[Effect of Kuanxiong aerosol on coronary heart disease angina patients: a multicenter randomized controlled clinical study]
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Published on: December 10, 2021
Insights
Kuanxiong Aerosol (KA) effectively relieved anginal attacks and improved ECG changes in coronary heart disease (CHD) patients. KA demonstrated a significantly lower adverse reaction rate compared to Nitroglycerin Tablet (NT).
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Context:
- Coronary heart disease (CHD) poses a significant global health burden, with angina pectoris being a primary symptom.
- Current treatments for angina, such as Nitroglycerin Tablet (NT), are effective but can be associated with adverse reactions.
- Novel therapeutic strategies are needed to improve angina relief and patient safety in CHD management.
Purpose:
- To evaluate the efficacy of Kuanxiong Aerosol (KA) in relieving anginal attacks in patients diagnosed with coronary heart disease (CHD).
- To assess the safety profile of Kuanxiong Aerosol (KA) by comparing its adverse reaction rate with that of Nitroglycerin Tablet (NT).
- To determine the impact of Kuanxiong Aerosol (KA) on electrocardiogram (ECG) changes indicative of myocardial ischemia.
Summary:
- A randomized controlled trial involving 780 CHD patients compared Kuanxiong Aerosol (KA) with Nitroglycerin Tablet (NT) for angina relief.
- KA showed comparable efficacy to NT in relieving anginal attacks within 3 and 5 minutes, and in improving ST-T changes on ECG.
- The treatment group using KA exhibited a significantly lower incidence of adverse reactions (9.31%) compared to the NT group (22.46%).
Impact:
- Kuanxiong Aerosol (KA) presents a viable alternative for angina management in CHD patients, offering comparable efficacy to NT with improved tolerability.
- The reduced adverse reaction profile of KA could lead to better patient compliance and quality of life.
- These findings support the integration of Kuanxiong Aerosol (KA) into clinical practice for the treatment of angina pectoris in coronary heart disease.
Objective:
To evaluate the anginal attack-relieving efficacy and safety of Kuanxiong Aerosol (KA) in patients with coronary heart disease (CHD).
Methods:
A total of 780 patients confirmatively diagnosed as CHD angina from November 2011 to December 2012 in 13 medical centers in the mainland area were assigned to 2 groups by blocked randomization, the treatment group (376 cases) and the control group (374 cases). When the angina attacked, patients in the treatment group received sublingual spray three times, 0.6 mL each time, while those in the control group sublingually dissolved Nitroglycerin Tablet (NT), 0.5 mg each tablet. The effective rate of angina relief, efficacy of electrocardiogram (ECG), and the incidence of adverse reactions were observed.
Results:
The 3 min and 5 min remission rates of angina attack were 53.72% (202/376) and 94.41% (355/376) in the treatment group, and 47.86% (179/374) and 90.64% (339/374) in the control group. The 95% confidence interval (CI) of the difference between the 2 groups of 3 min and 5 min remission rates of angina attacks were [(-1.84%, 12.32%) and (-1.33%, 6.85%) respectively, P > 0.05]. The total improvement rates of ST-T changes in the treatment group and the control group after treatment were 74.07% and 73.13% respectively (P > 0.05). The adverse reaction rate was 9.31 (35/376 cases) in the treatment group and 22.46% (84/374 cases) in the control group (P < 0.01).
Conclusion:
KA was not inferior to NT in relieving anginal attacks and improving ischemic ECG changes, and had obviously less adverse reaction.
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