Qiao-Ning Yang1, Rui-Na Bai1, Guo-Ju Dong1, Chang-Jiang Ge2, Jing-Min Zhou3, Li Huang4, Yan He5, Jun Wang6, Ai-Hua Ren7, Zhan-Quan Huang8, Guang-Li Zhu9, Shu Lu10, Shang-Quan Xiong11, Shao-Xiang Xian12, Zhi-Jun Zhu13, Da-Zhuo Shi1, Shu-Zheng Lu2, Li-Zhi Li14, Ke-Ji Chen15. 1. Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. 2. Department of Cardiology, Beijing Anzhen Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Beijing, 10029, China. 3. Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China. 4. Department of Cardiology, China-Japan Friendship Hospital, Beijing, 10029, China. 5. Department of Cardiology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shaihai, 200126, China. 6. Department of Cardiology, Zhejiang Hospital of Integrated Traditional Chinese and Western Medicine, Hangzhou, 310003, China. 7. Department of Cardiology, Zhejiang Hospital, Hangzhou, 310013, China. 8. Department of Cardiology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, 310006, China. 9. Department of Cardiology, Guangxing Hospital Affiliated to Zhejiang Chinese Medical University, Hangzhou, 310007, China. 10. Department of Cardiology, Wuxi Traditional Chinese Medicine Hospital, Nanjing University of Traditional Chinese Medicine, Wuxi, 214001, Zhejiang Province, China. 11. Department of Cardiology, People's Hospital Affiliated Fujian University of Traditional Chinese Medicine, Fuzhou, 350004, China. 12. Department of Cardiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. 13. Department of Cardiology, The 117th Hospital of People's Liberation Army of China, Hangzhou, 310007, China. 14. Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. lilizhi0723@126.com. 15. Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. drchenky@126.com.
Abstract
OBJECTIVE: To evaluate the effect and safety of Kuanxiong Aerosol (, 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 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 inflfluencing 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 signifificantly different (94.41% vs. 90.64%, P>0.05). The angina CCS class signifificantly inflfluenced 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 CCSII and III subgroups (P>0.05), while they were signifificantly better for KA in the CCSI and II subgroups (P<0.05 or P<0.01). Furthermore, the incidence of adverse reactions was signifificantly 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. (Registration No. ChiCTRIPR-15007204).
RCT Entities:
OBJECTIVE: To evaluate the effect and safety of Kuanxiong Aerosol (, 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 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 inflfluencing 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 signifificantly different (94.41% vs. 90.64%, P>0.05). The angina CCS class signifificantly inflfluenced 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 CCSII and III subgroups (P>0.05), while they were signifificantly better for KA in the CCSI and II subgroups (P<0.05 or P<0.01). Furthermore, the incidence of adverse reactions was signifificantly 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. (Registration No. ChiCTRIPR-15007204).
Entities:
Keywords:
Canadian Cardiovascular Society classification of angina; Chinese medicine; Kuanxiong Aerosol; angina pectoris; randomized controlled trial
Authors: Li-Zhi Li; Guo-Ju Dong; Chang-Jiang Ge; Jing-Min Zhou; Li Huang; Yan He; Jun Wang; Ai-Hua Ren; Zhao-Quan Huang; Guang-Li Zhu; Shu Lu; Shang-Quan Xiong; Shao-Xiang Xian; Zhi-Jun Zhu; Da-Zhuo Shi; Shu Lu; Ke-Ji Chen Journal: Zhongguo Zhong Xi Yi Jie He Za Zhi Date: 2014-04