复方I类新药依那普利叶酸片的创新思路

Innovation strategy for rationale and clinical significance of a new combination of drugs: enalapril maleate and folic acid tablets

脑卒中已经超过肿瘤成为我国第一位死因,"H型"高血压(高血压伴有同型半胱氨酸升高)是导致我国脑卒中高发的重要原因,依那普利叶酸片是体现多重危险因素(高血压、高同型半胱氨酸、低叶酸)综合防治的复方创新药物,已经获得国家食品药品监督管理局批准上市。文中从多重危险因素联合控制,FDA、EMEA关于复方药物的政策,高血压与高同型半胱氨酸的协同作用,补充叶酸可以显著降低脑卒中发生风险,降压的同时降低同型半胱氨酸是预防脑卒中的最佳策略等方面阐述了依那普利叶酸片的创新思路,同时阐明了本品的创新点、临床优势以及将来用于控制我国脑卒中发生和死亡率持续上升的重大意义。

Based on the third National Survey,stroke has surpassed cancer to become the leading cause of death in China.＂H-type＂ hypertension（defined as with elevated plasma homocysteine and hypertension） constitutes about 75% of all hypertensive patients in China,and is associated with remarkably high risk of stroke incidence and stroke death in China.Based on the concept of multiple risk factor control in cardiovascular disease prevention,a new combination of drugs,enalapril maleate and folic acid tablets,is specifically designed for effective control of H-type hypertension,i.e.to control hypertension,lower plasma homocysteine,and improve plasma folate level.This article presented the theoretical framework and rationale for simultaneous control of hypertension and elevated Hcy as the best strategy for primary stroke prevention,including the concept of H-type hypertension,H-type hypertension as a major risk factor for stroke,and the need to control for multiple risk factors in stroke prevention,FDA and EMEA＇s policies on compound drugs,and efficacy of stroke prevention by lowering plasma homocysteine using folic acid supplementation.This article also highlighted the scientific innovations and clinical advantage of enalapril maleate and folic acid tablets for treating hypertension,especially,H-type hypertension,and its great potential to control the upward trend of stroke morbidity and mortality in China.