Compound Orientin Lyophilized Treatment Of Angina Pectoris (blood Stasis Syndrome) Clinical Studies

ObjectivesTo evaluate the effectiveness and safety as well as the mechanisms via clinical trial of Compound Hongcao Freeze-dried Power Injection on CHD angina pectories(AP) with blood-stagnation syndrome, and provide the theory basis for further widespread clinical application.Methods1 Design96 patients of CHD AP with blood-stagnation syndrome were randomized, using double-blinded positive medicine parallel controlled method, into treatment group(n=72, treated with Compound Hongcao Freeze-dried Power Injection) and control group(n=24, treated with Compound Danshen Injection). All the patients involved were accorded with WHO's Standard of Name and Diagnosis on the lschemic Heart Disease, as well as the Principle to Clinical Research of Traditional Chinese Medicine Therapia for Hyperlipemia(2002 Edition).2 Medication and UsageCompound Hongcao Freeze-dried Power Injection was applied to treatment group(n=72) with a dose of 300rag, and the control group(n=24) was treated with Compound Danshen Injection, both intravenously, once a day, 14 days as a course. Other CHD or CHD-related medications other than glonoine were prohibited during the trial.3 Observation Indexes 3.1 Therapeutic Effects(1) Main indexes:①AP score: time of onset; severity; duration; glonoine in-take dose②ECG(2) Subordinate indexes:①TCM symptoms; tongue and pulse conditoin②blood lipids3.2 SafetyLaboratory examinations for routing blood, urine, feces test and liver, kidney function4 Results4.1 Therapeutic Effects(1) Notable-improved rotes of TCM symptoms in treatment group and control group were 45.5% and 40.9%, effective rates were 90.9% and 86.4%, respectively, with no significance(P＞0.05).(2) Comparison of TCM total score after 1 week between the two groups showed significant difference(P＜0.01), as well as a superior effect of treatment group to control group; whereas no significance seen 2 weeks later(P＞0.05).(3) Comparison of time to take effect indicated a significant superior effect of treatment group to control group(P＜0.01).(4) No significant differences were demonstrated after treatment between the two groups in therapeutic effects of ECG(P＞0.05).(5) No significant differences were demonstrated after treatment between the two groups in therapeutic effects of CHD angina pectories(P＞0.05).(6) Significant differences were demonstrated after treatment between the two groups in cholesterol content. (P＜0.05).4.2 Safety evaluationNo untoward reactions and abnormalities were observed both in clinical observations and in laboratory examinations. ConclusionIt was demonstrated in this clinical trial that Compound Hongcao Freeze-driedPower Injection, Similar in efficacy with that of Salvia Miltiorrhiza, was proved efficient and safe in application in CHD AP with blood stagnation syndromes. And the trial has provided theory basis for further widespread clinical application.