ObjectiveTo evaluate the efficacy and safety of Huoxinwan(concentrated pill)for the treatment of stable angina pectoris of coronary heart disease(CHD).MethodsA mutli-center randomized double-blinded,placebo,controlled trial was conducted.Totally 480 patients with stable angina pectoris of CHD were randomly assigned to two groups at the ratio of 3:1,the trial group(360cases)and the control group(120 cases).All patients received routine western medicine treatment,the trial group additionally took Huoxinwan(concentrated pill)2 pills for each time,3 times a day for 8 weeks.Meanwhile the control group received the placebo 3 times a day for 8 weeks.The primary outcomes(including scores of angina symptoms),secondary outcome(including reduction rate of nitroglycerin TCM Syndrome Evaluation and Seattle Angina Questionnaire)and adverse reactions were observed before and after treatment.ResultsTotally 454 cases were available,336 in the trial group and 118 in the control group.Better effect in improving angina scores the SAQ scores and TCM syndrome were obtained in the trial group compared with the control group in the after treatment.The effective rate of angina symptoms in the trial group was 80.95%,the nitroglycerin reduction rate was 80.70%,curative effective of TCM syndrome was 80.65%,significantly higher than those of the control group[36.44%?45.07%?38.99%(?2=58.21?40.94?66.55,p<0.01)].Compared with before treatment,scores of angina symptoms,TCM syndrome scores were decreased in both groups as well as the SAQ scores were improved in both groups(p<0.01).Among the cases in the trial group,the angina symptoms effective rate in subtype of MI previous was 83.22%,SAQ score was 361.74±62.10,the curative effective of TCM syndrome was 83.22%,significantly higher than those of the subtype without previous MI[60.92%?66.89%?(327.95±65.07)?(?2=13.89?13.26,p<0.01)].There is no adverse reaction occurred in the two groups during the treatment course.ConclusionThe curative effect of Huoxinwan(concentrated pill)on angina pectoris of CHD was significant,especially in patients with MI,without obvious adverse reaction. |