藥品如果產(chǎn)生長期的升壓作用，可使使用者的心血管風(fēng)險(xiǎn)增加。在開發(fā)過程中系統(tǒng)地描述藥物對血壓的影響，逐漸引起監(jiān)管部門的重視。美國食品藥品管理局（FDA）于2018年5月發(fā)布了“供企業(yè)用藥物升壓效應(yīng)評估指導(dǎo)原則”，旨在解決藥品開發(fā)期間評估效應(yīng)時血壓測量的準(zhǔn)確性。詳細(xì)介紹該指導(dǎo)原則主要內(nèi)容，期望對我國的新藥研發(fā)和藥品監(jiān)管有所幫助。

If the drug produces a long-term boost, it increases the cardiovascular risk of the user. In the process of development, the effects of drugs on blood pressure were systematically described, which gradually attracted the attention of regulators. In May 2018, FDA announced Assessment of Pressor Effects of Drugs Guidance for Industry, aiming to address the accuracy of blood pressure measurement when evaluating the effect during drug development. The main content of this guideline is introduced in detail, which is expected to be helpful for the development of new drugs and drug regulation in China.