长效降压药动态血压试验设计与定量分析方法实例介绍  

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

作　　者：尹芳[1] 李云飞[1] 黄继汉[1] 李禄金[1] 郑青山[1] 

机构地区：[1]上海中医药大学药物临床研究中心,上海201203

出　　处：《中国临床药理学与治疗学》2012年第6期666-671,共6页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：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)

摘　　要：目的:探讨长效降压药使用24h动态血压监测(24hABPM)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。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 AB- PM） to evaluate 24 h antihypertensive coverage. METHODS： Combined with the literature and international guideline, the collecting and recording methods of ABPM data and the calcula- tion 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. Never- theless 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.

关 键 词：原发性高血压 临床试验设计 24H动态血压 谷峰比值 平滑指数 

分 类 号：R544.1[医药卫生—心血管疾病]