Objective:To evaluate the effect of Jianxin-Pinglyu Pills combined with routine western medicine therapy on the patients with diabetes mellitus and ventricular arrhythmia (VA). Methods:A total of 92 patients with type 2 diabetes mellitus (T2DM) and VA who met inclusion criteria and treated in the hospital were enrolled between June 2019 and December 2020. According to random number table method, they were divided into observation group ( Jianxin-Pinglyu Pills on basis of control group) and control group (routine treatment), 46 cases in each group. Both groups were continuously treated for 2 months. Before and after treatment, TCM symptoms (chest pain and palpitation, chest distress and shortness of breath, dry mouth and thirst, fatigue) were scored. The fingertip blood was collected to detect levels of fasting blood glucose and 2 hPG. The 24 h dynamic electrocardiogram examination was conducted by electrocardiograph. The standard deviation of NN intervals (SDNN), standard deviation average of NN intervals (SDANN), the root mean square of successive R-R interval (RMSSD) and the percentage of adjacent NN intervals over 50 ms (PNN50) were statistically analyzed. The creatine kinase (CK) and creatine kinase isoenzymes (CK-MB) were detected by biochemical analyzer. The plasma brain natriuretic peptide (BNP) were detected by chemiluminescence immunoassay. The adverse reactions were recorded, and clinical curative effect was evaluated. Results:The differences in total response rate between observation group and control group were statistically significant [93.5% (43/46) vs. 78.3% (36/46); χ2=4.390, P=0.036]. After treatment, TCM symptoms (chest pain and palpitation, chest distress and shortness of breath, dry mouth and thirst, fatigue) in observation group were significantly lower than those in control group ( t=4.319, 2.714, 3.196, 4.667, P<0.01 or P<0.05), levels of fasting blood glucose and 2 hPG were significantly lower than those in control group ( t=2.025, 6.462, P<0.05 or P<0.01). After treatment, SDNN [(119.72 ± 5.86) ms vs. (115.27 ± 6.10) ms, t=3.568], SDANN [(112.80 ± 13.36) ms vs. (98.62 ± 14.51) ms, t=4.876], RMSSD [(46.87 ± 5.44) ms vs. (42.58 ± 5.73) ms, t=3.683] and PNN50 [(6.84 ± 0.66)% vs. (6.21 ± 0.64)%, t=4.648] in observation group were significantly higher than those in control group ( P<0.01), while the levels of CK [(263.82 ± 52.18) U/L vs. (306.59 ± 48.45) U/L, t=4.074] and CK-MB [(2.02 ± 0.62) g/L vs. (3.25 ± 0.49) g/L, t=10.556] were significantly lower than those in control group ( P<0.01), and level of plasma BNP [(126.99 ± 49.02) ng/L vs. (188.26 ± 54.30) ng/L, t=5.681] was significantly lower than that of control group ( P<0.01). During treatment, difference in incidence of adverse reactions between observation group and control group was not statistically significant [10.9% (5/46) vs. 4.3% (2/46); χ2 =0.619, P=0.432) ]. Conclusion:Jianxin-Pinglyu Pills combined with routine western medicine can effectively relieve clinical symptoms in patients with T2DM and VA, control hyperglycemia, improve heart rate variability, control levels of myocardial enzymes and plasma BNP, and safety.