美國(guó)食品藥品管理局（FDA）于2017年3月發(fā)布了“高血壓適應(yīng)癥：藥品說明書中有關(guān)心血管預(yù)后描述”的指導(dǎo)原則，要求抗高血壓藥品說明書增加有關(guān)降低血壓可預(yù)防嚴(yán)重心血管事件的內(nèi)容，詳細(xì)規(guī)定了說明書適應(yīng)證和臨床研究項(xiàng)目的標(biāo)準(zhǔn)描述，其目的是促進(jìn)高血壓患者合理使用抗高血壓藥物，把血壓降低到目標(biāo)水平，改善預(yù)后。介紹該指導(dǎo)原則主要內(nèi)容并列舉實(shí)例，期盼我國(guó)抗高血壓藥生產(chǎn)廠家和藥品監(jiān)管部門能借鑒FDA的這種做法，共同努力盡快修訂我國(guó)抗高血壓說明書，使患者受益。

FDA issued Guidance for Industry Hypertension Indication:Drug Labeling for Cardiovascular Outcome Claims in March 2017, requires that antihypertensive drug labeling should increase the content that lowering blood pressure can prevent serious cardiovascular events, provide a standard description of the INDICATIONS AND USAGE and CLINICAL STUDIES section in labeling in detail. The aim is to encourage the rational use of antihypertensive drugs in hypertensive patients, to reduce blood pressure to the target level, and to improve the outcomes. This paper introduces the main contents of guidance and enumerates a example, and look forward to that antihypertensive drug manufacturers and drug regulatory authorities can learn from this practice of FDA, and work together to revise antihypertensive drug labeling as soon as possible in our country, so as to benefit patients.