Effect of Kuanxiong Aerosol (宽胸气雾剂) 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

doi:10.1007/s11655-018-2833-5

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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

OriginalPaper | Updated：2021-08-27

- Effect of Kuanxiong Aerosol (宽胸气雾剂) on Patients with Angina Pectoris: A Non-inferiority Multi-center Randomized Controlled Trial
- Effect of Kuanxiong Aerosol (宽胸气雾剂) on Patients with Angina Pectoris: A Non-inferiority Multi-center Randomized Controlled Trial
- 中国结合医学杂志（英文版） 2018年24卷第5期页码：336-342
- Affiliations：
  
  1. Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences,Beijing,China
  2. Department of Cardiology, Beijing Anzhen Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University,Beijing,China
  3. Department of Cardiology, Zhongshan Hospital, Fudan University,Shanghai,China
  4. Department of Cardiology, China-Japan Friendship Hospital,Beijing,China
  5. Department of Cardiology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shaihai,China
  6. Department of Cardiology, Zhejiang Hospital of Integrated Traditional Chinese and Western Medicine,Hangzhou,China
  7. Department of Cardiology, Zhejiang Hospital,Hangzhou,China
  8. Department of Cardiology, The First Affiliated Hospital of Zhejiang Chinese Medical University,Hangzhou,China
  9. Department of Cardiology, Guangxing Hospital Affiliated to Zhejiang Chinese Medical University,Hangzhou,China
  10. Department of Cardiology, Wuxi Traditional Chinese Medicine Hospital, Nanjing University of Traditional Chinese Medicine,Wuxi,China
  11. Department of Cardiology, People’s Hospital Affiliated Fujian University of Traditional Chinese Medicine,Fuzhou,China
  12. Department of Cardiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou,China
  13. Department of Cardiology, The 117th Hospital of People’s Liberation Army of China,Hangzhou,China
- Author bio：
- Funds：
  
  Supported by the Traditional Chinese Medicine Public Welfare Scientific Research Project, State Administration of Traditional Chinese Medicine of China (No. 201007001)
- DOI：10.1007/s11655-018-2833-5
  中图分类号：
- 纸质出版日期：2018，
  
  网络出版日期：2018-2-13，
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Yang, Qn., Bai, Rn., Dong, Gj. et al. Effect of Kuanxiong Aerosol (宽胸气雾剂) on Patients with Angina Pectoris: A Non-inferiority Multi-center Randomized Controlled Trial., Chin. J. Integr. Med. 24, 336–342 (2018). https://doi.org/10.1007/s11655-018-2833-5

Qiao-ning Yang, Rui-na Bai, Guo-ju Dong, et al. Effect of Kuanxiong Aerosol (宽胸气雾剂) on Patients with Angina Pectoris: A Non-inferiority Multi-center Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2018,24(5):336-342.
Yang, Qn., Bai, Rn., Dong, Gj. et al. Effect of Kuanxiong Aerosol (宽胸气雾剂) on Patients with Angina Pectoris: A Non-inferiority Multi-center Randomized Controlled Trial., Chin. J. Integr. Med. 24, 336–342 (2018). https://doi.org/10.1007/s11655-018-2833-5 DOI：

Qiao-ning Yang, Rui-na Bai, Guo-ju Dong, et al. Effect of Kuanxiong Aerosol (宽胸气雾剂) on Patients with Angina Pectoris: A Non-inferiority Multi-center Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2018,24(5):336-342. DOI： 10.1007/s11655-018-2833-5.

摘要

To evaluate the effect and safety of Kuanxiong Aerosol (宽胸气雾剂

KA) on patients with angina pectoris. 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

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. 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). 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)

Abstract

To evaluate the effect and safety of Kuanxiong Aerosol (宽胸气雾剂

KA) on patients with angina pectoris. 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

and >5 min). Logistic regression analysis was performed to observe the factors inflfluencing the rate of effective angina remission

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). 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)

关键词

Kuanxiong Aerosolangina pectorisCanadian Cardiovascular Society classification of anginarandomized controlled trialChinese Medicine

Keywords

Kuanxiong Aerosolangina pectorisCanadian Cardiovascular Society classification of anginarandomized controlled trialChinese Medicine

references

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