| Objectives:To evaluate the effectiveness and safety of Compound Hongcao Freeze-dried Powder Injection on CHD angina pectoris (AP) with blood stagnation syndrome, and explore the mechanisms for further widespread clinical application.Methods:1. Methods of randomization, double-blindness, clinical noninferior trial were applied to the eligible 96 patients who were divided to Trial Group (n=72, given 300mg Compound Hongcao) and Control Group (n=24, given 20ml Compound Dansheng Injection). The 2 groups were comparable due to the insignificant differences on gender, age, course and underlying diseases (P>0.05), and received 2 weeks clinical observation simultaneously.2. Symptoms, signs, total improvement rate and obvious effective rate before and after treatment were observed and analyzed statistically for comparison for the therapeutic effects.3. Determination of poisonous or side effects of Compound Hongcao was conducted by observing indexes of routine examinations of blood, urine, stool, and the liver and kidney function as a measurement for safety.4. Changes of ECG, blood lipid, whole blood viscosity, blood plasma viscosity, erythrocyte aggregation index were observed before and after treatment.Results:1. For patients in both groups, apparent lower total scores for TCM syndrome and angina pectoris symptoms (See table 5) were observed after treatment than that before treatment, with statistically significance (P<0.05). And, no significance were seen in comparisons between the 2 groups before and after treatment on the same indexes (P>0.05).2. Comparisons on therapeutic effects of TCM syndrome and angina pectoris symptoms (See table 6, 7): a 93.0% total improvement rate was observed in Trial Group on efficacy on TCM syndrome, as well as a 76.4% on angina pectoris symptoms. In Control Group, they were respectively 83.3% and 66.7%, with no significant difference discovered (P>0.05).3. On ECG (See table 8): an obvious effective rate of 19.4% and total improvement rate of 51.4% were observed in Trial Group, as well as respectively 12.5% and 37.5% in that of Control Group. No statistical difference was discovered in comparison between the 2 groups (P>0.05).4. Comparison on blood lipids before and after treatment (See table 9): after administration of medicines, the Trial Group demonstrated obvious decreases in TC and TG, with statistically significance as compared with that of before treatment (P<0.05) and that of Control Group after treatment (P<0.05). In observing Control Group, it showed no significant difference before and after treatment (P>0.05).5. On hemorheology indexes (See table 10): the whole blood viscosity, blood plasma viscosity, erythrocyte aggregation index of Trial Group were obviously improved after treatment (P<0.05), whereas only one same result was seen on whole blood viscosity in Control (P<0.05). And significantly improvement was observed in Trial Group when compared with that of Control Group (both P<0.05).6. Both groups of sufferer use a medicine after of blood, urine, move bowels normal regulations, liver kidney function check all just like often, hint should medicine have no obvious poison side effect and bad reaction.Conclusions:Compound Hongcao Freeze-dried Powder Injection has proved safe and efficient in treating CHD angina pectoris with blood stagnation syndrome by an obvious improvement in patient's symptoms and signs. It is worth promoting clinical application. Improving blood viscosity and lowering blood lipids may be correlated to the mechanisms. |
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