| Objective:Study the clinical efficacy and safety of Tongyang Fulv decoction on treatment of bradyarrhythmia(xinyang depression,phlegm and blood stasis syndrome).Methods:1.Pick up 64 outpatients and inpatients with bradyarrhythmia(xinyang depression,phlegm and blood stasis syndrome)in Guang’anmen hospital of Traditional Chinese Medicine Academy of Science from March 2017 to March 2019.Patients were divided into two groups according to the principle of randomized control,32 cases in the treatment group with no shedding and 32 cases in control group with 2 cases in shedding.2.The treatment group was given tongyang fulv decoction and the control group was treated with Xinbao Pills for 8 weeks.3.Evaluated the efficacy of TCM syndromes and the effect of 24-hour Holter arrhythmia in the two groups before and after treatment.Compared the efficacy indicators of TCM integral syndrome scores,TCM single symptom scores,total heart rates,the slowest heart rates,average heart rates,the longest RR intervals and heart rate variability including SDNN,SDANN,PNN50 and RMSSD of 24-hour Holter.Safety indicators included blood,urine and stool routine examinations,liver and kidney functions and adverse reactions.4.Using the intentional analysis method,and the collected data was statistically analyzed with SPSS22.0 software.Results:1.Comparison of the effective rate of TCM syndromes:The total effective rate of TCM syndromes in the treatment group was 90.6%,while 62.5%in the control group.The treatment group was superior to the control group,and the difference was statistically significant(P<0.05).2.Comparison of TCM syndrome scores:after treatment of 4 and 8 weeks,the TCM integral syndrome scores of the two groups were significantly reduced,and the treatment group was superior to the control group(P<0.05).After treatment,the single symptom scores of TCM in both groups decreased.At 4 weeks of treatment.palpitation,chest tightness,shortness of breath,dizziness,fatigue and chills were significantly improved in both groups.After 8 weeks of treatment,palpitation,chest tightness,chest pain,shortness of breath,dizziness,fatigue,chills and pulse were significantly improved in both groups.At 4 and 8 weeks of treatment,the treatment group was superior to the control group specially in improving the symptoms of palpitation and chest tightness(P<0.05)3.Comparison of 24-hour Holter arrhythmia efficacy:the total effective rate of arrhythmia in the treatment group was 87.5%,and 65.6%in the control group.The treatment group was superior to the control,the difference was statistically significant(P<0.05)4.Comparison of 24-hour Holter indicators:after treatment,the total heart rates and slowest heart rates in both groups were significantly increased,and the longest RR intervals were significantly shortened in both groups and the treatment group was superior to the control group(P<0.05).The average heart rates in both groups were significantly increased,but no significant difference between the two groups(P>0.05).5.Comparison of 24-hour Holter heart rate variability:after treatment,SDNN,RMSSD,PNN50 in the treatment group were significantly decreased(P<0.01),while SDANN was not significantly changed(P>0.05).In the control group.SDNN and RMSSD were decreased(P<0.01),while PNN50 and SDANN were not significantly changed(P>0.05).The reduction of RMSSD and PNN50 in the treatment group was better than that in the control group(P<0.05).6.Comparison of safety indicators:before and after treatment,there were no significant abnormalities in blood routine,urine routine,stool routine examinations and liver and kidney functions of the two groups(P>0.05).During the medication,1 patient(3.12%)occurred gastric discomfort in treatment group.In the control group,1 patient(3.12%)experienced aggravation of palpitation and 2 patients(6.25%)occurred gastric discomfort.There was no severe adverse reaction in both groups.Treatment group had better safety.Conclusion:Tongyang Fulv decoction is effective in bradyarrhythmia of treating xinyang depression,phlegm and blood stasis syndrome.It can obviously improve the symptoms of palpitation and chest tightness,significantly increase the 24-hour Holter total heart rates,improve the slowest and average heart rates,and shorten the longest RR intervals.It can also decrease the indexes of heart rate variability SDNN,PNN50,RMSSD,inhibit vagal nerve activity,and balance the autonomic nervous system function.It is effective and safe on the treatment of bradyarrthymia,and better than Xinbao Pills. |