¿ÊÇ»ùÓÚÀï³Ì±®Ê½EMPA-REG OUTCOME ®Ñо¿µÄ»ý¼«½á¹û·¢ÆðµÄ¡£EMPA-REG OUTCOME ®Ñо¿·¢ÏÖ£¬Ó밲ο¼ÁÏà±È£¬ÔÚ»¼ÓÐ2ÐÍÌÇÄò²¡ºÏ²¢È·ÕïµÄÐÄѪ¹Ü¼²²¡µÄ³ÉÈËÖУ¬Ê¹Óö÷¸ñÁо»ÖÎÁƿɽ«Éö²¡Ð·¢ºÍ¶ñ»¯µÄ·çÏÕ½µµÍ39%¡£
EMPA-KIDNEYÁÙ´²Ñо¿ÓÉÅ£½ò´óѧÈ˿ڽ¡¿µÑо¿ÖÐÐÄҽѧÑо¿Î¯Ô±»á£¨MRC PHRU£©¶ÀÁ¢¿ªÕ¹¡¢·ÖÎöºÍ±¨¸æ£¬ÔÚÁÙ´²ÊÔÑé·þÎñÖÐÐĺÍÁ÷Ðв¡Ñ§Ñо¿ÖÐÐÄ£¨CTSU£©Óë¶Å¿ËÁÙ´²Ñо¿Ëù£¨DCRI£©ºÏ×÷½øÐС£²ªÁÖ¸ñÒó¸ñº²ºÍÀñÀ´Îª¸ÃÑо¿Ìṩ×ʽð¡£
ÕâÏî×îоö¶¨Ö®Ç°£¬2019Äê7ÔÂFDAÒ²ÔøÊÚÓè¶÷¸ñÁо»½µµÍÂýÐÔÐÄÁ¦Ë¥½ß»¼ÕßµÄÐÄѪ¹ÜËÀÍö·çÏÕºÍÒòÐÄÁ¦Ë¥½ßסԺµÄ·çÏÕµÄÑо¿ÒÔ¿ìËÙͨµÀ×ʸñ¡£
1GBDChronic Kidney Disease Collaboration.Global, regional, and national burden of chronic kidney disease, 1990 2017: a systematic analysis for the Global Burden of Disease Study 2017.The Lancet.2020; 395:709-23
2Levin A, Tonelli M, Bonventre J,et al. Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy.Lancet2017;390:1888-917.
3United States Renal Data System, USRDS 2012 Annual data report: Atlas of chronic kidney disease and end-stage renal disease inthe United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases,Bethesda, MD, 2012.Available from:http://www.usrds.org/reference.htm.SeeAppendix I, United States Renal Data System (USRDS).
4Liyanage T, Ninomiya T, Jha V,et al. Worldwide access to treatment for end-stage kidney disease: a systematic review.Lancet 2015; 385(9981):1975-82.
5Sarnak MJ, Levey AS, Schoolwerth AC,et al. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention.Hypertension2003;42:1050-65.
6Tonelli M, Wiebe N, Culleton B,et al. Chronic kidney disease and mortality risk: a systematic review.J Am Soc Nephrol.2006;17:2034-47.
7Schiffrin EL, Lipman ML and Mann JFE.Chronic kidney disease: effects on the cardiovascular system.Circulation2007;116:85-97.
8American Kidney Fund.Kidney Failure (ESRD) Causes, Symptos, & Treatments.Available at:http://www.kidneyfund.org/kidney-disease/kidney-failure/.AccessedMarch 2020.
9Wang Het al.Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980 2015: A systematic analysis for the Global Burden of Disease Study 2015.The Lancet 2016; 388(10053):1459 544.
10Arnold SVet al.Burden of cardio-renal-metabolic conditions in adults with type 2 diabetes within the Diabetes Collaborative Registry.Diabetes, Obesity and Metabolism.2018 Aug;20(8):2000-2003.
11Jardiance

