| Purpose：To evaluate the safety and efficacy of Ginkgo ketonic ester droppingin treating coronary heart disease and angina pectoris (CUD-AP) with heart bloodstagnation syndrome and discuss its mechanisms. This study is the clinical trialof Ginkgo ketonic ester dropping and will provide theoretical foundation forits clinical practice and promotion.Material and methods：1. Clinical data:240cases were selected to observe. These cases which werediagnosed with TCM syndrome of blood stagnation were divided into two groupsdouble blindly and randomly:60cases are in the Treatment Group and180casesbelong to the Control Group. According to statistic analysis, the laboratorytests, general data and TCM symptoms of the two groups were comparable.2. Observing Indicators：examinations of CBC，URT，fecal analysis，four indexesof coagulation test, liver function, kidney function, ECG, exerciseECG(several special cases choose this), etc were given to all patients beforeand after the experiment. Angina and related symptoms and signs were recordedbefore and after the treatment.3. Drug Administration：Both groups receive28days of treatment.8pills ofGinkgo ketonic ester dropping were given to Treatment Group each time, threetimes each day (25mr per pill). The Control Group was given same amount ofthe simulate agent of Ginkgo ketonic ester dropping. During the study period,medicines for the treatment of coronary heart disease except nitroglycerinwere forbidden.4Statistic Analysis：Fisher exact test and Correction chi-square methods wereapplied to count data. Rank sum test, Matched rank sum test, t-test，matchedt-test were used for measurement data. Results：1. Curative effect of electrocardiogram: the effect rate of treatment group ofelectrocardiogram is16.0%and total progress rate is36.1%; the effectiverate of control group is32.0%and total progress rate is68.2%. The treatmentgroup can improve electrocardiogram, reduce the normal electrocardiogramleads and the effect of reducing ST segments is good.2. Curative effect of angina: the effect rate of treatment group of angina is16.8%and the total progress rate is43.2%; the effective rate of control groupis29.4%and the total progress rate is79.4%. The treatment group can reducethe times of angina attacks and the integral of angina.3. Curative effect of SDSVD: the effect rate of treatment group of SDSVD is20.0%and total progress rate is46.2%; the effective rate of control group is40.0%and the total progress rate is85.4%. The treatment group can improve SDSVDand the effect of reducing the total integral of SDSVD is good.4. Analysis of security: there is no adverse reaction found in the control andtreatment groups and nor is the obvious abnormality of laboratory safety index.Conclusion：Ginkgo ketonic ester dropping is safe and effective for clinicaluse in treating coronary heart disease and angina pectoris (CUD-AP) with heartblood stagnation syndrome，without obvious side effects. No obviousabnormalities were found in the laboratory safety index and no statisticaldifference was found in the main therapeutic indexes compared with the controlgroup. |
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