长效降压药动态血压试验设计与定量分析方法实例介绍

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。

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

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.