Clinical Observation On Treatment Of Coronary Heart Disease Stable Angina Pectoris With Phlegm And Blood Stasis Syndrome By

Purpose:To explore the efficacy and safety of Lou Xiang Dan heart particleson stable angina phlegm and blood stasis syndrome.Material and method：1.Experiment Object:coronary artery disease patients with stable anginapectoris phlegm and blood stasis syndrome2.Study Design and Grouping method: We performed a multi-center, three blind,block randomized, parallel-group trial, using Trichosanthis Xiangdan macaroniparticles combined with Western medicine-based therapy. Volunteers wereselected according to: subject recruitment, diagnostic criteria, inclusioncriteria, exclusion criteria, compliance, and the ability to complete thescreening questionaire. Eligible volunteers were randomized1:1pro rata toenter clinical trials, to which120were equally allocated to treatment groupand control group.3.Interventions: experimental group were given macaroni Trichosanthis Xiangdanparticles with Western-based therapy (aspirin0.1Qdpo, atorvastatin calcium10mgQdpo, when necessary nitroglycerin sublingual), in the control group toTrichosanthis macaroni particles placebo Xiangdan with Western-based therapyfor8weeks, followed up for18weeks4.Measurements: The primary evaluation of efficacy was investigated using theSeattle Angina scale and characteristics of Chinese medicine syndromes scoringin Table1. Measurement time points are: SAQ:0week,2weeks,4weeks,8weeks;secondary outcome measurements are of blood lipids, blood glucose, ECG, ejectionfraction, measurements time points:0weeks,8weeks. Indexes for evaluatingsafty include blood, urine, liver function (alanine aminotransferase, aspartateaminotransferase), renal function (blood urea nitrogen, creatinine), coagulation (prothrombin time, plasma thrombin time, activated partialthromboplastin time, fibrinogen).5.Statistical Methods: We use SPSS15.0statistical software for data analysis.For continuous data following a normal distribution, two samples were comparedusing independent sample t test; continuous data that do not follow a normaldistribution was analyzed using non-parameter tests. A level of α=0.05isconsidered as significant. All tests are two-sided test, and we use X±S asdescriptive statistics. X2test was used to compare catogerical data.Outcome：1. Baseline observation：There was no significant difference (P>0.05) betweentwo groups in gender, marital status, ethnicity, age, height, weight, NYHAfunctional class, CCS angina class, indicating a relatively sound balance thatthe two groups were comparable.2. Quality of life results：Difference in SAQ scale each dimension was notstatistically significant (P>0.05) between groups at each time point. Patientswith normal lipid PL in first two weeks and the difference between the dimensions,the treatment group than the control group at Week0upturn, TS dimension4weeksscore better than the control group, the experimental group, patients withdyslipidemia PL dimensions better than the control group test group; treatmentgroup PL dimension, AF dimension scores better in patients with angina gradeⅠ ⅱ level in patients with angina score difference was statisticallysignificant (P≤0.05).3Syndromes results:Syndromes Scoring Table1compares the dimensions and totalscore were not significantly different (P>0.05) between groups at each timepoint. Syndrome in patients with angina grade Ⅰ dimensions experimental groupthan the control group improved test scores improved group than the control group,the difference was statistically significant (P≤0.05). Dimensions of the testgroup of diseases, syndrome dimension scores at each time point, angina pectorisbetter than patients with grade Ⅰ Ⅱ level in patients, the difference wasstatistically significant (P≤0.05). 4. Physical examination results: Lipids: triglycerides treatment group washigher compared with the control group, and the difference was statisticallysignificant (P≤0.05).5.Safety evaluation: Some cases of abnormal laboratory parameters normal occuredbut recovered to normal after the review, and they kept on treating. Side effectshappened in ne patient of Test group1, but no adverse reactions; control grouphad no adverse events and adverse reactions. Two adverse events and adversereactions was not significant difference between the two groups (P>0.05).6.Compliance assessment: the treatment group and the control group compliancewere all over95%, indicating good compliance, and compliance between groupsshowed no significant difference (P>0.05).Conclusion:1.Lou Xiang Dan heart particles treating coronary heart disease in patients withstable angina pectoris phlegm and blood stasis showed valid license,safety.Those who with normal lipids recovered from somatic limited. In patientwith mild diseases, the therapy led to a significantly improved adjustment aswell as the ability to adjust the physical phenomena2.To patients with different subpopulations of coronary heart disease and atdifferent points in time, the focus on the quality of life and improved syndromesshould be different.