| Objective:(1)Draw up preliminarily the clinical application specification and effect evaluation specification of traditional Chinese medicine paste for treating cardiovascular disease.(2) Through the observation of the symptoms, signs, laboratory examination and the quality of life change of patients of thoracic obstruction No. 1, palpitations No. 1, and Asthma No. 1 in the treatment of qi and blood stagnation type of chest obstruction, qi deficiency and timid heart type of palpitations and qi deficiency and blood stasis type of asthma patients, analyse the theory and clinical basis of traditional Chinese medicine paste treating cardiovascular disease, to evaluate the clinical effect, furtherly verify the practicability of clinical application specification and effect evaluation specification.Methods: Firstly, draw up the clinical application specification and effect evaluation specification of traditional Chinese medicine paste for treating cardiovascular disease. The clinical common types which are chest obstruction of qi and blood stagnation type, palpitations of qi deficiency and timid heart type and asthma of qi deficiency and blood stasis type were selected 133 cases, and divided into the chest obstruction group, palpitations group and asthma group, chest obstruction group has 20 cases, palpitations group has 58 cases, asthma group has 55 cases. Each group is divided into control group, decoction group and paste group. The control group is given conventional western medicine treatment, decoction group is given the conventional western medicine treatment plus traditional Chinese medicine decoction, paste group is given conventional western medicine plus traditional Chinese medicine paste. Evaluate the TCM single syndrome, total effect of clinical syndrome, quality of life, the particulars of hospitalization, cost of treatment and adverse reaction of the control group, decoction group and paste group,and statistic and analyse, and verify the effectiveness and advantages of the paste group with the method of EBM applications, furtherly verify the the clinical application specification and the effect evaluation specification.Results: the total effect of clinical symptoms of chest obstruction group: the total efficiency of the paste group is 83.33%, decoction group is 83.33% and control group is 62.50%, there had difference between them(P<0.05), so paste group and decoction group were better than the control group in improving symptoms efficiency. In compare of The score of trsditional Chinese medicine symptom the paste group and decoction group had significant difference(P<0.01) and the control group had difference(P<0.05). The score reduced more than the control group. The paste group and decoction group improved more significantly than the control group in symptoms of angina pectoris(P<0.05). In compare of the total medical costs during the study period the paste group and decoction group were less than the control group, there had difference between them(P<0.05). In compare of the total times of hospitalization and the average hospitalization time the paste group and decoction group were less than the control group, there had difference between them(P<0.05).the total effect of clinical symptoms of palpitations group: the total efficiency of the paste group is 100.00%, decoction group is 94.44% and control group is 85.00%, there had difference between them(P<0.05), so paste group and decoction group were better than the control group in improving symptoms efficiency. In compare of The score of trsditional Chinese medicine symptom the paste group and decoction group had significant difference(P<0.01) and the control group had difference(P<0.05). The score reduced more than the control group. In compare of the premature ventricular contraction times of 24 h the paste group and decoction group had significant difference(P<0.01) and the control group had difference(P<0.05). premature ventricular contraction symptoms improved more obviously than the control group. In compare of the total medical costs during the study period the paste group and decoction group were less than the control group, there had difference among them(P<0.05). In compare of the total times of hospitalization and the average hospitalization time the paste group and decoction group were less than the control group, there had difference between them(P<0.05).the total effect of clinical symptoms of asthma group: the total efficiency of the pastegroup is 95.00%, decoction group is91.30% and control group is 58.33%, there had difference between them(P<0.05), so paste group and decoction group were better than the control group in improving symptoms efficiency. In compare of The score of trsditional Chinese medicine symptom the paste group and decoction group had significant difference(P<0.01) and the control group had difference(P<0.05). The score reduced more than the control group. The paste group and decoction group improved more significantly than the control group in heart function grade of NYHA(P<0.05). In 6-minute walk test, the paste group and decoction group had significant difference(P<0.01) and the control group had difference(P<0.05), so they could improve 6-minute walk test. There were significant(P<0.01) difference among the paste group, decoction group and the control group in BNP value, paste group and decoction group could reduce BNP value, but there were no significant difference between them(P>0.05). There were difference among the paste group, decoction group and the control group in LVEF(P<0.05), so paste group and decoction group could improve LVEF. In compare of the total medical costs during the study period the paste group and decoction group were less than the control group, there had difference between them(P<0.05). In compare of the total times of hospitalization and the average hospitalization time the paste group and decoction group were less than the control group, there had difference between them(P<0.05).Conclusion: The clinical application and effect evaluation specification were applied to clinical trials. through the observation of the symptoms and signs, laboratory examination and quality of life change of chest obstruction group, palpitations group and asthma group, and statistical analysis, to verifies the validity and superiority of party group, and further confirmed the clinical application specification and effect evaluation specification of traditional Chinese medicine paste for treating cardiovascular disease. |
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