抗高血压复方药物合理研发及评价的考虑  

Considerations of development and evaluations for antihypertensive fixed- dose single- pill combinations

作　　者：徐伟仙[1] 王涛[2] 王水强[2] 康彩练[2] 华尉利[2] 赵红艳[3] 谢松梅[2] 

机构地区：[1]北京大学第三医院心血管内科,北京100191 [2]国家食品药品监督管理总局药品审评中心,北京100038 [3]山东大学附属济南市中心医院保健科心血管病房,济南250013

出　　处：《中国临床药理学杂志》2016年第3期286-288,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：临床联合用药是单药治疗疗效不佳的高血压患者降压治疗的一个重要原则。相对于自由组合的联合治疗,抗高血压复方药物有助于改善患者的依从性,但同时存在不方便临床个体化灵活调整药物种类和剂量的问题。因此,本文对此类药物研发立题的考虑要点、临床研发和评价的技术考虑、监管相关措施的有效引导等进行了探讨,以期对抗高血压复方药物的开发提供有益参考。Combination therapy is an important principle of antihyperten- sive therapy for the patients whose blood pressure is not well controlled by single antihypertensive therapy. Fixed - dose single - pill combinations can improve the compliance of patients with respect to the free combina- tion of antihypertensive drugs in some cases, but it is not convenient to adjust the categories and doses of the drugs in the clinical practice. Therefore, the key points of the developing rationality, technical consi- derations of clinical development and evaluations and the monitoring of regulatory authorities will be discussed in this paper in order to provide reference for the developing antihypertensive drugs in rational and scien- tific ways.

关 键 词：抗高血压药物 固定剂量复方 

分 类 号：R954[医药卫生—药学] R972.4