Clinical Testing Research of Elipulse Capsules
Clinical 9.The multicenter-clinical tests of Elipulse have being carried out in five hospitals including 454 cases of patients with coronary heart disease, angina pectoris have been observed. DR.Lu et al select cases based on clinical symptoms of coronary heart disease angina, like chest stuffiness and pains, and adds western medicine diagnostic criteria. Major projects of evaluation of therapeutic effects are angina pectoris, electrocardiogram, reduced use of nitroglycerin . T inspection, chi-square test, Ridit are used to analyze results. The result shows that the total effective rate for coronary artery disease(CAD) angina pectoris is 93.07%; the significant efficacy rate is 56.45%; the electrocardiogram (ecg) efficient rate is 68.65%; the significant efficacy rate is 34.98%; the discontinuation rate of nitroglycerin is 73.54%; the onset time of the angina pectoris are 7.72±3.68 days; the significant efficacy rate is 61.06%; compared with the control group, the difference is obvious (p＜0.01), the curative effects on various angina pectoris and different degrees of angina pectoris are good (p＞0.05). Results show that Elipulse is effective in the treatment of coronary heart disease and angina pectoris.
Clinical 10. Random and double blind, double-dummy, parallel contrast and multicenter-clinical tests on the efficacy and safety of Elipulse in the treatment of coronary heart disease stable angina are performed from March 9, 2011 to October 9, 2011. Experimental population of this study are mainly patients with coronary angiography diagnostic coronary heart disease, or coronary artery CTA of masculine gender (medium or above stenosis), or previous history of myocardial infarction, or positive exercise testing, or meeting diagnostic criteria of coronary heart disease stable form effort angina aging from 35 to 70. There are total 433 test cases, 325 experimental groups and 108 control groups. With the aid of statistical software, experimental method produces random arrangement of the subjects. Subjects shall be assigned to the experimental group and control group in accordance with the random proportion of 3:1, which is completed by 6 test centers.
Observation of curative effect indicators include the base line, improvement conditions of the angina, and nitroglycerin dosage on the 14th and 28th day after receiving the treatment, and the electrocardiogram, exercise load electrocardiogram (Bruce scheme is adopted, not less than 1/3 of the case loads), Seattle Angina Questionnaire was executed on the 28th day after receiving the treatment.
The statistical method of this clinical research is two-sided test. When P value is less than 0.05, the inspected difference is considered to have statistical significance. Bilateral difference test is used to inspect effective rate and the credibility interval with 95% D-value shall be given. Analysis results show that when comparing the major curative effects (angina pectoris curative effect) between the experimental group and control group, comparative differences between groups have statistical significance (P<0.05). Experimental group is better than the control group. When comparing secondary efficacies (including five standard score integral and total standard score analysis encompassing: electrocardiogram curative effect, exercise load electrocardiogram curative effect, efficacy in the way of reduced need for nitroglycerin and the Seattle Angina Questionnaire), the total effective rate of the experimental group symptoms of TCM comprehensive curative effect is 94.44%, total effective comparative differences between groups have statistical significance (P<0.05), total effective rate difference between groups (the experimental group and the control group) and 95% credibility interval are 11.11% (3.65%～18.57%). The experimental group is superior to the control group. Five terms of standard score integrals and total standard score analysis in Seattle Angina Questionnaire, the added value of the total standard Elipulse, the added value of the standard scores of anginal stability, satisfaction with treatment and the added value of the total standard scores of the disease perception are better than those of the control group.This combined clinical research shows that Elipulse can significantly reduces the pain degree of angina. The added value of the total standard scores in Seattle Angina Questionnaire and anginal stability, the satisfaction with treatment and the disease perception these three dimensionality improvement aspects are better than those of the control group. During the period of clinical observation, obvious toxic and side effects have not been found which indicates that the clinical efficacy of Elipulse is good and it is safe in the clinical application.