从药品技术指导原则的变迁看调脂药临床研究评价策略的进展

Advances in clinical evaluation of the new lipid-altering agents from the perspective of drug administration guidance

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。

The cardiovascular death ranks first place among all causes of death in China. Lipid disorder is an important risk factor of cardiovascular diseases. Research of lipid-altering drug is one of the hot spots in the discovery and development of the cardiovascular agents. Clinical research is the essential stage of evaluating the efficacy and safety of new drugs. The rational design and implementation of a clinical trial have major impact on the study results. Therefore, the drug administration agency provides technical suggestions for the industry in the form of guid-anee generally. Ttlis article reviews the guidances on clinical investigation of agenls for the treatment of lipid disorders. It may provide references for clinical research of new lipid-altering drugs in China.