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心血管疾病已居我国人群死亡原因的第一位。血脂异常是重要的心血管风险因素。新调脂药是近年来国内外心血管药物的开发热点之一。在新药的开发中,临床研究是证明新药人体有效性和安全性的重要环节,其设计和实施是否规范直接影响试验结果的可评价性。因而,药品管理机构常通过发布指导原则或者建议的方式,给企业提供临床研究方法的技术性建议。本文回顾了国内外药品管理机构不同时期的调脂药临床研究相关的指导原则,从中可以看出调脂药临床研究评价策略的进展,并可给我国的调脂药临床评价提供参考。
Cardiovascular disease ranks the first in the cause of death among our population. Dyslipidemia is an important cardiovascular risk factor. New lipid-lowering drugs in recent years, one of the hot development of cardiovascular drugs at home and abroad. In the development of new drugs, clinical research is to prove the effectiveness and safety of new drugs an important part of the human body, the design and implementation of norms directly affect the test results can be evaluated. Therefore, drug regulatory agencies often publish technical guidelines or recommendations to provide enterprises with technical advice on clinical research methods. This paper reviews the guiding principles of clinical research on lipid-lowering drugs in different periods of domestic and foreign drug regulatory agencies. From the results, we can see the progress of clinical evaluation of lipid-lowering drugs and provide a reference for the clinical evaluation of lipid-lowering drugs in our country.