| Background:The bradycardiac arrhythmia is a clinically common disease and the incidence is higher among the middle-aged and aged people in China.Modern medical research has made slow progress in drug research on bradycardiac arrhythmia.Drugs commonly used in clinical practice include atropine,salbutamol sulfate tablets,aminophylline or isoproterenol,etc.However,the efficacy of such western medicine in the treatment of the disease is limited,and the duration of the drug effect is relatively short,thereby easily resulting in some adverse reactions.Moreover,the long-term administration can be harmful to the body,sometimes even cause new arrhythmias,For patients who meet the indications of pacemaker,the placement of cardiac pacemakers is still the basic method for the treatment of the disease.It can significantly improve the quality of life of patients.However,its invasive procedures and high costs also make it difficult for many patients to accept.For the patients with sinus bradycardia who have some symptoms of insufficient cerebral blood supply and do not need pacing therapy for the time being,it has always been a concern of cardiologists to look for drugs that have positive and curative effect,high safety,and are suitable for long-term use.Compared with the western medicine,the traditional Chinese medicine is more efficient and has fewer toxic and side effects in the treatment of bradycardiac arrhythmia Moreover,it is noninvasive with a lower risk and the treatment cost is easy to be accepted by most people as compared with implantation of cardiac pacemaker.Besides,the recurrence rate is low and the development prospect is pretty supportable.Shenxian Shengmai Oral Liquid is the first proprietary Chinese patent medicine in China,which is used to treat the bradycardiac arrhythmia.And it plays a role of warming heart and nourishing kidney,activating blood circulation and removing blood stasis,which is used to treat yang-deficiency pulse delay syndrome.A number of clinical studies have shown that Shenxian Shengmai Oral Liquid is effective in the treatment of sinus bradycardia,atrioventricular block and sick sinus syndrome resulted from various causes.Further validation is required for the safety and effectiveness of Shenxian Shengmai Oral Liquid in the treatment of bradycardiac arrhythmiaObjective:This is a pilot study,preliminary analysis of the safety and efficacy of Shenxian Shengmai Oral Liquid in the treatment of bradyarrhythmia,observing the characteristics and population of the drug,laying the foundation for further clinical research.Method:This study was designed as a randomized,double-blind,placebo-controlled,parallel,two-center clinical trial.A total of 60 patient(sample size)were included in the trial,40 cases(n=40)in the treatment group and 20 cases(n=20)in the placebo group based at a ratio of 2:1.The patients in the treatment group were treated with Shenxian Shengmai Oral Liquid.While the patients in the placebo group received the mimetic agent of Shenxian Shengmai Oral Liquid.Subjects take orally,20ml each time,2 times a day.The visit cycle consisted of 12 weeks,with a total of five visits:The screening period was from 7 days prior to the trial to the day 0.Informed consent form was signed.The laboratory tests included blood routine,liver and kidney function,urine routine,electrocardiogram,24-hour dynamic electrocardiogram,and urine pregnancy tests for pregnant-age women.The TCM syndrome scores and demographic information collection were also collected.Visit 1 was on the first day of visit.After all the examinations and tests were completed,the subjects who met the inclusion criteria were assigned with random numbers for dispensing.Visit 2 was on the 28±3 days.Subjects were required to perform 24-hour ECG,TCM syndrome scoring,recovery of remaining drugs,and delivery of new drugs.Visit 3 was on the 56±3 days.Subjects were required to perform 24-hour ECG,TCM syndrome scoring,recovery of remaining drugs,and delivery of new drugs.Visit 4 was on the 86±3 days.The subjects were examined for discharge from the group,including blood routine,liver and kidney function,urine routine,electrocardiogram,24-hour dynamic electrocardiogram,and recovery of all the remaining drugs.The study centers involved in the experiment include;Guang' anmen Hospital of China Academy of Chinese Medical Sciences and Baokang Hospital Affiliated to Tianjin University of Traditional Chinese MedicineResults:The demographic data of the baseline period of the trial,gender,age,height,weight,body temperature,respiration,heart rate,blood pressure,etc.,were not statistically significant(P>0.05).The comparisons were carried out between the treatment group and the control group.At Visit 3 that is 8 weeks after taking the medicine,the difference in distribution of TCM syndrome score sub-syndromes of dizziness was statistically significant(P=0.032).The difference in distribution of TCM syndrome score fatigue was statistically significant(P=0.015).While the difference in 24-hour ECG,TCM syndrome scores and laboratory tests was not statistically significant in other visit phases between the two groups(P>0.05).Intra-group comparisons were carried out among the patients of treatment group according to sex,age and diseases.In the holther group comparison,For the comparisons among the subjects' diseases,three kinds of diseases including simple sinus bradycardia,sick sinus syndrome and various blocks were compared.It was found that the average heart rate and the total number of heart beats had a first-order and a second-order rising trend at four time points.The difference in the minimum value of average heart rate was statistically significant among those diseases(P=0.015).It was also found that the heart rate increased significantly in patients with sick sinus syndrome,and there was no interaction between time and disease.It was found that there was a first-order or second-order downward trend at all four time points among three scoring indexes between the male and female groups in the comparison of TCM syndrome scores.There is a difference in gender between the main symptoms(P=0.012),There is a difference in gender between the Evaluation of TCM symptoms(P=0.018).The male scores decreased more significantly in all three scores.During the trial,30 adverse events occurred and no serious adverse event.There was not statistically significant in safety analysis.Conclusion:1.The primary outcome index:There was no significant difference in the improvement of heart rate between the treatment group and the control group.The heart rate in patients with sick sinus syndrome increased more significantly than that of other diseases when comparing diseases.2.The secondary outcome indices include:It was found that the difference in distribution of TCM syndrome score sub-syndromes of dizziness and fatigue was statistically significant at Visit 3 that was 8 weeks after taking the medicine.It was found that the scores of TCM syndromes decreased more significantly in men with bradycardiac arrhythmia than in women after 12 weeks of treatment as compared by sex.3.The safety indices include;No SAEs were occurred during the test,30 adverse events occurred,and the difference was not statistically significant in safety analysis.4.The results of the study also require a large number of clinical trials to verify. |
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