长效降压药动态血压试验设计与定量分析方法实例介绍

中国临床药理学与治疗学 ›› 2012, Vol. 17 ›› Issue (6): 666-671.

长效降压药动态血压试验设计与定量分析方法实例介绍

尹芳, 李云飞, 黄继汉, 李禄金, 郑青山

上海中医药大学药物临床研究中心,上海 201203

收稿日期:2012-03-03 修回日期:2012-04-12 出版日期:2012-06-26 发布日期:2012-06-25
通讯作者: 郑青山,男,教授,博士生导师,主要从事定量药理学与临床药理学研究。Tel: 021-51323006 E-mail: zhengqscn@21cn.com
作者简介:尹芳,女,硕士研究生,主要从事临床药理学研究。
基金资助:
国家科技支撑计划(2008BAI51B03);重大新药创制新药临床评价研究技术平台(2012ZX09303-003);上海市教委项目(E03008,J50303)

A example introduce: clinical design and quantitative evaluation of ambulatory blood pressure monitoring for once daily antihypertensive drugs

YIN Fang, LI Yun-fei, HUANG Ji-han, LI Lu-jin, ZHENG Qing-shan

Center for Drug Clinical Research, Shanghai University of Chinese Medicine, Shanghai 201203, China

Received:2012-03-03 Revised:2012-04-12 Online:2012-06-26 Published:2012-06-25

摘要/Abstract

摘要： 目的: 探讨长效降压药使用 24 h动态血压监测(24 h ABPM)进行疗效评价时临床试验操作要点和相关指标定量分析方法。方法: 结合相关文献和国际指南,对动态血压数据采集和记录方法,谷峰比值计算方法进行介绍。以一个实例的模拟数据计算谷峰比值和平滑指数等降压疗效指标。结果: 谷峰比值群体计算法结果较个体计算法显著。ABPM达标受试者收缩压的谷峰比值和平滑指数,试验组高于对照组(P<0.05);而全部病例进行分析时相应指标无统计学差异(P>0.05)。结论: 计算谷峰比值和平滑指数时需分别采用群体计算法和个体计算法,并同时考量以评价平稳降压疗效。需对所有受试者和ABPM达标者分别分析。

关键词: 原发性高血压, 临床试验设计, 24 h 动态血压, 谷峰比值, 平滑指数

Abstract: AIM: To explore the operation points and quantitative measures of clinical trial of once daily antihypertensive drugs using 24 h ambulatory blood pressure monitoring (24 h ABPM) to evaluate 24 h antihypertensive coverage. METHODS: Combined with the literature and international guideline, the collecting and recording methods of ABPM data and the calculation of trough: peak (T/P) ratios are introduced. The T/P ratios and smoothness index (SI) are analysed with primary data simulated from a real example. RESULTS: The values of individual T/P ratios are more evident than the global T/P ratios'. The T/P ratios and SI values of SBP of ABPM responders show statistical significant differences between two groups. Nevertheless the corresponding indexes of two groups are comparable for all subjects. CONCLUSION: Both the global and individual T/P ratios should be calculated and considered when evaluating the duration of action of antihypertensive agents. We should separately analysis the whole subjects and ABPM responders.

Key words: Essential hypertension, Clinical trial design, Ambulatory blood pressure, Trough peak ratio, Smoothness index

中图分类号:

R544.1

尹芳, 李云飞, 黄继汉, 李禄金, 郑青山. 长效降压药动态血压试验设计与定量分析方法实例介绍[J]. 中国临床药理学与治疗学, 2012, 17(6): 666-671.

YIN Fang, LI Yun-fei, HUANG Ji-han, LI Lu-jin, ZHENG Qing-shan. A example introduce: clinical design and quantitative evaluation of ambulatory blood pressure monitoring for once daily antihypertensive drugs[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2012, 17(6): 666-671.

参考文献

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