目的 評價(jià)益心復(fù)脈顆粒治療氣陰兩虛兼血瘀型緩慢性心律失常的臨床療效及安全性。方法 將2018年10月-2020年4月就診于遼寧中醫(yī)藥大學(xué)附屬醫(yī)院確診為氣陰兩虛兼血瘀型緩慢性心律失常的300例患者，隨機(jī)分為觀察組（200例）及對照組（100例），對照組予常規(guī)化學(xué)藥治療，觀察組在化學(xué)藥基礎(chǔ)治療上，加服益心復(fù)脈顆粒15 g/次、3次/d，均服用4周。比較治療前后兩組患者中醫(yī)證候積分、24 h動態(tài)心電圖平均心率、最慢心率、心搏總數(shù)、早搏次數(shù)等療效性指標(biāo)，以及血常規(guī)、尿常規(guī)、心電圖、肝腎功能等安全性指標(biāo)，評價(jià)其療效及安全性。結(jié)果 與治療前比較，兩組患者治療后中醫(yī)證候積分降低、心率提升、心律失常改善明顯提高（P<0.05），且觀察組療效優(yōu)于對照組（P<0.05）。試驗(yàn)中共發(fā)現(xiàn)5例不良事件，觀察組3例（1.56%），對照組2例（2.08%），兩組不良事件發(fā)生率比較，差異無統(tǒng)計(jì)學(xué)意義。結(jié)論 益心復(fù)脈顆粒治療氣陰兩虛兼血瘀型緩慢性心律失常效果明顯，可明顯提升患者平均心率、最慢心率、心搏總數(shù)，改善心律失常，緩解臨床癥狀，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.

R285.6;R972