2月4日，阿斯利康宣布安達(dá)唐®（通用名：達(dá)格列凈）在中國(guó)正式獲批，用于成人射血分?jǐn)?shù)降低型心衰患者的治療（HFrEF，NYHA II-IV級(jí)），可降低心血管死亡和因心衰住院（hHF）風(fēng)險(xiǎn)。

慢性心力衰竭是一種致命性疾病，可導(dǎo)致心臟泵血功能下降，難以滿足身體需要[1]。其中至少有一半的患者是射血分?jǐn)?shù)降低型心力衰竭（HFrEF）[2]，通常表現(xiàn)為左心室心肌無(wú)法充分收縮進(jìn)而使得循環(huán)及外周組織的血液供應(yīng)減少[3-5]。

此次達(dá)格列凈在中國(guó)獲批心衰適應(yīng)癥是基于《新英格蘭醫(yī)學(xué)雜志》上發(fā)表的具有里程碑意義的DAPA-HF III期臨床試驗(yàn)的積極結(jié)果。2020年5月，中國(guó)國(guó)家藥品監(jiān)督管理局（NMPA）藥品審評(píng)中心（CDE）將DAPA-HF研究納入優(yōu)先審評(píng)。

關(guān)于心力衰竭

心力衰竭（HF）影響全球約6400萬(wàn)人（其中至少有一半為射血分?jǐn)?shù)降低型心衰）[2,7]，其中包括歐盟1500萬(wàn)，美國(guó)600萬(wàn)8,9和中國(guó)700萬(wàn)被治療的成人心衰患者[10]。心衰是一種慢性疾病，過(guò)半的患者會(huì)在診斷后的五年內(nèi)死亡11。根據(jù)射血分?jǐn)?shù)（EF：即每搏輸出量占心室舒張末期容積量的百分比）的數(shù)值將心衰分為兩大類：射血分?jǐn)?shù)降低型心衰（HFrEF）和射血分?jǐn)?shù)保留型心衰（HFpEF）[3]。射血分?jǐn)?shù)降低型心衰表現(xiàn)為左心室心肌未能充分收縮進(jìn)而使得循環(huán)及外周組織的血液供應(yīng)減少[4-5]。心衰與男性（前列腺癌和膀胱癌）和女性（乳腺癌）中某些最常見的癌癥一樣致命[12]，也是65歲以上患者住院的主要原因，為醫(yī)生帶來(lái)巨大的臨床負(fù)擔(dān)，為患者帶來(lái)巨大的經(jīng)濟(jì)負(fù)擔(dān)[13]。

注：原文有刪減

參考資料

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 Falc?o 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.