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美国食品药品管理局(FDA)于2017年3月发布了“高血压适应症:药品说明书中有关心血管预后描述”的指导原则,要求抗高血压药品说明书增加有关降低血压可预防严重心血管事件的内容,详细规定了说明书适应证和临床研究项目的标准描述,其目的是促进高血压患者合理使用抗高血压药物,把血压降低到目标水平,改善预后。介绍该指导原则主要内容并列举实例,期盼我国抗高血压药生产厂家和药品监管部门能借鉴FDA的这种做法,共同努力尽快修订我国抗高血压说明书,使患者受益。
The United States Food and Drug Administration (FDA) issued in March 2017 the “Hypertension Indications: Drug Description Guidelines for Cardiovascular Outcomes,” which require antihypertensives to increase blood pressure and prevent severe heart disease The content of the vascular event details the description of the indications and clinical research project standard description, the purpose is to promote the rational use of antihypertensive drugs in patients with hypertension, the blood pressure to the target level and improve prognosis. The main content of the guiding principle is introduced and examples are given. It is hoped that antihypertensives manufacturers and drug regulators in our country can draw lessons from this approach by the FDA and make joint efforts to revise the antihypertensive instruction in China so as to benefit the patients as soon as possible.