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

查看全文 作　　者：YANG Qiao-[1]ning;BAI Rui-[1]na;DONG Guo-[1]ju;GE Chang-[2]jiang;ZHOU Jing-[3]min;HUANG [4]Li;HE [5]Yan;WANG [6]Jun;REN Ai-[7]hua;HUANG Zhan-[8]quan;ZHU Guang-[9]li;LU [10]Shu;XIONG Shang-[11]quan;XIAN Shao-[12]xiang;ZHU Zhi-[13]jun;SHI Da-[1]zhuo;LU Shu-[2]zheng;LI Li-[1]zhi;CHEN Ke-[1]ji

机构地区：[1]Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences;[2]Department of Cardiology, Beijing Anzhen Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University;[3]Department of Cardiology, Zhongshan Hospital, Fudan University;[4]Department of Cardiology, China-Japan Friendship Hospital;[5]Department of Cardiology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine;[6]Department of Cardiology, Zhejiang Hospital of Integrated Traditional Chinese and Western Medicine;[7]Department of Cardiology, Zhejiang Hospital;[8]Department of Cardiology, The First Affiliated Hospital of Zhejiang Chinese Medical University;[9]Department of Cardiology, Guangxing Hospital Affiliated to Zhejiang Chinese Medical University;[10]Department of Cardiology, Wuxi Traditional Chinese Medicine Hospital, Nanjing University of Traditional Chinese Medicine;[11]Department of Cardiology, People's Hospital Affiliated Fujian University of Traditional Chinese Medicine;[12]Department of Cardiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine;[13]Department of Cardiology, The 117th Hospital of People's Liberation Army of China

出　　处：《Chinese Journal of Integrative Medicine》索引2018年第24卷第5期,共7页

基　　金：Supported by the Traditional Chinese Medicine Public Welfare Scientific Research Project,State Administration of Traditional Chinese Medicine of China(No.201007001) 摘　　要：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 m L per spray). The control group received 1 sublingual nitroglycerin tablet(NT, 0.5 mg/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 CCSⅠ and Ⅳ subgroups(P>0.05), while they were significantly better for KA in the CCSⅡ and Ⅲ subgroups(P<0.05 or P<0.01). Furthermore, the incidence of adverse reactions was significantly lower in the KA group than in the control group for the CCSⅡ 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 CCSⅡ and Ⅲ patients, KA is superior to NT, with a lower incidence of adverse reactions. 关键词：Kuanxiong Aerosol angina pectoris Canadian Cardiovascular Society classification of angina randomized controlled trial Chinese medicine

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

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