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

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单位: [1]CardiovascuIar Diseases Cente r.Xiyuan Hospita1.China Academy of Chinese MedicaI Sciences,Beijing(100091),China [2]Department of Cardiology,Beiling Anzhen Hospital,Beiiing Jnstitute of Respiratory Medicine.Capital Medical Unive rsity Beijing(10029),China [3]Department of Cardiology,Zhongshan HosPjtaI,Fudan Unive rsitv,Shanghai(200032),China: Department of Cardiology,China-Japan Friendship HospitaI, Beiiing(10029),China [4]Department of Cardiology,Longhua Hospital Shanghai University of Traditional Chinese MediciRe, Shaihai(200126),China [5]Department of Cardiology,Zhejiang Hospital of lntegrated Traditional Chinese and Western Medicine. Hangzhou(310003),China [6]Depa r1ment of Cardiology, Zhejiang Hospital,Hangzhou(31OO13),Chiha [7]Department of Cardiology,The First Affiliated Hospital of Zheiiang Chinese MedicaI University。Hangzhou(310006),China [8]Department of Cardiology,Guangxing Hospital Aftiliated to Zhejiang Chinese MedicaI University,Hangzhou(310007),China [9]Department of Cardiology Wuxi TraditionaI Chinese Medicine Hospita1.Nanjing University of TradItional Chinese MediciRe,Wuxi(214001), Zhejiang Province.China [10]Department of Cardiology Peopleo's HospitaI Aff⋯ated Fuiian University of T raditionaI Chinese Medicine,Fuzhou(350004),China [11]Department of Cardiology, The First Affiliated Hospitaf of Guangzhou University of Chinese MedicIRe,Guangzhou(510405),China [12]Department Of Cardiology The 117th Hospital of Peopleo's Liberation Am1v 0f China,Hangzhou(310007),China
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关键词: Kuanxiong Aerosol angina pectoris Canadian Cardiovascular Society classification of angina randomized controlled trial Chinese medicine

摘要:
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.

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出版当年[2017]版:
大类 | 4 区 医学
小类 | 4 区 全科医学与补充医学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 全科医学与补充医学
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出版当年[2016]版:
Q4 INTEGRATIVE & COMPLEMENTARY MEDICINE
最新[2023]版:
Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

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第一作者单位: [1]CardiovascuIar Diseases Cente r.Xiyuan Hospita1.China Academy of Chinese MedicaI Sciences,Beijing(100091),China
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