血壓升高可增加卒中、心臟病發(fā)作和死亡的風(fēng)險，美國食品藥品監(jiān)督管理局（FDA）主張將評估藥物對血壓的作用納入藥物風(fēng)險評估。為此，F(xiàn)DA于2018年5月發(fā)布了“藥物升壓效應(yīng)評估”供企業(yè)用的指導(dǎo)原則草案，提出了有關(guān)藥物對血壓作用上市前評估的建議。2022年2月，F(xiàn)DA又發(fā)布了該指導(dǎo)原則草案的第1次修訂版，增加了對研究設(shè)計的許多細(xì)節(jié)的建議，還增加了對其評估結(jié)果列入藥品說明書的具體建議。中國目前還沒有類似的指導(dǎo)原則，詳細(xì)介紹該指導(dǎo)原則的修訂版內(nèi)容，期待國內(nèi)的藥物研發(fā)人員對此予以重視，主動將新藥對血壓的影響列入藥物臨床風(fēng)險研究；也期待藥品監(jiān)管部門制定相應(yīng)的法規(guī)和指導(dǎo)原則。

Elevated blood pressure increases the risk of stroke, heart attack and death. FDA advocates that the evaluation of the effect of drugs on blood pressure should be included in the drug risk assessment. Therefore, in May 2018, FDA issued the Assessment of Pressor Effects of Drugs Draft Guidance for Industry, and put forward suggestions on the premarketing assessment of a drug's effect on blood pressure. Four years later, in February 2022, FDA issued the first revision of the draft guidance, adding suggestions on many details of the study design and specific suggestions on the inclusion of the evaluation results in the drug labelings. At present, there is no similar guidance in China. This paper introduces the revised version of the guidance in detail, and expects the researchers of drug development in China to pay attention to it and take the initiative to include the effect of the developed drugs on blood pressure in the clinical risk study of drugs. At the same time, China's drug regulatory authorities are expected to put forward regulatory requirements and formulate corresponding regulation and guidance.