Effect of Kuanxiong Aerosol(宽胸气雾剂)on Patients with Angina Pectoris:A Non-inferiority Multi-center Randomized Controlled Trial

Objective： To evaluate the effect and safety of Kuanxiong Aerosol （宽胸气雾剂, KA） on patients with angina pectoris. Methods： Block randomization was performed to randomly allocate 750 patients into KA （376 cases） and control groups （374 cases）. During an angina attack, the KA group received 3 consecutive sublingual sprays of KA （0.6 mL per spray）. The control group received 1 sublingual nitroglycerin tablet （NT, 0.5 rag/tablet）. Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment （1,2, 3, 4, 5, and 〉5 min）. Logistic regression analysis was performed to observe the factors influencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society （CCS） classes of angina. Results： The 5-min remission rates in the KA and control groups were not significantly different （94.41% vs. 90.64%, P〉0.05）. The angina CCS class significantly influenced the rate of remission （95% confidence interval = 0.483-0.740, P〈0.01）. In the CCS subgroup analysis, the 3- and 5-min remission rates for KA and NT were similar in the CCS I and IV subgroups （P〉0.05）, while they were significantly better for KA in the CCS Ⅱ and Ⅲ subgroups （P〈0.05 or P〈0.01）. Furthermore, the inciden0ce of adverse reactions was significantly lower in the KA group than in the control group for the CCS Ⅱ and Ⅲ subgroups （9.29% vs. 26.22%, 10.13% vs. 20.88%, P〈0.05 or P〈0.01）. Conclusions： KA is not inferior to NT in the remission of angina. Furthermore, in CCS Ⅱ and Ⅲ patients, KA is superior to NT, with a lower incidence of adverse reactions. （Registration No. ChiCTR- IPR-15007204）

基于数学模型加拿大心绞痛严重度分级与SAQ、SF12的相关性研究

背景:目前缺乏加拿大心绞痛严重度分级与SAQ、SF12的相关性研究。目的:数据采集通过多中心、随机、大样本横断面调查法建立加拿大心绞痛严重度分级与SAQ、SF12数学模型,明确加拿大心绞痛严重度分级与其的相关性,探索加拿大心绞痛严重度分级与SAQ、SF12的重要条目的关系,建立加拿大心绞痛严重度分级的函数式。方法:研究选择了全国12家医院作为分中心,采集人群涉及到不同地区。样本总量1788,经过严格质量控制和数据录入。用统计学相关系数法选取变量,用logistic回归方法建模,从而得到加拿大心绞痛严重度分级与SAQ、SF12相关性特征。结果与讨论:入选合格病例共为1788。SAQ、SF12的所有条目都与加拿大心绞痛严重度分级有关(P<0.05),建立的logistic回归模型是对加拿大心绞痛严重度分级进行评判。

基于数学模型的加拿大心绞痛严重度分级与理化指标的相关性研究

背景:目前缺乏加拿大心绞痛严重度分级与理化指标之间的相关性研究,且对加拿大心绞痛严重度分级的判别缺乏利用现代科学技术指导的系统研究。目的:通过多中心、随机、大样本横断面调查法建立基于数学模型的加拿大心绞痛严重度分级判别函数式,明确加拿大心绞痛严重度分级的相关理化指标之间的相关性。方法:本研究选择国内12所医院作为分中心,采用流行病学调查法采集不同地区人群的数据资料。样本数为1788,经过严格质量控制数据录入。用统计学方法选取变量,用Logistic回归及判别分析方法建模,从而得到加拿大心绞痛严重度分级的判别方程极其主要特征。结果与讨论:29个理化指标经过因子分析得出13个公因子。建立的Logistic回归及判别模型是对加拿大心绞痛严重度分级进行评判,拟合度比较差。加拿大心绞痛严重度分级的主要相关理化指标为ST段下降总和、I、V5、AVL、V4、V6、V3、心脏彩超、颈动脉彩超、凝血酶原时间、射血分数。