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

Qiao-ning Yang; Rui-na Bai; Guo-ju Dong; Chang-jiang GE; Jing-min Zhou; Li Huang; Yan HE; Jun Wang; Ai-hua Ren; Zhan-quan Huang; Guang-li Zhu; Shu LU; Shang-quan Xiong; Shao-xiang Xian; Zhi-jun Zhu; Da-zhuo Shi; Shu-zheng LU; Li-zhi LI; Ke-ji Chen

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

Author: Qiao-Ning YANG ¹ ; Rui-Na BAI ¹ ; Guo-Ju DONG ¹ ; Chang-Jiang GE ² ; Jing-Min ZHOU ³ ; Li HUANG ⁴ ; Yan HE ⁵ ; Jun WANG ⁶ ; Ai-Hua REN ⁷ ; Zhan-Quan HUANG ⁸ ; Guang-Li ZHU ⁹ ; Shu LU ¹⁰ ; Shang-Quan XIONG ¹¹ ; Shao-Xiang XIAN ¹² ; Zhi-Jun ZHU ¹³ ; Da-Zhuo SHI ¹ ; Shu-Zheng LU ² ; Li-Zhi LI ¹⁴ ; Ke-Ji CHEN ¹⁵
Author Information

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.
Publication Type:Journal Article
Keywords: Canadian Cardiovascular Society classification of angina; Chinese medicine; Kuanxiong Aerosol; angina pectoris; randomized controlled trial
MeSH: Aerosols; adverse effects; therapeutic use; Angina Pectoris; drug therapy; Case-Control Studies; Drugs, Chinese Herbal; adverse effects; therapeutic use; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Remission Induction; Treatment Outcome
From: Chinese journal of integrative medicine 2018;24(5):336-342
CountryChina
Language:English
Abstract:
OBJECTIVETo evaluate the effect and safety of Kuanxiong Aerosol (, KA) on patients with angina pectoris.
METHODSBlock 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.
RESULTSThe 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).
CONCLUSIONSKA 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).