2月4日，阿斯利康宣布安达唐®（通用名：达格列净）在中国正式获批，用于成人射血分数降低型心衰患者的治疗（HFrEF，NYHA II-IV级），可降低心血管死亡和因心衰住院（hHF）风险。

慢性心力衰竭是一种致命性疾病，可导致心脏泵血功能下降，难以满足身体需要[1]。其中至少有一半的患者是射血分数降低型心力衰竭（HFrEF）[2]，通常表现为左心室心肌无法充分收缩进而使得循环及外周组织的血液供应减少[3-5]。

此次达格列净在中国获批心衰适应症是基于《新英格兰医学杂志》上发表的具有里程碑意义的DAPA-HF III期临床试验的积极结果。2020年5月，中国国家药品监督管理局（NMPA）药品审评中心（CDE）将DAPA-HF研究纳入优先审评。

关于心力衰竭

心力衰竭（HF）影响全球约6400万人（其中至少有一半为射血分数降低型心衰）[2,7]，其中包括欧盟1500万，美国600万8,9和中国700万被治疗的成人心衰患者[10]。心衰是一种慢性疾病，过半的患者会在诊断后的五年内死亡11。根据射血分数（EF：即每搏输出量占心室舒张末期容积量的百分比）的数值将心衰分为两大类：射血分数降低型心衰（HFrEF）和射血分数保留型心衰（HFpEF）[3]。射血分数降低型心衰表现为左心室心肌未能充分收缩进而使得循环及外周组织的血液供应减少[4-5]。心衰与男性（前列腺癌和膀胱癌）和女性（乳腺癌）中某些最常见的癌症一样致命[12]，也是65岁以上患者住院的主要原因，为医生带来巨大的临床负担，为患者带来巨大的经济负担[13]。

注：原文有删减

参考资料

1. Mayo Clinic. Heart Failure; 29 May 2020 [cited 5 January 2021]. Available from:URL:https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.

2. Travessa AMR, Menezes Falcão LF de. Treatment of Heart Failure With Reduced Ejection Fraction-Recent Developments. Am J Ther 2016; 23(2):e531-49.

3. American Heart Association. Ejection Fraction Heart Failure Measurement; 2017 [cited 2 Nov 2020]. Available from: URL: https://www.heart.org/en/health-topics/heart-failure/diagnosing-heart-failure/ejection-fraction-heart-failure-measurement.

4. Ponikowski P et al. 2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure of the European Society of Cardiology (ESC) Developed with the Special Contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J 2016; 37(27):2129–200.

5. National Guideline Centre (UK). Chronic Heart Failure in Adults: Diagnosis and Management. London: National Institute for Health and Care Excellence (UK); 2018 Sep. (NICE Guideline, No. 106.) 13, Glossary.

6. McMurray JJV et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med 2019; 381(21):1995–2008.

7. Vos T et al. Global, Regional, and National Incidence, Prevalence, and Years Lived with Disability for 328 Diseases and Injuries for 195 Countries, 1990–2016: A Systematic Analysis for the Global Burden of Disease Study 2016. Lancet 2017; 390(10100):1211–59.

8. Dickstein K et al. ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in Collaboration with the Heart Failure Association of the ESC (HFA) and Endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J 2008; 29:2388–442.

9. Centers for Disease Control and Prevention. Heart Disease: Heart Failure. 8 September 2020. https://www.cdc.gov/heartdisease/heart_failure.htm#:~:text=Facts%20About%20Heart%20Failure%20in,estimated%20%2430.7%20billion%20in%202012.

10. AstraZeneca. Data on File. February 2020.

11. Mozaffarian D et al. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation 2016; 133(4):e38–360.

12. Mamas MA et al. Do Patients Have Worse Outcomes in Heart Failure than in Cancer? A Primary Care-Based Cohort Study with 10-year Follow-up in Scotland. Eur J Heart Fail 2017; 19(9):1095–104.

13. Azad N, Lemay G. Management of Chronic Heart Failure in the Older Population. J Geriatr Cardiol 2014; 11(4):329–37.