| Objective:This research evaluated the clinical efficacy and safety of Zishen-Yangxin Decoction in the treatment of premature ventricular contractions patients with the syndrome of disharmony between heart and kidney by clinical randomized controlled trials,and provided clinical evidence for further promotion and application in the future.Methods:Sixty patients with premature ventricular contractions who met the inclusion and exclusion criteria were randomly divided into the control group(n=30)and the experimental group(n=30)in a 1:1 ratio.Patients in the experimental group were treated with Zishen-Yangxin Decoction,while patients in the control group were treated with metoprolol tartrate tablets.Both the experimental group and the control group received clinical treatment for 4 weeks,and the 24-hour dynamic electrocardiogram(DCG)results,TCM clinical symptom score and safety indexes of the two groups before and after treatment were recorded.Results:ln this study,54 cases were finally included,there were 27 cases in the experimental group and 27 cases in the control group,the shedding rate was controlled at 10%.Among them,there were 20 males and 34 females,the ratio of male to female was 0.59:1,and female patients were more than male patients.Ⅰ.The outcome of Western medicine observation indicators:(1)The total clinical effective rate of dynamic electrocardiogram:The total effective rate was calculated according to the number of premature ventricular contractions decreased before and after treatment and the change of Myerburg grading score.The total effective rate in the clinical trial group was 77.78%and that in the control group was 62.96%,the total clinical effective rate of the experimental group was higher than that of the control group.There was no significant difference in the total effective rate between the two groups(P>0.05),therefore,the experimental group and the control group were both effective in the treatment of premature ventricular contractions patients with the syndrome of disharmony between heart and kidney.(2)The number of premature ventricular contractions:The baseline comparison of the number of premature ventricular contractions of 24-hour DCG before treatment between the two groups showed no statistical difference and was comparable,P=0.938>0.05.The number of premature ventricular contractions in the experimental group was significantly reduced after treatment compared with that before treatment,P=0.000*<0.05,with statistical difference.The number of premature ventricular contractions in the control group was also significantly reduced after treatment compared with that before treatment,P=0.000*<0.05,showing a statistical difference.After treatment,the number of ventricular premature contractions between the experimental group and the control group was compared,and there was no statistical difference between the two groups(P>0.05),indicating that both the experimental group and the control group had clinical significance in reducing the number of ventricular premature contractions.(3)Quantitative efficacy evaluation of ventricular premature contractions:The total effective rate was 77.78%in the experimental group and 48.15%in the control group after treatment,and the effective rate in the experimental group was significantly higher than that in the control group.The difference between the two groups was statistically significant(P<0.05),indicating that the experimental group was significantly superior to the control group in reducing the number of premature ventricular contractions.(4)Premature ventricular contractions load:Baseline comparison was made between the two groups on the percentage of premature ventricular contractions in heart rate before treatment,P=0.917>0.05,the difference was not statistically significant and comparable.The percentage of premature ventricular contractions in the heart beat of the experimental group was significantly reduced after treatment compared with that before treatment,P=0.000*<0.05,showing a statistical difference.After treatment,the percentage of premature ventricular contractions in the heart beat of the control group was significantly lower than that before treatment,P=0.001*<0.05,with statistical difference.After treatment,the percentage of premature ventricular contractions in the heart rate of the experimental group and the control group was compared between the two groups,and there was no statistical difference between the two groups(P>0.05),indicating that both the experimental group and the control group had clinical significance in reducing the load of ventricular premature contractions.(5)Evaluation of the effect of Myerburg grading:The total effective rate of Myerburg fractional efficacy in the experimental group was 51.85%,and that in the control group was 44.44%.The clinical effective rate of Myerburg grading in the experimental group was higher than that in the control group.The effective rates of the two groups were compared between the two groups,and the difference was not statistically significant(P>0.05),indicating that both the experimental group and the control group could effectively reduce the Myerburg grading score of the patients.Ⅱ.Observation indexes on the efficacy of Chinese medicine:(1)Total score of TCM symptom scale:The total score of TCM symptom scale before treatment was compared between the two groups at baseline,P=0.938>0.05,with no statistical significance,and it’s comparable.The total score of TCM symptom scale in the experimental group was significantly reduced after treatment compared with that before treatment,P=0.000*<0.05,with statistical difference.The total score of TCM symptom scale in the control group was also significantly reduced after treatment,P=0.000*<0.05,with statistical difference.After treatment,the total scores of TCM symptom scale in the experimental group and the control group were compared between the two groups,P=0.033*<0.05,with statistical difference,the experimental group was significantly better than the control group.(2)Efficacy evaluation of TCM symptom score scale:After treatment,the effective rate of TCM symptom score was 88.89%in the experimental group and 59.3%in the control group.The total effective rate between the two groups was compared,P=0.013<0.05,with statistical significance.The effective rate of the experimental group was higher than that of the control group.(3)The TCM symptom scale single integral:Before treatment,single item scores of TCM symptoms in the two groups were compared between the two groups at baseline,P>0.05,with no statistical significance and it’s comparable.After the treatment,the scores of each single symptom in the experimental group and the control group decreased compared with that before the treatment.Compared with the control group after treatment,there was a significant difference between the two groups in the scores on the four TCM symptoms of palpitation,cold limbs,edema and insomnia(P<0.05).The results showed that the experimental group was significantly better than the control group in improving the symptoms of palpitation,cold limbs,edema and insomnia,which had statistical significance.Conclusion:Zishen-Yangxin Decoction and metoprolol tartrate tablets are effective in the clinical treatment of premature ventricular contractions with the syndrome of disharmony between heart and kidney.Zishen-Yangxin Decoction has a higher clinical effective rate than metoprolol tartrate tablets in the evaluation of the efficacy of dynamic electrocardiogram,reduction of the number of premature ventricular contractions,and reduction of Myerburg grading score.Among them,the experimental group was significantly better than the control group in reducing the effective rate of the number of premature ventricular contractions,with statistical significance.Zishen-Yangxin Decoction is significantly superior to metoprolol tartrate tablets in improving the total score of TCM symptoms and improving the total effective rate of TCM symptom score.Zishen-Yangxin Decoction is significantly superior to metoprolol tartrate tablets in improving palpitations,cold limbs,edema and insomnia in premature ventricular contractions patients with the syndrome of disharmony between heart and kidney,and can significantly improve the life quality of patients.During the treatment,patients in both groups did not report any obvious discomfort symptoms,adverse reactions or serious cardiovascular events.The experimental treatment had no abnormal effect on blood pressure,heart rate,liver and kidney function and other safety indexes.To sum up,Zishen-Yangxin Decoction is safe and effective in the clinical application of treating premature ventricular contractions patients with the syndrome of disharmony between heart and kidney. |
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