心血管复方药物临床评价的思考  

Considerations on the Clinical Evaluation of Compound Preparations for Cardiovascular Diseases

作　　者：康彩练[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国执业药师》2012年第11期8-10,24,共4页China Licensed Pharmacist

摘　　要：心血管复方制剂的开发要选择联合用药基础广泛、作用机制协同或互补、安全范围宽、治疗方案固定以及临床试验数据充分的药物进行组合,按照界定的适应证人群合理地开展临床试验。优质的心血管复方制剂具有简化治疗方案、增强顺应性、多靶点同时干预和广覆盖的特点,同时也要防止随意组合、不切临床实践、缺乏临床研究基础的复方制剂过度开发。ABSTRACT For the development of the compound preparations for cardiovascular diseases, considerations should be taken that the drug substances to be chosen should be broadly used in combination, with cooperated or complemented fimc- tionary mechanism, with wide safety range, confirmatory treatment program and sufficient clinical data. The clinical trials should he conducted properly in the population with well-defmed indications. The high-quality compound preparations for cardiovascular diseases should have such characteristics as simplifying the treatment program, enhancing the compliance, and having multi-targets＇ interferes and an abroad covering. However in the development of compound preparations ran- dom combination and overexploitation departed from clinical practice or without clinical research basis should be avoided. KEY WORDS Cardiovascular Disease; Compound Preparations; Clinical Evaluation

关 键 词：心血管疾病 复方制剂 临床评价 

分 类 号：R969[医药卫生—药理学]