加味温胆汤对糖尿病患者自主神经功能紊乱的疗效及心率变异性的影响

Effect of Modified Wendan Decoction on Autonomic Nervous Dysfunction in Diabetes and Its Influence on Heart Rate Variability

目的:探讨加味温胆汤对糖尿病患者自主神经功能紊乱的疗效及心率变异性(HRV)的影响。方法:采用随机、单盲、对照临床试验设计,选取2020年1月-2021年8月在中山市中医院接受治疗的84例糖尿病自主神经功能紊乱患者进行研究,将其应用随机数字表法分为对照组和治疗组,各42例,所有患者均依据《中国2型糖尿病防治指南(2017年版)》给予规范化的西药治疗,治疗组在此基础上联合应用加味温胆汤进行治疗。比较两组治疗前后自主神经功能紊乱症状变化情况,同时检测并比较治疗前后两组HRV主要参数变化情况。结果:治疗组治疗后多汗、体位性低血压、胃肠功能紊乱、睡眠障碍和记忆力减退比例均低于对照组(P<0.05)。治疗后,两组全部窦性心搏间期标准差(SDNN)、每5分钟窦性心搏间期平均值标准差(SDANN)、全程相邻窦性心搏间期差的平方根(rMSSD)、相邻的R-R间期之差大于50 ms的心搏数占总心搏数的百分比(PNN50)较治疗前均升高,且治疗组均高于对照组,差异均有统计学意义(P<0.05)。两组治疗期间均未发生影响治疗的严重不良反应,仅出现胃肠道反应,两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:加味温胆汤能明显缓解患者自主神经症状,改善HRV指标,且无明显不良反应。

Objective:To investigate the effect of modified Wendan Decoction on autonomic nervous dysfunction in diabetes and its influence on heart rate variability(HRV).Method:A randomized,single blind,controlled clinical trial design was used,84 patients with autonomic nervous dysfunction in diabetes who treated in Zhongshan Hospital of Traditional Chinese Medicine from January 2020 to August 2021 were selected for the study.They were divided into the control group and the treatment group by random number table,with 42 cases in each group.All patients were given standardized Western medicine treatment guided by the Guideline for Prevention and Treatment of Type 2 Diabetes in China(2017 Edition),the treatment group was treated with modified Wendan Decoction on this basis.The changes of symptoms of autonomic nerve dysfunction before and after treatment were compared between two groups,and the changes of main parameters of HRV were detected and compared before and after treatment.Result:The proportions of hyperhidrosis,postural hypotension,gastrointestinal dysfunction,sleep disorder and memory loss in the treatment group were less than those in the control group(P<0.05).After treatment,the SDNN,SDANN,rMSSD and PNN50 in two groups were higher than those before treatment,and those in the treatment group were higher than those in the control group,the differences were statistically significant(P<0.05).There were no serious adverse reactions affecting the treatment in two groups during treatment,only gastrointestinal reactions,there was no significant difference in the incidence of adverse reactions between two groups(P>0.05).Conclusion:Modified Wendan Decoction can significantly alleviate patients’autonomic nerve symptoms,improve HRV indexes,and there is no obvious adverse reaction.