摘要
药物临床试验目的是确证药物的安全性和有效性,但最根本的目标是为了更合理的使用药物、更有效的改善患者的生活质量。对照研究是临床研究经常采用的一种方法,在开展药物对照试验时,合理选择对照药物是一个关键点、亦是难点。分析试验目的、结合不同的医疗需求,合理选择对照药物进行临床研究方案设计,可以使临床试验给医疗工作带来的价值更大。本文结合实例简要介绍如何选择对照药物。
The aim of clinical trials for drugs is to ensure the safety and effectiveness,and its ultimate goal is to improve the appropriateness of drug administration and patients'quality of life.Controlled group is frequently used in clinical studies,and the key is the choice of reference drug,which is never made easy.An optimal choice of reference drug through taking into consideration the research purpose and medical requirements will contribute to the value of clinical trials to medical practice.In this paper,we discuss the ways to choose appropriate control drugs,based on illustrative examples.
作者
翁鸿
尹庆锋
王朝阳
曾宪涛
WENG Hong;YIN Qing-feng;WANG Chao-yang;ZENG Xian-tao(Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University; Center for Evidence-Based and Translational Medicine, Wuhan University Based Medicine and Clinical Epidemiology, The Second Clinical College, Wuhan University, Wuhan 430071, China)
出处
《中国循证心血管医学杂志》
2017年第4期385-387,共3页
Chinese Journal of Evidence-Based Cardiovascular Medicine
基金
国家重点研发计划专项基金(2016YFC0106300)
关键词
临床研究
临床试验
对照研究
对照药物
Clinical research
Clinical trial
Controlled study
Reference drug
