益心复脉颗粒治疗缓慢性心律失常的疗效研究

Study on therapeutic effect of Yixin Fumai Granule in treating bradyarrhythmia

目的评价益心复脉颗粒治疗气阴两虚兼血瘀型缓慢性心律失常的临床疗效及安全性。方法将2018年10月—2020年4月就诊于辽宁中医药大学附属医院确诊为气阴两虚兼血瘀型缓慢性心律失常的300例患者,随机分为观察组(200例)及对照组(100例),对照组予常规化学药治疗,观察组在化学药基础治疗上,加服益心复脉颗粒15 g/次、3次/d,均服用4周。比较治疗前后两组患者中医证候积分、24 h动态心电图平均心率、最慢心率、心搏总数、早搏次数等疗效性指标,以及血常规、尿常规、心电图、肝肾功能等安全性指标,评价其疗效及安全性。结果与治疗前比较,两组患者治疗后中医证候积分降低、心率提升、心律失常改善明显提高(P<0.05),且观察组疗效优于对照组(P<0.05)。试验中共发现5例不良事件,观察组3例(1.56%),对照组2例(2.08%),两组不良事件发生率比较,差异无统计学意义。结论益心复脉颗粒治疗气阴两虚兼血瘀型缓慢性心律失常效果明显,可明显提升患者平均心率、最慢心率、心搏总数,改善心律失常,缓解临床症状,且安全性良好。

Objective To evaluate the clinical efficacy and safety of Yixin Fumai Granules in the treatment of bradyarrhythmias with deficiency of both qi and yin and blood stasis.Methods From October 2018 to April 2020,288 patients with bradyarrhythmia of Qi and Yin deficiency and blood stasis type were diagnosed at the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine.They were randomly divided into an observation group(n=200)and a control group(n=100).The patients in control group were treated with conventional western medicine,while patients in observation group were treated conventional western medicine plus Yixin Fumai Granules,15 g each time,three times a day for four weeks.Comparison of efficacy indicators such as Traditional Chinese Medicine(TCM)syndrome scores,24-hour Holter ECG average heart rate,slowest heart rhythm,total heart beats,number of premature beats,as well as blood routine,urine routine,and electrocardiogram before and after treatment.Liver and kidney function and other safety indicators to evaluate its efficacy and safety.Results Comparing before treatment,after treatment,the two groups of patients had lower TCM syndrome scores,increased heart rate,improved arrhythmia(P<0.05),and the efficacy of the observation group was better than that of the control group(P<0.05).A total of five cases of adverse events were found in the trial,including three cases(1.56%)in the observation group and two cases(2.08%)in the control group.There was no statistically significant difference in the incidence of adverse events between the two groups.Conclusion Yixin Fumai Granule is effective in treating bradycardia with deficiency of both qi and yin and blood stasis.It can significantly increase the patient’s average heart rate,slowest heart rate,and total number of heartbeats,improve arrhythmia,relieve clinical symptoms,and the safety is good.