A Randomized, Double-blind, Multicenter Clinical Study Of Xinsuning Capsule In The Treatment Of Ventricular Premature Beats

Purpose:1.To comment the efficacy of Xinsuning Capsules over premature ventricular contractions by monitoring the 24-hour Holter monitor and main improvement of symptoms before and after the treatment of Xinsuning Capsules.2.To make further comments on the safety of Xinsuning Capsules by observing changes of the blood routine,urine routine and stool routine and whether adverse events occur before and after treatment.Methods:Stratified block randomized,double-blind,multi-center clinical trial designs are applied in this study.In this clinical study,64 patients of premature ventricular contractions are randomly divided into two groups,i.e.the experimental group of 32 patients and the control group of 32 patients.The experimental group patients are treated with peroral treatment of Xinsuning Capsules+Mexiletine Hydrochloride Mimetic Agents,while the control group patients are treated with peroral treatment of Mexiletine Hydrochloride+Xinsuning Capsule Mimetic Agents.The course of treatment lasts for four weeks.After four weeks of treatment,observe the disease control of those patients of premature ventricular contractions;during the second and fourth week of the treatment,make corresponding statistics and comparative analysis of the heart palpitation rates,chest tightness rates of patients to analyze the improvement of their clinical symptoms;and then after the four-week treatment,check the changes of laboratory parameters and the occurrence of adverse events to make further comments on the safety of Xinsuning Capsules.Results:This study was conducted on a total of 64 patients,among which 29 patients of the experimental group of 32 patients were surveyed with 3 patients in loss,while 31 patients of the control group of 32 patients were surveyed with 1 patients in loss.Since clinical materials including the survey completion,age,sex,height,weight,heart rate and main symptoms of premature ventricular contractions between the two groups have no significant difference,these two groups are comparable.After four weeks of treatment,it found that both the patients of premature ventricular contractions in the experimental group and the control group saw apparent reduce in the number of occurrences of premature ventricular contractions,and no obvious difference exited between the two groups in terms of the symptom improvement;the effective rate of the experimental group and the control group was specifically 86%and 80%with no obvious statistical difference.It also found that symptoms of heart palpitations in patients of the two groups were both significantly improved during the first two weeks and the four weeks with no obviously statistical difference.For the experimental group patients,symptoms of chest tightness were not improved after two-week treatment,which saw great improvement in the fourth week of treatment.Comparatively,symptoms of chest tightness in the control group patients were significantly improved both in the two weeks’ treatment and the four weeks’ treatment.Moreover,no obviously statistical difference were seen in terms of the chest tightness symptom improvement after four weeks’ treatment both in the experimental group and the control group.Conclusion:Xinsuning Capsules can significantly reduce the number of occurrence of premature ventricular contractions in patients with arrhythmia,and bring significant symptom improvement in heart palpitations,chest tightness and the of patients with premature ventricular contractions.