通脉养心丸治疗缓慢性心律失常（气阴两虚证）的随机对照研究

A randomized controlled study on Tongmai Yangxin Pill in the treatment of bradyarrhythmia (qi-yin deficiency syndrome)

关键词:  通脉养心丸|缓慢性心律失常|气阴两虚证|临床观察

Key words:  Tongmai Yangxin Pill|bradyarrhythmia|qi-yin deficiency syndrome|clinical observation

摘要:

[目的] 观察通脉养心丸治疗缓慢性心律失常（气阴两虚证）的临床效果。[方法] 纳入72例缓慢性心律失常受试者，随机分成通脉养心丸试验组和安慰剂对照组，试验组服用通脉养心丸，对照组服用安慰剂，治疗8周，观察两组动态心电图总疗效、动态心电图心率指标、中医证候总疗效及中医单项症状疗效的差异。[结果] 通脉养心丸对缓慢性心律失常心率有良好的治疗作用，试验组平均心率、总心搏数、最慢心率和最快心率均较治疗前有提升，与治疗前比较差异有统计学意义（P<0.05）。动态心电图总有效率，试验组为83.9%，对照组为43.3%，试验组显著高于对照组，差异有统计学意义（P<0.05）。中医证候方面，试验组总有效率90.3%，显著高于对照组43.3%，差异有统计学意义（P<0.05）；单项症状疗效，试验组在改善心悸、气短懒言、疲倦乏力、多汗、五心烦热、口干、头晕等症状方面疗效较好，优于对照组，差异有统计学意义（P<0.05），在治疗失眠多梦症状方面，两组均有较好的改善作用，差异无统计学意义（P>0.05）。[结论] 通脉养心丸治疗缓慢性心律失常（气阴两虚证）疗效显著，能有效提升心率，改善临床症状。

Abstract:

[Objective] To observe the clinical effect of Tongmai Yangxin Pills on bradyarrhythmia(qi-yin deficiency syndrome).[Methods] The 72 subjects with bradyarrhythmia were included and divided into experimental group and control group randomly. The experimental group was treated with Tongmai Yangxin Pills,while the control group was treated with placebo for 8 weeks. The differences of total curative effect,heart rate index,total curative effect of traditional Chinese medicine(TCM) syndrome and single symptom of TCM between the two groups were observed.[Results] Tongmai Yangxin Pills has a good therapeutic effect on the heart rate of slow arrhythmia. The average heart rate,total heart rate,slowest heart rate and fastest heart rate of experimental group were increased compared with before treatment (P<0.05). The total effective rate of dynamic electrocardiogram was 83.9% in experimental group and 43.3% in control group,the experimental group was higher than the control group (P<0.05). In TCM syndrome,the total effective rate of experimental group was 90.3%,it was significantly higher than the control group with 43.3%(P<0.05);The efficacy of single symptom in the experimental group was better than that in the control group in improving symptoms such as palpitation,shortness of breath and lazy speech,fatigue and fatigue,hyper sweating,five irritability fever,dry mouth and dizziness(P<0.05),both groups had good efficacy in improving the symptoms of insomnia and multiple dreams,with no statistical significance(P>0.05).[Conclusion] Tongmai Yangxin Pills has a significant effect in the treatment of patients with bradyarrhythmia (qi-yin deficiency syndrome),which can effectively increase heart rate and improve clinical symptoms.