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目的:观察依帕司他对糖尿病无症状心肌缺血(SMI)患者心率变异性(HRV)的影响。方法:60例糖尿病SMI患者随机分为对照及观察组各30例,两组均常规予胰岛素和(或)口服降糖药物控制血糖,ARB或ACEI及CCB等降压、他汀类调脂及抗血小板聚集等治疗,不使用β受体阻断药。观察组在此基础上加服依帕司他片50 mg,po,tid,连服4周。观察两组治疗前后空腹血糖(FPG)、餐后2h血糖(2h PG)、糖化血红蛋白(Hb A1c)、收缩压(SBP)、舒张压(DBP)、血清总胆固醇(TC)、三酰甘油(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C),以及24 h平均心率(Mean HR)、总体标准差(SDNN)、均值标准差(SDANN)、标准差均值(SDNNI)、差值的均方根(RMSSD)、差值>5ms的百分比(PNN50)等HRV指标变化情况。观察并记录治疗期间两组药品不良反应发生情况。结果:两组患者治疗后FPG、2h PG、Hb A1c、SBP、DBP、TC、LDL-C等指标均较治疗前明显下降(P<0.05),而两组间主要血糖、血压、血脂等指标比较,间差异均无统计学意义(P>0.05)。观察组治疗后SDNN、SDANN、SDNNI、RMSSD、PNN50及Mean HR有明显改善(P<0.05),且显著优于对照组(P<0.05)。两组不良反应发生率比较差异无统计学意义(P>0.05)。结论:糖尿病SMI患者临床常规治疗的基础上加用依帕司他口服可明显改善HRV相关指标,降低猝死风险,且与其他药物联用未见明显不良反应,临床安全性好。
Objective: To observe the effect of epalrestat on heart rate variability (HRV) in patients with diabetic asymptomatic myocardial ischemia (SMI). Methods: Sixty diabetic patients with diabetes mellitus were randomly divided into control and observation groups of 30 cases. Both groups were given routine insulin and / or oral hypoglycemic agents to control blood sugar, antihypertensive drugs such as ARB or ACEI and CCB, Platelet aggregation and other treatment, do not use β-blockers. On the basis of the observation group, patients in the observation group were given epivalysine tablets 50 mg, po, tid for 4 weeks. The levels of fasting blood glucose (FPG), 2h PG, Hb A1c, SBP, DBP, TC, triglyceride TG, HDL-C, LDL-C, 24 h Mean HR, SDNN, SDANN, Difference Mean (SDNNI), Root Mean Square (RMSSD), Percent Difference> 5ms (PNN50). Observe and record the incidence of adverse drug reactions in two groups during treatment. Results: The indexes of FPG, 2h PG, Hb A1c, SBP, DBP, TC, LDL-C in the two groups after treatment were significantly lower than those before treatment (P <0.05), while the main indicators of blood glucose, blood pressure, There was no significant difference between the two groups (P> 0.05). SDNN, SDANN, SDNNI, RMSSD, PNN50 and Mean HR in observation group were significantly improved (P <0.05), and were significantly better than those in control group (P <0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P> 0.05). Conclusion: Based on the routine clinical treatment of patients with SMI in diabetes mellitus, the addition of epalrestat orally can significantly improve HRV-related indicators, reduce the risk of sudden death, and no obvious adverse reactions combined with other drugs, clinical safety is good.