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 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 CCSII and III subgroups (P > 0.05), while they were significantly better for KA in the CCSI and II 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.
[1]China Acad Chinese Med Sci, Xiyuan Hosp, Cardiovasc Dis Ctr, Beijing 100091, Peoples R China.
[2]Capital Med Univ, Beijing Anzhen Hosp, Beijing Inst Resp Med, Dept Cardiol, Beijing 10029, Peoples R China.
[3]Fudan Univ, Zhongshan Hosp, Dept Cardiol, Shanghai 200032, Peoples R China.
[4]China Japan Friendship Hosp, Dept Cardiol, Beijing 10029, Peoples R China.
[5]Shanghai Univ Tradit Chinese Med, Longhua Hosp, Dept Cardiol, Shanghai 200126, Peoples R China.
[6]Zhejiang Hosp Integrated Tradit Chinese & Western, Dept Cardiol, Hangzhou 310003, Zhejiang, Peoples R China.
[7]Zhejiang Hosp, Dept Cardiol, Hangzhou 310013, Zhejiang, Peoples R China.
[8]Zhejiang Chinese Med Univ, Affiliated Hosp 1, Dept Cardiol, Hangzhou 310006, Zhejiang, Peoples R China.
[9]Zhejiang Chinese Med Univ, Guangxing Hosp, Dept Cardiol, Hangzhou 310007, Zhejiang, Peoples R China.
[10]Nanjing Univ Tradit Chinese Med, Wuxi Tradit Chinese Med Hosp, Dept Cardiol, Wuxi 214001, Zhejiang, Peoples R China.
[11]Fujian Univ Tradit Chinese Med, Peoples Hosp, Dept Cardiol, Fuzhou 350004, Fujian, Peoples R China.
[12]Guangzhou Univ Chinese Med, Affiliated Hosp 1, Dept Cardiol, Guangzhou 510405, Guangdong, Peoples R China.
[13]Peoples Liberat Army, Hosp 117, Dept Cardiol, Hangzhou 310007, Zhejiang, Peoples R China.
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