复律宁颗粒治疗气阴两虚型或心血亏虚型心悸(室性早搏)的临床研究

Clinical research of Fulvning Granules on palpitation(premature ventricular beats) of qi-yin deficiency or deficiency of heart blood

目的:评价复律宁颗粒治疗气阴两虚型或心血亏虚型心悸(室性早搏)的疗效与安全性。方法:选取90例气阴两虚型或心血亏虚型心悸患者,根据1∶1比例随机进入治疗组与对照组。治疗组给予复律宁颗粒,每次10g,每日2次;对照组给予心律平,每次3片,每日3次。两组观察周期均为4周。观察两组治疗前后的常规12导联心电图、24h动态心电图、相关中医症状积分及安全性指标等。结果:治疗后,两组24h动态心电图室性早搏疗效和心率变异性指标对比均无统计学差异;两组中医症候表现程度比较有统计学差异,且治疗组改善明显优于对照组(P<0.05)。试验过程中未出现不良反应。结论:复律宁颗粒对于气阴两虚型或心血亏虚型心悸患者的室性早搏疗效与心律平相当,并能有效改善中医临床症候。

Objective: To observe the clinical efficacy and safety of Fulvning Granules on palpitation(premature ventricular beats) of qi-yin deficiency or deficiency of heart blood.Methods: Ninety patients with palpitation of qi-yin deficiency type or deficiency of heart blood type were randomly divided into treatment group and control group according to the ratio of 1 to 1.The treatment group was given Fulvning Granules,10 g each time,twice a day,and the control group was given Propafenone,3 pills each time,three times a day.Observation period was last for 4 weeks.The routine 12 lead electrocardiogram,24 h dynamic electrocardiogram,related TCM symptom score and safety index were observed before and after treatment in the two groups.Results: After treatment,there was no statistically significant difference between the two groups in 24 h dynamic electrocardiogram room premature beat efficacy and heart rate variability indicators.TCM symptoms in two groups showed statistically significant differences.The treatment group was significantly better than the control group(P<0.05).Safety evaluation showed no adverse reactions during the experiment.Conclusion: Fulvning Granules have equivalent curative effect in ventricular premature patients of qi-yin deficiency and deficiency of heart blood to that of propafenone.Meanwhile,it could effectively improve the clinical symptoms of traditional Chinese medicine.