[Effect of Kuanxiong aerosol on coronary heart disease angina patients: a multicenter randomized controlled clinical study].

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 2groups 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 3min 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,P0.05].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(P0.05).The adverse reaction rate was 9.31(35/376 cases)in the treatment group and 22.46%(84/374 cases)in the control group(P0.01).Conclusion KA was not inferior to NT in relieving anginal attacks and improving ischemic ECG changes,and had obviously less adverse reaction.