| Objective:Drug intervention with Yang Xin Fu Mai Ding Ji Decoction was given to patients with premature ventricular contraction accompanied by insomnia syndrome of Qi and Yin deficiency.Changes in the number of premature ventricular contraction,Pittsburgh Sleep Quality index(PSQI),Hamilton Anxiety Scale(HAMA)score and TCM syndrome score of 24 hours before and after treatment were observed.To analyze the clinical efficacy and safety of Yang Xin Fu Mai Ding Ji Decoction in the treatment of patients with premature ventricular contraction accompanied by insomnia syndrome of Qi and Yin deficiency,and to provide effective clinical basis and scheme for the treatment of patients with premature ventricular contraction accompanied by insomnia with TCM characteristics.Methods:Sixty patients with premature ventricular contraction accompanied by insomnia syndrome of Qi and Yin deficiency were selected from Dongcheng,Tongzhou and International Department of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine from December 2021 to February 2023.According to the principle of randomization,they were divided into experimental group and control group,with 30 cases each.The treatment group was given Yang Xin Fu Mai Ding Ji Decoction,water infusion,1 bag/time bid;The control group was treated with metoprolol tartrate 12.5mg bid for 4 weeks.The changes of ventricular premature beats,PSQI score,HAMA score and TCM syndrome score of 24 hours dynamic electrocardiogram before and after treatment were observed,and the name,time and severity of adverse events were recorded.The collected data were imported into SPSS26.0 statistical software for t test,Chi-square test,non-parametric test and other analysis,so as to evaluate the efficacy of Yang Xin Fu Mai Ding Ji Decoction.Results:There were 30 cases in the experimental group,1 case fell off due to the incomplete 4-week treatment cycle during the test,29 cases remained,30 cases in the control group,and 29 cases were eliminated due to loss to follow-up during the test.A total of 58 patients were included in the statistical analysis.1.24h dynamic electrocardiogram:After treatment,the average heart rate,the number of premature ventricular contraction and the load of premature ventricular contraction in the two groups were decreased compared with that before treatment,among which the number of premature ventricular contraction in the experimental group was decreased(3051 ± 3056.88)and that in the experimental group was decreased(704.45±3677.50).Between the two groups,the number of ventricular premature(P=0.044)and premature beat load(P=0.042)reduced the difference,with P<0.05,the difference was statistically significant.P=0.188(>0.05)was not statistically significant in reducing the mean heart rate.Before and after treatment in the experimental group,all P values were<0.05,with statistical difference.Subgroup analysis showed that when the number of premature beats was 5000-10000,the number of ventricular early beats decreased(P=0.04)and premature beat load(P=0.04)between the two groups,P<0.05,and the difference was statistically significant.2.PSQI:PSQI scores of experimental group and control group decreased significantly after drug intervention,compared between experimental group and control group after intervention,P=0.03(<0.05).In PSQI each individual symptoms,the intervention group after the treatment group(P=0.009)in sleep time,sleep disorder(P=0.000),daytime dysfunction(P=0.001),P<0.01,with difference statistically significant,3.HAM A:Comparison of HAMA scores between the two groups after intervention showed that t=-1.247,P=0.218(>0.05),showing no statistical difference.The difference values before and after HAMA scores of the two groups were compared between the two groups,and it was concluded that t=-7.045,P=0.00(<0.05),the difference was statistically significant.4.TCM syndrome score:After the intervention,the experimental group and the control group compared the efficacy of TCM syndrome,and the total TCM syndrome score decreased in both groups,with the effective rate of 89.7%in the experimental group and 65.5%in the control group.The results showed that P value was<0.05,and the difference was statistically significant.The scores of the two groups in the aspects of each single syndrome of TCM decreased.Compared between groups,palpitation and restlessness(P=0.015),fatigue(P=0.006),five upset fever(P=0.00),night sweats(P=0.008),all P<0.05,were statistically significant.Conclusions:1.Yang Xin Fu Mai Ding Ji Decoction is more effective than metoprool tartrate in reducing the number and load of premature ventricular contraction in patients with insomnia syndrome of Qi and Yin deficiency,and the advantages are more obvious when the number of premature beats is between 5000-10000.2.Yang Xin Fu Mai Ding Ji Decoction has more advantages than metoprool tartrate in solving insomnia and anxiety in patients with premature ventricular contraction accompanied by insomnia syndrome of Qi and Yin deficiency.It can significantly improve patients’ sleep quality,reduce clinical discomfort caused by sleep disorders,and relieve patients’ anxiety and tension.3.Yang Xin Fu Mai Ding Ji Decoction can improve the symptoms of traditional Chinese medicine of patients,significantly reduce the patients’ palpitation and restlessness caused by frequent premature ventricular contraction,and also has a good effect on the clinical symptoms of Qi and Yin deficiency syndrome such as fatigue,five upset heat,night sweat. |
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